EUROLAB
usp-1106-whole-package-integrity-testing
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 2.6.14 Microbiological Integrity Testing for PackagingEP 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 <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

USP <1106> Whole Package Integrity Testing: Laboratory Testing Services by Eurolab

USP <1106> Whole Package Integrity Testing is a laboratory testing service that ensures the integrity of packaging materials and systems. This test is governed by various international and national standards, including ISO 11608, ASTM D882, EN 868, TSE 1125, and others.

The legal and regulatory framework surrounding this testing service is primarily driven by regulations and guidelines from organizations such as the US Pharmacopeia (USP), the International Organization for Standardization (ISO), and national standards bodies. These regulations require pharmaceutical and medical device manufacturers to ensure that their packaging systems meet specific requirements for safety, efficacy, and quality.

The following international and national standards apply to USP <1106> Whole Package Integrity Testing:

  • ISO 11608: Packaging for Medical Products Part 1: Requirements

  • ASTM D882: Standard Test Method for Tensile Properties of Thin Plastic Sheeting

  • EN 868: Sterilization of medical devices using ionizing radiation Requirements for the development, validation and routine control of a sterilization process

  • TSE 1125: Packaging materials for pharmaceuticals Requirements

    • Standard development organizations such as ISO, ASTM, and IEC play a crucial role in developing and maintaining standards related to packaging integrity testing. These organizations collaborate with industry stakeholders, regulatory bodies, and other experts to ensure that standards are up-to-date and relevant.

    Standards evolve over time due to advances in technology, changes in regulations, or new research findings. Standard development involves ongoing revision and updates to reflect current best practices and requirements.

    Here is a summary of key standard numbers and their scope:

    Standard Title Scope

    --- --- ---

    ISO 11608 Packaging for Medical Products Part 1: Requirements Requirements for packaging materials, containers, closures, labels, and packaging systems.

    ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting Tensile properties of thin plastic sheeting used in packaging applications.

    EN 868 Sterilization of medical devices using ionizing radiation Requirements for the development, validation and routine control of a sterilization process Requirements for sterilization processes using ionizing radiation.

    TSE 1125 Packaging materials for pharmaceuticals Requirements Requirements for packaging materials used in pharmaceutical applications.

    Standard compliance is essential for industries such as pharmaceuticals, medical devices, and cosmetics. Non-compliance can result in product recalls, regulatory penalties, and damage to a companys reputation.

    USP <1106> Whole Package Integrity Testing is required by various regulations and guidelines due to the risk of contamination, damage, or failure during transportation and storage. This test ensures that packaging systems meet specific requirements for safety, efficacy, and quality.

    Business and technical reasons for conducting this test include:

  • Ensuring product integrity and quality

  • Preventing contamination and damage during transportation and storage

  • Meeting regulatory requirements and compliance standards

  • Protecting brand reputation and customer trust

  • Reducing recalls and regulatory penalties

    • Consequences of not performing USP <1106> Whole Package Integrity Testing include:

  • Product recalls due to packaging failure or contamination

  • Regulatory penalties and fines for non-compliance

  • Damage to brand reputation and customer trust

  • Increased costs associated with product rework, replacement, or disposal

    • Industries that require this testing service include:

  • Pharmaceuticals

  • Medical devices

  • Cosmetics

  • Food and beverage

  • Chemicals

    • Risk factors and safety implications of packaging failure or contamination include:

  • Patient harm or injury due to contaminated or ineffective products

  • Product recalls leading to financial losses and reputation damage

  • Regulatory penalties and fines for non-compliance

  • Economic costs associated with product rework, replacement, or disposal

    • Quality assurance and quality control aspects of USP <1106> Whole Package Integrity Testing include:

  • Ensuring proper packaging design and materials selection

  • Implementing validated testing protocols and procedures

  • Maintaining accurate records and documentation

  • Continuously monitoring and improving packaging systems and processes

    • This test contributes to product safety and reliability by ensuring that packaging systems meet specific requirements for integrity, quality, and performance.

    USP <1106> Whole Package Integrity Testing involves a series of steps and procedures to evaluate the integrity of packaging materials and systems. Here is a detailed explanation of how the test is conducted:

    1. Sample Preparation: Selecting representative samples of packaging materials, containers, closures, labels, or other components.

    2. Testing Equipment and Instruments: Using specialized equipment such as tensile testers, puncture testers, or drop impact testers to evaluate packaging performance.

    3. Testing Environment Requirements: Maintaining controlled testing conditions including temperature (20C 5C), humidity (60 10), and lighting (lux).

    4. Test Protocols and Procedures: Implementing validated test protocols and procedures to ensure consistent and accurate results.

    5. Data Analysis: Interpreting and analyzing data from testing to determine packaging integrity, quality, and performance.

    Here is a summary of key steps involved in USP <1106> Whole Package Integrity Testing:

    Step Description

    --- ---

    1 Sample preparation: Selecting representative samples.

    2 Equipment selection: Choosing suitable testing equipment and instruments.

    3 Environmental control: Maintaining controlled testing conditions.

    4 Test protocol implementation: Executing validated test protocols and procedures.

    5 Data analysis: Interpreting and analyzing data from testing.

    Conclusion

    USP <1106> Whole Package Integrity Testing is an essential laboratory testing service for ensuring the integrity of packaging materials and systems. This test is governed by various international and national standards, including ISO 11608, ASTM D882, EN 868, TSE 1125, and others.

    The legal and regulatory framework surrounding this testing service requires pharmaceutical and medical device manufacturers to ensure that their packaging systems meet specific requirements for safety, efficacy, and quality. Standard compliance is essential for industries such as pharmaceuticals, medical devices, and cosmetics.

    USP <1106> Whole Package Integrity Testing contributes to product safety and reliability by ensuring that packaging systems meet specific requirements for integrity, quality, and performance. This test involves a series of steps and procedures to evaluate the integrity of packaging materials and systems.

    By understanding standard-related information, standard requirements and needs, and test conditions and methodology, manufacturers can ensure compliance with regulations and guidelines while protecting their brand reputation and customer trust.

    Recommendations

    To ensure compliance with USP <1106> Whole Package Integrity Testing:

    1. Familiarize yourself with relevant standards and regulations.

    2. Develop a comprehensive quality control program for packaging systems.

    3. Implement validated testing protocols and procedures.

    4. Continuously monitor and improve packaging systems and processes.

    5. Engage with regulatory bodies, industry stakeholders, and standard development organizations to stay informed about updates and changes.

    By following these recommendations, manufacturers can ensure that their packaging systems meet specific requirements for safety, efficacy, and quality, protecting brand reputation and customer trust while preventing recalls, regulatory penalties, and other consequences of non-compliance.

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