Sterile Products

We provide microbiological testing of sterile products in a sterility test suite with two half-suit workstation isolators, four transfer isolators, an autoclave isolator integrated with a GMP sterilizer, and three VHP 1000 units. Testing services include: Sterility Endotoxin Particulate Matter Microbial Immersion Studies H2O2 D-Value Studies AAMII Sterilization Validation Media Fills Organism Identification   Literature "Isolators in a Contract Laboratory - Sample and Product Management Considerations" presentation by Mark W. Kaiser, Manager, of Pharmaceutical Microbiology and Stability Services "Meeting the Challenges of Environmental Monitoring in Isolators" presentation by Mark W. Kaiser, Manager, of Pharmaceutical Microbiology and Stability Services