USP

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 1-2 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 material and finished products. Testing of raw materials is useful in determining whether the raw materials are contaminated with microorganisms prior to use while testing of the manufactured products helps determine if the products have been contaminated during the manufacturing process.

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 given acceptance criteria provided under the USP guidelines. If the specified microorganisms are found within the acceptable limit then the product is deemed to have passed the test. If any of the targeted microorganisms are detected above the acceptable limit then the product is declared to be contaminated and needs further research and remedial actions.

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 62 testing can be used to detect contamination in dietary supplements. Ensuring that dietary supplements are free from specified harmful microorganisms helps protect consumer health and maintain product integrity.

If the product fails the test, then manufacturers must take corrective measures which involves 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 that fail USP 62 testing include Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella species, Candida albicans, and Clostridium species.

Unlike other medical devices tests, USP 62 testing 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.