Mobile Pharmacy Cleanroom Trailer

Mobile PHARMACY Cleanrooms

USP800 and USP797 Compliant


MDI Mobile Cleanroom Pharmacy Compounding Labs offer the most technologically advanced design, equipment and material in a portable, mobile unit.  Our Mobile Cleanrooms are a temporary or permanent solution that can be delivered and operational in a short period of time.  

MDI Mobile Cleanroom product offerings:

  • Single-Purpose: We offer a 14’x28’  design which can be engineered as either 1) a USP797 sterile, non-hazardous cleanroom, or 2) a USP800 Hazardous Compounding cleanroom 
  • Dual-purpose: Our dual-purpose cleanroom is a larger 14’x48’ unit which has a single point of entry airlock/workroom connected to a USP797 Sterile Non-Hazardous room on one side and a USP800 Hazardous Compounding room on the opposite side.  


Advantages of an MDI Mobile Cleanroom:  MDI’s Mobile Cleanrooms are the largest in the industry.  Compared to a “trailer” or chassis-based platform which are 8’ wide our units are much wider with a 14’ width throughout either a 30’ length or a 48’ long unit.   The larger width means that MDI’s Mobile Pharmacy Cleanrooms truly meet and exceed the requirements of the  USP Chapter 797 Pharmaceutical Compounding-Sterile Preparations and USP 800 Chapter for handling hazardous drugs.   Furthermore, we engineer and manufacture our own buildings so we control the production cycle and can manufacture new units as needed.  ​

DESIGN AND ENGINEERING


Control System:  

The MDI Mobile Cleanroom Compounding Pharmacy is controlled by our integrated PLC-based control and monitoring systems. 

  • The system will provide electronic temperature, pressure, and relative humidity monitoring, control, and alarming in all zones. 
  • The system will control, monitor and alarm the process exhaust fan control. 
  • The system will provide refrigerator temperature monitoring and alarms for the refrigerator included with the Cleanroom. 
  • The system will have a 15” diagonal touch-screen display for password-protected access. 
  • The system will provide continuous data logging and trending, as well as external alarms to selected smartphones via text messaging as well as email. Two-way communication will allow CRD personnel to trouble-shoot operations remotely. 
  • The installation will include digital-display manometer gauge/ transmitters that will deliver the signals to the control panel for temperature, relative humidity and temperatures. 
  • Alarms are sent via text and email messaging to CRD offices and selected personnel of end user.
Mobile Cleanroom Passthrough

​Mobile

Cleanrooms

Mobile Cleanroom PLC Control Panel

MDI MOBILE CLEANROOMS

INTERIOR FINISHES:


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.

CUSTOM PASS-THROUGHS: 


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 MDI Mobile Cleanroom will arrive at your facility inspected and fully operational, ready to begin your local certification process. This assures you the shortest time from delivery to start up.  

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. ​​

RELOCATABLE CLEANROOMS

Mobile Cleanroom Trailer

Upgrade to USP 797/800 standards

Mobile Clean Room

(800) 456-3369

RELOCATABLE CLEANROOMS

MEP SYSTEMS:  


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



COMMISSIONING/CERTIFICATION: 


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.



TRAINING:  


MDI will arrange to train the Mobile Cleanroom operators and facility maintenance personnel in understanding all about the mobile cleanrooms and Cleanroom equipment functions.