EUROLAB
pda-tr-69-bioburden-and-cleanroom-microbial-control
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 70 Sterilization of Drug Products by Moist HeatPh. 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

Eurolabs PDA TR 69 Bioburden and Cleanroom Microbial Control Laboratory Testing Service

Eurolabs PDA TR 69 Bioburden and Cleanroom Microbial Control laboratory testing service is governed by a set of international and national standards that ensure the accuracy, reliability, and consistency of test results. These standards are developed and published by organizations such as ISO, ASTM, EN, TSE, and others.

ISO Standards

  • ISO 14644-1:2015 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

  • ISO 14644-2:2009 - Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove designated classification

  • ISO 14698-1:2004 - Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

    • ASTM Standards

  • ASTM E2275 - Standard Guide for Evaluation of Microbial Contamination in Controlled Environments

  • ASTM E2428 - Standard Practice for Evaluating the Effectiveness of Cleaning Procedures for Surfaces in Cleanrooms and Other Controlled-Environment Applications

  • ASTM E2453 - Standard Test Method for Determination of Bioburden on Cleanroom Surfaces

    • EN Standards

  • EN 14644-1:2004A2:2010 - Cleanrooms and associated controlled environments. Part 1: Classification of air cleanliness

  • EN 14698-1:2007 - Cleanrooms and associated controlled environments. Biocontamination control. Part 1: General principles and methods

    • TSE Standards

  • TSE 17001:2005 - Quality Management Systems - Requirements for GMP (Good Manufacturing Practice)

  • TSE 17002:2010 - Application of ISO 9001:2008 in Medical Devices

    • Standard Development Organizations

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

  • American Society for Testing and Materials (ASTM) - Develops and publishes standards related to materials, products, systems, and services

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

    • Standard Evolution and Update

    Standards evolve over time as new technologies and methodologies emerge. Updates are made to reflect changes in industry practices and regulations. Eurolab stays up-to-date with the latest standards and ensures that all testing services are conducted in accordance with the most recent versions.

    International and National Standards

    Eurolabs PDA TR 69 Bioburden and Cleanroom Microbial Control laboratory testing service adheres to international standards such as ISO, ASTM, EN, and national standards specific to various countries. These standards ensure that test results are accurate, reliable, and consistent across different locations.

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for industries operating in controlled environments. Eurolabs testing services help clients meet regulatory requirements and maintain product quality and safety.

    ...

    Eurolabs PDA TR 69 Bioburden and Cleanroom Microbial Control laboratory testing service involves a series of steps to ensure accurate and reliable results. The following section details the test conditions, methodology, and equipment used:

    1. Sample Preparation

  • Samples are collected from surfaces in controlled environments using sterile materials

  • Samples are transported to Eurolabs laboratory in sealed containers

    • 2. Testing Equipment and Instruments

  • Inoculation loops and streak plates for surface testing

  • Microscopes and photomicrographic systems for microbial identification

  • Automated counting instruments for bioburden analysis

    • 3. Testing Environment Requirements

  • Temperature: 20-25C (68-77F)

  • Humidity: 30-60

  • Pressure: Ambient

    • 4. Sample Preparation Procedures

  • Samples are prepared according to ISO and ASTM standards

  • Sterile materials and equipment are used throughout the process

    • 5. Testing Parameters and Conditions

  • Bioburden analysis using automated counting instruments

  • Microbial identification using microscopy and photomicrographic systems

    • 6. Measurement and Analysis Methods

  • Bioburden counts are recorded and analyzed according to ISO and ASTM standards

  • Microbial identification is performed using taxonomic classification

    • 7. Calibration and Validation Procedures

  • Equipment and instruments are calibrated regularly according to manufacturers instructions

  • Validation procedures ensure that equipment and instruments meet performance criteria

    • 8. Quality Control Measures During Testing

  • Sampling plans are followed strictly

  • Duplicate samples are tested for accuracy and reliability

    • 9. Data Collection and Recording Procedures

  • Data is recorded using electronic recording systems

  • Raw data is stored on secure servers

    • 10. Testing Timeframes and Duration

  • Testing is conducted within 24 hours of sample receipt

  • Reporting is completed within 5 working days of testing completion

    • ...

    This comprehensive guide provides detailed information on the standards, methodology, equipment, and procedures used in Eurolabs PDA TR 69 Bioburden and Cleanroom Microbial Control laboratory testing service. Clients can rely on Eurolab for accurate, reliable, and consistent test results that meet regulatory requirements.

    Conclusion

    Eurolabs commitment to quality, accuracy, and reliability ensures that clients receive the best possible testing services for their controlled environments. By adhering to international and national standards, Eurolab maintains its position as a leader in laboratory testing services. Clients can trust Eurolab for:

  • Accurate and reliable bioburden analysis

  • Microbial identification using taxonomic classification

  • Compliance with regulatory requirements

  • High-quality reporting

    • Appendix

    A comprehensive list of references used in this guide is provided below.

    References:

    1. ISO 14644-1:2015 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

    2. ASTM E2275 - Standard Guide for Evaluation of Microbial Contamination in Controlled Environments

    3. EN 14698-1:2007 - Cleanrooms and associated controlled environments. Biocontamination control. Part 1: General principles and methods

    4. TSE 17001:2005 - Quality Management Systems - Requirements for GMP (Good Manufacturing Practice)

    5. International Organization for Standardization (ISO) - Develops and publishes international standards

    ...

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