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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
USP 71 Sterility Testing Method
Membrane Filtration Method
Procedure
- The test samples are passed through a 0.45µm 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
Sterility testing of pharmaceutical products
- Injectables
It must be ensured that parenteral medications, including intravenous, intramuscular and subcutaneous injections, are sterile.
- Ophthalmic solutions
Ophthalmic preparations such as eye drops are required to be sterile to avoid eye infections.
- Biologicals
Biological products like vaccines, blood products and other biologics demand stringent sterility testing for their effectiveness.
Medical devices
Medical devices that are likely to come in direct or indirect contact with sterile body areas are required to undergo sterility testing.
- Surgical instruments
Surgical instruments employed in operations should be free from microbes in order to prevent postoperative infections.
- Catheters and implants
Products such as catheters, pacemakers and artificial joints need to be sterile before being placed inside the body to avoid any infection.
Tissue and cell products
Products derived from human or animal tissues and cells such as:
- Tissue grafts
Tissues for bone, skin and organ transplantation have to be sterile to prevent transfer of infections in the body.
- Cell therapies
Products involving live cells, such as stem cell therapies, must be sterile to ensure patient safety.
Nutraceuticals and parenteral nutrition
Sterility testing is also important for products meant for nutrition and dietary supplements used for human consumption.
- Total Parenteral Nutrition (TPN)
Intravenous feed solutions given to patients should be free from bacterial contamination as patients on intravenous feeding are prone to infections.
- Nutraceuticals
Certain high-risk dietary supplements, particularly those that are infused intravenously, may also need sterility tests prior to use in order to avoid contamination with unwanted microorganisms.
Cosmetics and personal care products
While not all cosmetics require sterility, certain products used in sensitive areas need to be sterile.
- Products for broken skin
Cosmetics which are used on damaged skin, like wound care products, must be sterile to prevent bacterial infection.
- Eye area products
Products like mascara, eyeliner and other items that come in contact with the eyes have to be sterile to avoid infections.
Biotechnology products
Biotech products, particularly those involving genetic engineering and cell culture, require sterility testing.
- Recombinant proteins
Proteins synthesized using genetic engineering which are utilized in treating different diseases, should be free from contaminants.
- Gene therapies
Products used in gene therapy techniques must be devoid of any existing impurities that may harm patients receiving these therapies.
Compounded sterile preparations
- Hospitals and clinics
CSPs prepared in hospital and clinic pharmacies must be sterile to ensure patient safety during treatment.
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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