On the production and use of clean clothes

The production and development of all technologies are based on the needs of production, so is the clean technology At the beginning of the second industrial revolution, there were many incidents of unqualified products caused by the pollution of field workers in the fields of medical devices and pharmaceutical industry In response to these problems, the American Institute of Environmental Sciences (ies) has set up several working groups to record and standardize the rich practical experience in the above industries The shared practical experience of pollution control has been recommended by the Institute of environmental science and Technology (iest) These recommended methods have also become the basis of ISO14644 standards for clean room and related clean room environment The current version of the relevant regulations of clean clothes is iest-rp-cc003.4 issued in 2011 1 There are three types of fabrics and weaving types of structural textile industry: woven, knitted and non-woven 100% filament polyester or polyester carbon composite fiber is selected as woven fabric to minimize particle shedding, which is often used as a reusable clean room fabric Knitted fabrics are not usually used in clean rooms Nonwoven fabrics are mainly used for the weaving of polyolefin fiber disposable clean clothes, including spunbond and thermal bonding, spunbond / melt blown / spunbond (SMS), microporous film laminate, etc Different weaving structures can also affect the performance of products Polyester / carbon mesh fabric is designated for microelectronics and spraying cleanroom industries, while polyester / carbon stripe fabric is designated for medical equipment, pharmaceutical, biopharmaceutical and food cleanroom industries Take anti-static dust-free clothing as an example There are three kinds of fabrics: 0.5 strip, 0.5 grid and 0.25 grid The more dense the anti-static performance is, the better 2 The common tests of clean room clothing include weight, thickness, tear strength, wet steam permeability, permeability, pore size, hydrostatic pressure, flammability, surface resistivity, electrostatic attenuation, bacterial filtration efficiency, etc In addition, several recommended test items for clean room clothing are listed in iest-rp-cc003.4 2.1 particle interception rate and falling off detection iest-rp-cc003.4 it is recommended that the clothing used in the clean room conform to the class I particle cleanliness measured by Hank roller The classification table describes the cleanliness category with the size range of 0.3um-0.5um In addition, the particle interception rate of the whole clothing system from inside to outside was tested in 100% HEPA filter environment Microbial penetration tests assess the ability of clothing fabrics to prevent the penetration of viable and infeasible particles A combination of the results of all these tests provides a comprehensive assessment of the interception and shedding of reusable cleanroom fabrics or clothing 2.2 sterilization verification if the sterilization method is gamma radiation or electron beam radiation, the clean room materials used in the sterile clean room must be tested for radiation dose in accordance with iso11137-2 and verified for sterility assurance level in accordance with ISO 11137-1 Gamma radiation sterilization is preferred for disposable clean clothes, and wet heat sterilization can be selected for reusable clean clothes, but relevant test reports such as sterilization times and material performance are required In general, FDA stipulates that the aseptic grade of 10-6 Sal shall be met during the production of products and raw materials in aseptic cleanrooms 3 It is recommended to use disposable clean clothes when toxic and harmful products are produced, drug quality requirements are high, and clothing cleaning service resources are low Because of the large amount and high cost of clean clothes, reusable clean clothes can be used Of course, considering the strict requirements of drug quality and stable production needs, disposable clean clothes are still 4 Many laws and regulations on aseptic dressing process have relevant regulations on dressing process China's new GMP stipulates that "dressing and hand washing should be carried out in accordance with the operating procedures, which may reduce the pollution to the clean area or bring pollutants into the clean area." In general, hand washing facilities can only be installed at the stage of changing clothes "The cGMP of the United States points out that" personnel engaged in the production, processing, packaging or storage of drugs should wear clean clothes suitable for their duties, and wrap their heads, faces, hands and buttocks to prevent drug contamination "The FDA guidelines mention that" only qualified personnel can wear appropriate clothes before they are allowed to wear them " Enter sterile manufacturing area " , "sterile gloves must be sterilized or replaced frequently after changing clothes", which shows the importance of standardized sterile changing process in avoiding pollution and controlling risks The primary specification of disposable and reusable clean clothes should be to wear them correctly all the time and to protect the products and processes produced in clean rooms Keep in mind the principle of aseptic dressing process, that is, aseptic surface can only contact aseptic surface, non aseptic surface can only contact non aseptic surface Correct aseptic dressing process can effectively prevent virus, bacteria, dust particles, fibers and other high-risk pollutants from polluting the clean area or aseptic area The following figure is the dressing procedure for entering the A / b clean area, FYI (for reference only) 5 The cleaning process of reusable clean clothing standard is defined in the cleaning and sterilization process of clean room clothing iest-rp-cc003.4 It specifies that cleaning of clean clothes requires linear process flow and closed-loop service, including the use of non-ionic surfactants with known ingredients and residue determination as detergents, softened and filtered washing water or reverse osmosis pure water, 18m Ω, 0.22um filtered deionized water and HEPA filtered air for drying (HEPA can effectively intercept 0.3um particles , the efficiency is up to 99.999%) The washed clothing should be folded in a higher level clean area, and packaged independently and in multiple layers The sterilization method can be gamma radiation sterilization or damp heat sterilization Store the packed clean clothes on the special shelf at the entrance of the clean room In the clothing storage area, specially trained staff will wipe the surface of the outer package to control the potential pollution (usually sterile or non sterile 70% isopropanol) during the storage and changing process At the same time, the laminar flow protection in the clean room can effectively control the number of particles in the clean room until they are used