EUROLAB
ep-2614-microbiological-integrity-testing-for-packaging
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

Comprehensive Guide to EP 2.6.14 Microbiological Integrity Testing for Packaging Laboratory Testing Service

EP 2.6.14 Microbiological Integrity Testing for Packaging is a laboratory testing service provided by Eurolab that ensures the microbiological safety of packaging materials used in various industries, including food, pharmaceuticals, and cosmetics. The standard-related information for this test is governed by several international and national standards.

International Standards

  • ISO 11133:2008(E) - Microbiology of food, water, and feedstuffs - Preparation of test samples

  • ISO 11137-1:2012(E) - Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical purposes

  • ASTM E1053/E1053M-18 - Standard Practice for Sampling Fluids for Microbiological Examination

    • National Standards

  • EN ISO 11133:2009 - Microbiology of food, water, and feedstuffs Preparation of test samples

  • TSE (Turkish Standards Institution) 2220:2018 - Packaging materials for medical devices - Determination of microbiological properties

    • Standard Development Organizations and Their Role

    The standard development organizations responsible for the creation and maintenance of these standards include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations play a crucial role in developing, maintaining, and revising standards to ensure that they remain relevant and effective.

    Evolution of Standards

    Standards evolve over time as new technologies, methods, and best practices emerge. Regular reviews and updates are necessary to reflect changes in the industry, technology, or regulatory requirements.

    Specific Standard Numbers and Their Scope

    The following standard numbers and their scope are relevant to EP 2.6.14 Microbiological Integrity Testing for Packaging:

  • ISO 11133:2008(E) - Preparation of test samples

  • ISO 11137-1:2012(E) - Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical purposes

    • Standard Compliance Requirements

    Compliance with these standards is mandatory for industries that require packaging materials to meet specific microbiological integrity criteria. Non-compliance can result in product recalls, loss of customer trust, and damage to business reputation.

  • The testing frequency and scope depend on the type of packaging material, intended use, and industry regulations.

  • Packaging materials must be tested for microbiological contaminants, including bacteria, yeast, and mold.

  • Test results are used to determine whether the packaging materials meet specific microbiological criteria.

    • EP 2.6.14 Microbiological Integrity Testing for Packaging is essential for industries that require high-quality packaging materials to ensure product safety and reliability.

    Why This Specific Test Is Needed and Required

    The test is necessary due to the following reasons:

  • Packaging materials can harbor microbiological contaminants that pose a risk to human health.

  • Non-compliance with regulatory requirements can result in product recalls, loss of customer trust, and damage to business reputation.

  • The testing service ensures compliance with industry regulations and standards.

    • Business and Technical Reasons for Conducting EP 2.6.14 Microbiological Integrity Testing for Packaging

    The testing service is conducted due to the following reasons:

  • To ensure product safety and reliability

  • To comply with regulatory requirements and industry standards

  • To maintain customer trust and confidence

    • Consequences of Not Performing This Test

    Non-compliance with this test can result in severe consequences, including:

  • Product recalls

  • Loss of customer trust and reputation damage

  • Regulatory fines and penalties

    • Industries and Sectors That Require This Testing

    The following industries and sectors require EP 2.6.14 Microbiological Integrity Testing for Packaging:

  • Food and beverage industry

  • Pharmaceutical industry

  • Cosmetics industry

  • Medical device industry

    • Risk Factors and Safety Implications

    Microbiological contaminants in packaging materials pose a risk to human health, including:

  • Infection and illness from contaminated products

  • Loss of customer trust and reputation damage

    • Quality Assurance and Quality Control Aspects

    Eurolab ensures the quality of testing services through:

  • Accreditation and certification by recognized third-party organizations

  • Implementation of quality management systems (QMS) that meet industry standards

  • Regular calibration and maintenance of testing equipment

  • Training and qualification of personnel

    • EP 2.6.14 Microbiological Integrity Testing for Packaging involves the following steps:

    1. Sample Preparation

    Packaging materials are collected from manufacturing sites or suppliers.

    2. Testing Equipment Calibration

    The testing equipment is calibrated to ensure accuracy and precision.

    3. Testing Procedure

    The packaging materials are tested using various methods, including microbiological examination, according to industry standards.

    4. Data Analysis

    Test results are analyzed to determine whether the packaging materials meet specific microbiological criteria.

    Quality Control Measures

    Eurolab implements quality control measures to ensure accuracy and precision of test results, including:

  • Regular calibration and maintenance of testing equipment

  • Training and qualification of personnel

  • Implementation of QMS that meets industry standards

  • The testing frequency and scope depend on the type of packaging material, intended use, and industry regulations.

  • Packaging materials must be tested for microbiological contaminants, including bacteria, yeast, and mold.

    • Reporting and Documentation

    Eurolab provides detailed reports and documentation to clients, including:

  • Test results

  • Methodology used

  • Calibration records

    • Interpretation of Results

    Test results are interpreted in accordance with industry standards and regulations, taking into account the type of packaging material, intended use, and customer requirements.

    Reporting Requirements

    Eurolab ensures that test results are reported accurately and within the required timeframe.

    Conclusion

    EP 2.6.14 Microbiological Integrity Testing for Packaging is essential for industries that require high-quality packaging materials to ensure product safety and reliability. Compliance with industry regulations and standards is mandatory, and non-compliance can result in severe consequences.

    Appendix

  • List of international and national standards relevant to EP 2.6.14 Microbiological Integrity Testing for Packaging

  • Description of testing methods used by Eurolab

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