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  • How much experience does BioClean have with meeting the needs of various critical environments?
  • At BioClean we have over 50 years of technical experience in cleanrooms and critical operating environments. This wealth of industry experience gives us a unique and priceless knowledge base that we use to help our distributors and their customers find the right products for their needs. If you have any queries then please do not hesitate to contact us.

  • If a faulty product is supplied what will BioClean do about it?
  • At BioClean we take great pride in our customer service and the quality of our products. In the unlikely event that a faulty product is supplied, the lot number and batch number will allow us to quickly trace the fault at its source. We will take back any faulty items that are supplied and immediately provide a replacement. Thereafter we will investigate the fault to provide the customer with a detailed explanation and to ensure that it does not happen again.

  • What kind of companies do BioClean supply?
  • BioClean products are used across the world, we supply many distributors to the life sciences industries (pharmaceutical, biotechnology and medical device manufacturing), semiconductor and microelectronics manufacturing and assembly industry.

  • Why is the expiry date not mentioned on the Certificate of Irradiation?
  • The Certificate of Irradiation cannot state the expiry date of the product. Irradiation is carried out by Sterigamma and they have not been part of the expiry data setting of any products that they process. It is the manufacturers responsibility to do that. The only information that Sterigamma are allowed to put on the Certificate are product identification data and data that they are directly responsible for, e.g. date for sterilisation, max and min dose.

  • I am concerned about the safety of my EtO sterilised goggles, what can you tell me about EtO exposure levels?
  • The permissible levels of EO residuals are specified in ISO 10993 7: 2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals. There are two residual chemicals of concern namely Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH). As part of the sterilisation validation we tested for residuals and found the average levels to be EO = 0.43mg and ECH = 0.06mg per goggle. Approximately 6% of the goggle is in contact with the wearer so the residuals that are transferrable to the wearer are EO = 0.026mg and ECH = 0.004mg. The standard defines three exposure categories for the device then assigns safe exposure limits for each category. The categories are: a) Limited exposure: devices whose single or multiple use or contact is likely to be up to 24 h; b) Prolonged exposure: devices whose single, multiple, or long-term use or contact is likely to exceed 24h but not 30 days; c) Permanent contact: devices whose single, multiple, or long-term use or contact exceeds 30 days. With a product like the goggles the time worn in total is taken into account, not the time that each goggle is worn. Given the definitions above, a typical worker is going to exceed 30 days so we need to treat the exposure as permanent contact. The following table gives the limits from ISO 10993 7 and the actual performance of our EtO sterilised BCGS1. NOTE: ISO 10993-7 defines Lifetime as 25,000 days. So, our EtO sterilised goggles are well within the limits set by ISO with the actual results being about a quarter of the allowable levels. Turning to FDA requirements, the only document dealing with residuals is a draft guidance document from June 1978, which never progressed beyond the draft stage. In that document the limits were set at 250 parts per million for EO and also for ECH. We have looked up several guidance documents for specific medical devices that are EO sterilised and in those there are references to ISO 10993-7 for the evaluation of residuals. That guidance looks to have started in about 2000 and ISO 10993-7 is now listed on the FDA site as a Recognised Consensus Standard which means that it can be used in claims of compliance in 510(k) submissions. We have not found anything on the FDA website which discourages the use of Ethylene Oxide as a method of sterilisation. In fact ISO 11135-1, which is the standard for the Ethylene Oxide sterilisation process, is also listed as a Recognised Consensus Standard which would indicated that it is an acceptable method of sterilisation.

  • Will BioClean™ products protect against the Ebola virus?
  • Ebola virus disease (formerly known as Ebola haemorrhagic fever) is a severe, often fatal illness, with a death rate of up to 90%. The illness affects humans and nonhuman primates (monkeys, gorillas, and chimpanzees). The World Health Organization recommends the following: • All visitors and health care workers should rigorously use what is known as personal protective equipment (PPE). PPE should include at least: gloves, an impermeable gown, boots/closed shoes with overshoes, a mask, and eye protection for splashes (goggles or face shields). Below is a guide to the BioClean PPE available: Gloves: Most BioClean gloves are Category 3 PPE, which is only applied to products used in higher risk applications. BioClean gloves are available in a choice of lengths to provide complete protection; they are also manufactured in a wide variety of materials to suit individual preferences. Double-donning is essential when dealing with patients with Ebola. Gloves need to be donned using the correct procedure and must cover the bio-suit/coverall cuff. Coveralls: All BioClean-D™ garments including coveralls with collar or hood, overboots, sleeve covers and hoods are Category 3 PPE, which is only applied to products used in higher risk applications. BioClean-D garments are specially designed and manufactured from CleanTough™ lightweight low-linting durable material. They provide an excellent combination of both comfort and protection. Goggles & Facemasks: BioClean Clearview™ single-use goggles are Category 2 PPE and have anti-fog optically correct toughened lenses and an indirect ventilation system. They are suitable for those who wear eye-glasses and are 100% latex-free. All BioClean facemasks have a hydrophilic inner layer to absorb moisture for increased comfort and a hydrophobic outer layer to repel liquids, providing a very efficient particle and bacterial barrier. It is imperative that the goggles and facemask are donned correctly to ensure no skin is exposed between the coverall hood and the googles and facemask. For further information on the type of PPE recommended when dealing with Ebola please visit; http://www.who.int/csr/resources/publications/ebola/filovirus_infection_control/en/ http://www.bbc.co.uk/news/health-29518703 This information is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall Nitritex Ltd be liable for damages arising from its use.

  • Why are certain products are not CE marked?
  • We are often asked why certain products are not CE marked. The CE mark is the manufacturer's declaration that the product is in compliance with any necessary EU legislation. A product can only be CE marked if it is covered by EU legislation defined in the CE Marking Directives. If a product is not covered by a CE Marking Directive it must not be CE marked because it could be misleading and is, therefore, illegal.

    active implantable medical devices
    appliances burning gaseous fuels
    cableway installations designed to carry persons
    eco-design of energy related products
    electromagnetic compatibility
    equipment and protective systems intended for use in potentially explosive atmospheres
    explosives for civil uses
    hot-water boilers
    household refrigerators and freezers
    in vitro diagnostic medical devices
    lifts
    low voltage electrical equipment
    machinery
    measuring instruments
    medical devices
    noise emission in the environment
    non-automatic weighing instruments
    personal protective equipment
    pressure equipment
    pyrotechnics
    radio and telecommunications terminal equipment
    recreational craft
    safety of toys
    simple pressure vessels

    Nitritex CE marked products are intended either for use as medical devices (Profile and Omega ranges) or as personal protective equipment (numerous products in the BioClean range). Some Profile and Omega Gloves are dual marked as medical devices (MD) and personal protective equipment (PPE). BioClean products which are not covered by the PPE Directive, such as prep mats, wipes, overshoes, paper, etc., are not covered by any of the CE Marking Directives and therefore must not be CE marked. There is frequent confusion about cross-over products where a product may or may not be classified under a CE Marking Directive dependent upon the manufacturer's intended purpose. For example, Nitritex has a range of BioClean Cleanroom Wipes; as they are for general cleanroom use they are not covered by any of the Directives or Regulations and must not be CE marked. If, however, one of them was repackaged, labelled and sold with the intended purpose of cleaning medical equipment, it would then fall under the Medical Devices Directive and require CE marking. EU Declaration of Conformity The EU Declaration of Conformity is a legal document, drawn up by the manufacturer, attesting to the conformity of the product to the relevant EU legislation. If a product is not covered by EU CE marking legislation an EU Declaration of Conformity cannot be drawn up. EU Guidance

    The European "Blue Guide" on the implantation of EU product rules can be downloaded here.

  • Are my gloves suitable for use with Cytotoxic (Chemotherapy) drugs?
  • BioClean has a comprehensive range of gloves suitable for use in this highly specialized area. Gloves within the BioClean Chemo Safety Wear range have been tested against ASTM D6978-05 for a wide range of Cytotoxic drugs, recording excellent barrier performance under the ASTM defined permeation rates of 0.01µg/cm2/min – a level 100 times more stringent than that of EN374-3:2003. We will be pleased to supply further information on request.

  • What materials are BioClean gloves made from?
  • BioClean gloves are manufactured from a range of materials including latex, vinyl, nitrile and polychloroprene, to suit all critical environment requirements.

  • What are Latex Gloves?
  • Latex gloves are manufactured from natural rubber latex, derived from the sap of the rubber tree, Hevea brasiliensis.

  • What are the characteristics of Latex Gloves?
  • Because of the inherent elasticity of latex, the gloves provide excellent tactility, very comfortable fit and excellent strength and barrier properties.

  • What about Glove Allergies?
  • A glove allergy, or hypersensitivity, occurs when a person's immune system reacts to the natural latex proteins and/or the additives used during the manufacturing process of gloves. The reactions range from mild (skin rash, runny nose, itchy, watery eyes) to more extreme manifestations such as facial or throat swelling, and difficulty in breathing. Whilst most allergies or sensitivities are generally slight, a very small percentage of users may experience very severe reactions.

  • What is the difference between Type 1 and Type 4 Allergies?
  • Type 1: The most serious and the rarest form, Type 1 is an immediate and potentially life threatening reaction, not unlike the severe reaction some people have to bee stings. This form of Allergy is normally associated with latex proteins. Latex allergies can be acquired over time due to prolonged contact with latex products.

    Type 4: Also known as allergic contact dermatitis. This involves a delayed skin rash with blistering and oozing of the skin, and is usually attributed to the accelerators used in the processing of rubber products. BioClean offer products that are manufactured without accelerators - further information can be supplied on request.

  • How do I know if I have a latex allergy?
  • The only way to know for sure if you have a true latex allergy is to have allergy testing done. Some examples of common reactions may include:

    Skin rashes or reactions on your hands from wearing rubber gloves.

    Rashes on your face or skin from touching it if you did not wash your hands after wearing rubber gloves.

    Tingling, swelling or rashes on your lips or face after blowing up a balloon, or having rubber products near your face.

    Skin rashes, itching, or swelling from wearing clothes with rubber elastics next to your skin, such as a bra or underwear.

  • How can latex allergies be prevented?
  • We produce our latex gloves from latices that are extremely low in natural proteins, and then we process them to be as clean of proteins as possible and below the industry-wide standards. In spite of this there may be some individuals who will be affected. Activities which can also protect such workers from latex exposure are:

    Provide sensitised workers with non-latex gloves (e.g. Polychloroprene, Nitrile, Vinyl gloves).

    Ensure that workers use good housekeeping practices to remove latex-containing dust from the workplace.

    Provide workers with education programs about latex allergy.

    Individuals allergic to latex rubber products should advise their physicians and dentists so that they can decide if alternate products should be used in any treatment that normally requires the use of rubber products.

  • What are Vinyl Gloves?
  • Vinyl gloves are manufactured from polyvinyl chloride, a petroleum-based compound.

  • What are the characteristics of Vinyl Gloves?
  • Whilst not quite as form-fitting and comfortable as latex gloves, they contain no natural proteins to irritate the skin.

    Although softeners or plasticizers are used in vinyl to give the gloves better elasticity for a good fit, vinyl can only be stretched with difficulty and therefore lacks the fuller elasticity of latex. The cuffs are relatively baggy, compromising the barrier integrity and fit of the gloves.

    Vinyl gloves can be used as general protection for short-term, non-critical applications, or where there is some need for cleanliness with minimal risk of contact with hazardous or infectious materials.

  • What are Nitrile Gloves?
  • Nitrile gloves are manufactured from a petroleum-based, cross-linked synthetic latex film that is formed by the co-polymerization of butadiene with acrylonitrile to yield a nitrile elastomer.

  • What are the characteristics of Nitrile Gloves?
  • Nitrile has good elasticity, exhibiting some memory, and the gloves tend to conform to the shape of the wearer's hands after a few minutes. Moreover, nitrile gloves have inherently good puncture resistance, excellent tensile strength and, because they contain no latex proteins, there is no chance of Type I Allergy reactions.

    As well as being very durable, nitrile gloves generally provide greater protection against a wider range of chemicals and oils than vinyl or latex gloves.

  • I've heard that Nitrile & Latex Gloves can sometimes become discoloured - Is this true?
  • Yes, although this does not affect all wearers, this reaction can be caused by a chemical reaction between contaminants (usually metallic) that are already on the wearer's skin and the Carbamate accelerator used in the gloves. There are two distinct mechanisms that can cause this contamination:

    Before donning the gloves the wearer's hands may come into contact with metals such as copper (from coins, for example) or iron which is transferred to the inside of the glove causing the reaction and discolouration.

    The other and more subtle cause is the sweat produced by the wearer's hands. The palms of the hands have a high concentration of Eccrine sweat glands (also found on the forehead and the soles of the feet). One of the functions of these glands is to flush out toxic metals such as copper, lead, zinc and mercury from the body. If the wearer has been exposed to atmospheres where the levels of these metals are high they will be sweated out inside the gloves. Although this is a natural bodily function the effects vary from person to person, which results in the phenomena being quite rare.

    It is important to stress that this is a cosmetic phenomenon - the chemical reaction causes discolouration or stains on the gloves, but the barrier properties and physical characteristics of the gloves are not affected.

  • What are Polychloroprene Gloves?
  • Polychloroprene gloves are manufactured from polymers of chloroprene (2-chloro-I, 3-butadiene), which form a petroleum-based, cross-linked film that provides barrier protection and performance very similar to that of latex.

  • What are the characteristics of Polychloroprene Gloves?
  • Polychloroprene gloves have elasticity that is very close to that of latex, providing comfort and fit that is comparable to Latex. With a modulus (force required to stretch the glove) very similar to NRL, Polychloroprene gloves are comfortable to wear for long periods of time. Moreover, because Polychloroprene contains no natural latex proteins, there is no chance of Type 1 Allergic reactions.

  • What is the difference between Polychloroprene and Neoprene?
  • There is no difference they are the same. Neoprene is the DuPont registered brand name for Polychloroprene. Polychloroprene is a family of synthetic rubbers that are produced by polymerization of chloroprene.

  • I am confused... Some gloves are sold in Small, Medium & Large, others are 7.0, 7.5, 8.0 etc.
  • Ambidextrous gloves (which fit either hand) are generally sold in Small, Medium, Large and Extra Large sizes.

    Anatomical or hand specific gloves are usually sold in numeric sizes from 5 (Smallest) through to 10.0 (largest) in 0.5 steps.

    Dimensions for both types are covered under EN455: 2000 and EN374-1:2003.

  • I've heard about gloves with holes in them!
  • No producer in the world can guarantee that their gloves are totally free from pinholes. This fact is recognised by the industry worldwide, and even though all steps are taken to reduce them to a minimum, pinholes are an unavoidable fact of life.

    To help understand the process, gloves are made by dipping ceramic formers into a tank of liquid natural latex (or other materials).

    During this dipping process, bubbles very occasionally attach themselves to the former as it passes through the tank. Any air bubble attached to a former can cause a thin spot in the film that can then turn into a pin hole.

    To address this issue, the EN 455 European Standard for Medical Gloves sets an absolute limit for the incidence of pinholes, which is set according to the International Standard ISO 2859-1 Sampling by Attributes. For example, the EN 455 standard states that for Medical Gloves, General Inspection Level 1 has to be used with a level of AQL 1.5 (Acceptance Quality Limit).

    Translating these requirements into practical terms means that if we manufacture a batch of over 500,000 gloves a sample of 500 pieces has to be taken at random, and tested for pinholes. Of these 500 samples, if 14 or fewer have pinholes the batch is of an acceptable standard. If 15 or more have pinholes the entire batch has to be rejected and cannot be sold as medical quality.

  • What does the CE mark on products signify?
  • Any product that is regulated in Europe by the application of a European Directive has to bear the CE Mark. The CE Mark is the manufacturer's declaration that the product complies with all of the requirements of applicable Directives.

  • Why do some CE marks have a number next to them?
  • The CE Marking Directives allow different levels of regulatory certification based on the relative risk levels associated with the use of the device. Low risk devices can be CE marked by the manufacturer without reference to regulatory authorities and are marked with the CE logo only.

    Higher risk devices can only be CE marked once they have been approved by a certification company that has been accredited by the regulatory authorities. The accredited certification company is known as a Notified Body and each Notified Body has a unique reference number issued by the Notifying authorities of EU Member States. Higher risk devices are required to be marked with the CE mark and the number of the Notified Body that was involved in its approval. BioClean products are marked with CE 0120 where the 0120 is the Notified Body number of SGS UK Ltd.

  • When does a PPE glove become a Category 3 Glove for chemical protection?
  • According to the Personal Protective Equipment Directive (89/686/EC) any 'PPE providing only limited protection against chemical attack...' is PPE of complex design, i.e. Cat 3.

    Any glove that protects against 'cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.)' are defined as simple design by the directive, i.e. Cat 1.

    So, any glove that is intended to protect against anything other than the weakest of chemicals is a Cat 3 glove.

  • How is a Cat 3 glove recognisable from a Cat 1 glove?
  • All PPE must be CE marked and any Cat 3 PPE has to be examined and approved by a Notified Body before it can be brought to market. Cat 1 will have a simple CE mark and Cat 3 will have a CE mark plus the number of the Notified Body, e.g. CE 0120. Some manufacturers may put the wording 'Cat 3' or similar on their packaging, but this has no meaning within the regulations. The term Cat 3 or Category 3 is a colloquial expression that has emerged from the PPE community because it easier to say than 'PPE of complex design'.

  • How are gloves sterilised?
  • The most common method is using gamma irradiation whereby products are exposed to gamma radiation which is able to penetrate the packaging and kill all micro-organisms. Gamma processing does not cause any significant rise in temperature or leave behind any chemical residue. All of our products are processed to a Sterility Assurance Level of 10-6.

  • What does SAL 10-6 mean?
  • A Sterility Assurance Level of 10-6 means that for every 1,000,000 items sterilised there may be one that contains bacteria that have survived the sterilisation process. The SAL is a statistical probability that is used because it is impossible to prove that all bacteria have been killed during the sterilisation process. In practice the theoretical degree of processing to achieve the desired SAL is determined, and then routine processing is set at a higher level in order to achieve 'overkill'.

  • How can I tell if gloves have been sterilised?
  • The packaging clearly shows they are sterile gloves.

    Each carton will have a red circular irradiation sticker, showing that the contents have been Gamma sterilised. The irradiation sticker is yellow prior to sterilisation and changes colour to red during processing.

    A Certificate of Irradiation is available showing the Lot No and Carton No and confirming that the gloves have been sterilised.

    They are, of course, more expensive than the non-sterile equivalent.

  • If gloves are sterilised by irradiation are they at all radio-active?
  • No. The Gamma rays pass straight through the packaging and the gloves and out the other side killing any bacteria on the way. It is a natural phenomenon of Gamma rays that they pass through objects without leaving any traces of radiation behind.

  • What is the shelf life of gloves?
  • Providing gloves are correctly stored in the right conditions, they do not have a fixed shelf life. In fact the stated shelf life can vary from product to product and is determined by a combination of industry norms and regulatory requirements. Sterile Gloves generally show an expiry date on the packaging which can be between 3 and 5 years from date of manufacture, as long as the integrity of the packaging is not compromised or damaged in any way.

  • Are my gloves suitable for use with Cytotoxic (Chemotherapy) drugs?
  • BioClean has a comprehensive range of gloves suitable for use in this highly specialized area. Gloves within the BioClean Chemo Safety Wear range have been tested against ASTM D6978-05 for a wide range of Cytotoxic drugs, recording excellent barrier performance under the ASTM defined permeation rates of 0.01µg/cm2/min - a level 100 times more stringent than that of EN374-3:2003. We will be pleased to supply further information on request.

  • What is the powder used in powdered gloves?
  • This is generally an inert, USP grade cornstarch powder. However, there are number of drawbacks associated with powdered gloves such as:

    Powder can act as a carrier for latex proteins, which can cause allergic reactions if inhaled.

    Powder can delay healing on scar tissue.

    Powder can absorb microorganisms and increase the risk of cross-infections.

  • Can all gloves be taken into a Cleanroom?
  • No. Cleanroom gloves should be powderfree, extra-clean and specially packed to minimise contamination in the cleanroom environment. All BioClean™ branded gloves are suitable for cleanroom use.

  • Are BioClean Gloves Anti-Static?
  • BioClean can specifically confirm that BioClean Nitrile, Vinyl and Polychloroprene Gloves have been tested to EN 1149-1 and found to be suitable for use where anti-static characteristics are required.

    Further information can be supplied on request.

  • Are any animal products used to manufacture gloves?
  • We cannot speak for competitors, but we can confirm that NO animal products are used in the manufacture of any BioClean products.

  • What are the storage guidelines for gloves?
  • Gloves should always be stored in the original packaging in a cool, dry and well ventilated area.

    Protect the gloves from dust, direct sunlight, moisture, X-ray, and excesses of temperature.

    Generally we recommend storage temperatures of between 5 and 35 degrees Centigrade.

  • Can I re-use the gloves?
  • The gloves are single use only and should not be re-used because they will be contaminated. The contamination will not be removed effectively with washing, and washing will also reduce the barrier properties of the gloves.

  • What is the easiest way to put on a glove?
  • To put a glove on the hand (known as donning) the hands should be clean and dry.

    Slide the glove into the hand and pull the cuff part of the glove onto the wrist and ensure a comfortable fit especially around the fingers.

  • Is there a recommended method for removing gloves?
  • Removing gloves (known as doffing) can be done safely by removing one of the gloves by peeling from the cuff down to leave it inside out. The removed glove should be held scrunched in the gloved hand and the glove removed from that hand in the same manner. The first glove will then be contained within the second glove and the pair can be disposed of in accordance with standard operating procedures.

  • Is there a recommended method for disposing of used gloves?
  • The method of glove disposal depends on how the glove was used. If the glove is contaminated with a toxic compound or biological material that is covered by any disposal regulations, the gloves must be handled in the same way as the toxic material itself. If gloves are not contaminated or have been properly decontaminated, either landfill or incineration is a satisfactory means of disposal (see below).

    Since ordinary aerobic or anaerobic decomposition processes in gloves will not form any toxic products, gloves may be disposed of in any landfill. Breakdown in landfill will be very slow except for products made of natural rubber. Incineration is an optimum choice, but glove disposal by incineration can lead to pollution by the release of toxins. However, a good incinerator unit will completely burn all types of gloves as well as any intermediate decomposition products formed during the process.

    The environmental impact of used-glove disposal has become an increasing concern for all industries. The factors that must be considered when choosing incineration or disposal in a landfill vary with material type:

    Combustion of natural rubber latex gloves is quite clean, although some hydrocarbons, minute quantities of unreacted nitrogen-based chemicals, and sulphur dioxide may be produced at low incineration temperatures. In a landfill, residual chemicals will leach out as the rubber bio-degrades.

    Incineration of vinyl gloves reduces the PVC to hydrochloric acid gas, minor residual chemicals, and ash. Under standard landfill conditions, vinyl is not biodegradable. However, esters of phthalic acid, which are used as plasticizers and make up about 50% of the total volume, will leach from the material if it comes in contact with nonaqueous solvents. Before choosing incineration for PVC gloves, users should ensure that local laws do not ban such a practice.

    Nitrogen-based reaction products are released minimally during incineration of nitrile gloves; the other chemical by-products are similar to those produced by natural latex. In a landfill, residual chemicals such as accelerators will leach out, as they do in rubber gloves; the nitrile itself will resist degradation.

    Polychloroprene gloves release hydrochloric acid gas, carbon monoxide and dioxide, various hydrocarbon and partially oxidised hydrocarbon and partially oxidised organic compounding chemicals during incineration and they are not biodegradable. Always comply with local regulatory agencies rules for proper disposal.

    If you have any questions or concerns that are not covered here then please contact us and we will be pleased to help.

  • What is the best material for protection against IPA?
  • Polychloroprene gloves are far superior to latex, nitrile and vinyl for protection against IPA. Our BioClean Ultimate (BUPS) polychloroprene gloves have been tested to provide over 480 minutes breakthrough time against 100% IPA.

  • Why would people double don gloves?
  • We recommend double donning gloves to provide extra protection. The more layers, the more protection against chemicals. Also, double donning limits the chance of penetration through pinholes. Statistically, there is a very low chance of two pinholes being in exactly the same place on two gloves.

  • Why would I use a 12"/16" glove?
  • You would use a 16" glove if you want more protection up to the elbows when covering the sleeve. Also, a 16" glove will hold the sleeve in-place better than a 12" glove. There is growing interest in 16" gloves because of these benefits. Our BioClean N Plus (BNPS) 16" Nitrile Glove provides such protection.

  • BioClean BarrierPlus™ Gauntlets are 100% inspected, how?
  • BioClean's BarrierPlus Gauntlet manufacturing process has five separate product inspections throughout. Each gauntlet is visually inspected 100% for holes, along with water and air pressure testing. This is achieved by the gauntlet being filled with air to a specified pressure before being submerged underwater for three minutes. The water is checked for any bubbles identifying whether the product has a pinhole leak. This 100% inspection guarantees delivery of a gauntlet free from holes, and is more rigorous than the AQL approach for surgical gloves which is based on a statistical sampling plan.

  • With increasing concerns about allergic reactions to latex products, what can you tell me about latex allergies?
  • Like any substance derived from natural resources latex can cause an allergic reaction. Whilst rare, allergic reactions to latex can be highly dangerous. The proteins present in latex are the component that cause the allergic reaction. Detailed below are the different types of allergic reactions associated with latex and their symptoms.

    • Irritant Contact Dermatitis. The most common allergic reaction to latex products is Irritant Contact Dermatitis. Symptoms of this include dry and itchy skin usually found on the hands. This reaction may be caused by skin irritation from using gloves. It is worth bearing in mind that the reaction detailed above can also by caused by use of cleaners and sanitization products. Powders added to certain gloves can also cause Irritant Contact Dermatitis.
    • Allergic Contact Dermatitis. This reaction is delayed, with no immediate sign of an allergic reaction. Allergic Contact Dermatitis results from exposure to chemicals added to latex during harvesting, processing, or manufacturing. The rash usually shows 24 to 48 hours after contact and may cause the skin to blister.
    • Latex Allergy or Immediate Hypersensitivity. This can result in a more serious reaction to latex than Irritant Contact Dermatitis or Allergic Contact Dermatitis. Certain proteins in latex may cause sensitization. The exact amount of exposure required to cause a reaction is unknown, however even very low levels can trigger allergic reactions in more sensitive individuals within seconds after exposure. Mild symptoms include skin redness, hives, or itching. More severe reactions may involve respiratory symptoms such as runny nose, sneezing, itchy eyes, scratchy throat, and asthma (difficulty breathing, coughing spells, and wheezing).
    There are ways in which you can lessen the possibility of latex allergies happening. Each employer should always offer a non-latex alternative such as polychloroprene (Neoprene), nitrile and vinyl gloves. If latex gloves are a necessity then the employer should provide a low protein, powder free latex glove as some chemicals found in the powder used in latex gloves can cause similar reactions to those detailed above. Employees can also lessen the risk by only using the gloves when it is necessary.

  • What is the material used?
  • This is our proprietary Clean-tough™ material which is spun bonded non-woven polypropylene laminated with a film of polyethylene. This allows comfort and flexibility during use and protection against fine sprays and particles.

  • What about the seams? How are they constructed?
  • The seams are just one of the areas where the BioClean-D range of disposable garments displays superior design features normally found only in high quality reusable garments. The seams are bound with an extra piece of material for maximum barrier protection and strength covering all raw edges to minimize particle shedding.

  • Does the zip area provide the same level of protection?
  • Yes - providing the garment is correctly worn. The zip has a protective flap of Clean-tough™ material which can be closed over the zip once it has been pulled up. Double sided tape on the reverse of the zip flap allows it to be secured in place so that it covers the zip completely and does not open up during movement.

  • I have noticed that there is an information sheet packed with the garments. Won't the sheet contaminate the cleanroom when the garment is unpacked?
  • No. The information sheet is printed on non-particulating, cleanroom compatible paper.

  • What is the material used?
  • This is our proprietary Clean-tough™ material which is spun bonded non-woven polypropylene laminated with a film of polyethylene. This allows comfort and flexibility during use and protection against fine sprays and particles.

  • What about the seams? How are they constructed?
  • The seams are just one of the areas where the BioClean-D range of disposable garments display superior design features normally only found in high quality re-usable garments. The seams are bound with an extra piece of material which allows maximum barrier protection and strength and covers all raw edges to minimize particle shedding.

  • Does the zip area provide the same level of protection?
  • Yes - providing the garment is correctly worn. The zip has a protective flap of Clean-tough™ material which can be closed over the zip once it has been pulled up. Double sided tape on the reverse of the zip flap allows it to be secured in place so that it covers the zip completely and does not open up during movement.

  • What does the CE mark on products signify?
  • Any product that is regulated in Europe by the application of a European Directive has to bear the CE Mark. The CE Mark is the manufacturer's declaration that the product complies with all of the requirements of applicable Directives.

  • Why do some CE marks have a number next to them?
  • The CE Marking Directives allow different levels of regulatory certification based on the relative risk levels associated with the use of the device. Low risk devices can be CE marked by the manufacturer without reference to regulatory authorities and are marked with the CE logo only. Higher risk devices can only be CE marked once they have been approved by a certification company that has been accredited by the regulatory authorities. The accredited certification company is known as a Notified Body and each Notified Body has a unique reference number issued by the Council of Europe. Higher risk devices are required to be marked with the CE mark and the number of the Notified Body that was involved in its approval. BioClean products are marked with CE 0120 where the 0120 is the Notified Body number of SGS UK Ltd.

  • The label states PPE Category 3 Type 5/6 - what does this mean?
  • The Personal Protective Equipment (PPE) Directive (89/686/EC) defines items providing protection into various categories. Garments are generally referred to as simple design - in which case they are Category 1, or complex design - which are Category 3.

    All PPE Products must be CE marked and any Cat 3 PPE item has to be examined and approved by a Notified Body before it can be brought to market. Cat 1 will have a simple CE mark and Cat 3 will have a CE mark plus the number of the Notified Body e.g. 0120 which is the number for SGS Ltd.

    Part of the examination process includes evidence of testing. Within Category 3 there are various levels of protection. The BioClean-D range meets the requirements of Type 5 & 6 which are as follows:

    Type 5: Confirms the ability to withstand fine dry particles

    Type 6: Confirms the ability to withstand exposure to a light spray, liquid aerosols or low pressure, low volume splashes, against which a complete liquid permeation barrier (at the molecular level) is not required.

  • What is the difference between Type 5 & 6 and Type PB[5] & Type PB[6]?
  • The coveralls are designed to provide whole body protection and these are covered under Type 5 & 6. However, there are also items in the BioClean-D range which cover just part of the body e.g. sleeve covers. Because these only provide partial body protection they are referred to as PB[5] & PB[6].

  • What is meant by chemical permeation and penetration?
  • Chemical permeation is the passage of a chemical through a barrier layer at a molecular level. Molecules of the chemical are absorbed by the barrier material and as the number of molecules absorbed increases, the chemical gradually works its way through the material and out of the other side. By way of illustration, imagine a layer of dry sponge that has a trickle of water poured upon it. At first the water sits on the surface of the sponge. It then starts to soak in and as it does so it spreads out throughout the sponge. As more water is poured on, the sponge 'fills up' until the volume held reaches the point of saturation and water starts to trickle from the opposite side. The trickle of water emerging will increase in volume until a steady rate of flow is reached.

    Chemical penetration is a much simpler mechanism whereby the chemical passes through holes in the barrier. The illustration for this mechanism is that of a polythene bag full of water. If the polythene is intact the water will stay in place. If the polythene has any holes (e.g. pinholes) the water will penetrate and escape.

  • Are the garments anti-static?
  • Yes. Anti static garments are available which meet the requirements of EN1149-1:2006 i.e. they have a surface resistance less than 5 x 1010 Ω.

    These require extra manufacturing processes which increases the cost slightly. Many users do not require anti-static garments so we do have both versions available. Please be sure to specify which type you require when placing your order.

  • Are the garments suitable for use in cleanrooms?
  • We follow the IEST recommended practice which covers garment system considerations for cleanrooms and other controlled environments. (IEST-RP-CC003.3)

    There are a number of recommendations regarding the construction of the garment, as well as the materials to be used in its construction. We use these guidelines as the basis for our own construction, e.g. the threads should be synthetic, non-particulating and suitable for sterilisation, and of the materials recommended, one is non-woven. Our garments are constructed on this basis. Additionally, there are a number of ways recommended for closing the seams on the garment. We choose bound seams as we find this is the best way to prevent particulation as this system completely seals the seams, stopping particulates from escaping.

    Additionally, we conduct, according to the standard, particle shedding analysis using the Helmke drum test. The results are well under the limit set for category 2 on the Helmke Drum classification.

    There are no solid rules, or pass / fail criteria for ISO Cleanroom compatibility. Much surrounding the suitability of Cleanroom consumables will depend on the manner in which they are used. For example, if the operator is sitting still for most of his or her working day, the likelihood is that their garment / gloves etc. will generate far less particulates than an operator who is constantly moving around while working.

    What we do is to ensure that our garments are as particulate free as possible when they are packed. We also ensure that they are constructed in such a way as to minimise any opportunities for particulation to occur. In this, we can say that our garments are suitable for use in an ISO Class 4 cleanroom.

    The packaging is printed with IPA resistant ink to ensure there is no contamination and each bag has an 'easy-tear' opening. The products are packed in a carton liner which is sealed with a twist tie to prevent contamination.

  • How are garments sterilised?
  • The most common method is using gamma irradiation whereby products are exposed to gamma radiation which is able to penetrate the packaging and kill all micro-organisms. Gamma processing does not cause any significant rise in temperature or leave behind any chemical residue. All of our products are processed to a Sterility Assurance Level of 10-6.

  • What does SAL 10-6 mean?
  • A Sterility Assurance Level of 10-6 means that for every 1,000,000 items sterilised there may be one that contains bacteria that have survived the sterilisation process. The SAL is a statistical probability that is used because it is impossible to prove that all bacteria have been killed during the sterilisation process. In practice the theoretical degree of processing to achieve the desired SAL is determined, and then routine processing is set at a higher level in order to achieve 'overkill'.

  • If garments are sterilised by irradiation are they at all radio-active?
  • No. The Gamma rays pass straight through the packaging and the garments and out the other side killing any bacteria on the way. It is a natural phenomenon of Gamma rays that they pass through objects without leaving any traces of radiation behind.

  • Can non-sterile garments be sterilised?
  • No. To ensure similar performance of both options, the starting products for each variant is not identical and therefore non-sterile garments should not be Gamma irradiated as this causes significant deterioration in some of the materials used for non-sterile garments.

  • How do I know the garments are sterile?
  • The product code for all sterile items in the BioClean-D range of garments starts with S-.

    The outer carton clearly shows sterile product as a description. The irradiation sticker on the top left hand corner of each bag will be red.

    The irradiation sticker is yellow prior to gamma sterilisation and changes colour during processing.

    A certificate of Irradiation is available showing the Lot No and Carton No, confirming that the garments have been sterilised.

    The BioClean-D range of disposable garments have successfully passed a full sterility validation.

    They cost more than the non-sterile equivalent.

  • What other items are there in the range?
  • The BioClean-D range of garments is comprehensive and includes the following in both sterile and non-sterile options:

    Coverall with Hood

    Coverall with Collar

    Sleeve Covers

    Lab Coats

    Hoods

    Overboots

  • Can I re-use the garments?
  • The garments are single use only and should not be re-used because they will be contaminated. Also, the opening of the zip cover flap may well destroy the coverall. Laundering BioClean-D garments destroys the Clean-tough material causing delamination of the layers and considerably weakening the structural strength of the garment.

  • Is there a recommended method for disposing of used BioClean-D garments?
  • The method of garment disposal depends on how it was used. If the garment is contaminated with a toxic compound or biological material that is covered by any disposal regulations, the garment must be handled in the same way as the contamination material itself. If the garment is not contaminated or has been properly decontaminated, either landfill or incineration is a satisfactory means of disposal. Since ordinary aerobic or anaerobic decomposition processes in garments will not form any toxic products, they may be disposed of in any landfill. However, breakdown in landfill will be very slow. Incineration is an optimum choice and since Polypropylene and Polyethylene only consist of hydrogen and carbon atoms, in an incineration plant only water and carbon dioxide are produced.

  • What is the shelf life of garments?
  • Providing garments are correctly stored in the right conditions, they do not have a fixed shelf life.

    Sterile garments generally show an expiry date on the packaging which is 3 years from date of manufacture, as long as the integrity of the packaging is not compromised or damaged in any way.

  • What are the storage guidelines for garments?
  • Garments should always be stored in the original packaging in a cool, dry and well ventilated area. Protect the garments from dust, direct sunlight, moisture, X-ray, and excesses of temperature. Generally we recommend storage temperatures of between 5 and 35 degrees Centigrade.

  • Why is the expiry date not mentioned on the Certificate of Irradiation?
  • The Certificate of Irradiation cannot state the expiry date of the product. Irradiation is carried out by Sterigamma and they have not part in setting the expiry data of any products that they process. It is the manufacturer's responsibility to do that. The only information that Sterigamma are allowed to put on the Certificate are product identification data and data that they are directly responsible for, e.g. date for sterilisation, max and min dose.

  • Why is aseptic donning so important?
  • The purpose of a cleanroom garment is to protect the product or process from contamination caused by the wearer. With the average wearer dispersing millions of particles (including skin, hair, perspiration) from their bodies every minute, and a square inch of skin on average harbouring 32 million bacteria, the potential to spread contamination is great!

  • Why are sterile facemasks more expensive than non-sterile ones?
  • This is not just because of the sterilisation processing costs. Our standard non-sterile masks are made from polypropylene, which is a relatively inexpensive material. Unfortunately polypropylene degrades when it is sterilised by irradiation seriously compromising its filtration performance. To obtain acceptable filtration performance after irradiation the masks have to be made from the more expensive polyester, which does not suffer the same reaction.

  • What does BFE, PFE & Delta P mean?
  • When selecting a facemask for cleanroom use it's important to choose one with the right filtration efficiency for the level of protection needed. The BFE % of a facemask is the measurement of bacterial filtration efficiency and PFE % is the measurement of particle filtration efficiency. Facemasks with a high BFE and PFE % are recommended for use in cleanrooms, ensuring high filtration of both bacteria and particles. The ΔP symbol stands for Differential Pressure (Delta P) and refers to the pressure drop across a facemask (or the resistance to air flow) and is measured in mmH2O/cm2. Therefore higher the Delta P of the facemask the less breathability but the better the filtration.

  • How can I monitor the number of autoclave cycles the goggles I'm using have been subjected to?
  • - Before autoclaving the BCAG or BCAP BioClean Clearview Cleanroom goggles for the first time, mark each goggle with a unique number on the inside of the frame (not outside) with an indelible, steam resistant marker. This can be sequential numbers for example, if a quantity of 500 pieces is purchased, then mark them from #1 to #500. - At the same time, create a document listing the number of times each numbered goggle has been processed. So, for example the document could be called "GOGGLE CYCLE COUNT - BCAP 1" on which is listed the individual goggle number applied to each goggle, and the number of times it has been autoclaved. By doing this, the number of autoclave cycles can be easily tracked. - If a customer prefers not to use an indelible marker, an alternative solution is to use a steam resistant, individually numbered tag that can be applied/fixed to the goggle strap, bearing in mind that it would be looser and not so secure as an indelible mark. Therefore, we would recommend using the indelible marker on each goggle as above as the most appropriate way of numbering the goggles.

  • How to prevent autoclavable goggles from fogging up
  • BioClean™ autoclavable goggles are not anti-fog treated before delivery because the permanent anti-fog film will not withstand multiple autoclaving. Instead, if fogging is a problem, use BioClean sterile anti-fog spray - a few sprays onto the inside of the lens, wiped dry with a sterile wipe will help reduce the effects of fogging.

  • What tests should you look for when choosing a wipe?
  • Wipes should be extensively tested to IEST-RP-CC003.3 Helmke Drum test for particle release and IEST-RP-CC004.3 for the physical properties including NVR (nonvolatile residue), extractables, absorption capacity and absorption rate. BioClean wipes are tested using these test methods, with results available on request.

  • How do BioClean sterile bags differ from standard polythene bags?
  • BioClean Sterile Bags are manufactured from low-density ultraclean polythene produced entirely within a cleanroom environment. Because the material is free of additives, there is virtually no contamination from particulates, surface leaching chemicals or outgassing. BioClean sterile bags are suitable for general-purpose use, ideal as waste bags, transportation bags or storage bags and commonly used within the pharmaceutical, medical, semiconductor, aerospace and many other industries.

  • What are Pharma Covers?
  • Manufactured from Tyvek®, BioCleanâ„¢ Pharma Covers provide a microbial barrier against environmental impurities during product storage, transportation and processing. The form-fitted covers have a high quality elasticated band for a secure fit, are autoclavable and available in a large range of sizes - ideal for pipes, beakers, media bottles, flasks and even stopper bowls. Lint-free, moisture and puncture resistant, these covers are essential for critical environments where product protection is paramount.

  • What is the difference in the quality of the fabrics?
  • The fabric MT12 is a plain weave and has excellent filtration properties. It can be irradiated and is suitable for all cleanroom classifications from ISO 4 (Grade A and B) through to ISO 7 (Grade C) and ISO 8 (Grade D). The fabric MT031 is a twill weave as opposed to a plain weave and has a slightly heavier unit weight, making this fabric feel more silky. It is also suitable for all classifications of cleanroom as above. The fabric MT811 is a twill weave fabric but its filtration performance at the smallest particle sizes is not quite as good as MT12 and MT031, which makes MT811 suitable for ISO 7 (C) and ISO 8 (D).

General

  • How much experience does BioClean have with meeting the needs of various critical environments?
  • At BioClean we have over 50 years of technical experience in cleanrooms and critical operating environments. This wealth of industry experience gives us a unique and priceless knowledge base that we use to help our distributors and their customers find the right products for their needs. If you have any queries then please do not hesitate to contact us.

  • If a faulty product is supplied what will BioClean do about it?
  • At BioClean we take great pride in our customer service and the quality of our products. In the unlikely event that a faulty product is supplied, the lot number and batch number will allow us to quickly trace the fault at its source. We will take back any faulty items that are supplied and immediately provide a replacement. Thereafter we will investigate the fault to provide the customer with a detailed explanation and to ensure that it does not happen again.

  • What kind of companies do BioClean supply?
  • BioClean products are used across the world, we supply many distributors to the life sciences industries (pharmaceutical, biotechnology and medical device manufacturing), semiconductor and microelectronics manufacturing and assembly industry.

  • Why is the expiry date not mentioned on the Certificate of Irradiation?
  • The Certificate of Irradiation cannot state the expiry date of the product. Irradiation is carried out by Sterigamma and they have not been part of the expiry data setting of any products that they process. It is the manufacturers responsibility to do that. The only information that Sterigamma are allowed to put on the Certificate are product identification data and data that they are directly responsible for, e.g. date for sterilisation, max and min dose.

  • I am concerned about the safety of my EtO sterilised goggles, what can you tell me about EtO exposure levels?
  • The permissible levels of EO residuals are specified in ISO 10993 7: 2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals. There are two residual chemicals of concern namely Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH). As part of the sterilisation validation we tested for residuals and found the average levels to be EO = 0.43mg and ECH = 0.06mg per goggle. Approximately 6% of the goggle is in contact with the wearer so the residuals that are transferrable to the wearer are EO = 0.026mg and ECH = 0.004mg. The standard defines three exposure categories for the device then assigns safe exposure limits for each category. The categories are: a) Limited exposure: devices whose single or multiple use or contact is likely to be up to 24 h; b) Prolonged exposure: devices whose single, multiple, or long-term use or contact is likely to exceed 24h but not 30 days; c) Permanent contact: devices whose single, multiple, or long-term use or contact exceeds 30 days. With a product like the goggles the time worn in total is taken into account, not the time that each goggle is worn. Given the definitions above, a typical worker is going to exceed 30 days so we need to treat the exposure as permanent contact. The following table gives the limits from ISO 10993 7 and the actual performance of our EtO sterilised BCGS1. NOTE: ISO 10993-7 defines Lifetime as 25,000 days. So, our EtO sterilised goggles are well within the limits set by ISO with the actual results being about a quarter of the allowable levels. Turning to FDA requirements, the only document dealing with residuals is a draft guidance document from June 1978, which never progressed beyond the draft stage. In that document the limits were set at 250 parts per million for EO and also for ECH. We have looked up several guidance documents for specific medical devices that are EO sterilised and in those there are references to ISO 10993-7 for the evaluation of residuals. That guidance looks to have started in about 2000 and ISO 10993-7 is now listed on the FDA site as a Recognised Consensus Standard which means that it can be used in claims of compliance in 510(k) submissions. We have not found anything on the FDA website which discourages the use of Ethylene Oxide as a method of sterilisation. In fact ISO 11135-1, which is the standard for the Ethylene Oxide sterilisation process, is also listed as a Recognised Consensus Standard which would indicated that it is an acceptable method of sterilisation.

  • Will BioClean™ products protect against the Ebola virus?
  • Ebola virus disease (formerly known as Ebola haemorrhagic fever) is a severe, often fatal illness, with a death rate of up to 90%. The illness affects humans and nonhuman primates (monkeys, gorillas, and chimpanzees). The World Health Organization recommends the following: • All visitors and health care workers should rigorously use what is known as personal protective equipment (PPE). PPE should include at least: gloves, an impermeable gown, boots/closed shoes with overshoes, a mask, and eye protection for splashes (goggles or face shields). Below is a guide to the BioClean PPE available: Gloves: Most BioClean gloves are Category 3 PPE, which is only applied to products used in higher risk applications. BioClean gloves are available in a choice of lengths to provide complete protection; they are also manufactured in a wide variety of materials to suit individual preferences. Double-donning is essential when dealing with patients with Ebola. Gloves need to be donned using the correct procedure and must cover the bio-suit/coverall cuff. Coveralls: All BioClean-D™ garments including coveralls with collar or hood, overboots, sleeve covers and hoods are Category 3 PPE, which is only applied to products used in higher risk applications. BioClean-D garments are specially designed and manufactured from CleanTough™ lightweight low-linting durable material. They provide an excellent combination of both comfort and protection. Goggles & Facemasks: BioClean Clearview™ single-use goggles are Category 2 PPE and have anti-fog optically correct toughened lenses and an indirect ventilation system. They are suitable for those who wear eye-glasses and are 100% latex-free. All BioClean facemasks have a hydrophilic inner layer to absorb moisture for increased comfort and a hydrophobic outer layer to repel liquids, providing a very efficient particle and bacterial barrier. It is imperative that the goggles and facemask are donned correctly to ensure no skin is exposed between the coverall hood and the googles and facemask. For further information on the type of PPE recommended when dealing with Ebola please visit; http://www.who.int/csr/resources/publications/ebola/filovirus_infection_control/en/ http://www.bbc.co.uk/news/health-29518703 This information is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall Nitritex Ltd be liable for damages arising from its use.

  • Why are certain products are not CE marked?
  • We are often asked why certain products are not CE marked. The CE mark is the manufacturer's declaration that the product is in compliance with any necessary EU legislation. A product can only be CE marked if it is covered by EU legislation defined in the CE Marking Directives. If a product is not covered by a CE Marking Directive it must not be CE marked because it could be misleading and is, therefore, illegal.

    active implantable medical devices
    appliances burning gaseous fuels
    cableway installations designed to carry persons
    eco-design of energy related products
    electromagnetic compatibility
    equipment and protective systems intended for use in potentially explosive atmospheres
    explosives for civil uses
    hot-water boilers
    household refrigerators and freezers
    in vitro diagnostic medical devices
    lifts
    low voltage electrical equipment
    machinery
    measuring instruments
    medical devices
    noise emission in the environment
    non-automatic weighing instruments
    personal protective equipment
    pressure equipment
    pyrotechnics
    radio and telecommunications terminal equipment
    recreational craft
    safety of toys
    simple pressure vessels

    Nitritex CE marked products are intended either for use as medical devices (Profile and Omega ranges) or as personal protective equipment (numerous products in the BioClean range). Some Profile and Omega Gloves are dual marked as medical devices (MD) and personal protective equipment (PPE). BioClean products which are not covered by the PPE Directive, such as prep mats, wipes, overshoes, paper, etc., are not covered by any of the CE Marking Directives and therefore must not be CE marked. There is frequent confusion about cross-over products where a product may or may not be classified under a CE Marking Directive dependent upon the manufacturer's intended purpose. For example, Nitritex has a range of BioClean Cleanroom Wipes; as they are for general cleanroom use they are not covered by any of the Directives or Regulations and must not be CE marked. If, however, one of them was repackaged, labelled and sold with the intended purpose of cleaning medical equipment, it would then fall under the Medical Devices Directive and require CE marking. EU Declaration of Conformity The EU Declaration of Conformity is a legal document, drawn up by the manufacturer, attesting to the conformity of the product to the relevant EU legislation. If a product is not covered by EU CE marking legislation an EU Declaration of Conformity cannot be drawn up. EU Guidance

    The European "Blue Guide" on the implantation of EU product rules can be downloaded here.

Gloves

  • Are my gloves suitable for use with Cytotoxic (Chemotherapy) drugs?
  • BioClean has a comprehensive range of gloves suitable for use in this highly specialized area. Gloves within the BioClean Chemo Safety Wear range have been tested against ASTM D6978-05 for a wide range of Cytotoxic drugs, recording excellent barrier performance under the ASTM defined permeation rates of 0.01µg/cm2/min – a level 100 times more stringent than that of EN374-3:2003. We will be pleased to supply further information on request.

  • What materials are BioClean gloves made from?
  • BioClean gloves are manufactured from a range of materials including latex, vinyl, nitrile and polychloroprene, to suit all critical environment requirements.

  • What are Latex Gloves?
  • Latex gloves are manufactured from natural rubber latex, derived from the sap of the rubber tree, Hevea brasiliensis.

  • What are the characteristics of Latex Gloves?
  • Because of the inherent elasticity of latex, the gloves provide excellent tactility, very comfortable fit and excellent strength and barrier properties.

  • What about Glove Allergies?
  • A glove allergy, or hypersensitivity, occurs when a person's immune system reacts to the natural latex proteins and/or the additives used during the manufacturing process of gloves. The reactions range from mild (skin rash, runny nose, itchy, watery eyes) to more extreme manifestations such as facial or throat swelling, and difficulty in breathing. Whilst most allergies or sensitivities are generally slight, a very small percentage of users may experience very severe reactions.

  • What is the difference between Type 1 and Type 4 Allergies?
  • Type 1: The most serious and the rarest form, Type 1 is an immediate and potentially life threatening reaction, not unlike the severe reaction some people have to bee stings. This form of Allergy is normally associated with latex proteins. Latex allergies can be acquired over time due to prolonged contact with latex products.

    Type 4: Also known as allergic contact dermatitis. This involves a delayed skin rash with blistering and oozing of the skin, and is usually attributed to the accelerators used in the processing of rubber products. BioClean offer products that are manufactured without accelerators - further information can be supplied on request.

  • How do I know if I have a latex allergy?
  • The only way to know for sure if you have a true latex allergy is to have allergy testing done. Some examples of common reactions may include:

    Skin rashes or reactions on your hands from wearing rubber gloves.

    Rashes on your face or skin from touching it if you did not wash your hands after wearing rubber gloves.

    Tingling, swelling or rashes on your lips or face after blowing up a balloon, or having rubber products near your face.

    Skin rashes, itching, or swelling from wearing clothes with rubber elastics next to your skin, such as a bra or underwear.

  • How can latex allergies be prevented?
  • We produce our latex gloves from latices that are extremely low in natural proteins, and then we process them to be as clean of proteins as possible and below the industry-wide standards. In spite of this there may be some individuals who will be affected. Activities which can also protect such workers from latex exposure are:

    Provide sensitised workers with non-latex gloves (e.g. Polychloroprene, Nitrile, Vinyl gloves).

    Ensure that workers use good housekeeping practices to remove latex-containing dust from the workplace.

    Provide workers with education programs about latex allergy.

    Individuals allergic to latex rubber products should advise their physicians and dentists so that they can decide if alternate products should be used in any treatment that normally requires the use of rubber products.

  • What are Vinyl Gloves?
  • Vinyl gloves are manufactured from polyvinyl chloride, a petroleum-based compound.

  • What are the characteristics of Vinyl Gloves?
  • Whilst not quite as form-fitting and comfortable as latex gloves, they contain no natural proteins to irritate the skin.

    Although softeners or plasticizers are used in vinyl to give the gloves better elasticity for a good fit, vinyl can only be stretched with difficulty and therefore lacks the fuller elasticity of latex. The cuffs are relatively baggy, compromising the barrier integrity and fit of the gloves.

    Vinyl gloves can be used as general protection for short-term, non-critical applications, or where there is some need for cleanliness with minimal risk of contact with hazardous or infectious materials.

  • What are Nitrile Gloves?
  • Nitrile gloves are manufactured from a petroleum-based, cross-linked synthetic latex film that is formed by the co-polymerization of butadiene with acrylonitrile to yield a nitrile elastomer.

  • What are the characteristics of Nitrile Gloves?
  • Nitrile has good elasticity, exhibiting some memory, and the gloves tend to conform to the shape of the wearer's hands after a few minutes. Moreover, nitrile gloves have inherently good puncture resistance, excellent tensile strength and, because they contain no latex proteins, there is no chance of Type I Allergy reactions.

    As well as being very durable, nitrile gloves generally provide greater protection against a wider range of chemicals and oils than vinyl or latex gloves.

  • I've heard that Nitrile & Latex Gloves can sometimes become discoloured - Is this true?
  • Yes, although this does not affect all wearers, this reaction can be caused by a chemical reaction between contaminants (usually metallic) that are already on the wearer's skin and the Carbamate accelerator used in the gloves. There are two distinct mechanisms that can cause this contamination:

    Before donning the gloves the wearer's hands may come into contact with metals such as copper (from coins, for example) or iron which is transferred to the inside of the glove causing the reaction and discolouration.

    The other and more subtle cause is the sweat produced by the wearer's hands. The palms of the hands have a high concentration of Eccrine sweat glands (also found on the forehead and the soles of the feet). One of the functions of these glands is to flush out toxic metals such as copper, lead, zinc and mercury from the body. If the wearer has been exposed to atmospheres where the levels of these metals are high they will be sweated out inside the gloves. Although this is a natural bodily function the effects vary from person to person, which results in the phenomena being quite rare.

    It is important to stress that this is a cosmetic phenomenon - the chemical reaction causes discolouration or stains on the gloves, but the barrier properties and physical characteristics of the gloves are not affected.

  • What are Polychloroprene Gloves?
  • Polychloroprene gloves are manufactured from polymers of chloroprene (2-chloro-I, 3-butadiene), which form a petroleum-based, cross-linked film that provides barrier protection and performance very similar to that of latex.

  • What are the characteristics of Polychloroprene Gloves?
  • Polychloroprene gloves have elasticity that is very close to that of latex, providing comfort and fit that is comparable to Latex. With a modulus (force required to stretch the glove) very similar to NRL, Polychloroprene gloves are comfortable to wear for long periods of time. Moreover, because Polychloroprene contains no natural latex proteins, there is no chance of Type 1 Allergic reactions.

  • What is the difference between Polychloroprene and Neoprene?
  • There is no difference they are the same. Neoprene is the DuPont registered brand name for Polychloroprene. Polychloroprene is a family of synthetic rubbers that are produced by polymerization of chloroprene.

  • I am confused... Some gloves are sold in Small, Medium & Large, others are 7.0, 7.5, 8.0 etc.
  • Ambidextrous gloves (which fit either hand) are generally sold in Small, Medium, Large and Extra Large sizes.

    Anatomical or hand specific gloves are usually sold in numeric sizes from 5 (Smallest) through to 10.0 (largest) in 0.5 steps.

    Dimensions for both types are covered under EN455: 2000 and EN374-1:2003.

  • I've heard about gloves with holes in them!
  • No producer in the world can guarantee that their gloves are totally free from pinholes. This fact is recognised by the industry worldwide, and even though all steps are taken to reduce them to a minimum, pinholes are an unavoidable fact of life.

    To help understand the process, gloves are made by dipping ceramic formers into a tank of liquid natural latex (or other materials).

    During this dipping process, bubbles very occasionally attach themselves to the former as it passes through the tank. Any air bubble attached to a former can cause a thin spot in the film that can then turn into a pin hole.

    To address this issue, the EN 455 European Standard for Medical Gloves sets an absolute limit for the incidence of pinholes, which is set according to the International Standard ISO 2859-1 Sampling by Attributes. For example, the EN 455 standard states that for Medical Gloves, General Inspection Level 1 has to be used with a level of AQL 1.5 (Acceptance Quality Limit).

    Translating these requirements into practical terms means that if we manufacture a batch of over 500,000 gloves a sample of 500 pieces has to be taken at random, and tested for pinholes. Of these 500 samples, if 14 or fewer have pinholes the batch is of an acceptable standard. If 15 or more have pinholes the entire batch has to be rejected and cannot be sold as medical quality.

  • What does the CE mark on products signify?
  • Any product that is regulated in Europe by the application of a European Directive has to bear the CE Mark. The CE Mark is the manufacturer's declaration that the product complies with all of the requirements of applicable Directives.

  • Why do some CE marks have a number next to them?
  • The CE Marking Directives allow different levels of regulatory certification based on the relative risk levels associated with the use of the device. Low risk devices can be CE marked by the manufacturer without reference to regulatory authorities and are marked with the CE logo only.

    Higher risk devices can only be CE marked once they have been approved by a certification company that has been accredited by the regulatory authorities. The accredited certification company is known as a Notified Body and each Notified Body has a unique reference number issued by the Notifying authorities of EU Member States. Higher risk devices are required to be marked with the CE mark and the number of the Notified Body that was involved in its approval. BioClean products are marked with CE 0120 where the 0120 is the Notified Body number of SGS UK Ltd.

  • When does a PPE glove become a Category 3 Glove for chemical protection?
  • According to the Personal Protective Equipment Directive (89/686/EC) any 'PPE providing only limited protection against chemical attack...' is PPE of complex design, i.e. Cat 3.

    Any glove that protects against 'cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.)' are defined as simple design by the directive, i.e. Cat 1.

    So, any glove that is intended to protect against anything other than the weakest of chemicals is a Cat 3 glove.

  • How is a Cat 3 glove recognisable from a Cat 1 glove?
  • All PPE must be CE marked and any Cat 3 PPE has to be examined and approved by a Notified Body before it can be brought to market. Cat 1 will have a simple CE mark and Cat 3 will have a CE mark plus the number of the Notified Body, e.g. CE 0120. Some manufacturers may put the wording 'Cat 3' or similar on their packaging, but this has no meaning within the regulations. The term Cat 3 or Category 3 is a colloquial expression that has emerged from the PPE community because it easier to say than 'PPE of complex design'.

  • How are gloves sterilised?
  • The most common method is using gamma irradiation whereby products are exposed to gamma radiation which is able to penetrate the packaging and kill all micro-organisms. Gamma processing does not cause any significant rise in temperature or leave behind any chemical residue. All of our products are processed to a Sterility Assurance Level of 10-6.

  • What does SAL 10-6 mean?
  • A Sterility Assurance Level of 10-6 means that for every 1,000,000 items sterilised there may be one that contains bacteria that have survived the sterilisation process. The SAL is a statistical probability that is used because it is impossible to prove that all bacteria have been killed during the sterilisation process. In practice the theoretical degree of processing to achieve the desired SAL is determined, and then routine processing is set at a higher level in order to achieve 'overkill'.

  • How can I tell if gloves have been sterilised?
  • The packaging clearly shows they are sterile gloves.

    Each carton will have a red circular irradiation sticker, showing that the contents have been Gamma sterilised. The irradiation sticker is yellow prior to sterilisation and changes colour to red during processing.

    A Certificate of Irradiation is available showing the Lot No and Carton No and confirming that the gloves have been sterilised.

    They are, of course, more expensive than the non-sterile equivalent.

  • If gloves are sterilised by irradiation are they at all radio-active?
  • No. The Gamma rays pass straight through the packaging and the gloves and out the other side killing any bacteria on the way. It is a natural phenomenon of Gamma rays that they pass through objects without leaving any traces of radiation behind.

  • What is the shelf life of gloves?
  • Providing gloves are correctly stored in the right conditions, they do not have a fixed shelf life. In fact the stated shelf life can vary from product to product and is determined by a combination of industry norms and regulatory requirements. Sterile Gloves generally show an expiry date on the packaging which can be between 3 and 5 years from date of manufacture, as long as the integrity of the packaging is not compromised or damaged in any way.

  • Are my gloves suitable for use with Cytotoxic (Chemotherapy) drugs?
  • BioClean has a comprehensive range of gloves suitable for use in this highly specialized area. Gloves within the BioClean Chemo Safety Wear range have been tested against ASTM D6978-05 for a wide range of Cytotoxic drugs, recording excellent barrier performance under the ASTM defined permeation rates of 0.01µg/cm2/min - a level 100 times more stringent than that of EN374-3:2003. We will be pleased to supply further information on request.

  • What is the powder used in powdered gloves?
  • This is generally an inert, USP grade cornstarch powder. However, there are number of drawbacks associated with powdered gloves such as:

    Powder can act as a carrier for latex proteins, which can cause allergic reactions if inhaled.

    Powder can delay healing on scar tissue.

    Powder can absorb microorganisms and increase the risk of cross-infections.

  • Can all gloves be taken into a Cleanroom?
  • No. Cleanroom gloves should be powderfree, extra-clean and specially packed to minimise contamination in the cleanroom environment. All BioClean™ branded gloves are suitable for cleanroom use.

  • Are BioClean Gloves Anti-Static?
  • BioClean can specifically confirm that BioClean Nitrile, Vinyl and Polychloroprene Gloves have been tested to EN 1149-1 and found to be suitable for use where anti-static characteristics are required.

    Further information can be supplied on request.

  • Are any animal products used to manufacture gloves?
  • We cannot speak for competitors, but we can confirm that NO animal products are used in the manufacture of any BioClean products.

  • What are the storage guidelines for gloves?
  • Gloves should always be stored in the original packaging in a cool, dry and well ventilated area.

    Protect the gloves from dust, direct sunlight, moisture, X-ray, and excesses of temperature.

    Generally we recommend storage temperatures of between 5 and 35 degrees Centigrade.

  • Can I re-use the gloves?
  • The gloves are single use only and should not be re-used because they will be contaminated. The contamination will not be removed effectively with washing, and washing will also reduce the barrier properties of the gloves.

  • What is the easiest way to put on a glove?
  • To put a glove on the hand (known as donning) the hands should be clean and dry.

    Slide the glove into the hand and pull the cuff part of the glove onto the wrist and ensure a comfortable fit especially around the fingers.

  • Is there a recommended method for removing gloves?
  • Removing gloves (known as doffing) can be done safely by removing one of the gloves by peeling from the cuff down to leave it inside out. The removed glove should be held scrunched in the gloved hand and the glove removed from that hand in the same manner. The first glove will then be contained within the second glove and the pair can be disposed of in accordance with standard operating procedures.

  • Is there a recommended method for disposing of used gloves?
  • The method of glove disposal depends on how the glove was used. If the glove is contaminated with a toxic compound or biological material that is covered by any disposal regulations, the gloves must be handled in the same way as the toxic material itself. If gloves are not contaminated or have been properly decontaminated, either landfill or incineration is a satisfactory means of disposal (see below).

    Since ordinary aerobic or anaerobic decomposition processes in gloves will not form any toxic products, gloves may be disposed of in any landfill. Breakdown in landfill will be very slow except for products made of natural rubber. Incineration is an optimum choice, but glove disposal by incineration can lead to pollution by the release of toxins. However, a good incinerator unit will completely burn all types of gloves as well as any intermediate decomposition products formed during the process.

    The environmental impact of used-glove disposal has become an increasing concern for all industries. The factors that must be considered when choosing incineration or disposal in a landfill vary with material type:

    Combustion of natural rubber latex gloves is quite clean, although some hydrocarbons, minute quantities of unreacted nitrogen-based chemicals, and sulphur dioxide may be produced at low incineration temperatures. In a landfill, residual chemicals will leach out as the rubber bio-degrades.

    Incineration of vinyl gloves reduces the PVC to hydrochloric acid gas, minor residual chemicals, and ash. Under standard landfill conditions, vinyl is not biodegradable. However, esters of phthalic acid, which are used as plasticizers and make up about 50% of the total volume, will leach from the material if it comes in contact with nonaqueous solvents. Before choosing incineration for PVC gloves, users should ensure that local laws do not ban such a practice.

    Nitrogen-based reaction products are released minimally during incineration of nitrile gloves; the other chemical by-products are similar to those produced by natural latex. In a landfill, residual chemicals such as accelerators will leach out, as they do in rubber gloves; the nitrile itself will resist degradation.

    Polychloroprene gloves release hydrochloric acid gas, carbon monoxide and dioxide, various hydrocarbon and partially oxidised hydrocarbon and partially oxidised organic compounding chemicals during incineration and they are not biodegradable. Always comply with local regulatory agencies rules for proper disposal.

    If you have any questions or concerns that are not covered here then please contact us and we will be pleased to help.

  • What is the best material for protection against IPA?
  • Polychloroprene gloves are far superior to latex, nitrile and vinyl for protection against IPA. Our BioClean Ultimate (BUPS) polychloroprene gloves have been tested to provide over 480 minutes breakthrough time against 100% IPA.

  • Why would people double don gloves?
  • We recommend double donning gloves to provide extra protection. The more layers, the more protection against chemicals. Also, double donning limits the chance of penetration through pinholes. Statistically, there is a very low chance of two pinholes being in exactly the same place on two gloves.

  • Why would I use a 12"/16" glove?
  • You would use a 16" glove if you want more protection up to the elbows when covering the sleeve. Also, a 16" glove will hold the sleeve in-place better than a 12" glove. There is growing interest in 16" gloves because of these benefits. Our BioClean N Plus (BNPS) 16" Nitrile Glove provides such protection.

  • BioClean BarrierPlus™ Gauntlets are 100% inspected, how?
  • BioClean's BarrierPlus Gauntlet manufacturing process has five separate product inspections throughout. Each gauntlet is visually inspected 100% for holes, along with water and air pressure testing. This is achieved by the gauntlet being filled with air to a specified pressure before being submerged underwater for three minutes. The water is checked for any bubbles identifying whether the product has a pinhole leak. This 100% inspection guarantees delivery of a gauntlet free from holes, and is more rigorous than the AQL approach for surgical gloves which is based on a statistical sampling plan.

  • With increasing concerns about allergic reactions to latex products, what can you tell me about latex allergies?
  • Like any substance derived from natural resources latex can cause an allergic reaction. Whilst rare, allergic reactions to latex can be highly dangerous. The proteins present in latex are the component that cause the allergic reaction. Detailed below are the different types of allergic reactions associated with latex and their symptoms.

    • Irritant Contact Dermatitis. The most common allergic reaction to latex products is Irritant Contact Dermatitis. Symptoms of this include dry and itchy skin usually found on the hands. This reaction may be caused by skin irritation from using gloves. It is worth bearing in mind that the reaction detailed above can also by caused by use of cleaners and sanitization products. Powders added to certain gloves can also cause Irritant Contact Dermatitis.
    • Allergic Contact Dermatitis. This reaction is delayed, with no immediate sign of an allergic reaction. Allergic Contact Dermatitis results from exposure to chemicals added to latex during harvesting, processing, or manufacturing. The rash usually shows 24 to 48 hours after contact and may cause the skin to blister.
    • Latex Allergy or Immediate Hypersensitivity. This can result in a more serious reaction to latex than Irritant Contact Dermatitis or Allergic Contact Dermatitis. Certain proteins in latex may cause sensitization. The exact amount of exposure required to cause a reaction is unknown, however even very low levels can trigger allergic reactions in more sensitive individuals within seconds after exposure. Mild symptoms include skin redness, hives, or itching. More severe reactions may involve respiratory symptoms such as runny nose, sneezing, itchy eyes, scratchy throat, and asthma (difficulty breathing, coughing spells, and wheezing).
    There are ways in which you can lessen the possibility of latex allergies happening. Each employer should always offer a non-latex alternative such as polychloroprene (Neoprene), nitrile and vinyl gloves. If latex gloves are a necessity then the employer should provide a low protein, powder free latex glove as some chemicals found in the powder used in latex gloves can cause similar reactions to those detailed above. Employees can also lessen the risk by only using the gloves when it is necessary.

Disposable Garments

  • What is the material used?
  • This is our proprietary Clean-tough™ material which is spun bonded non-woven polypropylene laminated with a film of polyethylene. This allows comfort and flexibility during use and protection against fine sprays and particles.

  • What about the seams? How are they constructed?
  • The seams are just one of the areas where the BioClean-D range of disposable garments displays superior design features normally found only in high quality reusable garments. The seams are bound with an extra piece of material for maximum barrier protection and strength covering all raw edges to minimize particle shedding.

  • Does the zip area provide the same level of protection?
  • Yes - providing the garment is correctly worn. The zip has a protective flap of Clean-tough™ material which can be closed over the zip once it has been pulled up. Double sided tape on the reverse of the zip flap allows it to be secured in place so that it covers the zip completely and does not open up during movement.

  • I have noticed that there is an information sheet packed with the garments. Won't the sheet contaminate the cleanroom when the garment is unpacked?
  • No. The information sheet is printed on non-particulating, cleanroom compatible paper.

  • What is the material used?
  • This is our proprietary Clean-tough™ material which is spun bonded non-woven polypropylene laminated with a film of polyethylene. This allows comfort and flexibility during use and protection against fine sprays and particles.

  • What about the seams? How are they constructed?
  • The seams are just one of the areas where the BioClean-D range of disposable garments display superior design features normally only found in high quality re-usable garments. The seams are bound with an extra piece of material which allows maximum barrier protection and strength and covers all raw edges to minimize particle shedding.

  • Does the zip area provide the same level of protection?
  • Yes - providing the garment is correctly worn. The zip has a protective flap of Clean-tough™ material which can be closed over the zip once it has been pulled up. Double sided tape on the reverse of the zip flap allows it to be secured in place so that it covers the zip completely and does not open up during movement.

  • What does the CE mark on products signify?
  • Any product that is regulated in Europe by the application of a European Directive has to bear the CE Mark. The CE Mark is the manufacturer's declaration that the product complies with all of the requirements of applicable Directives.

  • Why do some CE marks have a number next to them?
  • The CE Marking Directives allow different levels of regulatory certification based on the relative risk levels associated with the use of the device. Low risk devices can be CE marked by the manufacturer without reference to regulatory authorities and are marked with the CE logo only. Higher risk devices can only be CE marked once they have been approved by a certification company that has been accredited by the regulatory authorities. The accredited certification company is known as a Notified Body and each Notified Body has a unique reference number issued by the Council of Europe. Higher risk devices are required to be marked with the CE mark and the number of the Notified Body that was involved in its approval. BioClean products are marked with CE 0120 where the 0120 is the Notified Body number of SGS UK Ltd.

  • The label states PPE Category 3 Type 5/6 - what does this mean?
  • The Personal Protective Equipment (PPE) Directive (89/686/EC) defines items providing protection into various categories. Garments are generally referred to as simple design - in which case they are Category 1, or complex design - which are Category 3.

    All PPE Products must be CE marked and any Cat 3 PPE item has to be examined and approved by a Notified Body before it can be brought to market. Cat 1 will have a simple CE mark and Cat 3 will have a CE mark plus the number of the Notified Body e.g. 0120 which is the number for SGS Ltd.

    Part of the examination process includes evidence of testing. Within Category 3 there are various levels of protection. The BioClean-D range meets the requirements of Type 5 & 6 which are as follows:

    Type 5: Confirms the ability to withstand fine dry particles

    Type 6: Confirms the ability to withstand exposure to a light spray, liquid aerosols or low pressure, low volume splashes, against which a complete liquid permeation barrier (at the molecular level) is not required.

  • What is the difference between Type 5 & 6 and Type PB[5] & Type PB[6]?
  • The coveralls are designed to provide whole body protection and these are covered under Type 5 & 6. However, there are also items in the BioClean-D range which cover just part of the body e.g. sleeve covers. Because these only provide partial body protection they are referred to as PB[5] & PB[6].

  • What is meant by chemical permeation and penetration?
  • Chemical permeation is the passage of a chemical through a barrier layer at a molecular level. Molecules of the chemical are absorbed by the barrier material and as the number of molecules absorbed increases, the chemical gradually works its way through the material and out of the other side. By way of illustration, imagine a layer of dry sponge that has a trickle of water poured upon it. At first the water sits on the surface of the sponge. It then starts to soak in and as it does so it spreads out throughout the sponge. As more water is poured on, the sponge 'fills up' until the volume held reaches the point of saturation and water starts to trickle from the opposite side. The trickle of water emerging will increase in volume until a steady rate of flow is reached.

    Chemical penetration is a much simpler mechanism whereby the chemical passes through holes in the barrier. The illustration for this mechanism is that of a polythene bag full of water. If the polythene is intact the water will stay in place. If the polythene has any holes (e.g. pinholes) the water will penetrate and escape.

  • Are the garments anti-static?
  • Yes. Anti static garments are available which meet the requirements of EN1149-1:2006 i.e. they have a surface resistance less than 5 x 1010 Ω.

    These require extra manufacturing processes which increases the cost slightly. Many users do not require anti-static garments so we do have both versions available. Please be sure to specify which type you require when placing your order.

  • Are the garments suitable for use in cleanrooms?
  • We follow the IEST recommended practice which covers garment system considerations for cleanrooms and other controlled environments. (IEST-RP-CC003.3)

    There are a number of recommendations regarding the construction of the garment, as well as the materials to be used in its construction. We use these guidelines as the basis for our own construction, e.g. the threads should be synthetic, non-particulating and suitable for sterilisation, and of the materials recommended, one is non-woven. Our garments are constructed on this basis. Additionally, there are a number of ways recommended for closing the seams on the garment. We choose bound seams as we find this is the best way to prevent particulation as this system completely seals the seams, stopping particulates from escaping.

    Additionally, we conduct, according to the standard, particle shedding analysis using the Helmke drum test. The results are well under the limit set for category 2 on the Helmke Drum classification.

    There are no solid rules, or pass / fail criteria for ISO Cleanroom compatibility. Much surrounding the suitability of Cleanroom consumables will depend on the manner in which they are used. For example, if the operator is sitting still for most of his or her working day, the likelihood is that their garment / gloves etc. will generate far less particulates than an operator who is constantly moving around while working.

    What we do is to ensure that our garments are as particulate free as possible when they are packed. We also ensure that they are constructed in such a way as to minimise any opportunities for particulation to occur. In this, we can say that our garments are suitable for use in an ISO Class 4 cleanroom.

    The packaging is printed with IPA resistant ink to ensure there is no contamination and each bag has an 'easy-tear' opening. The products are packed in a carton liner which is sealed with a twist tie to prevent contamination.

  • How are garments sterilised?
  • The most common method is using gamma irradiation whereby products are exposed to gamma radiation which is able to penetrate the packaging and kill all micro-organisms. Gamma processing does not cause any significant rise in temperature or leave behind any chemical residue. All of our products are processed to a Sterility Assurance Level of 10-6.

  • What does SAL 10-6 mean?
  • A Sterility Assurance Level of 10-6 means that for every 1,000,000 items sterilised there may be one that contains bacteria that have survived the sterilisation process. The SAL is a statistical probability that is used because it is impossible to prove that all bacteria have been killed during the sterilisation process. In practice the theoretical degree of processing to achieve the desired SAL is determined, and then routine processing is set at a higher level in order to achieve 'overkill'.

  • If garments are sterilised by irradiation are they at all radio-active?
  • No. The Gamma rays pass straight through the packaging and the garments and out the other side killing any bacteria on the way. It is a natural phenomenon of Gamma rays that they pass through objects without leaving any traces of radiation behind.

  • Can non-sterile garments be sterilised?
  • No. To ensure similar performance of both options, the starting products for each variant is not identical and therefore non-sterile garments should not be Gamma irradiated as this causes significant deterioration in some of the materials used for non-sterile garments.

  • How do I know the garments are sterile?
  • The product code for all sterile items in the BioClean-D range of garments starts with S-.

    The outer carton clearly shows sterile product as a description. The irradiation sticker on the top left hand corner of each bag will be red.

    The irradiation sticker is yellow prior to gamma sterilisation and changes colour during processing.

    A certificate of Irradiation is available showing the Lot No and Carton No, confirming that the garments have been sterilised.

    The BioClean-D range of disposable garments have successfully passed a full sterility validation.

    They cost more than the non-sterile equivalent.

  • What other items are there in the range?
  • The BioClean-D range of garments is comprehensive and includes the following in both sterile and non-sterile options:

    Coverall with Hood

    Coverall with Collar

    Sleeve Covers

    Lab Coats

    Hoods

    Overboots

  • Can I re-use the garments?
  • The garments are single use only and should not be re-used because they will be contaminated. Also, the opening of the zip cover flap may well destroy the coverall. Laundering BioClean-D garments destroys the Clean-tough material causing delamination of the layers and considerably weakening the structural strength of the garment.

  • Is there a recommended method for disposing of used BioClean-D garments?
  • The method of garment disposal depends on how it was used. If the garment is contaminated with a toxic compound or biological material that is covered by any disposal regulations, the garment must be handled in the same way as the contamination material itself. If the garment is not contaminated or has been properly decontaminated, either landfill or incineration is a satisfactory means of disposal. Since ordinary aerobic or anaerobic decomposition processes in garments will not form any toxic products, they may be disposed of in any landfill. However, breakdown in landfill will be very slow. Incineration is an optimum choice and since Polypropylene and Polyethylene only consist of hydrogen and carbon atoms, in an incineration plant only water and carbon dioxide are produced.

  • What is the shelf life of garments?
  • Providing garments are correctly stored in the right conditions, they do not have a fixed shelf life.

    Sterile garments generally show an expiry date on the packaging which is 3 years from date of manufacture, as long as the integrity of the packaging is not compromised or damaged in any way.

  • What are the storage guidelines for garments?
  • Garments should always be stored in the original packaging in a cool, dry and well ventilated area. Protect the garments from dust, direct sunlight, moisture, X-ray, and excesses of temperature. Generally we recommend storage temperatures of between 5 and 35 degrees Centigrade.

  • Why is the expiry date not mentioned on the Certificate of Irradiation?
  • The Certificate of Irradiation cannot state the expiry date of the product. Irradiation is carried out by Sterigamma and they have not part in setting the expiry data of any products that they process. It is the manufacturer's responsibility to do that. The only information that Sterigamma are allowed to put on the Certificate are product identification data and data that they are directly responsible for, e.g. date for sterilisation, max and min dose.

  • Why is aseptic donning so important?
  • The purpose of a cleanroom garment is to protect the product or process from contamination caused by the wearer. With the average wearer dispersing millions of particles (including skin, hair, perspiration) from their bodies every minute, and a square inch of skin on average harbouring 32 million bacteria, the potential to spread contamination is great!

Facemasks & Veils

  • Why are sterile facemasks more expensive than non-sterile ones?
  • This is not just because of the sterilisation processing costs. Our standard non-sterile masks are made from polypropylene, which is a relatively inexpensive material. Unfortunately polypropylene degrades when it is sterilised by irradiation seriously compromising its filtration performance. To obtain acceptable filtration performance after irradiation the masks have to be made from the more expensive polyester, which does not suffer the same reaction.

  • What does BFE, PFE & Delta P mean?
  • When selecting a facemask for cleanroom use it's important to choose one with the right filtration efficiency for the level of protection needed. The BFE % of a facemask is the measurement of bacterial filtration efficiency and PFE % is the measurement of particle filtration efficiency. Facemasks with a high BFE and PFE % are recommended for use in cleanrooms, ensuring high filtration of both bacteria and particles. The ΔP symbol stands for Differential Pressure (Delta P) and refers to the pressure drop across a facemask (or the resistance to air flow) and is measured in mmH2O/cm2. Therefore higher the Delta P of the facemask the less breathability but the better the filtration.

Goggles

  • How can I monitor the number of autoclave cycles the goggles I'm using have been subjected to?
  • - Before autoclaving the BCAG or BCAP BioClean Clearview Cleanroom goggles for the first time, mark each goggle with a unique number on the inside of the frame (not outside) with an indelible, steam resistant marker. This can be sequential numbers for example, if a quantity of 500 pieces is purchased, then mark them from #1 to #500. - At the same time, create a document listing the number of times each numbered goggle has been processed. So, for example the document could be called "GOGGLE CYCLE COUNT - BCAP 1" on which is listed the individual goggle number applied to each goggle, and the number of times it has been autoclaved. By doing this, the number of autoclave cycles can be easily tracked. - If a customer prefers not to use an indelible marker, an alternative solution is to use a steam resistant, individually numbered tag that can be applied/fixed to the goggle strap, bearing in mind that it would be looser and not so secure as an indelible mark. Therefore, we would recommend using the indelible marker on each goggle as above as the most appropriate way of numbering the goggles.

  • How to prevent autoclavable goggles from fogging up
  • BioClean™ autoclavable goggles are not anti-fog treated before delivery because the permanent anti-fog film will not withstand multiple autoclaving. Instead, if fogging is a problem, use BioClean sterile anti-fog spray - a few sprays onto the inside of the lens, wiped dry with a sterile wipe will help reduce the effects of fogging.

Wipes

  • What tests should you look for when choosing a wipe?
  • Wipes should be extensively tested to IEST-RP-CC003.3 Helmke Drum test for particle release and IEST-RP-CC004.3 for the physical properties including NVR (nonvolatile residue), extractables, absorption capacity and absorption rate. BioClean wipes are tested using these test methods, with results available on request.

Accessories

  • How do BioClean sterile bags differ from standard polythene bags?
  • BioClean Sterile Bags are manufactured from low-density ultraclean polythene produced entirely within a cleanroom environment. Because the material is free of additives, there is virtually no contamination from particulates, surface leaching chemicals or outgassing. BioClean sterile bags are suitable for general-purpose use, ideal as waste bags, transportation bags or storage bags and commonly used within the pharmaceutical, medical, semiconductor, aerospace and many other industries.

  • What are Pharma Covers?
  • Manufactured from Tyvek®, BioCleanâ„¢ Pharma Covers provide a microbial barrier against environmental impurities during product storage, transportation and processing. The form-fitted covers have a high quality elasticated band for a secure fit, are autoclavable and available in a large range of sizes - ideal for pipes, beakers, media bottles, flasks and even stopper bowls. Lint-free, moisture and puncture resistant, these covers are essential for critical environments where product protection is paramount.

Reusable Garment

  • What is the difference in the quality of the fabrics?
  • The fabric MT12 is a plain weave and has excellent filtration properties. It can be irradiated and is suitable for all cleanroom classifications from ISO 4 (Grade A and B) through to ISO 7 (Grade C) and ISO 8 (Grade D). The fabric MT031 is a twill weave as opposed to a plain weave and has a slightly heavier unit weight, making this fabric feel more silky. It is also suitable for all classifications of cleanroom as above. The fabric MT811 is a twill weave fabric but its filtration performance at the smallest particle sizes is not quite as good as MT12 and MT031, which makes MT811 suitable for ISO 7 (C) and ISO 8 (D).

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