InB:Hauser's microbiology lab staff is trained on aseptic technique, media preparation, specific SOPs and cGMP regulations. The microbiology lab is maintained under the strictest environmental controls to ensure efficient, compliant testing.
All instruments undergo IQ / OQ / PQ, and are requalified annually. Applicable methods are validated according to procedures in USP or by ICH guidelines.
InB:Hauser Microbiology laboratory performs tests required by USP including microbial limits test, bioburden testing, water testing and environmental monitoring. The staff is qualified in providing these services in accordance with USP and NF. Training in operational, technical, quality, regulatory and safety issues is ongoing.
Microbial Limits Test
The microbial limits tests are designed to estimate the number of viable aerobic organisms present in pharmaceutical and raw materials. The test is also used to determine whether the articles harbor designated microbial species which are pathogenic in nature. These opportunistic organisms called for in the USP include Salmonella sp., E. coli, Staphylococcus aureus and Pseudomonas aerginosa.
Bioburden
Bioburden, the microbial population within a product, is a useful tool when used as a process control monitor and as a database for process design. Bioburden testing is used to enumerate aerobic bacteria, spores and fungi.
Water Testing
Water testing is performed to insure water is suitable for intended use. Water is tested following monographs for USP purified water and includes microbial testing, total organic carbon, pH and conductivity.
Environmental Monitoring
Environmental monitoring is conducted in manufacturing and support areas that are designated as critical to the production of a clean product. Monitoring includes testing of both viable air and surface samples and evaluation of total particulates greater than 0.5 microns in size.
Testing is conducted on established schedules and data is interpreted and limits set based on industry standards. Trending of the data is performed in accordance with client and regulatory agency expectations.
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