Microbiology

Microbiological operations are an integral part of pharmaceutical industry and play a significant role in the overall product life cycle such as during Drug Development: Development of new drugs - vaccines, antibiotics, Fermentation and Microbial bioconversions of drugs; during Drug Manufacturing: Aseptic processing, Sterilization, Process validation and Environmental Monitoring; during Quality Control: Microbiological Testing - Sterlity Testing or during Storage & Distribution: Preservation of drugs and Cold Chain. The microbiological attributes of pharmaceutical ingredients are often critical to final product quality. FDA expects manufacturers to measure and characterize the microbial quality of their pharmaceutical substances as well as of their final drug products. Contract microbiological testing service providers apply USP, Ph. Eur. and other international methods to a wide variety of biologics and traditional pharmaceuticals. These testing facilities should meet the demanding cleanliness and engineering requirements of microbiological testing programs. Class 100 hoods, clean rooms and isolators for microbial evaluation are important parts of their facilities. Biological and microbiological testing services include: Microbial limits tests (microbiological examination of non-sterile products); Sterility testing; Microbial contaminant identification; Antimicrobial effectiveness testing (sterile and non-sterile multi-dose forms) and microbial challenges; Mycoplasma testing; Microbiological assessment of antibiotics; Bacterial endotoxins testing; Sampling and analysis of water for pharmaceutical microbiology; Chemical disinfectant testing and cleaning studies; Environmental monitoring; Microbiological attribute studies (e.g. barrier testing for packaging, condoms and medical gloves, and hygienic and antibacterial testing for contact lenses, personal care products, and more.); Non-viable particulate testing, etc.