EUROLAB
iso-14644-7-separative-devices-clean-air-hoods-gloveboxes-etc
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 14644-8 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

ISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.) Laboratory Testing Service Provided by Eurolab

Standard-Related Information

ISO 14644-7 is a standard that defines the requirements for testing and certification of separative devices, also known as clean air hoods or gloveboxes. These devices are used in various industries to provide a controlled environment for processing sensitive materials, equipment, or products.

The standard is developed by the International Organization for Standardization (ISO) and is based on international best practices. The current version, ISO 14644-7:2018, was published in August 2018 and supersedes the previous version, ISO 14644-7:2004.

International Standards

  • ISO 14644-1:1999: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
  • ISO 14644-2:2000: Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove designated classification
  • ISO 14644-3:2014: Cleanrooms and associated controlled environments - Part 3: Test methods
  • National Standards

  • ASTM E2197-08: Standard Guide for Testing and Certification of Separative Devices (Clean Air Hoods, Gloveboxes)
  • EN 12437-1:2002: Clean rooms and associated controlled environments - Part 1: Classification of air cleanliness
  • TSE EN ISO 14644-7:2018: Kuruşlanma ve ilişkili kontrol edilen ortamlar - Bölüm 7: Ayırıcı cihazların test edilmesi ve belgelendirilmesi
  • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and publishing international standards. The American Society for Testing and Materials (ASTM) and the German Institute for Standardisation (DIN) are also involved in standard development.

    Evolution of Standards

    Standards evolve through a collaborative process between industry experts, regulatory bodies, and other stakeholders. New versions of standards are published to reflect changes in technology, best practices, or regulatory requirements.

    Standard Numbers and Scope

  • ISO 14644-7:2018 - Separative devices (clean air hoods, gloveboxes) - Part 7: Testing and certification
  • Specifies the requirements for testing and certification of separative devices

    Defines the classification system for air cleanliness

    Describes the test methods for verifying the designated classification

    Industry-Specific Requirements

  • Pharmaceuticals
  • Biotechnology
  • Semiconductors
  • Electronics
  • Aerospace
  • These industries require strict control over environmental conditions, including cleanroom standards, to ensure product quality and safety.

    Consequences of Not Performing This Test

    Failure to perform this test can result in:

  • Product contamination or defects
  • Loss of market access due to non-compliance with regulations
  • Financial losses due to rework, scrap, or recalls
  • Test Conditions and Methodology

    The testing process involves a series of steps, including:

    1. Sample preparation

    2. Testing equipment calibration

    3. Test setup and execution

    4. Data analysis and reporting

    Test Reporting and Documentation

    Test results are documented in a comprehensive report that includes:

  • Test summary
  • Results and conclusions
  • Recommendations for improvement
  • Certification and accreditation information
  • The report is typically presented in a standard format, with specific sections and headings.

    Why This Test Should Be Performed

    This test provides numerous benefits, including:

  • Risk Assessment: Identifies potential risks associated with non-compliance
  • Quality Assurance: Ensures compliance with industry standards and regulations
  • Competitive Advantage: Demonstrates commitment to quality and safety
  • Cost Savings: Prevents rework, scrap, or recalls due to contamination or defects
  • Why Eurolab Should Provide This Service

    Eurolab offers a comprehensive testing service for separative devices, including:

  • Expertise and experience in this field
  • State-of-the-art equipment and facilities
  • Qualified and certified personnel
  • Accreditation and certification details
  • Conclusion

    ISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.) laboratory testing service provided by Eurolab is a comprehensive solution for industries requiring strict control over environmental conditions. By following this guide, companies can ensure compliance with industry standards and regulations, prevent product contamination or defects, and maintain a competitive advantage.

    References

  • ISO 14644-7:2018 - Separative devices (clean air hoods, gloveboxes) - Part 7: Testing and certification
  • ASTM E2197-08: Standard Guide for Testing and Certification of Separative Devices (Clean Air Hoods, Gloveboxes)
  • EN 12437-1:2002: Clean rooms and associated controlled environments - Part 1: Classification of air cleanliness
  • Appendix

    Table 1: ISO 14644-7 Classification System

    Class Airborne Particle Concentration

    --- ---

    1 <0.1 particles/m³

    2 <100 particles/m³

    3 <10,000 particles/m³

    Additional Resources

    For more information on Eurolabs testing services or to schedule a test, please contact us at:

    Email: infoeurolab.com(mailto:infoeurolab.com)

    Phone: 1 (800) 123-4567

    Address: 123 Main St, Anytown, USA

    We look forward to serving your testing needs!

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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