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iso-14698-2-evaluation-methods-for-biocontamination-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 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 14698-2 Evaluation Methods for Biocontamination Control Testing Services Provided by Eurolab

ISO 14698-2 is a standard that outlines the evaluation methods for biocontamination control in cleanrooms and other controlled environments. This standard is part of the ISO 14698 series, which provides guidelines for the validation and verification of cleanroom performance.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 14698-2 testing is governed by various national and international standards. In the European Union, for example, EU GMP (Good Manufacturing Practice) regulations require manufacturers to implement controls to prevent contamination in pharmaceutical production environments. Similarly, in the United States, FDA guidelines outline the requirements for cleanroom operations.

International and National Standards

The following standards apply to ISO 14698-2 testing:

  • ISO 14698-1:2004 (now withdrawn)

  • ISO 14698-2:2019

  • ASTM E2453-09

  • EN 12196:1997

  • TSE 2215:2018

    • Standard Development Organizations

    Standards development organizations, such as the International Organization for Standardization (ISO), play a crucial role in creating and updating standards. These organizations bring together experts from various industries to develop and maintain standards that meet the needs of users.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. Updates to existing standards ensure that they remain relevant and effective in supporting quality management systems.

    Standard Numbers and Scope

    The following standard numbers and their scope are relevant to ISO 14698-2 testing:

  • ISO 14698-2:2019 - Evaluation of cleanroom performance

    • Scope: Specifies the methods for evaluating cleanroom performance

  • ASTM E2453-09 - Standard guide for evaluation of cleanroom performance

    • Scope: Provides guidance on evaluating cleanroom performance

  • EN 12196:1997 - Cleanrooms and associated equipment - Design, testing and operation

    • Scope: Outlines requirements for design, testing, and operation of cleanrooms

    Industry-Specific Compliance Requirements

    Compliance with ISO 14698-2 is essential in various industries, including:

  • Pharmaceutical production

  • Biotechnology

  • Medical device manufacturing

  • Food processing

  • Semiconductors

    • Failure to comply with this standard can result in contamination, product recalls, and damage to reputation.

    Why ISO 14698-2 Testing is Required

    ISO 14698-2 testing is essential for ensuring that cleanrooms and other controlled environments meet the required standards. This testing ensures:

  • Reduced risk of contamination

  • Improved product quality and safety

  • Compliance with regulations and industry standards

  • Enhanced reputation and competitiveness

    • Business and Technical Reasons for Conducting ISO 14698-2 Testing

    Conducting ISO 14698-2 testing provides several benefits, including:

  • Reduced costs associated with product recalls and remediation

  • Improved efficiency through reduced downtime and increased productivity

  • Enhanced customer confidence and trust

  • Compliance with regulations and industry standards

    • Consequences of Not Performing ISO 14698-2 Testing

    Failure to conduct ISO 14698-2 testing can result in severe consequences, including:

  • Contamination and product recalls

  • Damage to reputation and loss of business

  • Non-compliance with regulations and industry standards

  • Financial losses due to reduced productivity and increased costs

    • Industries and Sectors that Require ISO 14698-2 Testing

    The following industries and sectors require ISO 14698-2 testing:

  • Pharmaceutical production

  • Biotechnology

  • Medical device manufacturing

  • Food processing

  • Semiconductors

    • Risk Factors and Safety Implications

    Failure to conduct ISO 14698-2 testing can result in contamination, product recalls, and damage to reputation. This can have severe consequences for businesses, including financial losses and loss of customer confidence.

    Quality Assurance and Quality Control Aspects

    ISO 14698-2 testing ensures that cleanrooms and other controlled environments meet the required standards. This testing supports quality assurance and quality control by:

  • Ensuring reduced risk of contamination

  • Improving product quality and safety

  • Enhancing customer confidence and trust

    • Conducting ISO 14698-2 Testing

    ISO 14698-2 testing involves the following steps:

    1. Sampling: Sampling of the cleanroom environment to determine microbial contamination levels.

    2. Sample Preparation: Preparation of samples for analysis, including sterilization and extraction procedures.

    3. Testing Equipment: Use of specialized equipment for sampling and analysis, such as air samplers and microbiological analyzers.

    4. Testing Parameters: Evaluation of testing parameters, including temperature, humidity, and airflow rates.

    Sampling Methods

    The following sampling methods are used in ISO 14698-2 testing:

  • Air sampling

  • Surface sampling

  • Swabbing

    • Sample Preparation

    Sample preparation involves sterilization and extraction procedures to prepare samples for analysis.

    Testing Equipment

    Specialized equipment is used in ISO 14698-2 testing, including air samplers and microbiological analyzers.

    Testing Parameters

    Evaluation of testing parameters ensures that cleanrooms and other controlled environments meet the required standards.

    Test Results

    Test results are used to determine microbial contamination levels and evaluate cleanroom performance.

    Test Report

    A test report is issued after completing ISO 14698-2 testing, outlining the test results and any recommendations for improvement.

    Test Report Requirements

    The following information should be included in a test report:

  • Test method

  • Sampling location

  • Testing parameters

  • Results

    • Conclusion

    ISO 14698-2 testing ensures that cleanrooms and other controlled environments meet the required standards. This testing supports quality assurance and quality control by reducing risk of contamination, improving product quality and safety, and enhancing customer confidence and trust.

    The following information should be included in a test report:

  • Recommendations for improvement

  • Limitations of the testing method

  • Certification or accreditation details

    • Need help or have a question?
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