EUROLAB
ep-2612-microbial-limits-tests-for-non-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 2.6.14 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 <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 EP 2.6.12 Microbial Limits Tests for Non-Sterile Products Laboratory Testing Service Provided by Eurolab

EP 2.6.12 Microbial Limits Tests for Non-Sterile Products is a laboratory testing service that falls under the European Pharmacopoeia (Ph. Eur.) standards. The Ph. Eur. is a collection of standards and guidelines that govern the quality and safety of pharmaceutical products, including non-sterile products.

Relevant Standards

  • Ph. Eur. 2.6.12: Microbial limits tests for non-sterile products

  • ISO 11731:1998: Water quality Determination of dissolved oxygen

  • ASTM E2169-13: Standard Test Method for Determining the Microbial Purity of Non-Sterile Pharmaceutical Products

  • EN 12080:2014: Microbiological examination of non-sterile pharmaceutical preparations

    • Legal and Regulatory Framework

    The testing service is governed by various international and national regulations, including:

  • Good Manufacturing Practice (GMP)

  • Good Laboratory Practice (GLP)

  • Directive 2003/94/EC on the implementation of risk analysis and bioequivalence requirements for medicinal products

  • Directive 2004/27/EC on the principles of good manufacturing practice

    • International and National Standards

    Eurolab is accredited to perform EP 2.6.12 Microbial Limits Tests for Non-Sterile Products in accordance with Ph. Eur. standards. Our laboratory is equipped with state-of-the-art equipment and follows strict quality control measures to ensure compliance with international and national standards.

    Standard Development Organizations

    The development of standards for non-sterile products involves collaboration between various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • How Standards Evolve and Get Updated

    Standards are constantly being updated to reflect changes in technology, regulations, and industry practices. Eurolab stays up-to-date with the latest standards and guidelines through regular training, participation in workshops, and collaboration with other experts.

    Standard Numbers and Scope

    The following standard numbers apply to EP 2.6.12 Microbial Limits Tests for Non-Sterile Products:

  • Ph. Eur. 2.6.12

  • ISO 11731:1998

  • ASTM E2169-13

    • These standards govern the testing of microbial limits in non-sterile products, including pharmaceuticals, cosmetics, and food.

    Industry-Specific Compliance Requirements

    Compliance with EP 2.6.12 Microbial Limits Tests for Non-Sterile Products is mandatory for various industries, including:

  • Pharmaceutical

  • Cosmetics

  • Food

  • Biotechnology

    • Failure to comply with these standards can result in product recalls, financial losses, and damage to reputation.

    Why This Specific Test is Needed and Required

    EP 2.6.12 Microbial Limits Tests for Non-Sterile Products is essential to ensure the safety and efficacy of non-sterile products. The test detects microbial contaminants, including bacteria, yeast, and mold, which can pose serious health risks.

    Business and Technical Reasons for Conducting EP 2.6.12 Microbial Limits Tests

    Conducting this test:

  • Ensures compliance with regulatory requirements

  • Protects consumers from potential health risks

  • Maintains product quality and safety standards

  • Enhances reputation and trust among customers

    • Consequences of Not Performing This Test

    Failure to perform EP 2.6.12 Microbial Limits Tests for Non-Sterile Products can result in:

  • Product recalls

  • Financial losses due to contamination and spoilage

  • Damage to reputation and loss of customer trust

  • Regulatory fines and penalties

    • Industries and Sectors That Require This Testing

    The following industries require EP 2.6.12 Microbial Limits Tests for Non-Sterile Products:

  • Pharmaceutical

  • Cosmetics

  • Food

  • Biotechnology

    • Risk Factors and Safety Implications

    Microbial contaminants can pose serious health risks, including infections, allergic reactions, and even life-threatening conditions.

    Quality Assurance and Quality Control Aspects

    Eurolabs laboratory follows strict quality control measures to ensure compliance with international and national standards. Our quality management system is accredited by recognized certification bodies.

    How This Test Contributes to Product Safety and Reliability

    EP 2.6.12 Microbial Limits Tests for Non-Sterile Products ensures that products meet safety and efficacy standards, protecting consumers from potential health risks.

    Competitive Advantages of Having This Testing Performed

    By conducting EP 2.6.12 Microbial Limits Tests for Non-Sterile Products:

  • Companies demonstrate their commitment to product safety and quality

  • Enhance reputation and trust among customers

  • Comply with regulatory requirements, reducing the risk of fines and penalties

    • Test Methodology and Equipment

    Eurolabs laboratory is equipped with state-of-the-art equipment, including:

  • Microbial detection systems (e.g., PCR, qPCR)

  • Spectrophotometers for microbial growth measurement

  • Incubators for microbial cultivation

    • Our experienced technicians follow strict testing protocols to ensure accurate and reliable results.

    Interpretation of Test Results

    Eurolabs laboratory provides detailed reports on test results, including:

  • Microbial detection and identification

  • Quantification of microbial contaminants

  • Recommendations for corrective actions

    • Test Report Validation and Verification

    Eurolabs laboratory ensures that test reports are validated and verified to ensure compliance with international and national standards.

    Conclusion

    EP 2.6.12 Microbial Limits Tests for Non-Sterile Products is a critical testing service that ensures the safety and efficacy of non-sterile products. Eurolabs laboratory follows strict quality control measures to provide accurate and reliable results, ensuring compliance with regulatory requirements and industry standards.

    ... (insert additional information on standard-related topics)

    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