EUROLAB
pda-tr-70-sterilization-of-drug-products-by-moist-heat
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

Comprehensive Guide to Eurolabs PDA TR 70 Sterilization of Drug Products by Moist Heat Laboratory Testing Service

Eurolab provides a comprehensive laboratory testing service for PDA TR 70 Sterilization of Drug Products by Moist Heat, ensuring that drug products are sterilized to the highest standards. This section provides an in-depth overview of the relevant standards governing this testing service.

Relevant Standards

The following international and national standards apply to PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • ISO 13485:2016 (Medical devices Quality management systems Requirements for regulatory purposes)
  • ASTM E-1671-14 (Standard Guide for Validation of Processes in the Pharmaceutical Industry)
  • EN 285:2009 (Sterilisation - Large and small sterilizers - Requirements for the development, validation, operation and maintenance of sterilization processes)
  • TSE 2250 (Turkish Standard for Sterilization)
  • FDA Guidance on Sterility Testing (21 CFR Part 211.165)
  • Standard Development Organizations

    The following standard development organizations play a crucial role in developing and updating standards related to PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • Turkish Standards Institution (TSE)
  • Standard Evolution and Updates

    Standards are constantly evolving to reflect the latest technological advancements, scientific research, and regulatory requirements. Eurolab stays up-to-date with the latest standards and updates to ensure that our testing services meet the most stringent requirements.

    Specific Standard Numbers and Scope

    The following standard numbers and scope apply to PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes
  • Scope: Applies to medical device manufacturers, importers, and distributors

  • ASTM E-1671-14 - Standard Guide for Validation of Processes in the Pharmaceutical Industry
  • Scope: Applies to pharmaceutical manufacturers, contractors, and suppliers

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for industries involved in drug product development, manufacturing, and distribution. Eurolab ensures that our testing services meet or exceed the requirements specified in these standards.

    The following industries require PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • Pharmaceutical manufacturers
  • Biotechnology companies
  • Medical device manufacturers
  • Cosmetic product manufacturers
  • Food industry manufacturers
  • This section highlights the importance of standard compliance and provides a comprehensive overview of relevant standards, standard development organizations, and standard evolution.

    Eurolabs PDA TR 70 Sterilization of Drug Products by Moist Heat laboratory testing service is designed to meet the specific requirements of various industries. This section explains in detail why this test is needed and required.

    Business and Technical Reasons for Conducting PDA TR 70 Testing

    Conducting PDA TR 70 Sterilization of Drug Products by Moist Heat testing is essential for:

  • Ensuring product safety and reliability
  • Complying with regulatory requirements
  • Maintaining product quality and consistency
  • Reducing risk and liability associated with non-compliance
  • Enhancing customer confidence and trust
  • Consequences of Not Performing PDA TR 70 Testing

    Failure to conduct PDA TR 70 Sterilization of Drug Products by Moist Heat testing can result in:

  • Product recalls and withdrawals
  • Loss of business and revenue
  • Damage to reputation and brand image
  • Regulatory actions and penalties
  • Reduced customer confidence and trust
  • Industries and Sectors Requiring PDA TR 70 Testing

    The following industries require PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • Pharmaceutical manufacturers
  • Biotechnology companies
  • Medical device manufacturers
  • Cosmetic product manufacturers
  • Food industry manufacturers
  • This section highlights the importance of conducting PDA TR 70 Sterilization of Drug Products by Moist Heat testing and explains the consequences of non-compliance.

    Eurolabs PDA TR 70 Sterilization of Drug Products by Moist Heat laboratory testing service involves a comprehensive testing process. This section provides detailed step-by-step information on how the test is conducted.

    Testing Equipment and Instruments

    The following equipment and instruments are used for PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • Autoclaves
  • Sterilizers
  • Temperature control units
  • Humidity control units
  • Pressure gauges
  • Testing Environment Requirements

    The following environmental conditions are required for PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • Temperature: 121C (250F)
  • Pressure: 1 atmosphere (1013 mbar)
  • Humidity: 95-100
  • Sampling and Preparation

    Samples must be prepared according to the relevant standard, ISO 13485:2016. The sample preparation process involves:

  • Sample collection
  • Sample processing
  • Sample packaging
  • Testing Procedure

    The testing procedure for PDA TR 70 Sterilization of Drug Products by Moist Heat testing involves:

  • Pre-heating and pre-sterilizing the autoclave or sterilizer
  • Loading the samples into the autoclave or sterilizer
  • Sterilizing the samples according to the specified conditions
  • Cooling and unloading the samples
  • Testing Methodology

    The testing methodology for PDA TR 70 Sterilization of Drug Products by Moist Heat testing involves:

  • Monitoring temperature, pressure, and humidity during sterilization
  • Verifying sample sterility using a suitable detection method (e.g., microbial growth medium)
  • Recording and documenting test results
  • This section provides detailed information on the testing conditions, equipment, instruments, sampling, preparation, and methodology involved in PDA TR 70 Sterilization of Drug Products by Moist Heat testing.

    Test Results and Reporting

    Eurolabs PDA TR 70 Sterilization of Drug Products by Moist Heat laboratory testing service includes a comprehensive report detailing test results. The report will include:

  • Test method used
  • Sample identification and description
  • Temperature, pressure, and humidity conditions during sterilization
  • Sterility detection results
  • Conclusion and recommendations
  • Conclusion

    Eurolabs PDA TR 70 Sterilization of Drug Products by Moist Heat laboratory testing service is designed to ensure that drug products are sterilized to the highest standards. This section highlights the importance of standard compliance, provides a comprehensive overview of relevant standards, and explains the business and technical reasons for conducting PDA TR 70 testing.

    The consequences of non-compliance with PDA TR 70 Sterilization of Drug Products by Moist Heat testing are severe and can result in product recalls, loss of business, damage to reputation, regulatory actions, and reduced customer confidence. Eurolabs comprehensive testing service ensures that your products meet the most stringent standards.

    Appendix

    The following appendix provides additional information on:

  • Standard compliance requirements
  • Testing equipment and instruments
  • Sampling and preparation procedures
  • Testing methodology
  • This section provides a comprehensive overview of Eurolabs PDA TR 70 Sterilization of Drug Products by Moist Heat laboratory testing service, highlighting the importance of standard compliance and providing detailed information on the testing conditions, equipment, instruments, sampling, preparation, and methodology involved.

    References

    The following references provide additional information on PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • ISO 13485:2016 (Medical devices Quality management systems Requirements for regulatory purposes)
  • ASTM E-1671-14 (Standard Guide for Validation of Processes in the Pharmaceutical Industry)
  • EN 285:2009 (Sterilisation - Large and small sterilizers - Requirements for the development, validation, operation and maintenance of sterilization processes)
  • Glossary

    The following glossary provides definitions of key terms related to PDA TR 70 Sterilization of Drug Products by Moist Heat testing:

  • Autoclave
  • Sterilizer
  • Temperature control unit
  • Humidity control unit
  • Pressure gauge
  • This comprehensive guide provides detailed information on Eurolabs PDA TR 70 Sterilization of Drug Products by Moist Heat laboratory testing service, ensuring that your products meet the most stringent standards.

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    Please note that this is a sample and not an actual comprehensive guide. The content should be reviewed and modified according to your specific needs and requirements.

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