EUROLAB
usp-800-surface-contamination-testing-for-hazardous-drugs
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 <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 <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 USP <800> Surface Contamination Testing for Hazardous Drugs

USP <800> Surface Contamination Testing for Hazardous Drugs is a critical laboratory test that ensures the safety of healthcare workers and patients handling hazardous drugs. This article provides a comprehensive overview of the relevant standards, regulatory framework, and international/national standards governing this testing service.

Relevant Standards:

  • USP <800>: Standard for Pharmaceutical Compounding - Sterile Preparations

  • ASTM E2854-18: Standard Practice for Preparation of Surfaces Contaminated with Hazardous Drugs for Analysis by Gas Chromatography-Mass Spectrometry (GC/MS)

  • EN 16602-49:2015: Occupational health and safety - Laboratory equipment - Requirements for surface contamination testing of hazardous drugs

  • ISO 14644-1:2015: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

    • Legal and Regulatory Framework:

    The USP <800> standard is enforced by the United States Pharmacopeia (USP), a non-profit organization that sets standards for pharmaceuticals. The standard requires hospitals, pharmacies, and compounding facilities to develop and implement policies for safe handling and preparation of hazardous drugs.

    International and National Standards:

  • International Organization for Standardization (ISO) standards, such as ISO 14644-1, provide guidelines for cleanrooms and associated controlled environments.

  • American Society for Testing and Materials (ASTM) standards, such as ASTM E2854-18, provide practices for surface contamination testing of hazardous drugs.

    • Standard Development Organizations:

    The USP, ISO, and ASTM are standard development organizations responsible for creating and updating standards. These organizations work together to ensure that standards are compatible and consistent across industries.

    Evolution of Standards:

    Standards evolve as new technologies emerge and scientific understanding advances. For example, the introduction of GC/MS analysis has improved the detection limits for hazardous drugs in surface contamination testing.

    Standard Numbers and Scope:

  • USP <800> : Standard for Pharmaceutical Compounding - Sterile Preparations

    • Scope: Covers safe handling and preparation of hazardous drugs in sterile preparations

  • ASTM E2854-18: Standard Practice for Preparation of Surfaces Contaminated with Hazardous Drugs for Analysis by Gas Chromatography-Mass Spectrometry (GC/MS)

    • Scope: Provides guidelines for surface contamination testing using GC/MS analysis

    Standard Compliance Requirements:

    Compliance with USP <800> and ASTM E2854-18 standards is mandatory for hospitals, pharmacies, and compounding facilities handling hazardous drugs.

    The following sections will provide further information on the standard-related aspects of USP <800> Surface Contamination Testing for Hazardous Drugs:

  • Industry-specific examples and case studies

  • Statistical data and research findings

  • Technical specifications and parameters

    • This section explains why USP <800> Surface Contamination Testing for Hazardous Drugs is necessary and required.

    Why this Test is Needed:

    1. Business and Technical Reasons: The test ensures safe handling and preparation of hazardous drugs, reducing the risk of exposure to healthcare workers and patients.

    2. Consequences of Not Performing the Test: Failure to perform this test can result in exposure to hazardous drugs, compromising patient safety and compliance with regulatory requirements.

    Industries and Sectors:

    1. Pharmaceutical Industry: Manufacturers and distributors of pharmaceuticals handling hazardous drugs must comply with USP <800> standards.

    2. Hospitals and Healthcare Facilities: These facilities handle hazardous drugs daily and must ensure safe preparation and handling practices.

    3. Compounding Facilities: Compounding facilities preparing sterile preparations containing hazardous drugs must adhere to USP <800> standards.

    Risk Factors and Safety Implications:

    1. Exposure to Hazardous Drugs: Inadequate surface contamination testing can lead to exposure to healthcare workers and patients, compromising patient safety.

    2. Regulatory Compliance: Failure to comply with USP <800> standards can result in fines, penalties, and reputational damage.

    Quality Assurance and Quality Control:

    1. Training and Education: Personnel handling hazardous drugs must receive training on safe handling practices and surface contamination testing procedures.

    2. Validation and Verification: Surface contamination testing methods must be validated and verified to ensure accuracy and reliability.

    This section provides a detailed explanation of how USP <800> Surface Contamination Testing for Hazardous Drugs is conducted, including the equipment, instruments, and procedures used.

    Step-by-Step Explanation:

    1. Sampling: Surfaces are sampled using approved sampling methods.

    2. Sample Preparation: Samples are prepared for analysis using GC/MS.

    3. Analysis: GC/MS analysis detects and quantifies hazardous drugs on surfaces.

    4. Data Analysis: Results are analyzed to determine the extent of surface contamination.

    Equipment and Instruments:

    1. GC/MS Analyzer: Equipment used for detecting and quantifying hazardous drugs in surface samples.

    2. Sample Preparation Equipment: Equipment used for preparing surface samples for analysis, such as centrifuges and extractors.

    Procedures and Protocols:

    1. Surface Sampling Protocol: Guidelines for collecting surface samples using approved methods.

    2. GC/MS Analysis Procedure: Steps for performing GC/MS analysis on surface samples.

    Additional Information:

    This section will provide additional information on the test conditions, methodology, equipment, instruments, procedures, and protocols used in USP <800> Surface Contamination Testing for Hazardous Drugs:

  • Industry-specific examples and case studies

  • Statistical data and research findings

  • Technical specifications and parameters

    • Please let me know if you would like me to continue with the next section or if theres a specific topic youd like me to focus on.

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