Have you been keeping track of the recent developments in cleanroom apparel requirements? Have you already begun incorporating the updated EU GMP Annex 1 chapter regarding personal protective equipment (PPE) into your Contaminations Control Strategy (CCS)? If not, please read on and learn about the impact of the new specifications regarding PPE for cleanroom personnel, specifically socks.
In section 7, Personnel, paragraph 7.14 specifies, ‘Outdoor clothing (other than personal underwear) should not be brought into changing rooms leading directly to Grade B and C cleanrooms. Facility suits, covering the full length of the arms and the legs, and socks covering the feet, should be worn before entry to change rooms for Grades B and C. Facility suits and socks should not present a risk of contamination to the gowning area or processes’.
Did you know that one common everyday sock generates on average 44,000 particles? This means socks worn outside the cleanroom setting are simply unsuitable for a sterile contamination-controlled environment. Fortunately, Berkshire’s BCR® and Choice® Cleanroom Socks offer a solution that meets the specifications of this EU update.
Berkshire’s BCR® Cleanroom Socks offer an outstanding alternative insofar as they generate only 22 particles per sock – in other words, a massive 43,978 fewer particles per piece. Engineered with 96% microdenier nylon and 4% Lycra, this footwear is crafted with enhanced wicking capabilities that make it cool and soft for even the most extended periods of use. In addition, the fabric is hard-wearing, resisting degradation by heat, sweat, oils, and the normal shedding of skin particulates.
Choice® Cleanroom Socks are made of 99% continuous filament polyester and 1% spandex. They generate only 120 particles per sock, for an impressive 43,880 fewer particles entering a cleanroom. They offer operator comfort with a mid-calf length with an elastic cuff for a secure fit.
Both socks share the following features:
- Meet the requirements of EU GMP Annex 1 section 7.14
- Designed and manufactured principally for cleanroom applications
- Over 1,000 times cleaner than regular cotton/polyester socks
- Low fiber shed
- One size fits all – ambidextrous for easy stock control
- Incredibly soft and comfortable; designed for all-day wear
- Color: White