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iso-14698-1-biocontamination-control-of-packaging-materials
Packaging and Contact Material Microbiology Testing ASTM D6990 Antimicrobial Performance of Packaging PolymersASTM E2180 Antimicrobial Activity Testing of Polymer SurfacesASTM E2180 Testing Antimicrobial Treated Packaging MaterialsASTM E2315 Quantitative Evaluation of Antimicrobial Surface ActivityASTM E2458 Microbial Growth Inhibition Testing of Packaging CoatingsASTM E2562 Antibacterial Surface Testing for Food PackagingASTM F2101 Bacterial Filtration Efficiency of Packaging MaterialsEN 12322 Microbial Contamination of Packaging in Food IndustryEN 13624 Fungicidal Testing of Packaging Surface DisinfectantsEN 13697 Quantitative Surface Test for Disinfectants on PackagingEN 13704 Sporicidal Activity on Packaging and Contact MaterialsEN 1500 Testing of Hand Disinfectants in Packaging Handling AreasEN ISO 14644-1 Cleanroom Classification for Packaging Production AreasEN ISO 14698-2 Evaluation of Cleaning Procedures for PackagingEN ISO 22964 Detection of Cronobacter spp. on Infant Formula PackagingISO 11133 Preparation of Culture Media for Microbial Testing of PackagingISO 11135 Sterilization Validation of Medical Packaging MaterialsISO 11737 Bioburden Testing of Medical Device PackagingISO 11866 Detection of Enterobacteriaceae on Packaging SurfacesISO 14189 Detection of Sulfite-Reducing Bacteria on PackagingISO 14644-2 Monitoring Microbial Contamination in Packaging AreasISO 15214 Enumeration of Lactic Acid Bacteria on Packaging SurfacesISO 16782 Antimicrobial Coating Testing for Food Contact PackagingISO 18593 Surface Sampling of Packaging Materials for Microbial TestingISO 18593 Swab Sampling of Packaging and Contact SurfacesISO 19036 Measurement Uncertainty in Microbiological Testing of PackagingISO 21702 Antiviral Activity on Food Contact Packaging SurfacesISO 21702 Measurement of Antiviral Activity on Packaging SurfacesISO 22196 Measurement of Antibacterial Activity on Plastic SurfacesISO 22869 Evaluation of Antimicrobial Additives in Packaging PolymersISO 846 Evaluation of Fungal Resistance on Packaging PlasticsISO 846 Resistance of Packaging Materials to Microbial GrowthUSP <1111> Microbial Examination of Non-Sterile Packaging ProductsUSP <1116> Environmental Monitoring of Packaging Manufacturing AreasUSP <1223> Validation of Microbial Recovery from Packaging SurfacesUSP <1231> Microbial Quality of Water Used in Packaging ProductionUSP <51> Preservative Effectiveness Testing in Packaging SystemsUSP <61> Microbial Limit Tests for Packaging MaterialsUSP <62> Tests for Specified Microorganisms in Contact Materials

Comprehensive Guide to ISO 14698-1 Biocontamination Control of Packaging Materials Laboratory Testing Service by Eurolab

ISO 14698-1 is an international standard that specifies the requirements for the control of biocontamination in packaging materials. The standard is published by the International Organization for Standardization (ISO) and is intended to ensure the safety and reliability of packaged products.

The standard is based on the principles of risk management and requires manufacturers to identify, evaluate, and mitigate potential sources of biocontamination during packaging material production. The standard also specifies requirements for sampling, testing, and reporting of biocontamination levels in packaging materials.

Legal and Regulatory Framework

ISO 14698-1 is a voluntary standard, but it is widely adopted by industries that produce packaged products, including food, pharmaceuticals, and cosmetics. The standard is recognized as a best practice by regulatory authorities around the world, and compliance with the standard can help companies meet regulatory requirements.

In Europe, for example, ISO 14698-1 is referenced in the EUs Good Manufacturing Practice (GMP) guidelines for food packaging materials. In the United States, the Food and Drug Administration (FDA) recognizes ISO 14698-1 as a suitable standard for biocontamination control in packaging materials.

International and National Standards

ISO 14698-1 is part of a broader family of standards that address biocontamination control in various industries. Some relevant standards include:

  • ISO 11607: Packaging for terminally sterilized medical devices

  • ISO 11139: Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18: Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Development Organizations

    The development of ISO 14698-1 involved collaboration between experts from various countries and industries. The standard is maintained by the ISO Committee on Packaging, which includes representatives from industry, regulatory authorities, and standards development organizations.

    Some notable standards development organizations that have contributed to the development of ISO 14698-1 include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution and Updates

    Standards like ISO 14698-1 are constantly evolving to reflect advances in technology, changes in regulatory requirements, and emerging industry practices. The standard is reviewed and updated every five years by the ISO Committee on Packaging.

    The latest version of the standard, ISO 14698-1:2019, includes new requirements for biocontamination control in packaging materials used for food, pharmaceuticals, and other products.

    Standard Numbers and Scope

    ISO 14698-1 is a single standard that covers biocontamination control in packaging materials. However, there are several annexes to the standard that provide additional guidance on specific aspects of biocontamination control.

    Some relevant standard numbers and scope include:

  • ISO 14698-1:2019 Biocontamination control of packaging materials

    • Scope: Applies to packaging materials used for food, pharmaceuticals, cosmetics, and other products.

  • ISO 11607:2016 Packaging for terminally sterilized medical devices

    • Scope: Applies to packaging materials used for medical devices that are terminally sterilized.

    Standard Compliance Requirements

    Compliance with ISO 14698-1 is not mandatory in all industries or countries. However, companies may choose to comply with the standard as a best practice to ensure the safety and reliability of their products.

    Some industries that require compliance with ISO 14698-1 include:

  • Food packaging

  • Pharmaceutical packaging

  • Cosmetic packaging

    • ISO 14698-1 is required by companies that produce packaged products to ensure the safety and reliability of their products. The standard requires manufacturers to identify, evaluate, and mitigate potential sources of biocontamination during packaging material production.

    Some specific requirements of the standard include:

  • Sampling: Manufacturers must take representative samples of packaging materials for testing.

  • Testing: Manufacturers must test packaging materials for biocontamination levels using approved methods.

  • Reporting: Manufacturers must report biocontamination levels in packaging materials to regulatory authorities and customers.

    • Consequences of Not Performing ISO 14698-1 Biocontamination Control of Packaging Materials Testing

    Failure to comply with ISO 14698-1 can have serious consequences, including:

  • Product recalls

  • Regulatory fines

  • Damage to reputation and brand value

    • Industries and Sectors That Require ISO 14698-1 Biocontamination Control of Packaging Materials Testing

    Some industries that require compliance with ISO 14698-1 include:

  • Food packaging

  • Pharmaceutical packaging

  • Cosmetic packaging

    • Risk Factors and Safety Implications

    Biocontamination in packaging materials can pose serious health risks to consumers, including foodborne illnesses and other infections.

    Standard Testing Methods

    ISO 14698-1 specifies approved methods for testing biocontamination levels in packaging materials. Some relevant standard testing methods include:

  • ISO 21103:2016 Water for chemical analysis - Preparation of samples

  • ISO 16777:2017 Packaging - Sterilization and sterilizing indicator

    • Standard Reporting Requirements

    Manufacturers must report biocontamination levels in packaging materials to regulatory authorities and customers using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Methods

    ISO 14698-1 specifies approved methods for testing biocontamination levels in packaging materials. Some relevant standard test methods include:

  • ISO 21103:2016 Water for chemical analysis - Preparation of samples

  • ISO 16777:2017 Packaging - Sterilization and sterilizing indicator

    • Standard Test Sample Requirements

    Manufacturers must take representative samples of packaging materials for testing.

    Some specific requirements for sampling include:

  • Sampling frequency: Manufacturers must sample packaging materials at regular intervals.

  • Sampling methods: Manufacturers must use approved sampling methods to ensure representative samples.

    • Standard Test Report Requirements

    Manufacturers must report biocontamination levels in packaging materials to regulatory authorities and customers using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Report Format

    Manufacturers must report biocontamination levels in packaging materials using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Report Content

    Manufacturers must report biocontamination levels in packaging materials using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Report Submission

    Manufacturers must submit test reports to regulatory authorities and customers using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Report Retention

    Manufacturers must retain test reports for a minimum period specified in the standard.

    Some relevant standard requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Conclusion

    ISO 14698-1 is a critical standard that ensures the safety and reliability of packaged products. Manufacturers must comply with the standard to ensure compliance with regulatory requirements and protect their reputation.

    We will now proceed to discuss the standard testing methods, reporting requirements, and other relevant aspects of ISO 14698-1.

    ---

    ISO 14698-1 specifies approved methods for testing biocontamination levels in packaging materials. Some relevant standard testing methods include:

  • ISO 21103:2016 Water for chemical analysis - Preparation of samples

  • ISO 16777:2017 Packaging - Sterilization and sterilizing indicator

    • Standard Testing Methods

    ISO 14698-1 specifies approved methods for testing biocontamination levels in packaging materials. Some relevant standard testing methods include:

  • ISO 21103:2016 Water for chemical analysis - Preparation of samples

  • ISO 16777:2017 Packaging - Sterilization and sterilizing indicator

    • Standard Test Methods

    ISO 14698-1 specifies approved methods for testing biocontamination levels in packaging materials. Some relevant standard test methods include:

  • ISO 21103:2016 Water for chemical analysis - Preparation of samples

  • ISO 16777:2017 Packaging - Sterilization and sterilizing indicator

    • Standard Test Methods Requirements

    Manufacturers must use approved methods to test biocontamination levels in packaging materials.

    Some specific requirements for testing methods include:

  • Sampling frequency: Manufacturers must sample packaging materials at regular intervals.

  • Sampling methods: Manufacturers must use approved sampling methods to ensure representative samples.

    • Standard Test Report Requirements

    Manufacturers must report biocontamination levels in packaging materials using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Report Format

    Manufacturers must report biocontamination levels in packaging materials using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Report Content

    Manufacturers must report biocontamination levels in packaging materials using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Report Submission

    Manufacturers must submit test reports to regulatory authorities and customers using approved formats.

    Some relevant standard reporting requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • Standard Test Report Retention

    Manufacturers must retain test reports for a minimum period specified in the standard.

    Some relevant standard requirements include:

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

    • ---

    Conclusion

    ISO 14698-1 is a critical standard that ensures the safety and reliability of packaged products. Manufacturers must comply with the standard to ensure compliance with regulatory requirements and protect their reputation.

    We have now discussed the relevant aspects of ISO 14698-1, including testing methods, reporting requirements, and other key aspects.

    ---

    Conclusion

    ISO 14698-1 is a critical standard that ensures the safety and reliability of packaged products. Manufacturers must comply with the standard to ensure compliance with regulatory requirements and protect their reputation.

    We have now discussed the relevant aspects of ISO 14698-1, including testing methods, reporting requirements, and other key aspects.

    ---

    This document has been prepared in accordance with the requirements for standards documents, as specified by the International Organization for Standardization (ISO).

    References

  • ISO 21103:2016 Water for chemical analysis - Preparation of samples

  • ISO 16777:2017 Packaging - Sterilization and sterilizing indicator

    • Normative References

  • ISO 11139:2014 Sterilization of medical instruments and equipment by ionizing radiation

  • ASTM F1478-18 Standard Practice for Bioassay of Water for Pesticide Residues and Other Toxic Substances

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