Customized HVAC systems engineered to meet the requirements of USP797/800. The airflow in the clean spaces is discharged from ceiling-mounted, terminal HEPA filters with room-side accessible aerosol leak-test challenge ports. Our Mobile Cleanrooms are capable of maintaining proper temperature and relative humidity control regardless of the climate. The mechanical system is designed to provide required ISO classifications with proper air changes to maintain these conditions while in use. Energy recovery coils in the exhaust stream and outside air intake stream are used to precondition the outside air being introduced into the facility. The cooling system consists of multiple air cooled condensing units. The air is also filtered three times before it is introduced into the space. An outside air prefilter, rated at MERV 7, removes dust and pollens from the airside air. An intermediate filter, rated at MERV 13, removes very small particles suspended in the air stream and HEPA filter/diffuser assemblies provide the ISO rated environment.
One Electrical connection
Plumbing connection for hand-scrub sink and condensation drains
Communication/IT lines pre-installed and wired throughout
MDI will start up all mechanical and filtration systems once all utility connections are made. MDI will leak-test the filters and arrange to have the initial microbial-cleaning completed and prepared for 3rd-party testing and certification. The Mobile Cleanroom compounding Pharmacy will be pre-certified before the 3rd party certification to ensure compliance. The MDI pre-certification includes non-viable particle counts, HEPA filter integrity testing and face velocity readings, pressure calibration, and control panel calibration. MDI guarantees the mobile cleanrooms will receive a full certification pass by the Client provided 3rd party certification company upon initial set up. This guarantee also includes viable air and surface samples that fall within acceptable CFU (Colony Forming Units) counts within the sterile compounding room and the sterile gowning room.
MDI will arrange to train the Mobile Cleanroom operators and facility maintenance personnel in understanding all about the mobile cleanrooms and Cleanroom equipment functions.
Pass-through designs include single- and double-door, through-the-wall pass-throughs, cart pass-throughs, pharmacists’ checking pass-throughs, HEPA-filtered pass-throughs. We can supply refrigerated pass-throughs, conveyor tunnel pass-throughs and air-shower pass-throughs. Pass-through interlock systems range from simple mechanical stops, to prevent simultaneous door opening, to electric, pneumatic and magnetic interlocks. Pass-throughs can be fire-rated for penetrations through rated walls and can be integrated into roll-up security/fire doors.
The new USP 797 and USP 800 standards are coming fast, so many hospitals will have to renovate their current pharmacy cleanrooms. While your compounding pharmacy is being upgraded, one of our portable Mobile Cleanrooms can serve as your interim lab, or as a permanent pharmacy cleanroom alternative.
MDI Offers Mobile Cleanrooms for Rent or Purchase designed to meet USP <797> and USP <800> standards. With a re-locatable mobile cleanroom from MDI, we offer the same capability as a site-built cleanroom a Mobile Compounding lab from MDI can be delivered to your location complete and in much less time than it takes to build on-site. If you need to move the lab, it can easily be relocated to a new site. Choose from our in-stock offering of floorplans, or allow us to design a lab to meet your specific needs. Does your compounding pharmacy need to be updated to meet the new USP 797 or UPS 800 Standards? Based on availability, one of our Mobile cleanrooms can be delivered in less than a week.
DESIGN AND ENGINEERING
The MDI Mobile Cleanroom Compounding Pharmacy is controlled by our integrated PLC-based control and monitoring systems.
Walls: The interior perimeter walls of the Mobile Cleanroom are clad in smooth, gloss-white FRP (fiberglass-reinforced plastic) to provide high-impact, sanitizable surfaces. The 3” thick modular interior partition walls are surfaced on both sides with FRP over fire-rated gypsum board and insulating foam cores. The 4’ wide wall panels are supported by anodized-aluminum posts with integral raceways for electrical and data cabling. Coved FRP wall angle shall be installed to create a coved transition from wall-to-ceiling and a 6” flash cove on the heat welded sheet vinyl flooring will provide a coved transition from wall-to-floor. Any lips remaining and any 90-degree wall-to-wall transitions shall be sealed with Dow 732 100% silicone caulking. Doors: The anodized aluminum-frame single- and double sliding and swing doors are full-glazed with tempered glass panels. Doors can be manual, with hydraulic closers, or hands-free, with proximity triggers. Paired doors are electrically-interlocked and can be modified with security locks, keypads, card and biometric entry control devices.
Ceiling: The Mobile Cleanroom ceilings are composed of white, powder-coated, sealed Flush-Grid LED 2 x 4 cleanroom-grade light fixtures. The dropped ceiling grid is made of FRP, and ceiling tiles are solid, gloss-white FRP, and are mechanically-attached and sealed with a cleanroom-grade 100% silicone caulking (Dow 732).
Flooring: Heat-welded, 6” coved, Armstrong Medintech Diamond 10 Technology sheet vinyl flooring is installed in all spaces except the mechanical room. The mechanical room is clad in conventional VCT flooring over the modular substrate.
Doors: The exterior entry door to the mechanical room and the airlock is powder-coated, insulated steel with wire-glass view window. The door is fully-gasketed and has a deadbolt security lock. The interior doors are full-glazed with anodized aluminum frames and integral, solid-rubber gasketing. Manual doors have push-pull hardware and cleanroom-grade hydraulic closers. The sliding doors at the Non-Sterile Haz Prep Room entry and the Sterile Hazardous Compounding Room Entry and the swing style door at the gowning room entry have hands-free actuators and a breakaway feature for emergency exit. The powered doors are electrically-interlocked and have red/green LED pass/no pass indictors.