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Sterile clothing and cleanroom garments are becoming a requirement in many different industries. Aseptic critical environments and clean rooms are increasing in popularity especially in pharmaceutical compounding and medical device manufacturing. Cleanroom Connection is the leading source for all styles of sterile clothing for all industries that utilize clean rooms. Sterilized garments are individually packaged…
Cleanroom Apparel for Sterile Compounding Pharmacies Cleanroom Connection is an authorized master distributor for BioClean, one of the leading high-quality manufacturers of sterile compounding cleanroom supplies and protective apparel. USP 797 and USP 800 compliance has updated many of the gowning requirements, cleanliness needs, and types of sterile compounding cleanroom apparel and supplies that must…
Sterile cleanroom gowning and cleaning supplies are becoming the norm as compounding regulations are updated and becoming more strict. In addition to the requirement of non-shedding lint-free cleanroom apparel to be worn over your clothing, new regulations are calling for various apparel and cleaning products to be sterile as well. Cleanroom Connection is the leading…
Transitioning a compounding pharmacy to a compliant 503b outsourcing facility is challenging. Our cleanroom consultants specialize in conversion to and maintaining compliance for outsourcing facilities. Following the Drug Quality and Security Act made effective November 27, 2013, the 503b section in the FDCA applies. Under this 503B section a sterile compounding pharmacy must register as…