EUROLAB
usp-62-tests-for-specified-microorganisms
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 <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 <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 <62> Tests for Specified Microorganisms Laboratory Testing Service: A Comprehensive Guide

The USP <62> Tests for Specified Microorganisms testing service is governed by various international and national standards, which ensure the accuracy, reliability, and validity of test results. The most relevant standards related to this testing service include:

  • USP 62: Tests for Specified Microorganisms

  • ISO 14698-1:2004: Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

  • ASTM E2856-12: Standard Practice for Sterilization Validation of Hydrogen Peroxide Gas Plasma Sterilizers

  • EN ISO 11140-5:2013: Sterilisation of medical instruments and accessories Requirements for validation and routine testing

  • TSE L.1: Microbiological Examination of Foodstuffs

    • These standards are developed by various standard development organizations (SDOs), including the United States Pharmacopeia (USP), International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and Turkish Standards Institution (TSE). The SDOs play a crucial role in ensuring that standards are developed, reviewed, and updated regularly to reflect changes in technology, science, and regulations.

    The international and national standards that apply to this specific laboratory test are designed to ensure that the testing service is performed with high accuracy and reliability. These standards cover various aspects of testing, including sampling, sample preparation, testing conditions, measurement, and analysis.

    Standard Compliance Requirements for Different Industries

    Different industries have varying requirements for standard compliance, which may include:

  • Pharmaceutical Industry: USP <62> Tests for Specified Microorganisms are mandatory for pharmaceutical manufacturers to ensure product safety and efficacy.

  • Medical Device Industry: ISO 14698-1:2004 is applicable to medical device manufacturers to control biocontamination in cleanrooms and associated controlled environments.

  • Food Industry: TSE L.1 is applicable to food manufacturers to ensure microbiological safety of foodstuffs.

    • Failure to comply with these standards can result in product recalls, regulatory actions, and damage to reputation.

    The USP <62> Tests for Specified Microorganisms testing service is required due to the following reasons:

  • Product Safety: The test ensures that products are free from specified microorganisms, which can pose a risk to human health.

  • Regulatory Compliance: The test helps manufacturers comply with regulatory requirements and industry standards.

  • Quality Assurance: The test ensures that products meet quality requirements and specifications.

    • The consequences of not performing this test include:

  • Product Recalls: Non-compliance with regulations can result in product recalls, which can damage a companys reputation and financial performance.

  • Regulatory Actions: Failure to comply with standards can result in regulatory actions, including fines and penalties.

  • Damage to Reputation: Non-compliance with standards can damage a companys reputation and credibility.

    • The industries that require this testing include:

  • Pharmaceutical Industry: Pharmaceutical manufacturers require USP <62> Tests for Specified Microorganisms to ensure product safety and efficacy.

  • Medical Device Industry: Medical device manufacturers require ISO 14698-1:2004 to control biocontamination in cleanrooms and associated controlled environments.

  • Food Industry: Food manufacturers require TSE L.1 to ensure microbiological safety of foodstuffs.

    • The USP <62> Tests for Specified Microorganisms testing service involves the following steps:

    1. Sampling: Sampling is performed according to standard procedures, including sampling size, sample preparation, and transportation.

    2. Sample Preparation: Samples are prepared according to standard procedures, including homogenization, dilution, and inoculation.

    3. Testing Conditions: Testing conditions include temperature, humidity, pressure, and other environmental factors that may affect test results.

    4. Measurement and Analysis: Measurement and analysis involve the use of specialized equipment and software to detect specified microorganisms.

    The testing equipment and instruments used include:

  • Microbiological Analyzers: Such as automated microbial detection systems and spectrophotometers.

  • Incubators: For growing microorganisms under controlled conditions.

  • Centrifuges: For separating microorganisms from samples.

    • The test results are documented and reported according to standard procedures, including:

    1. Report Format: The report format includes a summary of the testing service performed, including sampling, sample preparation, testing conditions, measurement, and analysis.

    2. Interpretation of Results: The interpretation of results involves the analysis of data and presentation of findings in a clear and concise manner.

    3. Certification and Accreditation: Certification and accreditation aspects involve ensuring that testing services are performed by qualified personnel and laboratories.

    4. Documentation: Documentation includes maintaining records of test results, sampling, sample preparation, testing conditions, measurement, and analysis.

    Conclusion

    The USP <62> Tests for Specified Microorganisms laboratory testing service is a critical aspect of ensuring product safety and regulatory compliance. The standards related to this testing service are developed by various SDOs, including the United States Pharmacopeia (USP), International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and Turkish Standards Institution (TSE). The consequences of not performing this test include product recalls, regulatory actions, and damage to reputation.

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