EUROLAB
usp-61-microbial-enumeration-tests-for-raw-materials
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 <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 <61> Microbial Enumeration Tests for Raw Materials: Laboratory Testing Services

Standard-Related Information

The United States Pharmacopeia (USP) <61> Microbial Enumeration Tests for Raw Materials is a widely accepted standard for the testing of microbial contaminants in raw materials used in pharmaceutical and related industries. This standard provides guidelines for the enumeration of microorganisms, including bacteria, yeast, and mold, in various types of raw materials.

The USP <61> standard is based on international standards such as ISO 11133, ASTM E2758, and EN 12082, which provide similar guidelines for microbial testing. The European Pharmacopoeia (Ph. Eur.) also has a corresponding standard, Chapter 2.6.30, that provides guidelines for the enumeration of microorganisms in raw materials.

The legal and regulatory framework surrounding this testing service is governed by various national and international regulations, including:

  • USP <61>

  • ISO 11133

  • ASTM E2758

  • EN 12082

  • Ph. Eur. Chapter 2.6.30

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

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, and new scientific knowledge. The USP <61> standard, for example, has undergone several revisions since its initial publication in 1999.

    Standard Requirements and Needs

    The USP <61> Microbial Enumeration Tests for Raw Materials is a critical testing service required by various industries to ensure the quality and safety of raw materials used in pharmaceuticals, food, cosmetics, and other related products. The test is necessary to:

  • Ensure product safety and reliability

  • Comply with regulatory requirements

  • Detect microbial contaminants that can affect product quality or pose health risks

  • Verify the efficacy of cleaning and sanitizing processes

    • The consequences of not performing this test can include contamination of products, recalls, and damage to a companys reputation.

    Test Conditions and Methodology

    The USP <61> Microbial Enumeration Tests for Raw Materials involves several steps:

    1. Sample collection and preparation

    2. Inoculation of the sample onto agar plates or into broth

    3. Incubation of the inoculated samples at specific temperatures (e.g., 25C, 30C, 37C)

    4. Counting of microorganisms using a microscope or other counting methods

    The testing equipment and instruments used include:

  • Microscopes

  • Agar plate incubators

  • Broth incubators

  • Pipettes and other laboratory equipment

    • The testing environment requirements are critical to ensure accurate results. The temperature, humidity, and pressure conditions must be controlled to prevent contamination and maintain the integrity of the samples.

    Test Reporting and Documentation

    The test report should include:

  • Sample identification and description

  • Test method used

  • Results, including counts and observations

  • Conclusion and recommendations

    • The report format and structure are governed by regulatory requirements, such as USP <61> and ISO 11133. The interpretation of test results requires expertise in microbiology and laboratory testing.

    Why This Test Should Be Performed

    Performing the USP <61> Microbial Enumeration Tests for Raw Materials provides numerous benefits, including:

  • Ensuring product safety and reliability

  • Complying with regulatory requirements

  • Detecting microbial contaminants that can affect product quality or pose health risks

  • Verifying the efficacy of cleaning and sanitizing processes

    • The testing service also contributes to innovation and research development by providing data on microbial contamination and its impact on products.

    Why Eurolab Should Provide This Service

    Eurolabs expertise and experience in laboratory testing services, combined with state-of-the-art equipment and facilities, make it an ideal choice for this testing service. The companys qualified and certified personnel ensure accurate results, while the accreditation and certification details provide assurance of compliance with regulatory requirements.

    Additional Requirements

  • Eurolabs quality management systems and procedures ensure customer satisfaction and confidence

  • The companys turn-around time and efficiency advantages enable timely delivery of test reports

  • Competitive pricing and value proposition make Eurolab a cost-effective choice for laboratory testing services

    • Case Studies and Industry Examples

    Eurolab has successfully performed the USP <61> Microbial Enumeration Tests for Raw Materials for various industries, including pharmaceuticals, food, cosmetics, and biotechnology. The companys expertise in this area has helped clients ensure product safety and reliability.

    Conclusion

    The USP <61> Microbial Enumeration Tests for Raw Materials is a critical testing service required by various industries to ensure the quality and safety of raw materials used in products. Eurolabs expertise and experience in laboratory testing services make it an ideal choice for this testing service. The companys commitment to quality, accuracy, and customer satisfaction ensures that clients receive reliable results and timely delivery of test reports.

    References

    1. United States Pharmacopeia (USP) <61> Microbial Enumeration Tests for Raw Materials

    2. International Organization for Standardization (ISO) 11133

    3. American Society for Testing and Materials (ASTM) E2758

    4. European Committee for Standardization (CEN) EN 12082

    5. European Pharmacopoeia (Ph. Eur.) Chapter 2.6.30

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