EUROLAB
usp-71-sterility-testing-for-ophthalmic-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 Enumeration Test for Sterile ProductsUSP <61> Microbial Load Test for Oral Dosage FormsUSP <62> Test for Specified Microorganisms in Non-Sterile 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 <71> Sterility Testing for Ophthalmic Products: Eurolabs Laboratory Testing Service

USP <71> Sterility Testing for Ophthalmic Products is a laboratory testing service that assesses the sterility of ophthalmic products, such as contact lenses and lens care solutions. This testing is crucial to ensure the safety and efficacy of these products. The relevant standards governing this testing include:

  • USP <71> Sterility Tests

  • ISO 11138-1:2017 Sterilization of Medical Devices Part 1: Requirements for validation and routine control of a sterilization process for medical devices employing performance-oriented sterilization processes

  • ASTM E2112-17 Standard Practice for Evaluation of Sterilization Cycles for Medical Products Using a Biological Indicator

  • EN 556-1:2017 Sterility testing of medical devices - Part 1: General requirements

    • These standards outline the requirements for conducting sterility tests, including the selection of test organisms, sampling procedures, and evaluation criteria. The legal and regulatory framework surrounding this testing is governed by national and international regulations, such as:

  • US Food and Drug Administration (FDA) regulations

  • European Medicines Agency (EMA) guidelines

  • International Organization for Standardization (ISO) standards

    • These regulations dictate the requirements for sterility testing, including the need for a validated sterilization process and regular monitoring of sterility.

    USP <71> Sterility Testing for Ophthalmic Products is necessary to ensure the safety and efficacy of these products. The business and technical reasons for conducting this testing include:

  • Ensuring product sterility and preventing contamination

  • Validating sterilization processes

  • Regularly monitoring sterility levels

  • Complying with regulatory requirements

    • The consequences of not performing this test are severe, including:

  • Product recalls due to contamination

  • Loss of customer trust and reputation

  • Non-compliance with regulations

    • Industries and sectors requiring this testing include:

  • Ophthalmic manufacturing

  • Contact lens manufacturers

  • Lens care solution suppliers

    • Risk factors and safety implications associated with ophthalmic products include:

  • Eye infections and corneal ulcers

  • Vision loss and blindness

  • Economic losses due to product recalls

    • This test contributes to product safety and reliability by ensuring that ophthalmic products are free from contaminants. Competitive advantages of having this testing performed include:

  • Compliance with regulations

  • Enhanced customer trust and loyalty

  • Improved product quality and reputation

    • The cost-benefit analysis of performing this test shows significant benefits, including reduced risks and costs associated with product recalls.

    USP <71> Sterility Testing for Ophthalmic Products involves the following steps:

    1. Sampling: Selecting a representative sample from the batch

    2. Sample preparation: Preparing the sample for testing

    3. Inoculation: Inoculating the test organisms into the sample

    4. Incubation: Incubating the inoculated sample at controlled temperatures

    5. Measurement and analysis: Measuring and analyzing the growth of the test organisms

    Testing equipment and instruments used include:

  • Sterilization chambers

  • Incubators

  • Microscopes

  • Spectrophotometers

    • Testing environment requirements include:

  • Temperature: 30-37C

  • Humidity: 50-70

  • Pressure: 1 atm

    • Sample preparation procedures involve:

  • Aseptic sampling techniques

  • Sample homogenization

  • Inoculum preparation

    • Testing parameters and conditions include:

  • Sterilization process validation

  • Sampling frequency and interval

  • Test organism selection and inoculation

    • Measurement and analysis methods involve:

  • Microbiological assays (MBAs)

  • Biological indicator testing

  • Spectrophotometric analysis

    • Calibration and validation procedures are essential to ensure the accuracy and reliability of the test results.

    USP <71> Sterility Testing for Ophthalmic Products involves documenting and reporting the test results. The report format and structure include:

  • Summary of testing parameters

  • Test organism selection and inoculation details

  • Sampling procedures and frequency

  • Results and interpretation

  • Conclusion and recommendations

    • The certification and accreditation aspects involve:

  • ISO 17025:2018 General requirements for the competence of testing and calibration laboratories

  • EUROLABs laboratory accreditation and certification

    • Traceability and documentation requirements include:

  • Maintaining records of testing parameters and results

  • Documenting sampling procedures and frequency

  • Keeping a record of test organism selection and inoculation

    • Reporting standards and formats involve:

  • USP <71> Sterility Tests report format

  • EUROLABs reporting template

    • Results validation and verification involve:

  • Verification of test results against expected values

  • Validation of testing parameters and conditions

    • Persuasive and Commercial Appeal

    USP <71> Sterility Testing for Ophthalmic Products is a critical laboratory testing service that ensures the safety and efficacy of ophthalmic products. By complying with regulatory requirements and standards, manufacturers can enhance customer trust and loyalty while reducing risks and costs associated with product recalls.

    Eurolabs expertise in this area ensures accurate and reliable results, giving manufacturers confidence in their products quality and sterility. With our comprehensive guide to USP <71> Sterility Testing for Ophthalmic Products, you can ensure compliance with regulations and standards while enhancing your products reputation and customer trust.

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