Micro Biological Testing

The pharmaceutical, food, cosmetic, and chemical industries all require microbiological testing to ensure the safety, quality, and compliance of their products. At Chromak Research, we specialize in comprehensive microbiological testing of constitutive raw materials, in-process samples, and finished products. Our laboratory has over 40 years of industry experience and is ready to assist with your product development, quality assurance, and regulatory submission goals.

Microbiological testing is a process that involves finding and measuring particular microorganisms, including bacteria, yeast, and molds. It ascertains that the set microbiological criteria for specific products are met, meaning the products do not contain any pathogens. Essentially, this helps sustain product safety, effectiveness, and shelf life.

Pharmaceutical products, food items, and cosmetic formulations undergo microbiological testing within our advanced laboratory, aiding clients to comfortably meet national and international standards, aside from their proprietary rules and regulations such as USP, FDA/BAM, and others.

Microbiological testing is carried out in order:

Specific microbiological testing helps clients identify contamination issues first, thereby lessening the risk of contamination in products that are not safe and of good quality for the market.

Microbiology department for microbiological testing has defined and approved methods which are recognized and accepted in the industry, such as:

• Sterility assays
• Tests for microbial content and isolation
• Total viable count (TVC)
• Yeast and mold testing
• Pathogen testing (e.g., E. coli, Salmonella, Staphylococcus aureus)
• Bacterial endotoxins test using LAL
• Vitamin and antibiotic assays
• Preservative efficacy testing (Challenge test)

These Testing methods of microbiology are customized according to product type to assess its safety for use or distribution.

At Chromak Research, we specialize in conducting microbiological tests on pharmaceuticals. From raw materials to finished products, our lab ensures that all pharmaceutical products undergo necessary microbiological tests as per regulations.

The limiting steps in a validation study include, but are not limited to, the following:

• Total microbial count;
• Specific pathogens;
• Antimicrobial preservative effectiveness;
• Bacterial endotoxins;
• Sterility (when required).

Each of the microbiological tests is carried out according to the standards of United States Pharmacopeia Chapters <51>, <61>, and <62> compliance with regulations set.

Each microbiological test performed delivers value on its own:

Our services of microbiological testing cover many sectors, namely: nutraceutical, cosmetics, chemistry, food, and pharma, ensuring the regulations of the market, enhancing safety for the consumers.

Before routinely performing microbiological tests, method qualification serves as the base, allowing the setting of proper neutralizers, dilution factors, and enrichment media to mask anti-microbial effects already used in drug formulations. This process ensures we validate that the methods used for testing can be trusted for the matrix targeted.

We carry out methodology compliance testing as per the guidelines mentioned in:

• Testing of Antimicrobial Effectiveness USP <51>
• Microbial Enumeration Test USP <61>
• Listed Microorganisms USP <62>

Our microbiologists make sure all procedures are correct and complete, along with the method steps, product distribution, and regulatory directives.

Looking for reliable and accurate microbiological testing? Partner with Chromak Research now. Our staff of professionals is available to serve you with appropriate alternate methods of microbiological tests regarding pharmaceutical products and other items.