Suitability Testing's Role in Modern Rapid Microbiology Testing Systems

Among the most critical aspects of controlling the manufacturing process and providing microbiology quality assurance in the production process is maintaining the proper use and application of key testing procedures that were established during the research and development phase. Conventional methods used to monitor the performance of analytical procedures range from the use of control samples with known values for method validation, to the use of titration blanks, periodic calibration and instrument qualification. In addition, many test procedures can be monitored using system suitability tests.

The Crucial Role of Microbiology Testing in the Expanding Pharmaceutical Industry

Over the years, the U.S. has remained the world’s biggest market for pharmaceutical products and the global leader in biopharmaceutical research. In fact, the massive U.S. pharmaceutical industry accounts for about 80 percent of all research and development in biotechnology in the world. The United States National Institute of Health claims that there are approximately 140,000 clinical trials underway for pharmaceutical products awaiting FDA approval, which the Pharmaceutical Research and Manufacture of America (PhRMA) claims to have an annual value of over $67 billion.  

10 Assays for Simplified, Rapid, Automated Microbiology Testing

Through rapid automated microbiology systems, various industries can increase throughput and plant efficiency in the quality assurance of their products, as per the new requirements of the FDA. Each system comprises instruments that can test multiple, individual assay vials; software for the rapid and real-time transfer of results; and disposable vials for use in required microbiological assays. 10 vials are described below: 

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.