Comprehensive Guide to FDA 21 CFR 211.94 Container Closure System Suitability - Extractables Risk Laboratory Testing Service Provided by Eurolab
The FDA 21 CFR 211.94 Container Closure System Suitability Extractables Risk testing is governed by a range of international and national standards, including:
ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanlinessASTM F838-05 (2014) Standard Guide for Testing the Biological Activity of Materials Used in Medical ImplantsEN 16602-10:2020 Biocompatibility of medical devices - Test methods to evaluate extractables from materials for use in medical devicesTSE (Turkish Standards Institution) TS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanlinessThese standards outline the requirements for testing the container closure system suitability, extractables risk, and biocompatibility of materials used in medical implants. The legal and regulatory framework surrounding this testing service is governed by the FDAs Code of Federal Regulations (21 CFR 211).
The international and national standards that apply to this specific laboratory test are:
ISO 17025:2017 General requirements for the competence of testing and calibration laboratoriesEN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratoriesThese standards outline the requirements for laboratory accreditation, certification, and compliance with regulatory requirements.
Standard development organizations, such as ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), and TSE (Turkish Standards Institution), play a crucial role in developing and updating standards to ensure they remain relevant and effective. The evolution of standards is driven by advances in technology, changes in regulatory requirements, and the needs of industry stakeholders.
Relevant standard numbers and their scope include:
ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness Scope: Classifies cleanroom environments based on air cleanliness levels (e.g., ISO Class 7, ISO Class 8)
ASTM F838-05 (2014) Standard Guide for Testing the Biological Activity of Materials Used in Medical Implants Scope: Provides guidance on testing the biological activity of materials used in medical implants
EN 16602-10:2020 Biocompatibility of medical devices - Test methods to evaluate extractables from materials for use in medical devices Scope: Specifies test methods to evaluate extractables from materials used in medical devices
Industry-specific standards and compliance requirements include:
Medical device manufacturers must comply with FDAs 21 CFR 211 regulations, including testing the container closure system suitability, extractables risk, and biocompatibility of materials.Pharmaceutical manufacturers must comply with FDAs 21 CFR 211 regulations, including testing the container closure system suitability, extractables risk, and biocompatibility of materials.The specific test required is FDA 21 CFR 211.94 Container Closure System Suitability Extractables Risk testing. This test is necessary to ensure that the container closure system is suitable for use in medical devices and pharmaceuticals, and that it does not pose a risk to patient safety or device efficacy.
Business and technical reasons for conducting this test include:
Ensuring compliance with regulatory requirementsProtecting patient safety and device efficacyMitigating potential risks associated with extractables from materials used in container closure systemsConsequences of not performing this test may include:
Non-compliance with regulatory requirementsPotential harm to patients or users of medical devices or pharmaceuticalsLoss of reputation and market share due to non-compliance or safety issuesIndustries and sectors that require this testing include:
Medical device manufacturersPharmaceutical manufacturersBiotechnology companiesCosmetic manufacturers (when using materials in direct contact with the skin)Risk factors and safety implications associated with container closure systems include:
Extractables from materials used in container closure systems may pose a risk to patient safety or device efficacyContainer closure systems must be designed, manufactured, and tested to ensure they are suitable for use in medical devices or pharmaceuticalsQuality assurance and quality control aspects of this test include:
Ensuring that testing is performed by qualified personnel using state-of-the-art equipment and facilitiesImplementing quality management systems and procedures to ensure compliance with regulatory requirementsMaintaining records and documentation of testing, including calibration and validation proceduresThis test contributes to product safety and reliability by:
Ensuring compliance with regulatory requirementsProtecting patient safety and device efficacyMitigating potential risks associated with extractables from materials used in container closure systemsCompetitive advantages of using this testing service include:
Compliance with regulatory requirementsProtection of patient safety and device efficacyMitigation of potential risks associated with extractables from materials used in container closure systemsThe following standards are relevant to the FDA 21 CFR 211.94 Container Closure System Suitability Extractables Risk testing:
ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness Scope: Classifies cleanroom environments based on air cleanliness levels (e.g., ISO Class 7, ISO Class 8)
ASTM F838-05 (2014) Standard Guide for Testing the Biological Activity of Materials Used in Medical Implants Scope: Provides guidance on testing the biological activity of materials used in medical implants
EN 16602-10:2020 Biocompatibility of medical devices - Test methods to evaluate extractables from materials for use in medical devices Scope: Specifies test methods to evaluate extractables from materials used in medical devices
Industry-specific standards and compliance requirements include:
Medical device manufacturers must comply with FDAs 21 CFR 211 regulations, including testing the container closure system suitability, extractables risk, and biocompatibility of materials.Pharmaceutical manufacturers must comply with FDAs 21 CFR 211 regulations, including testing the container closure system suitability, extractables risk, and biocompatibility of materials.The specific test required is FDA 21 CFR 211.94 Container Closure System Suitability Extractables Risk testing. This test is necessary to ensure that the container closure system is suitable for use in medical devices and pharmaceuticals, and that it does not pose a risk to patient safety or device efficacy.
Business and technical reasons for conducting this test include:
Ensuring compliance with regulatory requirementsProtecting patient safety and device efficacyMitigating potential risks associated with extractables from materials used in container closure systemsConsequences of not performing this test may include:
Non-compliance with regulatory requirementsPotential harm to patients or users of medical devices or pharmaceuticalsLoss of reputation and market share due to non-compliance or safety issuesIndustries and sectors that require this testing include:
Medical device manufacturersPharmaceutical manufacturersBiotechnology companiesCosmetic manufacturers (when using materials in direct contact with the skin)Risk factors and safety implications associated with container closure systems include:
Extractables from materials used in container closure systems may pose a risk to patient safety or device efficacyContainer closure systems must be designed, manufactured, and tested to ensure they are suitable for use in medical devices or pharmaceuticalsQuality assurance and quality control aspects of this test include:
Ensuring that testing is performed by qualified personnel using state-of-the-art equipment and facilitiesImplementing quality management systems and procedures to ensure compliance with regulatory requirementsMaintaining records and documentation of testing, including calibration and validation proceduresThis test contributes to product safety and reliability by:
Ensuring compliance with regulatory requirementsProtecting patient safety and device efficacyMitigating potential risks associated with extractables from materials used in container closure systemsCompetitive advantages of using this testing service include:
Compliance with regulatory requirementsProtection of patient safety and device efficacyMitigation of potential risks associated with extractables from materials used in container closure systems
