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USP 71
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Quick understanding of the test
USP 71 - Sterility testing of Pharmaceutical Products
- Staphylococcus aureus (ATCC 6538)
- Bacillus subtilis
- Pseudomonas aeruginosa
- Clostridium sporogenes
- Candida albicans
- Aspergillus niger
- Test samples are filtered through a membrane under sterile conditions.
- The filtered membrane is then transferred to appropriate growth media.
- The inoculated media are incubated for a period of 14 days.
- After incubation, microbial growth on the membrane is analyzed
Direct Transfer Sterility Testing – In this method, sample products are transferred into Fluid Thioglycollate Medium (FTM) and Soybean Casein Digest Medium (SCDM).
Cultures are incubated for 14 days. Microbial growth is monitored through periodic observations during the incubation period.
- Ensures that products intended for medical use are sterile and safe
- Provides a reliable method to monitor and control microbial levels in pharmaceutical manufacturing.
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Abstract
Sterility testing is an essential process in industries that manufacture sterile products, such as pharmaceuticals, drugs, medical equipment, and radioactive drugs. The United States Pharmacopeia (USP) 71 specifies the guidelines on how products can be tested for sterility and the criteria for acceptance to ensure that pharmaceutical products are free of microbial contamination. Manufacturers need to abide by these guidelines to ensure that the quality of their products is high and meets the GMP requirements.
Sterility testing, on its own, cannot serve as proof of absolute sterility of the product. However, it does serve as a crucial validation step in the larger sterilization and quality control protocols.
Test Organisms Used in USP 71 Sterility Testing
Organisms typically tested include Staphylococcus aureus (ATCC 6538P), Klebsiella pneumoniae (ATCC 4352), Escherichia coli (ATCC 8739), Pseudomonas aeruginosa (ATCC 15442), Enterococcus hirae (ATCC 10541), MRSA (ATCC 33591), Salmonella enterica (ATCC 10708), and Candida albicans (MTCC 3017)
USP 71 Sterility Testing Test Methodology
Growth Promotion Test (GPT):
Growth promotion test is conducted to ensure that the culture media used in sterility testing can support the growth of microorganisms. Each batch of medium is inoculated with a small number of reference strains. The media are suitable if they show clearly visible growth within the prescribed incubation period (not more than 3 days for bacteria and 5 days for fungi).
Method Suitability Test:
Method suitability test is performed to verify that the sterility testing method used (membrane filtration or direct inoculation) is suitable for the specific product. A small number of microorganisms (not more than 100 CFU) are added to the product under test, and recovery/growth is compared with a control (medium without product).
- If growth is visible and comparable to the control, the method is suitable (meaning the product does not inhibit microbial recovery).
- If no growth is seen, the product may have antimicrobial properties. In that case, conditions (e.g., use of neutralizers, dilution, or washing) must be modified and the test repeated.
Membrane Filtration Method
Procedure
- The test samples are passed through a 0.45ยตm membrane filter under aseptic conditions.
- On completion of the filtration, the membrane filter is inoculated into a culture media* which supports the growth of the microorganisms and is incubated for 14 days.
- The growth of microbes in the media is analyzed.
*Growth media: Fluid Thioglycollate Medium (FTM) and Soybean Casein Digest Medium (SCDM) are used in this test. These media are used because they facilitate the growth of anaerobic bacteria, aerobic bacteria, and other microbes like fungi and yeast.
Direct Transfer Sterility Testing
- Direct transfer sterility testing is recommended for the testing of medical products.
- The test method involves the transfer of sample products independently into two types of culture media, FTM and SCDM, which facilitates the growth of microorganisms.
- The cultures are incubated for a period of 14 days with intermittent observations. The growth of microbes in the media is analyzed.
Importance of USP 71 Sterility Testing
Applications of USP 71 Sterility Testing
- Pharmaceuticals: All parenteral, ophthalmic, and biological drugs must be sterile to ensure patient safety.
- Medical Devices & Surgical: Instruments, implants, and catheters must be sterile to prevent infections.
- Tissue & Cell Therapies: Tissue grafts and live cell therapies require sterility to avoid disease transmission.
- Nutrition & Nutraceuticals: IV nutrition and high-risk supplements must be sterile to protect vulnerable patients.
- Cosmetics & Personal Care: Products for eyes or broken skin must be sterile to prevent microbial contamination.
- Biotechnology: Recombinant proteins and gene therapy products must be sterile to guarantee safe use.
Advantages of USP 71 Sterility Testing
- Regulatory compliance
The standard is well recognized by regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), making it a trusted standard for sterility testing.
- Product safety
Sterility testing ensures that products intended for sterile use do not pose a risk of infection for patients.
- Quality assurance
It validates the effectiveness of sterilization processes and ensures that manufacturing environments meet sterility requirements.
- Versatility
The standard accommodates a wide range of product types, including liquids, solids, and devices, with specific methodologies for each.
Sterility Testing at Microbe Investigations Switzerland (MIS) - USP 71
MIS performs sterility testing of pharmaceutical products using both direct transfer and membrane filtration methods. With extensive experience in research and analysis, our specialists are at the forefront of quality assurance. Additionally, in our testing lab, we have the full capacity to do the USP 51 Preservative Challenge test.
Contact us today to discuss your sterility testing needs and ensure the safety and efficacy of your products.
Frequently Asked Questions
DR. Martinoz Scholtz
The sample size depends on the product type and batch size.
ISO 21149 tests for the presence of bacteria while ISO 16212 tests for the presence of yeast and mold.
Yes, the standard can be used to test raw materials too.
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