BILLINGS, Mont.— All American Pharmaceutical announced it completed production of an in-house microbiology laboratory to ensure it could fully comply with federal GMPs (good manufacturing practices), which require more microbiological testing than previous guidelines, and increase production and processing speed.
The new fully automated system can deliver quicker results and automatically generate certificates of analysis (C of A) within 24 hours. The system was validated against new chapters of the USP <2021>, <2022> and <2023>. The faster processing will allow earlier release of raw materials and finished products while reducing quality control (QC) time.
The lab includes an analyzer with an optical system for rapid and automated detection of indicator microorganisms. An embedded optical sensor for the detection of CO2 is used for total aerobic count and yeast/mold. Simultaneous detection of coliform and E. coli bacteria is achieved using a combination of color and fluorescent dyes. The system is also validated for Pseudomonas, Enterobacteriaceae, Salmonella, Staphylococcus aureus, Gram negative and Lactic acid bacteria.
