by Pharmacy Directors. USP 797 requires that sterile drug compounding pharmacies maintain these documents in writing for all relevant operational compounding procedures. Some.... U.S. federal agencies demand that such documentation be specific and in general use in any given sterile drug compounding pharmacy service. Microtest develops client-specific... with industry, hospitals, and regulators in both microbiological testing and sterile drug compounding. All documents are customized to the specific layout, equipment, personnel...

and testing. These analyses insure that pharmacies end-product compounded sterile drug preparations (CSPs) are safe and effective for patient administration. Our testing menu includes... the following: Stability validation Sterility Shelf-on life dating Potency Endotoxin Your Pharmacy Service arranges for delivery of the CSP samples to Microtests FDA-registered...

Bioburden LAL (Endotoxin) Sterility Microbial Limits Analytical Virology TOC/Conductivity Reusable Studies Environmental Category 2: Select One Bioburden LAL (Endotoxin) Sterility... Microbial Limits Analytical Virology TOC/Conductivity Reusable Studies Environmental Category 3: Select One Bioburden LAL (Endotoxin) Sterility Microbial Limits Analytical Virology... TOC/Conductivity Reusable Studies Environmental Category 4: Select One Bioburden LAL (Endotoxin) Sterility Microbial Limits Analytical Virology TOC/Conductivity Reusable Studies...

States Pharmacopeia Chapter 797, Pharmaceutical Compounding: Sterile Preparations. Pharmacies inspected anytime after that date that fail to comply are risking exposure to patient... monitoring. We have everything that directors of sterile drug compounding pharmacies require both within hospitals and independent operations to respond to their urgent compliance...

USP 797 Environmental Monitoring Environmental Monitoring Per USP 797 regulations, sterile drug compounding pharmacies must develop and implement a microbial monitoring program... for their sterile drug compounding suites [Clean room] and compounding hoods. Schedules for viable air sampling programs plus mandated microbial alert and action count levels...