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USP 71

Sterility testing

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USP 71 – Sterility Testing

USP <71> is an essential GMP Microbiology testing requirement for sterile pharmaceutical formulations, medical devices, and radiopharmaceuticals. This sterility test is designed to ensure that no viable microorganisms are present in sterile products before they are used for patients.

The term sterile refers to the total absence of viable bacteria, viruses, yeasts, and fungi in a given sample. To maintain product quality and avoid microbial contamination, products are passed through the process of sterilization during manufacturing.

Sterility testing of pharmaceutical and biopharmaceutical products is very important for patient safety. Sterile products which encourage any form of microbial growth, are not considered to be sterile.

Thereby, USP 71 is intended to promote efficacy and innovation in the development of sterile products.

USP 71 Test Method

MIS performs the following methods for the sterility testing of products –

Membrane Filtration Method

Membrane Filtration Method is a regulatory method of choice for filterable pharmaceutical products. This method is suitable for product samples comprising preservatives, bacteriostatic, and fungistatic compounds that control the growth of microbial contaminants. 

    • With membrane filtration method, test samples are passed through the membrane filter of pore size  0.45 µm under aseptic conditions.
    • Once the filtration is complete, filter is added to the culture media and kept for 14 days incubation.
    • Two types of growth media i.e. fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM) are used in tests. They facilitate the growth of anaerobic, aerobic bacteria, and other microbes like fungi and yeast.

Direct Transfer Sterility Testing

Direct Transfer Sterility Testing (USP 71) is recommended for the sterility testing of medical devices. 

  • In this method, sample products are transferred independently to the two types of culture media (FTM and SCDM) which facilitate microbial growth.
  • The incubation period for test is 14 days with intermittent observations.

USP 71 – Sterility  Testing at Microbe Investigations (MIS)

MIS performs USP <71> sterility testing of products using both direct transfer and membrane filtration methods. Additionally, in our testing lab, we have the full capacity of doing USP 51 Preservative Challenge test.

We are a global microbiology testing service provider to major industries manufacturing cosmetics, disinfectants, paints, plastics, and textiles. We are specialized in entomology testing of insecticides, pesticides, and impregnated textiles in addition to antimicrobial testing.

With extensive experience in research and analysis, our specialists are at the forefront of quality assurance.

To submit your sample or get a quote on USP 71 tests, contact our experts here.

FAQs

USP 71, also known as sterility testing, is performed to confirm that sterile products are free of any viable microbial contaminants.

USP 71 test is used for product sterility testing for pharmaceutical, biopharmaceutical, and medical device industries. Products to be tested using USP 71 test includes, pharmaceutical formulations, medical devices, and radiopharmaceuticals.

USP 71 test takes 1-2 weeks to complete.

We test for USP 71 using the following microbial strains: Pseudomonas aeruginosa (ATCC 15442), Escherichia coli (ATCC 8739), Staphylococcus aureus (ATCC 6538P), Enterococcus hirae (ATCC 10541), Klebsiella pneumoniae (ATCC 4352), MRSA (ATCC 33591), Salmonella enterica ( ATCC 10708), Candida Albicans (MTCC 3017). Additional strains can be added on request.

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