0000001710 00000 n Inspect robotic systems or isolation technology, such as La Calhene units used for sterility testing. h�ܔMj�0��2'��m��qHVc{gLqQ�������[���b�H�z�43�C�B%� bb�:��X,�I�a�&O}o�X� The pharmaceutical industry, however, has not been as quick to embrace rapid microbiology despite the potential advantages. stream Potential applications The obvious application for RMM in pharmaceutical manufacturing is in the release of finished products, where the shorter ‘time to result’ may generate considerable cost savings. Even the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co operation Scheme (PIC/S), which generally can be counted on to provide details on almost everything microbiological, is silent on this point (12). An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Microbiological Pharmaceutical Quality Control Labs (7/93). Some of these changes have been due to the advance of rapid microbiological methods, knowledge gained from the study of the human microbiome, while others are changes to conventional testing methods. Get the latest updates in Rapid Microbiological Test Methods sent to your email? Alternatively, vials or ampules filled during media fills have also been used. Auto fluorescence detection has been commercialized by Rapid Micro Biosystems as The Growth Direct™ System, which uses a large area CCD imaging system without magnification to detect developing microcolonies in approximately half the time of the conventional culture method. ]�D,��p�YV�kP� >[v�8͊i5����9��Z9n� vN^�ɳ6E= �K�w�˄i�&,�,M,招r���i��� c�Lj� �B���݃l�� 5�T�4v�?Ѐ�W�:�;���@d����Yc t�幱6myS���d�L�����NDn However, for other products such as topicals, inhalants or nasal solutions where there is a major concern for microbiological contamination, isolates from plate counts, as well as enrichment testing, should be identified. Other growth parameters include a lower temperature and longer incubation time (at least 5 days) that provide a better survival condition for damaged or slow-growing cells. An example of a rapid endotoxin test system is the Endosafe®-PTS™ assay available from Charles River Laboratories International. 0000001224 00000 n Some suppliers also provide help to prospective customers looking to calculate costs and potential savings for alternative microbiological methods. Autofluorescence detection - All living cells auto fluoresce under blue light and this can be used to detect microbial colonies growing on a solid surface long before they are visible to the naked eye. This paper discusses some of the recent changes in areas of interest to microbiologists. endstream endobj 261 0 obj <>stream Perhaps more than in any other sector of industrial microbiology, the routine microbiological testing carried out by the pharmaceutical manufacturing industry is determined by regulatory requirements. x�b```�:V�/>�������3�Z8���Ӟ�T�S|���"q�]�V. Pharmaceutical Microbiology Testing. Endotoxin testing - Endotoxins are lipopolysaccharide contaminants derived from the cell walls of Gram-negative bacteria. Analytical results, particularly for those articles in which additional or retesting is conducted, should be reviewed. When summaries of this data are not available the inspection team is expected to review enough data to construct their own summary of the laboratory test results and quality control program. ii. Pharmaceutical Microbiology Manual . Therefore it is essential to include financial expertise in any evaluation of a new technology, so that an ROI can be calculated accurately and a robust business case for investment can be made. In the near future, the technology is likely to be available for continuous real-time monitoring of the manufacturing process, resulting in very significant savings in both time and production costs. 0000000016 00000 n But other techniques are needed to subsequently identify the contaminants and the source of contamination. 0000009471 00000 n In the past, difficulties with validation have proved to be a serious obstacle for the implementation of RMM in pharmaceutical manufacturing. The USP points out that the facilities used to conduct sterility tests should be similar to those used for manufacturing product. The .gov means it’s official.Federal government websites often end in .gov or .mil. Faster microbiology test results would provide better control over the manufacturing process. This guideline relates to all microbiology laboratories involved in the above outlined testing activities, whether they are independent or a department/unit of a pharmaceutical manufacturing facility. Therefore, each company is expected to develop microbial specifications for their non-sterile products. Scope This guidance document relates to microbiology laboratories involved in any microbiological testing activities associated with the manufacture of non-sterile pharmaceutical products. Molecular based microbial identification systems are also available for pharmaceutical applications and are described in more detail in our Test Method Guide to Microbial Identification and Strain Typing Using Molecular Techniques. However, for non-sealed bottles or flasks of media, non-sterile air has led to the contamination of media. Retest results should be reviewed and evaluated, and particular emphasis should be placed on the logic and rationale for conducting the retest. For example natural plant, animal and some mineral products for Salmonella, oral liquids for E. Coli, topicals for P. aeruginosa and S. Aureus, and articles intended for rectal, urethral, or vaginal administration for yeasts and molds. For sealed bottles of media, this would not present a problem. startxref For example, variations on impinger air sampler designs, such as the Coriolis®μ cyclonic air sampler (validated according to ISO 14698) made by Bertin Technologies (France), and the SAS-PCR sampler from Bioscience International, use a sterile liquid media, rather than the more common agar plate or strip; it allows subsequent detection of microbial contamination by rapid and specific molecular methods for identification and/or quantification. Rapid air monitoring - Environmental monitoring is another key requirement in pharmaceutical manufacturing facilities and rapid detection of airborne contamination in clean areas is particularly important. For example, in a recent inspection of a topical manufacturer, total plate count and testing for the USP indicator organisms were requested. Subscribe to the free rapidmicrobiology eNewsletter, rapidmicrobiology.com uses cookies in accordance with our Cookie Policy, CLICK HERE for COVID-19 Test Kits, Standards and Controls, Autofluorescence and Laser Induced Fluorescence, Faster/Automated detection of growth on agar, Test Method Guide to Endotoxin Detection Methods for Pharmaceuticals and Medical Devices, USP <1223> Validation of Alternative Microbiological Methods, Subscribe to the free rapidmicrobiology eNewsletter, See the latest products for endotoxin and pyrogen testing at 'What's on Show at PDA Microbiology', Story of the Steritest™ Invention: How Millipore Made the Sterility Test Reliable in the 1970s, One Stop Shop for Quick, Reliable Endotoxin and Beta-Glucan Testing, Simplify Growth Promotion Testing with Microbiologics’ EZ-Accu Shot™, A Complete System for Water and Bioburden Testing Designed for Pharma QC Labs, Trade in Your Manual Pipettes and Upgrade with Integra, High Throughput Quality Control for Bottled Water, Milliflex® Quantum Rapid Detection System, IMD-W™ Instantaneous Microbial Detection (water), BioVigilant - A Division of Azbil North America, IMD-A® Instantaneous Microbial Detection (air). Nevertheless, some have specific pharmaceutical applications and others have been developed solely for the pharmaceutical industry.
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