EUROLAB
usp-61-microbial-load-test-for-oral-dosage-forms
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 Enumeration Test for Sterile ProductsUSP <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

Comprehensive Guide to USP <61> Microbial Load Test for Oral Dosage Forms Laboratory Testing Service

Provided by Eurolab

The USP <61> Microbial Load Test for Oral Dosage Forms is a laboratory testing service that measures the microbial load of oral dosage forms, such as tablets and capsules. This test is governed by several international and national standards, including:

  • ISO 11133:2003 (Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of microorganisms)

  • ASTM E2161-16 (Standard Test Method for Determining the Microbial Load in Pharmaceutical Products)

  • EN 13620:2014 (Pharmaceutical preparations - Sterility testing)

  • TSE 1002:2016 (Microbiological examination of pharmaceutical products)

    • These standards provide the framework for conducting this test and ensure that results are reliable, accurate, and compliant with regulatory requirements.

    The legal and regulatory framework surrounding USP <61> Microbial Load Test for Oral Dosage Forms testing is governed by national and international regulations. For example:

  • The US FDA requires pharmaceutical companies to conduct microbial load testing on oral dosage forms as part of their quality control measures (21 CFR 211).

  • The European Medicines Agency (EMA) also requires pharmaceutical companies to conduct microbial load testing as part of their quality control measures.

    • Standard development organizations, such as ISO and ASTM, play a crucial role in developing and updating standards related to this test. These organizations work with industry experts and regulatory agencies to ensure that standards are relevant, effective, and compliant with regulatory requirements.

    Standards evolve over time due to advancements in technology, changes in regulations, or new scientific findings. For example, the ISO 11133 standard has undergone several revisions since its initial publication in 2003.

    The following table lists specific standard numbers and their scope:

    Standard Number Title

    --- ---

    ISO 11133:2003 Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of microorganisms

    ASTM E2161-16 Standard Test Method for Determining the Microbial Load in Pharmaceutical Products

    EN 13620:2014 Pharmaceutical preparations - Sterility testing

    TSE 1002:2016 Microbiological examination of pharmaceutical products

    Standard compliance requirements vary depending on the industry and sector. For example:

  • The pharmaceutical industry requires compliance with USP <61> Microbial Load Test for Oral Dosage Forms testing as part of their quality control measures.

  • The food industry requires compliance with ISO 11133:2003 (Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of microorganisms).

    • The USP <61> Microbial Load Test for Oral Dosage Forms is a critical testing service that ensures oral dosage forms meet regulatory requirements. This test is required to:

  • Ensure product safety and reliability

  • Prevent contamination and spoilage

  • Meet regulatory compliance requirements

  • Maintain product quality and consistency

  • Enhance customer confidence and trust

    • Consequences of not performing this test can include:

  • Product recalls and withdrawals

  • Regulatory fines and penalties

  • Loss of business reputation and credibility

  • Economic losses due to reduced sales and revenue

    • Industries that require this testing service include:

  • Pharmaceutical industry (oral dosage forms)

  • Food industry (food products requiring microbial load testing)

    • Risk factors and safety implications associated with this test include:

  • Microbial contamination of oral dosage forms, leading to product spoilage or contamination

  • Potential health risks associated with consumption of contaminated products

    • Quality assurance and quality control aspects are crucial when conducting this test. This includes:

  • Use of calibrated equipment and instruments

  • Maintenance of testing environment (temperature, humidity, pressure)

  • Sample preparation procedures to ensure accuracy and reliability

  • Testing parameters and conditions to ensure compliance with regulatory requirements

  • Calibration and validation procedures to ensure accurate results

    • This test contributes to product safety and reliability by ensuring that oral dosage forms meet regulatory requirements. It also provides competitive advantages through:

  • Enhanced customer confidence and trust

  • Regulatory compliance benefits

  • Quality assurance and quality control benefits

  • Cost savings and efficiency improvements

    • Conducting the USP <61> Microbial Load Test for Oral Dosage Forms involves several steps, including:

    1. Sample preparation: Samples are prepared according to standard procedures to ensure accuracy and reliability.

    2. Testing equipment and instruments: Calibrated equipment and instruments are used to conduct testing.

    3. Testing environment requirements: The testing environment is maintained at the required temperature (25C 5C), humidity (60 10), and pressure conditions.

    4. Sample size requirements: Samples are sized according to standard procedures to ensure accuracy and reliability.

    Testing parameters and conditions include:

  • Temperature (25C 5C)

  • Humidity (60 10)

  • Pressure

  • Incubation time

    • Calibration and validation procedures are conducted regularly to ensure accurate results. This includes:

  • Calibration of equipment and instruments

  • Validation of testing procedures

  • Regular maintenance of testing environment

    • Test Results and Interpretation

    Results from the USP <61> Microbial Load Test for Oral Dosage Forms are interpreted according to standard procedures. This includes:

  • Enumeration of microorganisms present on the sample

  • Calculation of microbial load (CFU/g)

  • Comparison with regulatory limits

    • Interpretation of results is critical in ensuring that oral dosage forms meet regulatory requirements.

    Conclusion

    The USP <61> Microbial Load Test for Oral Dosage Forms is a critical testing service that ensures oral dosage forms meet regulatory requirements. This test is governed by several international and national standards, including ISO 11133:2003, ASTM E2161-16, EN 13620:2014, and TSE 1002:2016.

    Consequences of not performing this test can include product recalls and withdrawals, regulatory fines and penalties, loss of business reputation and credibility, and economic losses due to reduced sales and revenue.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers