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usp-1116-microbiological-control-of-clean-rooms-and-controlled-environments
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 <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 <51> Preservative Effectiveness Testing of Multi-Dose PharmaceuticalsUSP <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 <1116> Microbiological Control of Clean Rooms and Controlled Environments: Laboratory Testing Services Provided by Eurolab

The USP <1116> Microbiological Control of Clean Rooms and Controlled Environments standard is a comprehensive guideline that outlines the requirements for controlling microbiological contamination in clean rooms and controlled environments. This standard is essential for industries that manufacture pharmaceuticals, biotechnology products, and medical devices.

International and National Standards

  • ISO 14644-1:2015: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

  • ASTM E3087-17: Standard Practice for Evaluating the Microbiological Control of Clean Rooms and Controlled Environments

  • EN 12190:2007: Clean rooms and associated controlled environments - Part 2: Validation of local exhaust ventilation systems

    • Standard Development Organizations

    The development of standards is a collaborative effort between various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards are continuously evolving to reflect new technologies, techniques, and industry needs. This ensures that the standards remain relevant and effective in ensuring quality and safety.

    Standard Numbers and Scope

    Some key standard numbers and their scope include:

  • ISO 14644-1:2015: Classification of air cleanliness

  • ASTM E3087-17: Evaluating microbiological control of clean rooms and controlled environments

  • EN 12190:2007: Validation of local exhaust ventilation systems

    • Compliance Requirements for Different Industries

    The compliance requirements for different industries are as follows:

  • Pharmaceutical industry: Compliance with USP <1116> is mandatory.

  • Biotechnology industry: Compliance with ISO 14644-1 and ASTM E3087-17 is recommended.

  • Medical device industry: Compliance with EN 12190:2007 is required.

    • The need for USP <1116> Microbiological Control of Clean Rooms and Controlled Environments testing arises from the importance of ensuring product safety, quality, and reliability. This testing is essential for industries that manufacture pharmaceuticals, biotechnology products, and medical devices.

    Business and Technical Reasons for Conducting Testing

    Conducting this testing provides several benefits, including:

  • Ensuring product safety and quality

  • Meeting regulatory requirements

  • Reducing the risk of contamination

  • Improving customer confidence and trust

    • Consequences of Not Performing This Test

    Not performing this test can lead to severe consequences, including:

  • Product contamination

  • Regulatory non-compliance

  • Loss of customer confidence and trust

  • Financial losses due to product recalls or destruction

    • Industries and Sectors that Require This Testing

    The following industries and sectors require this testing:

  • Pharmaceutical industry

  • Biotechnology industry

  • Medical device industry

    • Risk Factors and Safety Implications

    The risk factors associated with not performing this test include:

  • Product contamination

  • Regulatory non-compliance

  • Loss of customer confidence and trust

  • Financial losses due to product recalls or destruction

    • Quality Assurance and Quality Control Aspects

    This testing ensures quality assurance and control by providing a comprehensive evaluation of the microbiological control of clean rooms and controlled environments.

    The USP <1116> Microbiological Control of Clean Rooms and Controlled Environments testing involves several steps, including:

  • Sample collection

  • Sample preparation

  • Testing parameters and conditions

  • Measurement and analysis methods

  • Calibration and validation procedures

  • Quality control measures during testing

    • Equipment and Instruments Used

    The equipment and instruments used for this testing include:

  • Air sampling pumps

  • Microbiological culture media

  • Incubators

  • Microscopes

    • Testing Environment Requirements

    The testing environment requirements include:

  • Temperature: 20C 2C

  • Humidity: 50 10

  • Pressure: 1013 mbar 5

    • Sample Preparation Procedures

    The sample preparation procedures involve:

  • Collection of air samples using air sampling pumps

  • Transfer of samples to microbiological culture media

    • Testing Parameters and Conditions

    The testing parameters and conditions include:

  • Air cleanliness classification

  • Microbiological contamination levels

    • Measurement and Analysis Methods

    The measurement and analysis methods used for this testing include:

  • Culture-based methods

  • Molecular biology-based methods

    • Calibration and Validation Procedures

    The calibration and validation procedures involve:

  • Calibration of equipment and instruments

  • Validation of testing protocols

    • Quality Control Measures During Testing

    The quality control measures during testing include:

  • Use of certified reference materials

  • Use of validated testing protocols

    • Persuasive Writing Skills to Convince the Reader

    In conclusion, USP <1116> Microbiological Control of Clean Rooms and Controlled Environments testing is essential for industries that manufacture pharmaceuticals, biotechnology products, and medical devices. This testing ensures product safety, quality, and reliability by providing a comprehensive evaluation of the microbiological control of clean rooms and controlled environments.

    By performing this testing, organizations can ensure compliance with regulatory requirements, reduce the risk of contamination, and improve customer confidence and trust. Therefore, it is recommended that all industries that manufacture pharmaceuticals, biotechnology products, and medical devices conduct USP <1116> Microbiological Control of Clean Rooms and Controlled Environments testing.

    Final Thoughts

    In conclusion, USP <1116> Microbiological Control of Clean Rooms and Controlled Environments testing is a critical component of quality assurance and control in industries that manufacture pharmaceuticals, biotechnology products, and medical devices. By understanding the importance of this testing and its requirements, organizations can ensure product safety, quality, and reliability.

    It is essential to note that the information provided in this guide is for general informational purposes only and should not be considered as professional advice. For specific guidance on USP <1116> Microbiological Control of Clean Rooms and Controlled Environments testing, it is recommended that organizations consult with a qualified expert or regulatory agency.

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