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jp-405-bacterial-endotoxin-test-for-parenteral-drugs
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 4.06 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 <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

JP 4.05 Bacterial Endotoxin Test for Parenteral Drugs: Laboratory Testing Services

The JP 4.05 Bacterial Endotoxin Test for Parenteral Drugs is a laboratory testing service that ensures the safety and quality of parenteral drugs by detecting bacterial endotoxins. This test is governed by various international and national standards, including:

  • ISO 11133:2014 (Microbiology of food and animal feeding stuffs -- Part 1: Horizontal method for the detection of specific microorganisms)

  • ISO 10993-11:2017 (Biological evaluation of medical devices Part 11: Tests for systemic toxicity, in vitro and in vivo genotoxicity, carcinogenicity, and reproductive toxicity)

  • ASTM E2187-13 (Standard Test Method for Determining the Bacterial Endotoxin Content of Pharmaceuticals)

  • EN 14616:2012 (Biological evaluation of medical devices Part 11: Tests for systemic toxicity, in vitro and in vivo genotoxicity, carcinogenicity, and reproductive toxicity)

    • These standards provide a framework for ensuring the safety and quality of parenteral drugs by detecting bacterial endotoxins. The legal and regulatory framework surrounding this testing service is governed by various national and international regulations, including:

  • EU GMP (European Union Good Manufacturing Practice) guidelines

  • US FDA (United States Food and Drug Administration) regulations

  • ICH Q3B (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines

    • The JP 4.05 Bacterial Endotoxin Test for Parenteral Drugs is a critical testing service that ensures the safety and quality of parenteral drugs by detecting bacterial endotoxins. This test is required to:

  • Ensure the safety and efficacy of parenteral drugs

  • Comply with national and international regulations and standards

  • Prevent contamination and product recalls

  • Maintain customer trust and confidence

    • The consequences of not performing this test include:

  • Contamination and product recalls

  • Loss of customer trust and confidence

  • Non-compliance with regulations and standards

  • Financial losses due to product recalls and reputation damage

    • The JP 4.05 Bacterial Endotoxin Test for Parenteral Drugs is conducted using the following equipment and instruments:

  • Pyrolysis apparatus

  • Spectrophotometer

  • Calibration equipment

  • Validation software

    • The testing environment requirements include:

  • Temperature: 20-25C

  • Humidity: 40-60

  • Pressure: 1 atm

  • Lighting: fluorescent lighting

    • The sample preparation procedures involve:

  • Sample collection and storage

  • Sample dilution and preparation

  • Equipment calibration and validation

    • The testing parameters and conditions include:

  • Endotoxin concentration

  • Sample volume

  • Testing timeframes and duration

  • Statistical considerations

    • The test results are documented and reported using the following format and structure:

  • Report title and summary

  • Test method and equipment used

  • Sample information and preparation procedures

  • Results and conclusions

  • Recommendations for further action

    • The report is certified and accredited by Eurolabs quality management system, which ensures the accuracy and reliability of the test results.

    The benefits and advantages of performing the JP 4.05 Bacterial Endotoxin Test for Parenteral Drugs include:

  • Ensuring product safety and efficacy

  • Complying with regulations and standards

  • Preventing contamination and product recalls

  • Maintaining customer trust and confidence

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Quality assurance and compliance benefits

    • Eurolab is the ideal choice for this testing service due to:

  • Expertise and experience in bacterial endotoxin testing

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

  • Customer service and support capabilities

    • Additional Requirements

  • Industry-specific examples and case studies

  • Statistical data and research findings

  • Technical specifications and parameters

  • Confidentiality and data protection measures

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