April 28, 2026

News

Microbiological Testing - A Fundamental Element of Quality Assurance

Microbiological testing is a fundamental element of quality assurance in the cosmetics industry, and at Scientech Laboratories it is conducted with rigor to ensure product safety, stability, and regulatory compliance. Cosmetic formulations—especially those containing water—are inherently susceptible to microbial contamination during manufacturing, storage, and consumer use. Uncontrolled microbial growth can result in product degradation and potential health risks.

At Scientech Laboratories, microbiological evaluation includes microbial limit testing such as USP <61> & <62>, ISO 17516:2014 to quantify total viable counts and verify the absence of specified pathogens. This ensures products meet established microbiological quality criteria prior to release. Testing is performed in alignment with internationally recognized standards, including those from FDA, ISO, USP, and EP, supporting global regulatory acceptance.

Preservative efficacy testing (PET), or challenge testing, is also a key service. Formulations are inoculated with standardized microorganisms to evaluate preservative performance over time. Scientech Laboratories monitors microbial reduction to confirm protection throughout the product lifecycle, consistent with compendial expectations such as USP <51> and ISO 11930, PCPC.

Quality assurance further extends to raw material testing and environmental monitoring. Ingredients are assessed for microbiological quality prior to use, while controlled monitoring of air, water systems, and manufacturing surfaces minimizes contamination risks. These practices align with ISO and pharmacopeial guidance, ensuring comprehensive contamination control.

Microbial contamination may alter critical product attributes, including pH, viscosity, color, and odor. By integrating microbiological testing with stability studies, Scientech Laboratories supports accurate shelf-life determination and validation of storage conditions.

As demand for minimally preserved formulations increases, microbiological risks become more complex. Scientech Laboratories applies standardized methodologies and technical expertise to ensure safety without compromising formulation objectives.

Scientech Laboratories is an FDA cGMP-compliant and ISO 17025 accredited analytical services business that has been family-owned and operated for 45 years. We support the Pharmaceutical, OTC drug, Cosmetics, and Dietary Supplement industries with potency release testing, impurity profiling, heavy metals, nitrosamines, extractables & leachables, microbiology, stability studies and much more.