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.

Benefits of RMM Technologies
Unlike the food and medical industries, the pharmaceutical industry is not as quick to embrace rapid microbiological methods (RMMs). According to the American Pharmaceutical Review, one of the reasons why the industry is not keen on these rapid methods is the uncertainty over FDA approval.

However, it should be noted that the FDA has initiated programs to facilitate the adoption of RMMs in the industry. Two of these programs include the Process Analytical Technology (PAT) and the Pharmaceutical cGMPs for the 21st Century. These programs are initiated to determine whether or not a rapid method complies with requirements on accuracy, specificity, precision, range, and linearity.
Why should the pharmaceutical industry adopt these rapid testing methods?

Here are just some of the benefits:

·         higher accuracy

·         reduced waiting time for results

·         high degree of automation

·         more batches tested and fewer repeat tests

·         improved process control

·         cost-effective

·         simple to operate

·         user-friendly reagents

·         better company reputation

Rapid Microbiology Testing Methods for the Pharmaceutical Industry
With technological advancements comes the mushrooming of newer RMMs. Those that are applicable for pharmaceutical products (such as capsules and softgels) are classified into three main groups – qualitative, quantitative and identification.

Qualitative tests are conducted to determine whether or not a sample is contaminated. Quantitative methods, on the other hand, provide numerical data as regards microbial content. Identification tests are conducted to single out and indentify a microorganism.

Rapid microbiology testing methods for the pharmaceutical industry include the following:

1. Growth-based technologies
The conventional culture method is different from growth-based methods in that the latter relies on physiological changes rather than actual growth. For instance, instead of counting colonies, growth-based microbiological methods rely on bioluminescence, color change, and carbon dioxide production. Here are the three methods employed in growth-based technologies: ATP-bioluminescence, Colorimetric growth detection, Autofluorescence detection.

2. Viability-based technologies
Viability tests offer the perfect solution for identifying and quantifying organisms that are difficult to grow in a conventional medium. Instead of microbial growth, these methods detect total viable organisms using cell viability markers. Some examples of viability-based technologies include: flow cytometry, solid phase cytometry.

3. Endotoxin testing methods
Microbiologists check the presence of endotoxins when employing quality assurance for softgels and capsules. Endotoxins are derived from Gram-negative bacteria, and their presence in the human body can cause fever and inflammation. Examples of endotoxin methods include the following: gel-clot method, chromogenic method, turbidimetric method.

A variety of RMM technologies now exists to improve the pharmaceutical industry's microbiological testing methods. These methods offer several benefits, not just technical benefits but also from the business perspective. And as initiatives from the FDA have been established to help validate these methods' accuracy and efficiency, the industry should start changing its approach to microbiology testing.

Contact Biolumix for more information about rapid microbiology testing.

Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
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