QualiMetriX has established a fully equipped, GMP certified microbiological laboratory in order to perform in house, the microbial examination of pharmaceutical substances, finished products and medical devices as a means of testing their compliance with compendial requirements (Ph. Eur., USP, JP) or the specifications set by the manufacturer.
Microbiological Quality of:
- API
- Excipients
- Non-Sterile Pharmaceutical Preparations:
- TAMC
- TYMC
- Specified Microorganisms
- Escherichia coli
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Clostridium sporogenes
- Salmonella typhimurium
- Candida albicans
- Bile-tolerant gram-negative bacteria
- Containers/Materials (foil etc.)
- Water
Antimicrobial/Preservative Efficacy Testing
Testing is performed according to compendial requirements set by both USP <51> and EP 5.1.3. for non-sterile dosage forms of drugs that typically have preservatives added in order to protect them from microbial contamination.
Method Validation/Suitability
Compendial methods require a “simple” suitability test that verifies that the product matrix does not influence the test system and demonstrates the reliable detection of any microbial contamination
Microbiological Environmental Monitoring:
Provision of environmental monitoring plates for client use and subsequent return to our lab for incubation, enumeration, and identification.
Bacterial Viability and Challenge
In the frame of filter validation studies.
