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usp-51-preservative-effectiveness-testing-of-multi-dose-pharmaceuticals
Pharmaceutical Microbiology Testing ICH Q10 Pharmaceutical Quality System and Microbial ControlsICH Q6A Testing for Microbiological Attributes of Drug SubstancesICH Q7 GMP Guidelines for Microbial Control in APIsICH Q9 Risk-Based Approach to Microbial ContaminationISO 11737-1 Bioburden Testing for Medical Devices and Pharmaceutical PackagingISO 11737-2 Sterility Assurance and Validation for Pharmaceutical ComponentsISO 11930 Preservation Efficacy Testing for Topical PharmaceuticalsISO 14644-1 Cleanroom Classification for Pharmaceutical ManufacturingISO 14698-1 Biocontamination Control in CleanroomsISO 16212 Yeast and Mold Testing in Pharmaceutical Raw MaterialsISO 18415 Detection of Pathogenic Microorganisms in Non-Sterile ProductsISO 21149 Enumeration of Aerobic Mesophilic Bacteria in Cosmetic and PharmaJP XVII Bacterial Endotoxin Test for Injectable PharmaceuticalsJP XVII Microbial Limit Tests for Oral PreparationsJP XVII Sterility Test for Pharmaceutical ProductsPh. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical ProductsPh. Eur. 2.6.11 Detection of Pathogens in Veterinary PharmaceuticalsPh. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile ProductsPh. Eur. 2.6.13 Detection of Clostridia in Parenteral SolutionsPh. Eur. 2.6.14 Bacterial Endotoxins – Gel Clot MethodPh. Eur. 2.6.15 Test for Pseudomonas aeruginosa in Topical DrugsPh. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and GelsPh. Eur. 2.6.2 Mycoplasma Detection in Cell-Based PharmaceuticalsPh. Eur. 2.6.25 Testing for Anaerobic Bacteria in Sterile ProductsPh. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral DrugsPh. Eur. 2.6.30 Monitoring of Controlled EnvironmentsPh. Eur. 2.6.32 Control of Bacterial Contamination in Ophthalmic DrugsPh. Eur. 2.6.7 Mycobacteria Detection in BiopharmaceuticalsPh. Eur. 2.6.9 Test for Escherichia coli in Non-Sterile PharmaPh. Eur. 5.1.4 Microbiological Quality of Pharmaceutical PreparationsPh. Eur. 5.1.6 Alternative Methods for Microbiological Quality ControlPh. Eur. 5.1.8 Bioburden Limits in Parenteral ManufacturingUSP <1072> Disinfectants and Antiseptics Microbial Efficacy TestUSP <1111> Microbiological Examination of Non-Sterile ProductsUSP <1115> Bioburden Control of Non-Sterile Drug SubstancesUSP <1116> Microbiological Control of Clean Rooms and Controlled EnvironmentsUSP <1117> Microbial Best Practices for Pharmaceutical Lab PersonnelUSP <1207> Package Integrity Evaluation – Microbial Ingress TestUSP <1208> Integrity Testing for Sterile Barrier SystemsUSP <1223> Water Activity Determination in Drug ProductsUSP <1227> Validation of Microbial Recovery MethodsUSP <1229> Microbial Quality of Compendial Water SystemsUSP <1231> Water for Pharmaceutical Purposes – Microbiological TestingUSP <39> Bioburden Limit Testing for Bulk Active IngredientsUSP <39> Microbiological Quality of Compounding PharmaciesUSP <55> Biological Indicators for Sterilization ValidationUSP <61> Microbial Enumeration Tests for Raw Pharmaceutical MaterialsUSP <61>/<62> Microbial Limit Tests for Tablet and Capsule FormsUSP <62> Tests for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing of Injectable Pharmaceutical Products

USP <51> Preservative Effectiveness Testing of Multi-Dose Pharmaceuticals: Eurolabs Laboratory Testing Service

The testing service for USP <51> Preservative Effectiveness of Multi-Dose Pharmaceuticals is governed by several international and national standards. These include:

  • ISO 11133: This standard provides general guidelines for the validation and control of antimicrobial preservation in pharmaceuticals.
  • USP <51>: The United States Pharmacopeia (USP) establishes standards for various pharmaceutical products, including preservative effectiveness testing.
  • ASTM E2313-11: This standard covers the laboratory testing of preservatives in pharmaceuticals.
  • The regulatory framework surrounding this testing service includes:

  • The US Food and Drug Administration (FDA)
  • The European Medicines Agency (EMA)
  • The World Health Organization (WHO)
  • International standards that apply to this specific laboratory test include:

  • ISO 11133:2006
  • USP <51>:2009
  • ASTM E2313-11
  • Standard development organizations play a crucial role in the evolution and updating of standards. These organizations include:

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • The standard compliance requirements for different industries vary, but generally include:

  • Pharmaceuticals
  • Cosmetics
  • Food products
  • USP <51> Preservative Effectiveness Testing of Multi-Dose Pharmaceuticals testing is necessary to ensure the safety and efficacy of pharmaceutical products. This test is required by regulatory agencies, such as the FDA, to ensure compliance with Good Manufacturing Practices (GMPs).

    The consequences of not performing this test include:

  • Regulatory non-compliance
  • Product recalls
  • Financial losses
  • This testing service is required in various industries, including:

  • Pharmaceuticals
  • Cosmetics
  • Food products
  • The risk factors and safety implications associated with USP <51> Preservative Effectiveness Testing of Multi-Dose Pharmaceuticals include:

  • Contamination
  • Infection
  • Product failure
  • Quality assurance and quality control aspects of this testing service include:

  • Calibration and validation of equipment
  • Sample preparation and handling
  • Data collection and analysis
  • This test contributes to product safety and reliability by ensuring the effectiveness of preservatives.

    USP <51> Preservative Effectiveness Testing of Multi-Dose Pharmaceuticals involves several steps:

    1. Sample preparation: The testing sample is prepared according to the standard requirements.

    2. Testing equipment: Appropriate testing equipment, such as microplate readers or spectrophotometers, is used for data collection.

    3. Testing environment: The testing is performed in a controlled environment, with specific temperature and humidity conditions.

    The testing parameters and conditions include:

  • Incubation time
  • Temperature
  • Humidity
  • Measurement and analysis methods involve the use of appropriate statistical software to calculate the results.

    The test report includes:

  • Summary of the testing procedure
  • Results and data analysis
  • Conclusion and recommendations
  • The certification and accreditation aspects include:

  • Calibration and validation of equipment
  • Accreditation by a recognized accreditation body, such as ISO 17025.
  • The traceability and documentation requirements include:

  • Sample identification and tracking
  • Data collection and recording.
  • This testing service provides numerous benefits, including:

  • Regulatory compliance
  • Product safety and efficacy
  • Quality assurance and control
  • Risk assessment and mitigation through testing include:

  • Contamination control
  • Infection prevention
  • Quality assurance and compliance benefits include:

  • Calibration and validation of equipment
  • Accreditation by a recognized accreditation body.
  • Competitive advantages and market positioning are achieved through:

  • Regulatory compliance
  • Product safety and efficacy
  • Quality assurance and control.
  • Cost savings and efficiency improvements result from:

  • Reduced testing time
  • Improved data analysis
  • Legal and regulatory compliance benefits include:

  • Compliance with GMPs
  • Avoidance of product recalls and financial losses.
  • Eurolabs expertise and experience in USP <51> Preservative Effectiveness Testing of Multi-Dose Pharmaceuticals make it an ideal choice for this testing service. State-of-the-art equipment and facilities ensure accurate and reliable results.

    Accreditation and certification details include:

  • Accreditation by a recognized accreditation body, such as ISO 17025
  • Certification in relevant industries, including pharmaceuticals and cosmetics
  • Conclusion

    USP <51> Preservative Effectiveness Testing of Multi-Dose Pharmaceuticals is a crucial testing service for ensuring the safety and efficacy of pharmaceutical products. This guide provides a comprehensive overview of the standard-related information, testing procedure, and benefits associated with this testing service.

    Eurolabs expertise and experience in USP <51> Preservative Effectiveness Testing of Multi-Dose Pharmaceuticals make it an ideal choice for this testing service. By choosing Eurolab, you can ensure regulatory compliance, product safety and efficacy, and quality assurance and control.

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