Overview:
USP <61> provides a set of procedures for determining the microbial load in non-sterile products, including food, cosmetics, and health products. This method primarily focuses on determining the levels of aerobic bacteria and fungi, including yeast and molds. These tests help assess the safety and shelf life of non-sterile products and ensure that microbial contamination does not exceed acceptable levels.
Detailed Procedure:
- Sampling: The product is sampled, and a series of dilutions are made to ensure that a proper concentration of microorganisms is present for testing.
- Plating and Incubation: The diluted samples are plated on specific media designed for different types of microorganisms (e.g., Sabouraud agar for molds and yeasts, general-purpose media for bacteria).
- Incubation: Samples are incubated at specific temperatures (e.g., 30-35°C for bacteria, 20-25°C for molds and yeasts) for a set period.
- Counting: After incubation, colonies are counted to determine the microbial load. The results are compared to the acceptable limits outlined in the relevant regulatory guidelines.
Application:
- Food: In the food industry, USP 61 testing is used to ensure that non-sterile food products, like cheeses, bread, or prepared salads, meet microbiological safety standards. It helps detect contamination from environmental sources and during production.
- NHPs: Non-sterile natural health products, including dietary supplements and herbal products, are susceptible to microbial contamination. USP 61 ensures that these products do not contain harmful levels of bacteria, yeast, or molds, which could reduce their efficacy or pose a health risk.
- Cosmetics: For cosmetics, especially those that do not contain preservatives, USP 61 helps ensure that products like lotions, shampoos, and make-up are free from excessive microbial contamination that could affect their performance or safety.
- Cannabis Products: Non-sterile cannabis products such as edibles, tinctures, and topicals are tested for microbial contamination using USP 61 methods. This ensures that products meet the required safety standards, particularly for products that may be ingested or applied directly to the skin.
How CREM Co Labs Can Help:
CREM Co Labs uses the latest equipment and techniques to conduct USP 61 testing, ensuring that your products meet microbial safety standards. Whether you’re in the food, NHP, cosmetic, or cannabis industry, we offer reliable testing services to protect your products and your customers.