- ISO 14644-1: Specifies the maximum allowable concentration of particles in the air and outlines testing and monitoring procedures to ensure air cleanliness in cleanrooms and controlled environments.
- CFR Title 21 Part 211: Outlines the current good manufacturing practice (cGMP) requirements for cell and gene therapies. It covers all aspects of manufacturing, including facility design, equipment validation, and documentation.
- FDA Guidance for Industry - cGMP for Phase 1 Investigational Drugs: This guidance document provides recommendations for the manufacture of investigational drugs for use in Phase 1 clinical trials. It covers topics such as facility design, environmental monitoring, and personnel qualifications.
- USP 797: Requirements for Sterile Compounding. The United States Pharmacopeia (USP) General Chapter 797 provides updated requirements for Sterile Compounding.
- USP 800: Requirements for Sterile Compounding of Hazardous Drugs. The United States Pharmacopeia (USP) General Chapter 800 provides updated requirements for Sterile Compounding of Hazardous Drugs.
It is important to note that these standards and regulations are not exhaustive, and additional guidelines may apply depending on the specific product being manufactured and the regulatory jurisdiction in which it is being produced.
USP 797 / 800 Cleanrooms cleanrooms can be certified by a third party in many ways. Some common options include:
- Particle counting: Measures airborne particle concentration using particle counters.
- Airflow velocity measurement: Measures airflow velocity using an anemometer or similar device.
- Filter Integrity Testing: Ensure there are no pin holes that are compromise the performance of the HEPA filter.
- Smoke studies: Introduces smoke to observe airflow movement and design.
- Pressure differential measurement: Measures pressure differential to ensure proper isolation from outside contamination.
- Microbial sampling: Tests for presence of microorganisms or CFU (Colony Forming Units) to ensure cleanroom is free from viable contamination.
To maintain the standard of this certification, a cleanroom should be checked – at 6 month intervals for ISO 5 and 12 month intervals for ISO 6 and above – using the same or similar methods to the certification process.
- Use of appropriate personal protective equipment (PPE)
- Proper gowning and degowning procedures
- Establishment and maintenance of a cleanroom environment that adheres to standards and regulations
- Implementation of proper cleaning and disinfection procedures
- Adherence to aseptic technique
- Proper handling and storage of materials and equipment
- Proper cleanroom balancing to maintain positive cascading pressure (from the main cleanroom to the anterooms then to the outside)
- Regular monitoring and testing of the cleanroom environment to ensure continued compliance and minimize the risk of contamination.
Our team of experts can help you find the right cleanroom for your needs. Click get started to schedule a call with our team.
ICS is a top-tier cleanroom supplier that specializes in creating intentional and customized designs to meet clients' specific needs within industry-leading timeframes. All our cleanrooms are fully certified by third-party organizations, ensuring the highest standards of cleanliness and quality. With six decades of experience in cleanroom construction, we have won notable awards, including the Department of Energy's Small Business of the Year.