Pharmaceutical Microbiology

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. Drug safety is a major focus of pharmaceutical microbiology. 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.

When testing is required ?

  • To identify environmental and water microorganisms
  • Validation of stock cultures
  • Product Safety evaluation (Through Sterility test, M.L.T. etc…)
  • Process Validation

Tests

  • Isolate Identification: Environmental and water isolates are identiļ¬ed up to species level to check whether they belong to 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 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 insure 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. aurous, E.coli and P. aeruginosa, Salmonella spp, C. albicans, A. niger. Vitamin assays and Antibiotic assays

Value Added Services

  • Sample collection facility
  • Total technical support
  • In addition to wide range of tests offered; Biocare offers following services : Sterile sample containers, cooler boxes, coolant I ice bricks, swabs & air plates ( for environmental monitoring.)
  • Technically qualified consultants can visit clients outside to discuss I interpret microbiological test results, demonstrate sampling techniques, assist with problem solving, provide hands-on advice & develop tailor made sampling I testing plans ( To satisfy your Hygiene I GMP I HABCP I ISO needs ).