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USP 62
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Quick understanding of the test
USP 62 - Microbiological Examination of Non-Sterile Products
- Staphylococcus aureus
- Escherichia coli
- Enterococcus hirae
- Salmonella enterica
- Pseudomonas aeruginosa
- Clostridium sporogenes
- Candida albicans
- MRSA
- 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 test method that is performed to determine the presence of specified microorganisms in non-sterile products like cosmetics, pharmaceuticals and personal care products. In simple words, this test ensures that the product is safe for human use and does not cause any potential risks to a userโs health.
USP 62 Test Conditions
The USP62 testing is conducted within a controlled laboratory environment to ensure accurate and consistent results. During testing, specific environmental factors are meticulously monitored, including temperature, humidity, and air quality, all of which can significantly affect microbial growth and survival.
- Test organisms: Staphylococcus aureus (ATCC 6538P), Escherichia coli (ATCC 8739), Enterococcus hirae (ATCC 10541), Salmonella enterica (ATCC 10708), Pseudomonas aeruginosa (ATCC 15442), and Candida albicans (MTCC 3017)
- Test temperature:
- For bacterial cultures: 30โ – 35โ
- For fungal/yeast cultures: 20โ – 25โ
- Incubation periods:
- For bacterial cultures: 18 – 72 hrs (depending on the bacterial strain)
- For fungi cultures: 3 – 5 days
Samples are handled and processed under aseptic conditions in order to avoid any contamination that might interfere with the test’s accuracy. Such controlled conditions ensure that only the target organisms are identified and no extraneous microbial interference affects the results. This ensures that manufacturers meet quality standards while providing consumers with safe, reliable products.
Preparation of Test Strains
Standardized stable suspensions of the test microorganisms are used to prepare the test strains.
Preparation of bacterial test strains: Aerobic bacteria: Each bacterial strain to be tested is grown separately in Soybean-Casein Digest Broth or on Soybean-Casein Digest Agar at 30โ – 35โ for 18 – 24 hours.
Anaerobic bacteria: Clostridia sporogenes strain is the reference strain for anaerobic bacteria. The bacteria is grown under anaerobic conditions in Reinforced Medium for Clostridia at 30โ – 35โ for 24 – 48 hrs.
Preparation of fungal strains: For testing Candida albicans, the fungi are cultured on Sabouraud Dextrose Agar or Sabouraud Dextrose Broth at 20โ – 25โ for 3-5 days.
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
- In this method, the first step involves the enrichment of samples in Soybean Casein Digest Broth (Tryptic Soy Broth) or other appropriate media.
- Product samples are homogenized and prepared for inoculation.
- Samples are plated on selective and differential media, tailored to identify each target microorganism.
- Cultured samples are incubated under optimal conditions, promoting the growth of any target pathogens.
- After incubation, microbial colonies are examined for specific morphological traits or subjected to biochemical tests to confirm the presence of target microorganisms.
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.
USP Chapter 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.
Benefits of USP 62 Testing
Reduced risk of recalls
Product recall and bans are serious risks that may lead to financial and reputation losses. One of the most frequent reasons for product recall is microbial contamination, which primarily affects the production of drugs, cosmetics and other personal care products. Regular testing can help manufacturers determine areas of possible contamination at the early stages of production and, in turn, avoid recalls. Thus, it is possible to prevent significant financial losses and reputation damage through regular testing.
Regulatory approval
Pharmaceutical and cosmetic products must be approved by regulatory bodies such as the Food and Drug Administration in the US to be sold in the market. Meeting strict regulatory requirements is often required and it involves providing proof of the absence of pathogenic microorganisms in the product. Testing according to USP guidelines also provides manufacturers with the required data to issue necessary documents required for meeting compliance.
Competitive advantage
Compliance with this standard can be of great value. Businesses that have top-shelf microbiological testing and quality control practices will have competitive advantages over competitors who do not offer the same services. This will attract quality-driven, safety-conscious customers and business-oriented clientele.
Legal and financial protection
Compliance offers legal and financial assurance to the producers as they can defend themselves against lawsuits related to microbial contaminations. It also minimizes regulatory fines and sanctions threats while guaranteeing the businessโs stability and strategic effectiveness.
Conclusion
USP 62 testing is an extremely useful constituent of microbiological quality control practices for non-sterile product manufacturers. It helps industries meet regulatory compliance by providing reliable means for the detection of harmful microorganisms. Industries such as pharmaceuticals, cosmetics, personal care and food production units rely on this standard to ensure that their products are safe for consumer use.
At Microbe Investigations Switzerland, we offer both USP 61 and USP 62 tests for microbiological examination of non-sterile products.
Our microbiology experts work closely with our customers to fully understand their requirements, offering both standardized and customized methods to suit all their testing needs. We also provide a range of microbiology testing services in diverse areas like textiles, disinfectants and cosmetics.
For more information or to request a quote on the USP 62 test standard, 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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