Understanding Environmental Monitoring in the Pharmaceutical Industry

Many microbiologists believe that the most critical sources of contamination in the pharmaceutical and nutraceutical industries are raw materials and water. While these are important, effective quality assurance practices also need to include environmental monitoring. Many microorganisms exist in the atmosphere and on almost all surfaces. When left unattended, they can be a serious cause of infection and contaminate sensitive manufacturing operations. Besides the fact that proper control of the environmental conditions where manufacturing takes place is an FDA requirement, manufacturers also take environmental monitoring seriously because it is a crucial step in safeguarding and ensuring high-quality products. 

  

Numerous studies suggest that the level of environmental control has a direct impact on the final quality of the end product. The traditional methods used for environmental monitoring assess Total Organic Carbon (TOC), Adenosine Tri-Phosphate (ATP), and total particles in the air. When assessing the air, microbiologists use particle counters to collect a known sample of air quantity and then produce a breakdown of particle sizes in that sample. While they produce fast results to enable quick reaction and prompt investigation and correction, or closure of sections with high particle counts, these results do not provide a total count for viable microorganism in the production lines or environment. 

  

The conventional techniques used to test for viable microorganisms require the organism to be collected in an air sample or with contact plates. The sampling medium is then incubated for 3-7 days before counting the colonies. The delay implies that instant reaction to the contamination is hindered, and no timely investigations can be made. Furthermore, the results are obtained after the sample area has been cleaned multiple times, making re-sampling of the results pointless when searching for the origin of the contamination. Without real-time response, the batches are jeopardized.  

Fortunately, the pharmaceutical and nutraceutical industries can now use rapid microbiological methods for sterility testing for faster product throughput, though there are more regulations imposed on using RMM. Many of the RMM technologies employed in product testing can also be used for environmental monitoring. For instance, there are automated microbial detection systems that detect microorganism growth by assessing the production of carbon dioxide.  

To use this technique, the first step is to inoculate sterile liquid media bottle with the test sample. The second step is to load the bottle into the instrument. The microbiologist is supposed to choose the ideal media depending on the sample being tested, and the expected microorganism. If the test sample contains microorganisms, then you should expect to find CO2 in the sensor, since microorganisms release carbon dioxide as they metabolize the substrates within the culture medium. The CO2 reacts with a reagent in the sensor, which is usually below the sample and culture medium, causing it to change its optical properties, from dark to light.  

There are many other RMM techniques that can be used for quality assurance in environmental monitoring. Some of these include: fluorescent staining-based systems for use with swab samples with water and filterable products; optical technology for the instantaneous detection of microorganisms and particles in air samples; solid-phase cytometry; ATP bioluminescence; and real-time reverse transcriptase PCR assay. RMM systems are very effective in the detection of objectionable organisms like Salmonella, S. aureus, and E.coli in the environment. 

Contact Biolumix for more information about rapid microbiology testing and environmental monitoring in pharmaceutical microbiology.

Biolumix
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Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
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