Microbiological QC and Safety
Biovian performs several standard QC tests upon the customer’s raw materials, product intermediates and end products. Biovian QC-laboratory complies with the Ph.Eur. and USP as required.Services includes but are not limited to:
- Sterility testing (Ph.Eur, USP, membrane filtration and direct inoculation)
- Bioburden (Ph.Eur, USP)
- Test for specified organisms (Ph.Eur) eg. E. coli, Ps. aeruginosa
- Endotoxin testing (Ph.Eur, USP), Limit test (gel clot), quantitative (kinetic chromogenic)
- Microbiological tests (total viable aerobic count, Ph.Eur)
- Microbial challenge tests
- Mycoplasma assay
- Quarantine assays (cell culture)
- Ph.Eur chemical tests: Nitrates, heavy metals
- TOC (Total Organic Carbon, Ph.Eur and USP)
