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usp-1111-total-viable-count-for-raw-materials
Endotoxin & Bioburden Testing AAMI RD52 Endotoxin Limits for Dialysis FluidsAATCC TM100 Test for Antimicrobial Activity of TextilesANSI/AAMI ST72 Guidance on Bacterial Endotoxin Testing for Medical DevicesASTM D4414 Bioburden in Coated TextilesASTM D7295 Bioburden Testing on Coated Medical TextilesASTM E2314 Bioburden Testing in Medical Device ComponentsASTM E2406 Real-Time Endotoxin Detection Method ValidationASTM E2614 Bioburden in Industrial Water SystemsASTM E2883 Rapid Endotoxin Detection for Sterile PharmaceuticalsASTM F1608 Bacterial Filtration and Bioburden in Respiratory Protection DevicesASTM F1980 Bioburden Evaluation in Accelerated Aged ProductsASTM F2018 Endotoxin Testing of Contact Lens Care ProductsASTM F640 Bioburden Testing for Surgical DrapesEN 556 Sterilization of Medical Devices – Bioburden LimitsEN ISO 20857 Bioburden Control for Liquid Chemical SterilantsEP 2.6.1 Microbial Testing in Topical PreparationsEP 2.6.12 Microbial Limits Tests for Non-Sterile ProductsEP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical PreparationsEP 2.6.25 Limulus Amebocyte Lysate Test Methods ValidationEP 2.6.30 Endotoxin Testing in Biotechnology ProductsEP 2.6.31 Limulus Amebocyte Lysate Test for EndotoxinsEP 5.1.10 Guidelines for Bioburden Testing in Advanced Therapy Medicinal ProductsEP 5.1.2 Biological Indicators for Sterilization Process ControlEP Monograph 04/2013:20619 Pyrogen and Endotoxin TestingFDA CBER Guidance on Endotoxin Testing of VaccinesFDA CDER Guidance on Bioburden Control in Drug ManufacturingFDA Guidance for Industry on Pyrogen and Endotoxin TestingISO 10993-1 Biological Evaluation of Medical Devices – Endotoxin AssessmentISO 10993-18 Bioburden Interaction with Extractables and LeachablesISO 11137-2 Sterilization Process Validation and Bioburden TestingISO 11138-1 Biological Indicators for Sterilization – Bioburden EvaluationISO 11139 Sterilization Terminology and Bioburden DefinitionsISO 11607 Packaging for Terminally Sterilized Medical Devices – Bioburden ConsiderationsISO 11607-2 Packaging for Terminal Sterilized Devices – Bioburden ConsiderationsISO 11731 Detection of Legionella in Water SystemsISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-1 Bioburden on Reusable Surgical InstrumentsISO 11737-1 Bioburden Testing for Dental ImplantsISO 11737-2 Bioburden Testing for Sterile Barrier SystemsISO 11737-2 Sterility Assurance and Bioburden ControlISO 13408-1 Aseptic Processing Bioburden ControlISO 13408-2 Aseptic Processing Microbiological MonitoringISO 14160 Endotoxin Removal Validation for Sterile LiquidsISO 14161 Bioburden Reduction Using FiltrationISO 14161 Validation of Bioburden Testing MethodsISO 14698-1 Cleanroom Biocontamination Control and MonitoringISO 14971 Risk Management of Endotoxin Contamination in Medical DevicesISO 15883-1 Bioburden Testing for Washer-DisinfectorsISO 17665-1 Moist Heat Sterilization – Bioburden ValidationISO 18562-1 Evaluation of Bioburden in Medical Devices – Part 1ISO 18562-4 Bioburden Testing in Medical Device Gas PathwaysISO 22519 Ultrafiltration Bioburden Reduction TestingISO 29621 Microbiological Examination of CosmeticsISO 80369-1 Endotoxin Limits for Small-Bore ConnectorsISO 80369-7 Small Bore Connectors Bioburden EvaluationISPE Baseline Guide Volume 7 Bioburden Control in Biopharmaceutical ManufacturingJP 15.02 Endotoxin Limit Test for Dialysis FluidsJP 4.05 Bacterial Endotoxin Test for Parenteral DrugsJP 4.06 Bacterial Endotoxin Testing of BiopharmaceuticalsJP XVII Limulus Amebocyte Lysate (LAL) Gel-Clot Test for EndotoxinsPh. Eur. Recombinant Factor C Assay for Endotoxin DetectionUSP <1050> Environmental Monitoring and Bioburden ControlUSP <1072> Disinfectants and Bioburden Control in Healthcare SettingsUSP <1223> Rapid Endotoxin Test Method ValidationUSP <1223> Validation of Alternative Microbiological MethodsUSP <1225> Validation of Analytical Procedures for Endotoxin TestingUSP <1227> Validation of Microbial Recovery MethodsUSP <1229.10> Bioburden Testing in Steam SterilizationUSP <1229.12> Endotoxin Risk Assessment in Sterile ManufacturingUSP <1229.4> Microbial Testing for Aseptic Manufacturing EnvironmentsUSP <1229.9> Bioburden Validation in Isolator TechnologyUSP <1231> Bioburden Limits in Purified Water SystemsUSP <1231> Water for Pharmaceutical Purposes Microbial LimitsUSP <1232> Elemental Impurities and Bioburden ImpactUSP <61> Microbial Enumeration Test for Sterile ProductsUSP <61> Microbial Load Test for Oral Dosage FormsUSP <62> Test for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing for Ophthalmic ProductsUSP <800> Bioburden Control in Hazardous Drug CompoundingUSP <85> Bacterial Endotoxin Test for Injectable Pharmaceutical ProductsWHO TRS 1003 Endotoxin Testing Validation for Parenteral Products

Comprehensive Guide to USP <1111> Total Viable Count for Raw Materials Testing Services by Eurolab

The United States Pharmacopeia (USP) <1111> Total Viable Count (TVC) for Raw Materials is a widely accepted standard for evaluating the microbiological quality of raw materials used in pharmaceutical manufacturing. This standard is developed by the USP Convention, Inc., a non-profit organization that aims to establish standards for quality and purity of substances used in pharmaceuticals.

Relevant Standards

  • ISO 11133:2014 Microbiology of food, animal feeding stuffs and beverages - Preparation, production, storage and performance testing of culture media

  • ASTM E1173-18 Standard Test Method for Determining the Total Viable Count (TVC) of a Pharmaceutical Product in a Single Dose Container or Package

  • EN 14884:2019 Microbiology of pharmaceutical preparations Particular requirements for the preparation of inocula and production of standardized suspensions

  • TSE (Turkish Standards Institution) TS 12311:2017 Microbiology of food, animal feeding stuffs and beverages - Preparation, production, storage and performance testing of culture media

    • International and National Standards

    The USP <1111> Total Viable Count for Raw Materials is based on the principles outlined in the ISO 11133 standard. This standard provides a comprehensive framework for evaluating the microbiological quality of raw materials used in pharmaceutical manufacturing.

    Standard Development Organizations

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • How Standards Evolve and Get Updated

    Standards are constantly evolving to reflect new technologies, scientific discoveries, and changing regulatory requirements. Eurolab stays up-to-date with the latest standards and guidelines through its membership in standard development organizations and participation in international forums.

    Standard Numbers and Scope

  • USP <1111>: Total Viable Count for Raw Materials

  • ISO 11133:2014 Microbiology of food, animal feeding stuffs and beverages - Preparation, production, storage and performance testing of culture media

    • Industry-Specific Requirements

  • Pharmaceutical manufacturers must comply with USP <1111> and other relevant standards to ensure the quality and purity of their raw materials.

  • Food and beverage industries also follow similar standards, such as ISO 11133.

    • Standard Compliance Requirements for Different Industries

    Industry Relevant Standard

    --- ---

    Pharmaceuticals USP <1111>, ISO 11133:2014

    Food and Beverage ISO 11133:2014

    Consequences of Not Performing This Test

    Failure to conduct TVC testing can result in:

  • Contamination of raw materials

  • Product recalls and loss of revenue

  • Regulatory non-compliance and fines

    • Business and Technical Reasons for Conducting USP <1111> Total Viable Count for Raw Materials Testing

  • Ensure product safety and quality

  • Comply with regulatory requirements

  • Prevent contamination and product recalls

  • Maintain customer confidence and trust

    • Risk Factors and Safety Implications

  • Contamination of raw materials can lead to product recalls, loss of revenue, and damage to brand reputation.

  • Non-compliance with regulations can result in fines and penalties.

    • Step-by-Step Explanation of the Test Conducted by Eurolab

    1. Sample Preparation: Raw materials are collected from manufacturers and transported to Eurolabs laboratory for testing.

    2. Testing Equipment and Instruments: Eurolab uses state-of-the-art equipment, including automated microbiological analyzers and thermocyclers.

    3. Testing Environment Requirements:

    Temperature: 20-25C

    Humidity: 50-60

    Pressure: Standard atmospheric pressure

    4. Sample Preparation Procedures: Raw materials are prepared according to the standard protocols outlined in ISO 11133.

    5. Testing Parameters and Conditions: Eurolab conducts TVC testing under controlled conditions, including temperature, humidity, and pressure.

    6. Measurement and Analysis Methods: Eurolab uses automated microbiological analyzers to measure bacterial growth.

    Calibration and Validation Procedures

  • Equipment is calibrated regularly according to the manufacturers instructions

  • Validation procedures are performed on a regular basis to ensure accuracy and reliability

    • Quality Control Measures During Testing

  • Regular calibration of equipment

  • Use of control samples

  • Documented testing protocols

    • Data Collection and Recording Procedures

  • Test results are recorded electronically using Eurolabs laboratory information management system (LIMS).

  • Data is stored securely in accordance with EU data protection regulations.

    • Testing Timeframes and Duration

  • TVC testing typically takes 5-7 days, depending on the sample type and quantity.

  • Results are reported within 24 hours of completion of testing.

    • Sample Size and Quantity

  • Minimum sample size: 10 g

  • Maximum sample size: 100 g

    • Test Report and Certificate of Analysis (COA)

  • Test report includes TVC results, along with other relevant information.

  • COA is issued for each batch tested, including product description, test method, and analytical result.

    • Industry-Specific Requirements

    Industry Relevant Standard

    --- ---

    Pharmaceuticals USP <1111>, ISO 11133:2014

    Food and Beverage ISO 11133:2014

    Standard Compliance Requirements for Different Industries

    Industry Relevant Standard

    --- ---

    Pharmaceuticals USP <1111>, ISO 11133:2014

    Food and Beverage ISO 11133:2014

    Consequences of Not Performing This Test

    Failure to conduct TVC testing can result in:

  • Contamination of raw materials

  • Product recalls and loss of revenue

  • Regulatory non-compliance and fines

    • Business and Technical Reasons for Conducting USP <1111> Total Viable Count for Raw Materials Testing

  • Ensure product safety and quality

  • Comply with regulatory requirements

  • Prevent contamination and product recalls

  • Maintain customer confidence and trust

    • Risk Factors and Safety Implications

  • Contamination of raw materials can lead to product recalls, loss of revenue, and damage to brand reputation.

  • Non-compliance with regulations can result in fines and penalties.

    • The following sections will cover the remaining requirements for this comprehensive guide.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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