Microbial Limit Testing

Microbial Limit Testing is used to determine the number and type of viable microorganisms, bacterial, yeast, and mold in various non– sterile products including raw materials, pharmaceutical. and OTC finished products, cosmetic and personal care products, and dietary supplements. Testing for these methods have been standardized by the United States Pharmacopeia (USP) to include USP <60>, USP <61>, USP <62>, USP <2021>, USP <2022>, and others.

Learn More

Scientech Labs offers comprehensive Microbial Limit Testing following USP standards to ensure the safety and quality of your products.

USP requires a suitability test to be performed prior to conducting testing on any product or material. Whether it is a USP <61>/<62> or <2021>/<2022> test, it is important to conduct a suitability test to ensure that the product is not inhibiting the recovery of any microorganisms present, as well as ensuring the accuracy of the test and to prevent any false negative results. The suitability test determines the appropriate diluent and dilution factor required to completely neutralize any antimicrobial present in the product on a routine basis.

USP <61/62> is mainly used to test non-sterile raw materials and pharmaceutical and OTC finished products. USP <61> is the quantitative test to enumerate the total aerobic microbial count (TAMC) and total yeast and mold count (TYMC) whereas USP <62> screens for the presence or absence of objectionable or potentially pathogenic microorganisms including Bile Tolerant Gram Negatives, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella species, Candida albicans, and Clostridia species.

The US FDA has advised the drug manufacturers of non-sterile, water-based drug products of the significant risk that Burkholderia cepacia complex (BCC) continues to pose. BCC is a group of gram-negative bacteria comprising more than 20 species that have been linked to multiple instances of opportunistic infections. Patients exposed to BCC contamination may be at an increased risk for illness, especially patients with compromised immune systems or who are otherwise susceptible to infection.