EUROLAB
usp-1228-depyrogenation-validation-of-equipment
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 <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 <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 <1228> Depyrogenation Validation of Equipment Laboratory Testing Service

Ensuring the Safety and Quality of Pharmaceutical Products

As a leading provider of laboratory testing services, Eurolab is committed to helping pharmaceutical manufacturers and regulatory authorities ensure the safety and quality of their products. In this article, we will delve into the world of USP <1228> Depyrogenation Validation of Equipment testing, explaining its importance, requirements, and benefits.

USP <1228> Depyrogenation Validation of Equipment is a standard developed by the United States Pharmacopeia (USP) to ensure that equipment used in the pharmaceutical industry is properly decontaminated. The standard outlines the requirements for validating the effectiveness of depyrogenation processes, including temperature, time, and humidity.

The relevant standards governing USP <1228> Depyrogenation Validation of Equipment testing include:

  • ISO 8359:2007

  • ASTM E1794-96 (Reapproved 2012)

  • EN 12469:2003

  • TSE L.02 (2017)

    • These standards are developed and maintained by various organizations, including the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN).

    The development of these standards is a collaborative effort among industry experts, regulatory agencies, and standard development organizations. The standards evolve over time to reflect advances in technology and changes in regulations.

    USP <1228> Depyrogenation Validation of Equipment testing is required for equipment used in the manufacture of pharmaceutical products that are intended for parenteral administration, such as injections, infusions, and implants. This includes equipment such as autoclaves, dry heat sterilizers, and depyrogenation tunnels.

    The consequences of not performing this test can be severe, including:

  • Contamination of equipment and products

  • Deviation from regulatory requirements

  • Product recalls or withdrawals

  • Loss of customer trust and reputation

    • Industry sectors that require USP <1228> Depyrogenation Validation of Equipment testing include pharmaceuticals, biotechnology, medical devices, and cosmetics.

    The risk factors associated with this test are:

  • Contamination of equipment and products

  • Inadequate decontamination processes

  • Failure to validate equipment performance

    • Quality assurance and quality control aspects of USP <1228> Depyrogenation Validation of Equipment testing include:

  • Calibration and validation of testing instruments

  • Training and certification of personnel

  • Documented procedures for testing and reporting

  • Statistical analysis of test results

    • USP <1228> Depyrogenation Validation of Equipment testing involves several steps, including:

    1. Sample preparation: Preparation of equipment samples to be tested.

    2. Testing: Exposure of samples to controlled temperature, time, and humidity conditions.

    3. Measurement and analysis: Measurement of decontamination efficacy using techniques such as plate counts or DNA-based methods.

    The testing environment requirements include:

  • Temperature: 121C 1C

  • Humidity: 65 5

  • Pressure: Atmospheric pressure

    • Sample preparation procedures involve cleaning and preparing equipment samples to simulate in-use conditions.

    USP <1228> Depyrogenation Validation of Equipment testing results are documented and reported in a format that meets regulatory requirements. The report includes:

  • Test conditions and parameters

  • Sample preparation procedures

  • Testing instruments used

  • Measurement and analysis methods

  • Statistical analysis of test results

    • Certification and accreditation aspects include:

  • Accreditation by recognized third-party organizations

  • Certification of testing personnel

  • Documentation of quality control measures

    • USP <1228> Depyrogenation Validation of Equipment testing is essential for ensuring the safety and quality of pharmaceutical products. The benefits of this test include:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance with regulatory requirements

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

    • Eurolab is committed to providing high-quality laboratory testing services, including USP <1228> Depyrogenation Validation of Equipment testing. Our expertise and experience in this field ensure that our customers receive accurate and reliable results.

    Our state-of-the-art equipment and facilities provide a safe and controlled environment for testing. Our qualified and certified personnel ensure that all testing is conducted according to regulatory requirements.

    Additional Information

    Eurolabs USP <1228> Depyrogenation Validation of Equipment testing service includes:

  • Expert consultation and advisory services

  • Sampling and sample preparation procedures

  • Testing and analysis using state-of-the-art instruments

  • Statistical analysis and data interpretation

  • Reporting and documentation in a format that meets regulatory requirements

    • Conclusion

    USP <1228> Depyrogenation Validation of Equipment testing is an essential step in ensuring the safety and quality of pharmaceutical products. By following this standard, manufacturers can ensure that their equipment is properly decontaminated, reducing the risk of contamination and product recalls.

    Eurolab is committed to providing high-quality laboratory testing services, including USP <1228> Depyrogenation Validation of Equipment testing. Our expertise and experience in this field ensure that our customers receive accurate and reliable results. Contact us today to learn more about our USP <1228> Depyrogenation Validation of Equipment testing service.

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