USP-797 Cleanrooms
USP-797 / USP-800 Cleanroom Compounding Solutions
Modular Pharmacy Cleanrooms Designed for Compliance and Confidence
CleanAir Solutions, Inc. has developed a fully modular cleanroom system tailored to meet the latest USP-797 and USP-800 guidelines for non-hazardous and hazardous sterile compounding. Whether you're designing a new facility or retrofitting an existing pharmacy space, our cleanroom systems deliver turnkey compliance, fast installation, and long-term reliability — all in a modular, scalable format.
MC² Cleanroom System –
Modular. Compliant. Complete.
A proven formula for success!
Our MC² Cleanroom System (Modular Cleanroom × Compliance = MC²) is your "cleanroom-in-a-box" solution for compounding pharmacies. Every element is designed to meet or exceed Board of Pharmacy regulations, USP-797 environmental standards, and USP-800 containment protocols. Because the MC² system has all facility integration built in at the factory, it arrives fully assembled and pre-configured. You simply plug it into a dedicated 20 amp circuit, and you're up and running.*
Classified as capital equipment, the MC² system is budget-friendly and accelerates your time to compliance. No construction delays. No permit headaches. *Patent pending.
Designed to Overcome Real-World Pharmacy Constraints
We understand that pharmacies often need to retrofit compounding spaces within existing buildings — which can present architectural, mechanical, and compliance challenges.
Our modular USP cleanrooms are designed to:
Fit within constrained footprints
Be deployed without major building permits
Meet ISO Class 5 or better at the point of compounding
Include flexible layouts for ante rooms, negative pressure hoods, and segregated hazardous areas
✨ Cleanroom Features
💡 Integrated ISO 5 Primary Engineering Controls (PECs)
Laminar flow hoods and isolators designed for low particle counts at the point of compounding🧼 Wall-to-floor extruded cove base
Features a ¾" continuous radius for easy cleaning and sterile sealing🧰 Modular wall panels with sealed seams
Designed for cleanability and fast reconfiguration💨 Air handling systems
Incorporating HEPA filtration, pressure control, and temperature/humidity conditioning💡 Lighting and utilities
Integrated task lighting, electrical access, ionization emitters, and penetration sleeves🏗️ Optional portable sinks, gowning benches, and pass-throughs
Cost-Effective Compounding Cleanroom Solution Engineered to be modular - When your needs expand, so does the cleanroom!
Engineered for isolation and environmental control with ACT!
The MC² Cleanroom System from CleanAir Solutions, Inc. represents a new era of isolation and environmental control for the pharmaceutical and medical device industries. Engineered with flexibility and compliance in mind, this innovative modular solution makes it easier than ever to meet evolving USP-797 and USP-800 cleanroom standards.
At the core of the system is our Active Channel Technology (ACT) — a two-piece modular frame design that allows the use of insert materials ranging from 1/8" to 3/8" in thickness. This versatile channel system supports a wide selection of cleanroom-grade panels, including:
ABS (Acrylonitrile Butadiene Styrene)
Polycarbonate
Aluminum Composite
Acrylic
Tempered Glass
ACT allows for seamless integration of your chosen materials, delivering maximum adaptability while maintaining a flush-mount, cleanable interior—ideal for sterile environments requiring precision and particle control.
MC² Sterile USP-797 Modular Cleanroom
USP-797 Sterile Cleanroom
The MC² Cleanroom System can be configured with a wide range of modular wall panel inserts, including ABS, polycarbonate, aluminum composite, acrylic, tempered glass, or other cleanroom-rated materials — all selected to meet the specific requirements of USP-797 and USP-800 compliant pharmacy environments.
Smooth, easy-to-clean surfaces support sterile workflows required for pharmaceutical compounding, medical device manufacturing, assembly, and packaging.
Ideal for cleanroom classifications from ISO Class 8 (Class 100,000) to ISO Class 4 (Class 10).
The MC² modular cleanroom is available with an integrated cleanroom ceiling system and arrives in factory-assembled modules for fast, efficient installation.
All structural hardware is accessible from the exterior and fully sealed, delivering both cleanability and a professional, high-integrity appearance.
Flexible design options allow for either single-pass airflow or a recirculating configuration using air-chase walls and a ceiling plenum.
Frequently Asked Questions (FAQs)
Q: Is your cleanroom system compliant with my state’s Board of Pharmacy requirements?
A: Yes. Our MC² modular cleanroom systems are engineered to meet USP-797 and USP-800 standards, and we work directly with your architect or compliance officer to ensure local and state Board of Pharmacy guidelines are addressed.
Q: Can I install this cleanroom in an existing pharmacy without major renovation?
A: Absolutely. Our modular systems are designed to be self-contained and can be installed without altering existing building infrastructure.
Q: What ISO classification can your system support?
A: We provide cleanroom environments up to ISO Class 5 (Class 100) at the point of compounding, with configurations that include ISO 7 and ISO 8 ante and buffer zones.
Q: Can you help with airflow validation and certification?
A: Yes. We offer cleanroom testing, commissioning, and validation services to ensure full compliance and certification post-installation.
Ready to Build or Upgrade Your Compounding Cleanroom?
Whether you're a 503A compounding pharmacy upgrading for compliance or launching a new sterile compounding facility, CleanAir’s MC² Cleanroom System offers a fast, flexible, and fully compliant solution.
📥 Download our Pharmacy Cleanroom Selection Sheet
📄 Learn more about USP-800 requirements
📧 For a Needs Analysis Checklist or full product brochure, email:
Sales@CleanRoomSpecialists.com
📞 Or contact us today for a free consultation.
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