Custom Environmental Isolate and Objectionable Organism Controls
Your strain. Your format. Your convenience.
We simplify environmental isolate and objectionable organism testing by providing a
complete solution to help you meet FDA, USP and other regulations and guidelines. Using
your environmental isolate or targeted objectionable organism, we manufacture test-ready
controls quantitated for specific methods including:
- Antimicrobial Effectiveness Testing - USP <51>
- Aseptic Processing Environment - USP <1116>
- Disinfectant Qualification - USP <1072>
- Growth Promotion Testing - USP <60>, <61>, <62>, <71>
- Method Suitability - USP <51>, <60>, <61>, <62>, <71>
- Validation of Neutralization Methods - USP <1227>
- Water for Pharmaceutical Purposes - USP <1231>
Example Strains and Formats
We have developed custom environmental isolate and objectionable organism controls
for thousands of pharmaceutical and personal care manufacturers. If you are
curious about our capabilities, check out the lists below to see examples of
strains we have successfully developed in various Microbiologics product formats.