USP 797 / 800 Cleanrooms
Our rapidly deployable cleanrooms are built to meet USP 797 and 800 requirements for sterile drug compounding of both hazardous and non-hazardous drugs. With the compliance deadline fast approaching, our mobile cleanrooms can be parked in your parking lot to ensure turnkey compliance while we renovate your existing pharmacy to meet current standards.
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Mobile Cleanrooms Built Within a 53' Semi-Trailer
Our innovative mobile 797/800 compliant cleanrooms are built within a 53-foot semi-trailer, allowing for rapid and turnkey deployment. These rooms are certified to ISO 7 (Class 10,000) and can be easily equipped with a Class II Type A2 Biological Safety Cabinet and a pass-through. Our cleanrooms are designed to meet even the most demanding schedules with ease.
- Ship, Plug-in, and Certify
- USP 797/800 Compliant
- Temperature and Humidity Control
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Custom Sterile Compounding Cleanroom Renovations
With over 50 years of experience in building cleanrooms, our in-house design, construction, and quality teams will work directly with you to customize your cleanroom—both on time and within budget. Operating in all 50 states, we can build your cleanroom in a fraction of the standard industry lead time. Instant Cleanroom Solutions is a trusted supplier for hospitals across the country.
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Standards, Certifications, and Control Measures
- 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.
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Expert Cleanroom Design and Installation
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.