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21-cfr-part-211113-control-of-microbiological-contamination
Sterility and Microbial Limit Testing 21 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 <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

Comprehensive Guide to 21 CFR Part 211.113 Control of Microbiological Contamination Laboratory Testing Service Provided by Eurolab

21 CFR Part 211.113 Control of Microbiological Contamination is a regulatory requirement for the control of microbiological contamination in pharmaceutical manufacturing. This standard is governed by the US Food and Drug Administration (FDA) and applies to all pharmaceutical manufacturers, packers, or distributors.

Legal and Regulatory Framework

The legal and regulatory framework surrounding 21 CFR Part 211.113 Control of Microbiological Contamination testing includes:

  • US FDAs Code of Federal Regulations (CFR)

  • International Organization for Standardization (ISO) standards

  • American Society for Testing and Materials (ASTM) standards

  • European Committee for Standardization (CEN) standards

    • International and National Standards

    The following international and national standards apply to 21 CFR Part 211.113 Control of Microbiological Contamination testing:

  • ISO 14698-1:2004 - Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

  • ISO 14698-2:2004 - Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation of limits and evaluation of test methods for biocontaminated areas

  • ASTM E2756-11 - Standard Guide for Biocontamination Control in Clean Rooms and Associated Controlled Environments

    • Standard Development Organizations

    Standard development organizations (SDOs) play a crucial role in the development and maintenance of standards. Some prominent SDOs include:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • CEN (European Committee for Standardization)

    • Evolution of Standards

    Standards evolve over time to reflect advances in technology, changes in regulations, and new research findings. Eurolab stays up-to-date with the latest standards and guidelines to ensure that our testing services meet the highest quality and regulatory requirements.

    Standard Numbers and Scope

    Some key standard numbers and their scope are:

  • ISO 14698-1:2004 - Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (Scope: Provides general principles and methods for biocontamination control in clean rooms)

  • ASTM E2756-11 - Standard Guide for Biocontamination Control in Clean Rooms and Associated Controlled Environments (Scope: Provides guidelines for biocontamination control in clean rooms)

    • Standard Compliance Requirements

    Compliance with standards is mandatory for industries that require 21 CFR Part 211.113 Control of Microbiological Contamination testing. These industries include:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Medical device manufacturing

    • ...

    Why this specific test is needed and required

    21 CFR Part 211.113 Control of Microbiological Contamination testing is essential for ensuring the safety and efficacy of pharmaceutical products. The presence of microorganisms in clean rooms can lead to contamination, which can compromise product quality and safety.

    Business and Technical Reasons

    Conducting 21 CFR Part 211.113 Control of Microbiological Contamination testing has several business and technical reasons:

  • Ensures compliance with regulatory requirements

  • Reduces risk of contamination and associated losses

  • Improves product quality and safety

  • Enhances reputation and credibility

    • ...

    Step-by-Step Explanation

    The 21 CFR Part 211.113 Control of Microbiological Contamination test involves the following steps:

    1. Sample preparation

    2. Testing equipment calibration

    3. Testing environment setup

    4. Testing procedure

    5. Data collection and analysis

    ...

    Testing Equipment and Instruments

    Eurolab uses state-of-the-art testing equipment, including:

  • Microbiological air samplers

  • Surface sampling devices

  • Incubators

  • Microscopes

    • ...

    Sample Preparation Procedures

    Sample preparation involves collecting and preparing samples for testing. This includes:

  • Collecting air or surface samples using specialized equipment

  • Transporting samples to the laboratory

  • Preparing samples for analysis

    • ...

    Testing Parameters and Conditions

    The following parameters and conditions are considered during 21 CFR Part 211.113 Control of Microbiological Contamination testing:

  • Temperature (20-25C)

  • Humidity (40-60)

  • Air flow (10-20 cubic meters per hour)

  • Microorganism detection limits

    • ...

    Measurement and Analysis Methods

    Eurolab uses the following measurement and analysis methods for 21 CFR Part 211.113 Control of Microbiological Contamination testing:

  • Microbial air sampling

  • Surface sampling

  • Culture media analysis

  • Molecular techniques (e.g., PCR, DNA sequencing)

    • ...

    Please note that this is a comprehensive guide to the 21 CFR Part 211.113 Control of Microbiological Contamination laboratory testing service provided by Eurolab. It includes standard-related information, requirements, and methodology for conducting the test.

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