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USP 62
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Quick understanding of the test
USP <62> - Microbiological Examination of Non-Sterile Products
The USP 62 test determines the presence or absence of specific microorganisms in non-sterile products.
- Staphylococcus aureus
- Escherichia coli
- Salmonella enterica
- Pseudomonas aeruginosa
- Clostridium species
- Candida albicans
- Bile-tolerant gram negative bacteria
- Product samples are enriched in growth media.
- The samples are then sub-cultured on selective media and incubated.
- After incubation, colonies are examined for morphological traits and confirmed through biochemical tests.
- Helps identify microbial contamination of the product at early stages.
- Assists in meeting regulatory requirements required for market approval.
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Abstract
USP <62> is a critical qualitative test standard designed to detect the presence of specified in non-sterile pharmaceutical, cosmetic, nutraceutical, and personal care products via enrichment and selective plating. While the complementary test USP <61> focuses on quantifying the total microbial load (bioburden), USP <62> ensures presence/ absence of harmful or spoilage-causing microorganisms in a product. Both tests, defined under the United States Pharmacopeia (USP), ensure microbial quality and safety of products.
Which Microorganisms are detected in USP<62>?
- Staphylococcus aureus (ATCC 6538P)
- Escherichia coli (ATCC 8739)
- Salmonella enterica (ATCC 10708)
- Pseudomonas aeruginosa (ATCC 15442)
- Candida albicans (MTCC 3017)
- Clostridia species
- Bile-tolerant gram negative bacteria
Why is suitability testing required for USP<62>?
Prior to routine specified microorganisms testing in USP 62, suitability testing is completed. This test utilizes neutralization and dilution techniques to ensure that the growth of suspected (tested) microorganisms is not inhibited by antimicrobial agents that may already be present in the given product sample.
USP <62> Test Procedure
- A defined quantity of the product (usually 10 g or 10 mL) is mixed with suitable enrichment
- The mixture is incubated under specified conditions (30โ35 ยฐC for bacteria, 20โ25 ยฐC for fungi) to allow any microorganisms present to grow.
- The aliquots are then transferred from the enrichment broth onto selective media designed for specific target organisms.
- The plates are incubated at appropriate temperatures and durations depending on the target microorganism.
- After incubation, colonies are examined for characteristic morphology and to confirm identity through Gram staining, biochemical, or molecular tests to detect presence or absence of each specified microorganism.
Acceptance Criteria for USP <62> Test Standard
The outcome of this test is analyzed based on the acceptance criteria provided under the USP 1111 guidelines. Each microbial strain has a unique colony characteristic feature that is used to identify the presence or absence of a particular microorganism. The product complies with the test if no characteristic colonies are present or if the identification tests are negative.
Importance of USP <62> testing
USP 62 testing is essential for detecting microbial contamination early, helping manufacturers avoid costly product recalls and protect their reputation. It supports regulatory compliance by providing necessary data to meet standards set by bodies like the FDA. Additionally, it offers a competitive edge by demonstrating commitment to quality and safety, while also minimizing legal and financial risks associated with contamination-related issues.
USP <62> Industry Applications
Pharmaceutical industry
In pharmaceuticals, the USP test is vital for oral medications, topical formulations, and other non-sterile products. By controlling microbial contamination, pharmaceutical companies protect patients from harmful pathogens, safeguarding product quality and efficacy.
Cosmetic industry
For the cosmetic industry, USP testing ensures that products like creams, lotions, or makeup products do not cause any skin infection or allergy due to microbial contamination. Ensuring a clean, contaminant-free product helps build consumer trust.
Personal care products
Personal care products, such as soaps, shampoos, and toothpaste, tend to be easily contaminated by microorganisms due to their frequent use and long exposure to moist environments. Therefore, it is essential to test and confirm whether these products are safe and stable enough throughout their shelf life.
Food and beverage industry
The standard, primarily used in pharmaceuticals and cosmetics, can also be applied to the food and beverage industry. Testing provides companies with the assurance of the absence of harmful microorganisms in additives, supplements, and other non-sterile ingredients, thus ensuring their products are safe for consumption.
Nonsterile Product Testing Services at MIS
At Microbe Investigations Switzerland (MIS), we offer USP <62> and USP <61> testing services to ensure the microbiological quality and safety of non-sterile pharmaceutical, cosmetic, and personal care products. Our expertise delivers reliable, reproducible, and pharmacopeial-compliant results, helping you substantiate microbial quality claims and meet regulatory standards.
To get a quote on USP <61> or for any other information, contact our experts now, contact our experts here.
Frequently Asked Questions
DR. Martinoz Scholtz
USP 62 test is performed to determine the presence or absence of specific microorganisms present in non-sterile samples.
This test is applicable to non-sterile pharmaceuticals and other non-sterile products such as cosmetics and personal care products.
The test takes 2-3 weeks to complete.
This test is most relevant to the identification of specified microorganisms in non-sterile products, detecting certain objectionable microorganisms only. It can be distinguished from general microbiological tests like the total viable count or sterility test due to its targeted focus on microorganisms which are pathogenic to humans and are potentially detrimental to product integrity.
This test detects specified microorganisms, including but not limited to Staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomonas aeruginosa, Clostridium species, Salmonella species and Bile-tolerant gram-negative bacteria.
Yes, this test is applicable to both raw materials and finished products.
The test validates the safety of pharma products by indicating the presence of any harmful pathogen which could lead to product deterioration or potential health risks on human consumption.
The outcome of this test is analyzed based on the acceptance criteria provided under the USP 1111 guidelines. The product passes the test if no characteristic colonies are present or if the identification tests are negative.
This test has limitations such as targeting specific microorganisms, requiring specific conditions and media for accurate detection, and potentially causing false negatives or positives due to testing errors or sample handling issues.
The frequency of this test depends on the product type, regulatory requirements and the risk assessment of the manufacturing process. Typically, testing is performed on each batch of raw materials and finished products, but a risk-based approach may allow for less frequent testing if a robust quality control system is in place.
Yes, USP Chapter 62 testing can be used to detect contamination in dietary supplements.
If the product fails the test, then manufacturers must take corrective measures which involve determining the cause of the failed test, improving the manufacturing and quality control processes, and recall of the affected batch.
Common contaminants found in products include Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella species, Candida albicans, and Clostridium species.
Unlike other medical device tests, this test does not guarantee sterility since it is a test for non-sterile goods. Nonetheless, it may be a part of a chain of microbiological control measures to make sure that the medical devices would not support the growth of pathogenic microorganisms. For sterile medical devices, tests such as USP 71 would be more applicable.
USP 61 assesses microbial load, while USP 62 focuses on detecting specific harmful microorganisms.
Samples are prepared under aseptic conditions and may require dilution or homogenization before testing.
The test aligns with GMP by helping manufacturers meet regulatory requirements and produce safe, high-quality products.
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