USP 61/62 & USP 2021/2022: Essential Microbial Testing for Pharmaceuticals, Cosmetics, Food, and Supplements

Microbial contamination can pose serious risks to product safety, consumer health, and regulatory compliance. To ensure quality control, the United States Pharmacopeia (USP) has established key microbial testing standards: USP 61/62 and USP 2021/2022.These methods are widely recognized across various industries, including pharmaceuticals, cosmetics, food and beverages, and dietary supplements.

At PBR Laboratories, we provide precise and reliable microbial testing services to help businesses comply with these critical regulations while ensuring the safety and efficacy of their products.

Understanding USP 61 and USP 62

USP 61 – Microbial Enumeration Tests and USP 62 – Tests for Specified Microorganisms are microbiological standards that determine the total viable count of aerobic microorganisms in non-sterile products.

USP 61: Microbial Enumeration Tests

This test quantifies the total aerobic bacterial count (TAMC) and total yeast and mold count (TYMC) in a given sample. It ensures that microbial contamination remains within acceptable limits.

USP 62: Tests for Specified Microorganisms

This method is designed to detect specific pathogenic microorganisms that can be harmful if present in a product, including:

• • Escherichia coli
• • Staphylococcus aureus
• • Salmonella species
• • Pseudomonas aeruginosa
• • Candida albicans

Industries That Require USP 61/62 Testing

• • Pharmaceuticals & Biotechnology – Ensures drugs and biological products meet microbial safety standards.
• • Cosmetics & Personal Care – Verifies that lotions, shampoos, and skincare products are free from harmful pathogens.
• • Dietary Supplements & Nutraceuticals – Ensures the microbial safety of vitamins, probiotics, and herbal extracts.
• • Medical Devices – Confirms the sterility of wound care products, dressings, and surgical materials.
• • Cannabis & Herbal Products – Helps meet microbial safety standards for regulatory compliance.

USP 2021/2022: Microbial Testing for Food & Supplements

The USP 2021 (Microbial Enumeration of Non-Sterile Nutritional and Dietary Supplements) and USP 2022 (Tests for Specified Microorganisms in Dietary Supplements) are designed to ensure that food and dietary supplements are safe for consumption. These methods focus on microbial count limits and the absence of harmful pathogens.

Why USP 2021/2022 Testing Matters

These tests verify that food and supplement products do not contain harmful microorganisms such as:

• • Listeria monocytogenes
• • Clostridium species
• • E. coli (including Shiga toxin-producing strains)
• • Salmonella

Industries That Benefit from USP 2021/2022 Testing

• • Food & Beverage – Ensures microbial safety in raw materials, ingredients, and finished products.
• • Dietary Supplements – Confirms compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.
• • Animal Feed & Pet Food – Ensures safe microbial levels in livestock and pet nutrition products.
• • Environmental Testing – Helps maintain microbial integrity in water, soil, and agricultural inputs.

How PBR Laboratories Can Help

At PBR Laboratories, we offer state-of-the-art microbial testing services tailored to meet USP and regulatory requirements. Our laboratory ensures:

• ✅Comprehensive USP 61/62 and USP 2021/2022 testing
• ✅Fast turnaround times to support your production schedules
• ✅Fast turnaround times to support your production schedules
• ✅Customized testing solutions for industry-specific needs

Maintaining microbial safety is more than just a regulatory requirement—it is about protecting consumers, maintaining product integrity, and strengthening brand reputation.

Email: pbr@pbr.ca

Phone: 1-780-450-3957

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