EUROLAB
iso-14644-4-design-construction-and-start-up-of-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 14644-5 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 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 14644-4 Design, Construction and Start-Up of Cleanrooms Laboratory Testing Service Provided by Eurolab

ISO 14644-4 is a standard that provides guidelines for the design, construction, and start-up of cleanrooms. The standard is part of the ISO 14644 series, which covers various aspects of cleanroom performance and operation.

Relevant Standards

The following standards are relevant to ISO 14644-4:

  • ISO 14644-1: Classification of air cleanliness in terms of particulate concentration

  • ISO 14644-2: Specifications for testing and verifying the suitability of the test facility or installation where a cleanroom is installed

  • ISO 14644-3: Cleanrooms and associated controlled environments: tested methods for the determination of airborne particle concentrations

  • ISO 14644-5: Cleanrooms and associated controlled environments: operational guidelines

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 14644-4 is complex and varies depending on the country, industry, and sector. In general, cleanroom operators must comply with relevant regulations and standards to ensure the quality and safety of their products.

  • Regulatory Bodies: Regulatory bodies such as government agencies, trade associations, and professional organizations play a crucial role in enforcing standards and regulations.

  • Industry-Specific Regulations: Certain industries have specific regulations that govern cleanroom design, construction, and operation. For example, pharmaceutical companies must comply with regulatory requirements such as GMP (Good Manufacturing Practice).

  • Standards Development Organizations: Standards development organizations such as ISO, ASTM, EN, TSE, and others develop and publish standards for cleanrooms.

    • Standard Evolution and Update

    Standards are constantly evolving to reflect advances in technology, changes in regulations, and emerging industry needs. Eurolab stays up-to-date with the latest developments and updates to ensure that its testing services comply with current requirements.

  • Standard Review: Standards are reviewed regularly to ensure they remain relevant and effective.

  • Public Consultation: Stakeholders participate in public consultations to provide feedback on proposed changes.

  • Update Process: Updated standards are published after a thorough review and approval process.

    • Specific Standard Numbers and Scope

    The following standard numbers and scope are relevant to ISO 14644-4:

  • ISO 14644-1: Classification of air cleanliness in terms of particulate concentration. This standard defines the classification of cleanrooms based on particle concentrations.

  • ISO 14644-2: Specifications for testing and verifying the suitability of the test facility or installation where a cleanroom is installed. This standard specifies the requirements for testing and verifying the suitability of a cleanroom.

    • Industry-Specific Compliance Requirements

    Different industries have specific compliance requirements for ISO 14644-4:

  • Pharmaceuticals: GMP regulations govern cleanroom design, construction, and operation.

  • Semiconductors: Cleanrooms must comply with industry-specific standards such as ISO/TS 16202.

  • Medical Devices: Cleanrooms must meet regulatory requirements such as FDA guidelines.

    • Standard Compliance Requirements for Different Industries

    The following table summarizes standard compliance requirements for different industries:

    Industry Standard Scope

    --- --- ---

    Pharmaceuticals GMP (ISO 14644-1) Cleanroom design, construction, and operation

    Semiconductors ISO/TS 16202 Cleanroom performance testing

    Medical Devices FDA guidelines (ISO 14644-4) Cleanroom design, construction, and operation

    Standard-Related Information

    This section provides a comprehensive overview of the relevant standards governing ISO 14644-4. Eurolabs expertise in this area ensures that its testing services comply with current requirements.

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    ISO 14644-4 is essential for ensuring cleanroom performance, quality, and safety. The following sections explain why this test is necessary, the business and technical reasons for conducting it, and the consequences of not performing it.

    Why This Test Is Needed

    Cleanrooms are used in various industries to manufacture products that require high levels of cleanliness and purity. However, cleanroom design, construction, and operation can be complex, and ensuring compliance with regulatory requirements is essential.

  • Particle Concentration: Cleanrooms must maintain a specific level of particle concentration to prevent contamination.

  • Airflow: Cleanrooms require precise airflow control to minimize the risk of contamination.

  • Temperature and Humidity: Temperature and humidity levels must be controlled to ensure optimal cleanroom performance.

    • Business and Technical Reasons for Conducting ISO 14644-4

    Conducting ISO 14644-4 ensures that cleanrooms meet regulatory requirements, ensuring compliance with industry standards. This test is essential for various industries, including pharmaceuticals, semiconductors, and medical devices.

  • Regulatory Compliance: Cleanroom operators must comply with regulations such as GMP (Good Manufacturing Practice) and FDA guidelines.

  • Product Quality: ISO 14644-4 ensures that cleanrooms maintain a specific level of particle concentration, airflow control, temperature, and humidity levels.

  • Industry Standards: Industry-specific standards such as ISO/TS 16202 require cleanroom performance testing.

    • Consequences of Not Performing ISO 14644-4

    Not performing ISO 14644-4 can lead to non-compliance with regulatory requirements, compromised product quality, and financial losses.

  • Non-Compliance: Failure to comply with regulations can result in fines, penalties, and reputational damage.

  • Product Contamination: Inadequate cleanroom performance can lead to product contamination, compromising product quality.

  • Financial Losses: Non-compliance with regulatory requirements and compromised product quality can result in significant financial losses.

    • ---

    Standard Requirements and Needs

    This section highlights the importance of ISO 14644-4 for ensuring cleanroom performance, quality, and safety. Eurolabs expertise ensures that its testing services comply with current requirements, minimizing the risk of non-compliance and financial losses.

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