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. 

Importance of an Efficient Quality Assurance System in Microbiology Testing

In the nutraceuticals, pharmaceuticals, and cosmetics industries, quality means conformance to standards set by both the manufacturer and the industry. These standards must not only reflect a strong emphasis on the desired features of a product but also on its safety and efficacy.

To maintain quality, quality control (QC) procedures are employed. These procedures are in place to identify any action that does not meet the specified standards for quality. As a tool, QC is said to be corrective in nature. Its goal is to find and eliminate where problems in quality originate from. An example of QC in a typical micro laboratory is the regular monitoring of reagents and test samples.

Water Testing: Rapid Detection Methods for Heterotrophic Bacteria

Bacterial growth in water distribution systems is a commonly used indication of potential health issues. Gaining an accurate assessment of the heterotrophic bacteria count is crucial for determining how effective water treatment systems are working. Unfortunately traditional testing methods for heterotrophic bacteria are often inaccurate and slow. Below you can discover some of the primary limitations of heterotrophic bacteria testing methods and why advanced rapid detection systems have been developed.

The Pharmaceutical Industry's Use of Rapid Microbiology Testing

Pharmaceutical products such as supplements and prescribed drugs are capsuled in either a hard or soft shell. Just like the granules they contain, these shells are brought to the laboratory for testing. For the longest time, microbiologists have used the plate count methodology to determine a capsule's bacterial, yeast, and mold counts. But while this method is effective, it poses several difficulties. For instance, it is labor-intensive. From the preparation of the agar up to the counting of colonies, it can take five days to finish one test. Aside from that, this method is also prone to errors. Enter simplified, rapid, automated microbiology testing.