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PRODUCTION/MANUFACTURING Frequently Asked Questions

Which gloves should I use if I need ESD properties?

Nitrile, vinyl and polychloroprene gloves are good for ESD properties. Latex gloves are not suitable if ESD properties are needed.

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Where can I find the product test reports?

Product data sheets are used to present information about our products to customers in an easy-to-digest format. If you have specific queries about a product, we can provide detailed answers and reports. For some of our products there is a lot of information available, and for a number of those we have compiled product validation packs.

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What are the certifications of your cleanroom gloves?

All our CE-marked cleanroom gloves are certified to comply with the requirements of the Personal Protective Equipment Directive (PPE), Directive 89/686/EEC. Under the terms of the directive our gloves are classed as PPE of complex design (also known as Category III). The certificate gives us the authority to CE mark our gloves and claim that they satisfy the essential safety requirements of Directive 89/686/EEC, in accordance with the following standards below: EN 420:2003:      Protective gloves – general requirements EN 374-1:2003:    Protective gloves against chemicals and microorganisms. Terminology and performance requirements EN 374-2:2003:    Protective gloves against chemicals and microorganisms. Determination of resistance to penetration (LEVEL 3) EN 374-3:2003:    Protective gloves against chemicals and microorganisms. Determination of resistance to permeation by chemicals

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How long can cleanroom masks be worn?

As far as we are aware, there is no recommendation or code of practice that stipulates the length of time that a mask can be worn before it must be changed. Indeed every individual and every environment is different, so the length of time that a particular mask can be worn for depends on the conditions and should be assessessed by the company operating the cleanroom. In practice, due to regular comfort breaks during a work shift, the reality is that masks (along with gloves) will be changed every two to three hours, and so the question of the maximum amount of time that a mask can be worn becomes academic.

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I am concerned about the safety of my EtO sterilized 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.  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. With regard 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.

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Are my gloves suitable for use with cytotoxic (chemotherapy) drugs?

We have a comprehensive range of gloves suitable for use in this highly specialized area. Gloves tested against ASTM D6978-05 for a wide range of cytotoxic drugs recorded excellent barrier performance under the ASTM-defined permeation rates of 0.01µg/cm2/min, a level 100 times more stringent than that of EN16523-1:2015. We are pleased to supply further information on request.

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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 a PPE of complex design, i.e. Category 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. Category 1. So any glove that is intended to protect against anything other than the weakest of chemicals is a Category 3 glove.

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How are gloves sterilized?

The most common method is using gamma irradiation, whereby products are exposed to gamma radiation which penetrates the packaging and kills all microorganisms. 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.

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What does SAL 10-6 mean?

A Sterility Assurance Level of 10-6 means that for every 1,000,000 items sterilized there may be one that contains bacteria that have survived the sterilization process. The SAL is a statistical probability that is used because it is impossible to prove that all bacteria have been killed during the sterilization 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'.

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How can I tell if gloves have been sterilized?

The packaging clearly shows they are sterile gloves. Each carton will have a red irradiation sticker, showing that the contents have been gamma sterilized. The irradiation sticker is yellow prior to sterilization and changes color to red during processing. A certificate of irradiation is available showing the lot number and carton number and confirming that the gloves have been sterilized.

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Can all gloves be taken into a cleanroom?

No. Cleanroom gloves should be powderfree, extra clean, and specially packed to minimize contamination in the cleanroom environment. All BioClean branded gloves are suitable for cleanroom use.

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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.

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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.

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Why would I use a 12"/16" glove?

You would use a 16" glove if you want 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.

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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.

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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 Category 3 PPE item has to be examined and approved by a notified body before it can be brought to market. Category 1 will have a simple CE mark and Category 3 will have a CE mark and 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 and 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.

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What is the difference between Type 6 and Type PB[6]?

The coveralls are designed to provide whole body protection against light liquid spray and these are covered under Type 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[6].

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Are the garments anti-static?

Yes. Anti-static garments are available which meet the requirements of EN1149-5, i.e. they have a charge half-decay time of <4 seconds. These require extra manufacturing processes, which increase the cost slightly. Many users do not require anti-static garments so we offer both versions. Please be sure to specify which type you require when placing your order.

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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-CC005.4) There are a number of recommendations regarding the construction of the garment, as well as the materials used in its construction. We follow these guidelines as the basis for our construction, e.g. the threads should be synthetic, non-particulating, and suitable for sterilization, and the basis of the materials we use, such as non-woven. Additionally, there are a number of ways recommended for closing the seams on the garment. We use bound seams as this is the best way to prevent particulation, completely sealing the seams and stopping particulates from escaping. Additionally, we conduct 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 will depend on the manner in which the cleanroom consumables are used. For example, if the operator is sitting still for most of his or her working day, the likelihood is that her garment / gloves, etc. will generate far fewer particulates than an operator who is constantly moving around while working. We 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 minimize any opportunities for particulation to occur. Because of 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.

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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, and perspiration) from their bodies every minute, and a square inch of skin on average harboring 32 million bacteria, the potential to spread contamination is great.

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What does BFE, PFE & Delta P mean?

When selecting a face mask for cleanroom use it's important to choose one with the right filtration efficiency for the level of protection needed. The BFE % of a face mask 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 Delta P symbol stands for Differential Pressure (Delta P) and refers to the pressure drop across a face mask (or the resistance to air flow) and is measured in mmH2O/CM2. A lower Delta P indicates easier breathing, however higher filtration efficiency generally increases the Delta P.

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What is the difference between a Certificate of Irradiation (COI) and a Certificate of Processing (COP)?

The Certificate of Irradiation (COI) refers to products that are gamma irradiated, and the Certificate of Processing (COP) refers to products that are processed with ETO (e.g. goggles).

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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 contaminated material itself. If the garment is not contaminated or has been properly decontaminated, incineration is a satisfactory means of disposal. Incineration is the optimum choice, and since polypropylene and polyethylene consist of only hydrogen and carbon atoms, incineration produces only water and carbon dioxide.

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