USP<61>
USP<61>
refers to the United States Pharmacopeia chapter titled "Microbiological examination
of non-sterile products-Microbial Enumeration Tests”. USP<61> is a quantitative
test that determines the Total Aerobic Microbial Count (TAMC) and Total
Yeast and Mold Count (TYMC) present in non-sterile products. The purpose is to provide guidelines and procedures for determining the
microbial load present in non-sterile products. This test helps to ensure these
products are free from excessive microbial contamination that could harm
consumers. This test is commonly performed to check product
safety before releasing it to market.
The test involves taking a sample and using specific techniques
(like membrane
filtration, pour plating, or spread plate methods) to recover microorganisms from the
product followed by growing and counting the microorganisms present
in the non-sterile product. It helps determine if there are too many
microorganisms, which could be harmful to health or affect the quality of the
product.
USP <62> Absence Test- Specified Microorganisms
The
purpose of USP<62> is to conduct tests to determine the absence of
specified objectionable microorganisms in nonsterile products. These
microorganisms are considered harmful or potentially pathogenic, and their
presence could pose risks to patient health.
USP
62 test is a qualitative test that determines the absence of the
specified microorganism in the non-sterile product. If the product has a low count
of bacteria, yeast, and mold within the acceptable limit, it can still be
harmful if pathogens are present even though they are very low in number. Specific procedures are outlined in USP<62> to detect the
presence of these specified microorganisms. This typically involves taking
samples and cultivating any microorganisms present using suitable growth media,
and then using selective and differential methods to identify and confirm the
presence or absence of the specified microorganisms.
The microorganisms that can be tested for absence test include the following:
USP<1111> Limits
USP<1111> specifies limits for microbial contamination in nonsterile products, outlining acceptable levels of bacteria, yeast, mold, and specified pathogens. It is guidance for choosing the microorganism according to the product’s mode of administration for the absence test.
These
acceptance criteria help ensure that nonsterile products meet microbial quality
standards and are safe for use or consumption. Contact us for more information on the appropriate microbiological
examination of your product.
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February 18, 2024
Disinfection validation requirements based on the Spaulding classification for medical devices. Blog post by Sneha Mistry
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