new service

Microbiological Testing

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:

Non-Sterile Pharmaceutical Preparations:

Specified Microorganisms

 Escherichia coli
Staphylococcus aureus
Pseudomonas aeruginosa
Clostridium sporogenes
Salmonella typhimurium
Candida albicans
Bile-tolerant gram-negative bacteria

Containers/Materials (foil etc.)

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