Meet USP [797] Air Viable Particulate Certification Requirements
Based on USP [797] Guidance, to be effective May 1, 2008, Air Viable (microbial) particulate counts are required along side Total Air Particulate counts for Sterile Compounding Facility Certification. With the R2S or RAS Air Samplers alongside your total air particulate laser particle counter, you can meet both of these requirements. With the R2S, or RAS you can monitor bulk production, or support rooms (i.e., ISO 7 and ISO 8), as well critical ISO 5 environments (i.e., Rooms, LAF Hoods and Isolator Barriers) with the knowledge that you won't add additional contaminants to that environment. As with a laser particle counter, the sampling probe, in this case the sampling head, is placed into the critical environment without the controller unit, significantly reducing the introduction of unwanted particulate matter into the critical zone your are certifying.
(Refer to Pages 22-24 for Environmental Air Viable Testing Requirements)
USP_[797] Reference Copy
