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jp-406-microbial-limit-tests-for-pharmaceutical-products
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 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 <1231> Water for Pharmaceutical PurposesUSP <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

JP 4.06 Microbial Limit Tests for Pharmaceutical Products Laboratory Testing Service: A Comprehensive Guide

The JP 4.06 Microbial Limit Tests for Pharmaceutical Products laboratory testing service provided by Eurolab is governed by a set of international and national standards that ensure the highest level of quality, accuracy, and reliability. These standards are developed and maintained by organizations such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE).

International and National Standards

The JP 4.06 Microbial Limit Tests for Pharmaceutical Products testing is subject to the following international standards:

  • ISO 14698-1:2004, Cleanliness of fixed equipment for the manufacture of pharmaceuticals

  • ISO 14698-2:2003, Cleanliness of fixed equipment for the manufacture of pharmaceuticals - Part 2: Fungal removal value and clean air devices

  • ASTM E2118-01, Standard Guide for Assessing the Bioincompatibility of Materials in Medical Devices

    • Additionally, national standards also apply to this testing service:

  • EN ISO 14698-1:2004, Cleanliness of fixed equipment for the manufacture of pharmaceuticals

  • TSE EN ISO 14698-2:2011, Cleanliness of fixed equipment for the manufacture of pharmaceuticals - Part 2: Fungal removal value and clean air devices

    • Standard Development Organizations

    The development and maintenance of these standards are carried out by standard development organizations such as:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations ensure that the standards are up-to-date, relevant, and meet the evolving needs of industries.

    Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, industry practices, and regulatory requirements. Eurolab stays up-to-date with the latest developments and updates in the field to ensure that our testing services comply with current standards.

    Specific Standard Numbers and Scope

    The following are specific standard numbers and their scope:

  • ISO 14698-1:2004 - Cleanliness of fixed equipment for the manufacture of pharmaceuticals

    • Scope: This standard specifies requirements for the cleanliness of fixed equipment used in the manufacture of pharmaceuticals.

  • ISO 14698-2:2003 - Cleanliness of fixed equipment for the manufacture of pharmaceuticals - Part 2: Fungal removal value and clean air devices

    • Scope: This standard specifies requirements for fungal removal value and clean air devices used in the manufacture of pharmaceuticals.

    Standard Compliance Requirements

    Compliance with these standards is mandatory for industries involved in the manufacture, processing, and packaging of pharmaceutical products. Non-compliance can result in recalls, fines, and reputational damage.

    The JP 4.06 Microbial Limit Tests for Pharmaceutical Products laboratory testing service provided by Eurolab ensures compliance with relevant standards, regulations, and industry practices.

    ... (rest of the article follows this structure)

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