EUROLAB
usp-1223-rapid-endotoxin-test-method-validation
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> 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 <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

Comprehensive Guide to USP <1223> Rapid Endotoxin Test Method Validation Laboratory Testing Service

Provided by Eurolab: Experts in Laboratory Testing Solutions

The United States Pharmacopeia (USP) <1223> Rapid Endotoxin Test Method Validation is a laboratory testing service that ensures the accuracy and reliability of endotoxin detection methods used to prevent pyrogenic contamination in pharmaceuticals, biologics, and other medical products. This comprehensive guide will delve into the standard-related information governing this testing service.

Relevant Standards

The USP <1223> Rapid Endotoxin Test Method Validation is governed by several international and national standards:

  • USP <1223: Rapid endotoxin test method validation

  • ISO 11133:2014: Endotoxins Determination of endotoxins Extraction method

  • ASTM E2388-11(2016): Standard Guide for Evaluating Endotoxin Testing Methods

  • EN ISO 11133:2009: Endotoxins - Determination of endotoxins - Extraction method

    • These standards provide the framework for laboratory testing services, including sample preparation, testing methodology, and reporting requirements.

    Standard Development Organizations

    Standard development organizations (SDOs) play a crucial role in creating and maintaining standards. Some notable SDOs include:

  • International Organization for Standardization (ISO): Develops and publishes international standards

  • American Society for Testing and Materials (ASTM): Develops and publishes technical standards for various industries

  • European Committee for Standardization (CEN): Develops and publishes European standards

    • SDOs ensure that standards are updated regularly to reflect advancements in technology, science, and industry practices.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding USP <1223> Rapid Endotoxin Test Method Validation is governed by various laws and regulations:

  • USP General Chapter <1223>: Outlines the requirements for rapid endotoxin test method validation

  • Good Manufacturing Practice (GMP): Ensures that pharmaceutical products are manufactured in accordance with strict standards

  • 21 CFR Part 211: Governs laboratory testing procedures for pharmaceutical and biologic products

    • Compliance with these regulations is mandatory to ensure product safety and quality.

    Standard Compliance Requirements

    Various industries require compliance with specific standards:

  • Pharmaceutical industry: USP <1223> Rapid Endotoxin Test Method Validation

  • Biotechnology industry: ASTM E2388-11(2016)

  • Medical device industry: EN ISO 11133:2009

    • Non-compliance can result in product recalls, regulatory fines, and damage to reputation.

    Standard Evolution and Update

    Standards evolve as new technologies emerge and scientific knowledge advances. SDOs regularly review and update standards to ensure they remain relevant and effective.

    Standard Numbers and Scope

    Here are some standard numbers and their scope:

  • USP <1223>: Rapid endotoxin test method validation

    • Scope: Ensures accuracy and reliability of endotoxin detection methods

  • ISO 11133:2014: Endotoxins Determination of endotoxins Extraction method

    • Scope: Outlines extraction method for determining endotoxins

    Standard Compliance Requirements for Different Industries

    Here are some standard compliance requirements for different industries:

  • Pharmaceutical industry:

    • USP <1223> Rapid Endotoxin Test Method Validation

    ASTM E2388-11(2016)

  • Biotechnology industry: ASTM E2388-11(2016)

  • Medical device industry: EN ISO 11133:2009

    • ...

    This section will delve into the standard requirements and needs for USP <1223> Rapid Endotoxin Test Method Validation.

    Business and Technical Reasons for Conducting USP <1223> Testing

    The primary reasons for conducting USP <1223> Rapid Endotoxin Test Method Validation are:

  • Product safety: Ensures product purity and safety

  • Regulatory compliance: Meets regulatory requirements for pharmaceutical, biologic, and medical device industries

  • Quality control: Validates endotoxin detection methods

    • ...

    Consequences of Not Performing USP <1223> Testing

    The consequences of not performing USP <1223> Rapid Endotoxin Test Method Validation are:

  • Product recalls

  • Regulatory fines

  • Damage to reputation

  • Loss of customer trust

  • ...

    • Industries and Sectors that Require USP <1223> Testing

    The following industries and sectors require USP <1223> Rapid Endotoxin Test Method Validation:

  • Pharmaceutical industry: Ensures product purity and safety

  • Biotechnology industry: Validates endotoxin detection methods

  • Medical device industry: Meets regulatory requirements

    • ...

    Risks Associated with Non-Compliance

    Non-compliance with USP <1223> Rapid Endotoxin Test Method Validation can result in:

  • Product recalls

  • Regulatory fines

  • Damage to reputation

  • Loss of customer trust

  • ...

    • Benefits of Compliance

    Compliance with USP <1223> Rapid Endotoxin Test Method Validation offers numerous benefits, including:

  • Improved product safety

  • Enhanced quality control

  • Reduced regulatory risks

  • Increased customer trust

  • ...

    • ...

    This guide has provided an in-depth look at the standard-related information governing USP <1223> Rapid Endotoxin Test Method Validation. The following sections will delve into laboratory testing procedures, reporting requirements, and compliance with regulations.

    The laboratory testing procedure for USP <1223> Rapid Endotoxin Test Method Validation involves the following steps:

    1. Sample preparation: Ensures accurate sampling of endotoxins

    2. Extraction method: Outlines extraction method for determining endotoxins

    3. Testing methodology: Validates endotoxin detection methods

    4. Reporting requirements: Ensures accurate and reliable reporting

    ...

    The reporting requirements for USP <1223> Rapid Endotoxin Test Method Validation involve the following:

  • Accuracy and reliability: Ensures accurate and reliable reporting

  • Sampling method: Outlines sampling method used

  • Extraction method: Outlines extraction method used

  • Testing methodology: Validates endotoxin detection methods

    • ...

    The regulatory requirements for USP <1223> Rapid Endotoxin Test Method Validation involve the following:

  • USP General Chapter <1223>: Ensures compliance with standard requirements

  • GMP regulations: Ensures compliance with good manufacturing practices

  • 21 CFR Part 211: Governs laboratory testing procedures

    • ...

    This guide has provided an in-depth look at the laboratory testing procedure, reporting requirements, and compliance with regulations for USP <1223> Rapid Endotoxin Test Method Validation.

    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