EUROLAB
usp-61-microbial-enumeration-test-for-sterile-products
Endotoxin & Bioburden Testing AAMI RD52 Endotoxin Limits for Dialysis FluidsAATCC TM100 Test for Antimicrobial Activity of TextilesANSI/AAMI ST72 Guidance on Bacterial Endotoxin Testing for Medical DevicesASTM D4414 Bioburden in Coated TextilesASTM D7295 Bioburden Testing on Coated Medical TextilesASTM E2314 Bioburden Testing in Medical Device ComponentsASTM E2406 Real-Time Endotoxin Detection Method ValidationASTM E2614 Bioburden in Industrial Water SystemsASTM E2883 Rapid Endotoxin Detection for Sterile PharmaceuticalsASTM F1608 Bacterial Filtration and Bioburden in Respiratory Protection DevicesASTM F1980 Bioburden Evaluation in Accelerated Aged ProductsASTM F2018 Endotoxin Testing of Contact Lens Care ProductsASTM F640 Bioburden Testing for Surgical DrapesEN 556 Sterilization of Medical Devices – Bioburden LimitsEN ISO 20857 Bioburden Control for Liquid Chemical SterilantsEP 2.6.1 Microbial Testing in Topical PreparationsEP 2.6.12 Microbial Limits Tests for Non-Sterile ProductsEP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical PreparationsEP 2.6.25 Limulus Amebocyte Lysate Test Methods ValidationEP 2.6.30 Endotoxin Testing in Biotechnology ProductsEP 2.6.31 Limulus Amebocyte Lysate Test for EndotoxinsEP 5.1.10 Guidelines for Bioburden Testing in Advanced Therapy Medicinal ProductsEP 5.1.2 Biological Indicators for Sterilization Process ControlEP Monograph 04/2013:20619 Pyrogen and Endotoxin TestingFDA CBER Guidance on Endotoxin Testing of VaccinesFDA CDER Guidance on Bioburden Control in Drug ManufacturingFDA Guidance for Industry on Pyrogen and Endotoxin TestingISO 10993-1 Biological Evaluation of Medical Devices – Endotoxin AssessmentISO 10993-18 Bioburden Interaction with Extractables and LeachablesISO 11137-2 Sterilization Process Validation and Bioburden TestingISO 11138-1 Biological Indicators for Sterilization – Bioburden EvaluationISO 11139 Sterilization Terminology and Bioburden DefinitionsISO 11607 Packaging for Terminally Sterilized Medical Devices – Bioburden ConsiderationsISO 11607-2 Packaging for Terminal Sterilized Devices – Bioburden ConsiderationsISO 11731 Detection of Legionella in Water SystemsISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-1 Bioburden on Reusable Surgical InstrumentsISO 11737-1 Bioburden Testing for Dental ImplantsISO 11737-2 Bioburden Testing for Sterile Barrier SystemsISO 11737-2 Sterility Assurance and Bioburden ControlISO 13408-1 Aseptic Processing Bioburden ControlISO 13408-2 Aseptic Processing Microbiological MonitoringISO 14160 Endotoxin Removal Validation for Sterile LiquidsISO 14161 Bioburden Reduction Using FiltrationISO 14161 Validation of Bioburden Testing MethodsISO 14698-1 Cleanroom Biocontamination Control and MonitoringISO 14971 Risk Management of Endotoxin Contamination in Medical DevicesISO 15883-1 Bioburden Testing for Washer-DisinfectorsISO 17665-1 Moist Heat Sterilization – Bioburden ValidationISO 18562-1 Evaluation of Bioburden in Medical Devices – Part 1ISO 18562-4 Bioburden Testing in Medical Device Gas PathwaysISO 22519 Ultrafiltration Bioburden Reduction TestingISO 29621 Microbiological Examination of CosmeticsISO 80369-1 Endotoxin Limits for Small-Bore ConnectorsISO 80369-7 Small Bore Connectors Bioburden EvaluationISPE Baseline Guide Volume 7 Bioburden Control in Biopharmaceutical ManufacturingJP 15.02 Endotoxin Limit Test for Dialysis FluidsJP 4.05 Bacterial Endotoxin Test for Parenteral DrugsJP 4.06 Bacterial Endotoxin Testing of BiopharmaceuticalsJP XVII Limulus Amebocyte Lysate (LAL) Gel-Clot Test for EndotoxinsPh. Eur. Recombinant Factor C Assay for Endotoxin DetectionUSP <1050> Environmental Monitoring and Bioburden ControlUSP <1072> Disinfectants and Bioburden Control in Healthcare SettingsUSP <1111> Total Viable Count for Raw MaterialsUSP <1223> Rapid Endotoxin Test Method ValidationUSP <1223> Validation of Alternative Microbiological MethodsUSP <1225> Validation of Analytical Procedures for Endotoxin TestingUSP <1227> Validation of Microbial Recovery MethodsUSP <1229.10> Bioburden Testing in Steam SterilizationUSP <1229.12> Endotoxin Risk Assessment in Sterile ManufacturingUSP <1229.4> Microbial Testing for Aseptic Manufacturing EnvironmentsUSP <1229.9> Bioburden Validation in Isolator TechnologyUSP <1231> Bioburden Limits in Purified Water SystemsUSP <1231> Water for Pharmaceutical Purposes Microbial LimitsUSP <1232> Elemental Impurities and Bioburden ImpactUSP <61> Microbial Load Test for Oral Dosage FormsUSP <62> Test for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing for Ophthalmic ProductsUSP <800> Bioburden Control in Hazardous Drug CompoundingUSP <85> Bacterial Endotoxin Test for Injectable Pharmaceutical ProductsWHO TRS 1003 Endotoxin Testing Validation for Parenteral Products

USP <61> Microbial Enumeration Test for Sterile Products Laboratory Testing Service Provided by Eurolab

Standard-Related Information

The USP <61> Microbial Enumeration Test for Sterile Products is a laboratory testing service that ensures the sterility of pharmaceutical products, medical devices, and other sterile goods. This test is governed by various international and national standards, which are developed and maintained by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Electrotechnical Standardization (CENELEC), Turkish Standards Institution (TSE), and others.

Legal and Regulatory Framework

The USP <61> Microbial Enumeration Test for Sterile Products is governed by regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national health authorities worldwide. These regulations require pharmaceutical manufacturers to ensure the sterility of their products through various testing methods, including the USP <61> Microbial Enumeration Test.

International and National Standards

The following international and national standards apply to the USP <61> Microbial Enumeration Test for Sterile Products:

  • ISO 11135:2009(E) - Sterilization of medical instruments and equipment by irradiation

  • ASTM E2118-13 - Standard Practice for Estimating the Probability of Sterility

  • CENELEC EN ISO 11138-1:2017 - Sterilization of medical devices Requirements for validation and routine control of a sterilization process

  • TSE TD ISO 11137-3:2019 - Sterilizasyon (Işaretli) cihazlar için sterilizasyon prosesinin doğrulanması ve düzenli kontrolü

    • Standard Compliance Requirements

    Compliance with these standards is mandatory for all manufacturers and suppliers of sterile products. Failure to comply can result in product recalls, fines, and loss of business reputation.

    Standard Development Organizations

    Standard development organizations such as ISO, ASTM, CENELEC, and TSE play a crucial role in developing and maintaining international and national standards. These organizations ensure that standards are up-to-date and relevant to industry needs.

    Why This Test is Needed and Required

    The USP <61> Microbial Enumeration Test for Sterile Products is necessary to ensure the sterility of pharmaceutical products, medical devices, and other sterile goods. The test helps to prevent contamination and infection, which can lead to serious health issues.

    Consequences of Not Performing This Test

    Failure to perform this test can result in product recalls, fines, and loss of business reputation. In severe cases, it can also lead to harm or death due to contaminated products.

    Industries and Sectors That Require This Testing

    The following industries and sectors require the USP <61> Microbial Enumeration Test for Sterile Products:

  • Pharmaceutical manufacturers

  • Medical device manufacturers

  • Biotechnology companies

  • Healthcare institutions

    • Risk Factors and Safety Implications

    The risk factors associated with non-sterile products include contamination, infection, and illness. The safety implications of non-sterile products are severe and can result in harm or death.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality assurance and quality control procedures ensure that all testing services meet the required standards and regulations. Our laboratory is accredited by international accrediting bodies such as ILAC and ISO 17025:2017, demonstrating our commitment to quality and competence.

    How This Test Contributes to Product Safety and Reliability

    The USP <61> Microbial Enumeration Test for Sterile Products contributes significantly to product safety and reliability. By ensuring the sterility of products, we prevent contamination and infection, which can lead to serious health issues.

    Competitive Advantages of Having This Testing Performed

    Performing this test provides several competitive advantages, including:

  • Compliance with regulatory requirements

  • Increased customer confidence and trust

  • Improved product safety and reliability

  • Enhanced business reputation

    • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of performing the USP <61> Microbial Enumeration Test for Sterile Products is evident in several areas, including:

  • Reduced risk of contamination and infection

  • Compliance with regulatory requirements

  • Increased customer confidence and trust

  • Improved business reputation

    • Test Conditions and Methodology

    The following is a detailed explanation of how the test is conducted:

    1. Sample collection: Samples are collected from production batches or inventory.

    2. Sample preparation: Samples are prepared for testing according to standard protocols.

    3. Testing equipment and instruments: Eurolab uses state-of-the-art equipment, including automated microbial analyzers.

    4. Testing environment requirements: The laboratory maintains a controlled environment with precise temperature, humidity, and pressure conditions.

    5. Measurement and analysis methods: Results are measured using validated analytical techniques.

    Test Reporting and Documentation

    The following is an explanation of how test results are documented and reported:

    1. Test report format: Reports are formatted according to standard requirements.

    2. Data interpretation: Results are interpreted and presented in a clear and concise manner.

    3. Certification: Certificates of compliance are issued upon successful completion of testing.

    Conclusion

    Eurolabs USP <61> Microbial Enumeration Test for Sterile Products is a critical component of our laboratory services. By ensuring the sterility of products, we contribute significantly to product safety and reliability. Our commitment to quality and competence ensures that all testing services meet the required standards and regulations.

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