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iso-14644-5-operations-in-cleanrooms
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 14644-6 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 ControlPDA 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

Comprehensive Guide to ISO 14644-5 Operations in Cleanrooms Testing Services Provided by Eurolab

ISO 14644-5 is a standard that defines the requirements for cleanrooms and controlled environments in various industries, including pharmaceuticals, biotechnology, and electronics. This standard provides guidelines for designing, building, and operating cleanrooms to ensure that they meet specific cleanliness levels and prevent contamination.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 14644-5 Operations in Cleanrooms testing is governed by international standards such as ISO 14644-1:2015, which defines the classification of cleanrooms and associated controlled environments. National standards, such as ASTM E2500-17, provide specific requirements for cleanroom design, construction, and operation.

International and National Standards

The following standards are relevant to ISO 14644-5 Operations in Cleanrooms testing:

  • ISO 14644-1:2015 (Classification of air cleanliness)

  • ISO 14644-2:2014 (Cleanrooms and associated controlled environments - Specifications for testing and monitoring to prove designed performance)

  • ASTM E2500-17 (Standard Practice for Designing, Testing, and Operating Clean Rooms and Clean Zones)

  • EN 13945-1:2003 (Cleanroom technology - Classification of cleanrooms)

  • TSE ISO 14644-5:2017 (Turkish Standard for Cleanrooms)

    • Standard Development Organizations

    The standard development organizations responsible for creating and maintaining these standards include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time to reflect changing industry needs, technological advancements, and emerging best practices. Updates to standards ensure that they remain relevant and effective in ensuring quality and safety.

    Standard Numbers and Scope

    Some specific standard numbers and their scope are:

  • ISO 14644-5:2014 (Cleanrooms and associated controlled environments - Part 5: Operations)

    • Provides guidelines for cleanroom operations, including air cleanliness levels, temperature control, humidity control, and personnel hygiene.

  • ASTM E2500-17

    • Defines the requirements for designing, testing, and operating clean rooms and clean zones.

    Compliance Requirements

    Compliance with ISO 14644-5 Operations in Cleanrooms requires adherence to specific guidelines and standards. Industries that require compliance include:

  • Pharmaceuticals

  • Biotechnology

  • Electronics

  • Semiconductors

    • Failure to comply with these standards can result in contamination, product failure, and regulatory fines.

    ISO 14644-5 Operations in Cleanrooms testing is required for various reasons:

  • Quality Assurance: Ensures that cleanrooms meet specific cleanliness levels and prevent contamination.

  • Regulatory Compliance: Meets international and national standards for cleanroom design, construction, and operation.

  • Product Safety: Prevents contamination and ensures product quality.

  • Competitive Advantage: Demonstrates commitment to quality and safety.

    • Industries and Sectors

    The following industries and sectors require ISO 14644-5 Operations in Cleanrooms testing:

  • Pharmaceuticals

  • Biotechnology

  • Electronics

  • Semiconductors

    • Risk Factors and Safety Implications

    Failure to comply with ISO 14644-5 Operations in Cleanrooms can result in:

  • Contamination

  • Product failure

  • Regulatory fines

  • Loss of reputation

  • Economic losses

    • Quality Assurance and Control

    ISO 14644-5 Operations in Cleanrooms testing ensures that cleanrooms meet specific cleanliness levels, preventing contamination and ensuring product quality.

    Step-by-Step Explanation of the Test

    The ISO 14644-5 Operations in Cleanrooms test involves:

    1. Cleanroom Design: Ensures that the cleanroom meets specific design requirements.

    2. Testing Equipment and Instruments: Utilizes specialized equipment to measure cleanliness levels, temperature control, humidity control, and personnel hygiene.

    3. Sample Preparation: Prepares samples for testing, including air sampling and surface sampling.

    4. Measurement and Analysis Methods: Uses measurement and analysis methods to determine cleanliness levels, temperature control, humidity control, and personnel hygiene.

    Testing Equipment and Instruments

    The following equipment is used in ISO 14644-5 Operations in Cleanrooms testing:

  • Air samplers

  • Surface samplers

  • Thermometers

  • Hygrometers

  • Microscopes

    • Testing Environment Requirements

    Cleanrooms require specific environmental conditions to ensure cleanliness levels, including:

  • Temperature control (20C 2C)

  • Humidity control (40-60 relative humidity)

  • Pressure control (<1.0 Pa)

    • Sample Preparation Procedures

    Cleanroom samples are prepared using specialized equipment and techniques, including:

  • Air sampling

  • Surface sampling

    • Measurement and Analysis Methods

    Measurement and analysis methods used in ISO 14644-5 Operations in Cleanrooms testing include:

  • Particle counting (PCS)

  • Viable particulate count (VPC)

  • Surface analysis (SA)

    • Test Conditions and Methodology

    The following test conditions and methodology are used in ISO 14644-5 Operations in Cleanrooms testing:

  • Temperature control: Maintains a temperature range of 20C 2C.

  • Humidity control: Maintains a relative humidity range of 40-60.

  • Pressure control: Maintains a pressure level of <1.0 Pa.

    • Test Results and Reporting

    Results are reported in accordance with the ISO 14644-5 standard, including:

  • Cleanliness levels

  • Temperature control

  • Humidity control

  • Personnel hygiene

    • Conclusion

    ISO 14644-5 Operations in Cleanrooms testing is a critical component of ensuring quality and safety in various industries. By following these guidelines, organizations can ensure that their cleanrooms meet specific cleanliness levels, preventing contamination and ensuring product quality.

    Eurolabs ISO 14644-5 Operations in Cleanrooms Testing Services

    Eurolab provides comprehensive ISO 14644-5 Operations in Cleanrooms testing services to ensure that your organization meets international and national standards for cleanroom design, construction, and operation. Our team of experts will guide you through the testing process, ensuring that your cleanroom meets specific cleanliness levels and prevents contamination.

    Benefits of Eurolabs ISO 14644-5 Operations in Cleanrooms Testing Services

  • Compliance with International and National Standards: Ensures that your organization meets international and national standards for cleanroom design, construction, and operation.

  • Quality Assurance: Ensures that your cleanroom meets specific cleanliness levels, preventing contamination and ensuring product quality.

  • Competitive Advantage: Demonstrates commitment to quality and safety.

    • By partnering with Eurolab, you can ensure that your organization meets the highest standards of quality and safety. Contact us today to learn more about our ISO 14644-5 Operations in Cleanrooms testing services.

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