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usp-1231-water-for-pharmaceutical-purposes
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

USP <1231> Water for Pharmaceutical Purposes Laboratory Testing Service: A Comprehensive Guide

The USP <1231> Water for Pharmaceutical Purposes standard is a critical requirement for the pharmaceutical industry, ensuring the quality and purity of water used in pharmaceutical manufacturing processes. This standard is governed by the United States Pharmacopeia (USP), an independent, non-profit organization that sets standards for the identity, strength, quality, and purity of substances used in healthcare.

International and National Standards

The USP <1231> Water for Pharmaceutical Purposes standard is based on international and national standards, including:

  • ISO 3696-1:2017, Water for analytical laboratory use - Part 1: Test sieves for sieving

  • ASTM D1193-15, Standard Specification for Reagent Water

  • EN 1262:2009A1:2015, Water quality - Laboratory water used in the analysis of substances

  • TSE (Turkish Standards Institution) EN 1262:2009A1:2015

    • These standards specify the requirements and guidelines for laboratory testing, including sample preparation, equipment calibration, and measurement methods.

    Standard Development Organizations

    The USP <1231> Water for Pharmaceutical Purposes standard is developed by the following organizations:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations collaborate to ensure that standards are consistent, relevant, and up-to-date.

    Evolution of Standards

    Standards evolve over time due to advances in technology, changes in regulations, or new research findings. Updates to the USP <1231> Water for Pharmaceutical Purposes standard may occur every 5-10 years.

    Standard Numbers and Scope

    The current edition of the USP <1231> Water for Pharmaceutical Purposes standard is:

  • USP <1231>, Water for Pharmaceutical Purposes (2022)

    • The scope of this standard includes the testing requirements for water used in pharmaceutical manufacturing processes, including:

  • pH value

  • Conductivity

  • Total dissolved solids (TDS)

  • Microbiological contamination

    • Compliance Requirements

    Pharmaceutical manufacturers must comply with the USP <1231> Water for Pharmaceutical Purposes standard to ensure that their products meet regulatory requirements.

    Industries and Sectors

    This testing service is required by:

  • Pharmaceutical manufacturing companies

  • Biotechnology firms

  • Medical device manufacturers

  • Cosmetics and personal care product manufacturers

    • Failure to comply with this standard can result in product recalls, fines, or even closure of operations.

    Business and Technical Reasons for Conducting USP <1231> Water for Pharmaceutical Purposes Testing

    Conducting USP <1231> Water for Pharmaceutical Purposes testing is essential for:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Maintaining quality control

  • Preventing contamination and spoilage

    • Quality Assurance and Quality Control Aspects

    This testing service ensures that water used in pharmaceutical manufacturing processes meets the required standards, ensuring:

  • Consistency of results

  • Reliability of equipment

  • Validity of measurements

  • Compliance with regulations

    • Consequences of Not Performing This Test

    Failure to conduct USP <1231> Water for Pharmaceutical Purposes testing can result in:

  • Product recalls and withdrawals

  • Financial losses due to regulatory non-compliance

  • Damage to reputation and brand image

  • Risk to public health and safety

    • Competitive Advantages of Having this Testing Performed

    Conducting USP <1231> Water for Pharmaceutical Purposes testing demonstrates a commitment to quality, safety, and regulatory compliance, providing:

  • Competitive edge in the market

  • Increased customer confidence and trust

  • Improved product reliability and consistency

  • Enhanced reputation and brand image

    • Cost-Benefit Analysis of Performing this Test

    The cost of conducting USP <1231> Water for Pharmaceutical Purposes testing is negligible compared to the potential costs associated with non-compliance, including:

  • Regulatory fines and penalties

  • Product recalls and withdrawals

  • Financial losses due to damage to reputation and brand image

    • The USP <1231> Water for Pharmaceutical Purposes testing service involves the following steps:

    1. Sample Preparation: Collecting water samples from various sources, including taps, wells, and treatment plants.

    2. Equipment Calibration: Calibrating testing equipment, such as pH meters, conductivity meters, and spectrophotometers, to ensure accuracy and reliability.

    3. Measurement Methods: Conducting measurements according to the standard requirements, including:

    pH value

    Conductivity

    Total dissolved solids (TDS)

    Microbiological contamination

    4. Data Collection and Recording: Recording test results and data, including:

    Sample ID and source

    Test date and time

    Results of measurements

    5. Reporting: Providing a comprehensive report detailing the test results, including:

    Summary of findings

    Graphs and charts illustrating the data

    Conclusion and recommendations

    Test Methods

    The USP <1231> Water for Pharmaceutical Purposes standard specifies the following test methods:

  • pH value: Using a pH meter calibrated to 0.01 pH units.

  • Conductivity: Using a conductivity meter calibrated to 1 of full-scale range.

  • Total dissolved solids (TDS): Using gravimetric or titrimetric methods.

    • Test Equipment

    The testing service utilizes the following equipment:

  • pH meters

  • Conductivity meters

  • Spectrophotometers

  • Gravimetric or titrimetric equipment

    • Test Personnel

    The testing service is conducted by trained and certified laboratory personnel, including:

  • Laboratory technicians

  • Chemists

  • Microbiologists

    • Quality Control Measures

    To ensure the accuracy and reliability of test results, we implement quality control measures, including:

  • Equipment calibration checks

  • Blank sample analysis

  • Standardization of reagents and chemicals

  • Regular maintenance of testing equipment.

    • Test Reporting and Certification

    The USP <1231> Water for Pharmaceutical Purposes testing service provides a comprehensive report detailing the test results, including:

  • Sample ID and source

  • Test date and time

  • Results of measurements

  • Summary of findings

  • Graphs and charts illustrating the data

    • A certification letter will be issued upon completion of the testing service, indicating compliance with the USP <1231> Water for Pharmaceutical Purposes standard.

    Conclusion

    The USP <1231> Water for Pharmaceutical Purposes laboratory testing service is a critical requirement for pharmaceutical manufacturers to ensure product safety and efficacy. By conducting regular testing and implementing quality control measures, companies can demonstrate their commitment to regulatory compliance and maintain a competitive edge in the market.

    References

  • United States Pharmacopeia (USP), <1231>, Water for Pharmaceutical Purposes

  • ISO 3696-1:2017, Water for analytical laboratory use - Part 1: Test sieves for sieving

  • ASTM D1193-15, Standard Specification for Reagent Water

  • EN 1262:2009A1:2015, Water quality - Laboratory water used in the analysis of substances

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