Pharmaceutical microbiology is the part of industrial microbiology that is responsible for ensuring medications do not contain harmful levels of microbes such as bacteria, yeasts and moulds. It is critical to ensure drugs and medical equipments are safe.
Pathogenic bacteria, yeasts, moulds and toxins produced by microorganisms are all possible contaminants of medicines although stringent, regulated processes are in place to ensure the risk is minimal.
Bioburden defines the presence of microbial load in medical devices, masks, stents, orthopedic implants, Personal Protective Equipments (PPE) Kits, and so on.
Testing ensures the quality of the products offered.
Here is a list of tests we perform for the pharamceutial sector, why are they required, and how we stand out.
Isolate Identification: Environmental and water isolates are identified up by species to check whether they belong to a list of objectionable organisms. Validation of stock culture.
Antimicrobial activity: The product is "challenged" with a known amount of specific microorganisms, such as E.coli and C.albicans and the anti-microbial activity is monitored.
Sterility testing: This test procedure determines if a pharmacopeial article purporting to be sterile complies with the requirements of the test and is not by itself designed to ensure that a batch of product is sterile.
Microbial limit test: This test is designed to determine total aerobic microbial count and yeast and mold count. This test demonstrates that the product is free of S. aureus, E.coli and P. aeruginosa, Salmonella spp, C. albicans, A. niger. Vitamin assays and any Antibiotic assay.
To identify environmental and water microorganisms
In addition to a wide range of tests offered, Biocare offers following services: Sterile sample containers, cooler boxes, coolant, ice bricks, swabs & air plates (for environmental monitoring).
Technically qualified consultants can discuss & interpret microbiological test results, demonstrate sampling techniques, assist with problem solving, provide hands-on advice & develop tailor-made sampling testing plans to satisfy your hygiene, GMP, HACCP & ISO needs.