Tips for Passing ISO, cGMP, FDA and Other Certifications
Know your ISO requirement
A Terra product specialist can offer general design advice or make a consultation referral. Regulated industries such as pharmaceutical compounding maintain clear requirements for ISO cleanliness and related cleanroom characteristics. Other operations may require a certification consultant to specify these design requirements based on specific operations being performed.
Either way, make sure you know the applicable performance requirements before you select a room design or cleanliness level.
FFU Ceiling Coverage and Air Change Rate
ISO specifies permissible particle counts for each cleanliness level but not how many fan/filter units are required to meet these target values. Other organizations, including the Institute for Environmental Science, provide recommended ranges for FFU ceiling coverage.
Terra recommends the high value within each range, which in most cases accommodates typical contamination loads presented by personnel and equipment. Modular Power Distribution Modules make it easy to add as requirements change – plug-and-play connections eliminate the need for hard-wiring by an electrician.
Cleanroom Design and Materials
A Terra Product Specialist will advise on the proper panel and other component materials to meet specific requirements for ISO compatibility, sterilization, chemical resistance, static safety, and other environmental concerns.
Environmental Control and Documentation
Adjustable exhaust vents and manual FFU speed controls on all Terra cleanrooms allow regulation of air change rates. For centralized display and control, select low-cost automated FFU speed controls, which also allow remote Building Management System (BMS) fan control and even dynamic fan adjustment in response to programmed pressure levels. Air pressure, temperature, and humidity data are logged for a traceable operating history.
Modular cleanrooms are available with stand-alone air conditioning modules or can be integrated with existing A/C systems. Humidification and De-humidification systems meet specific RH requirements.
To determine if you need a left-hand or right-hand frame, stand on the side of the door where it swings away from you. If it opens to the left, it’s a left-hand door; if it opens to the right, it’s a right-hand door.
Frameless design is as stylish as it is clean! Shown: 47” x 36” BioSafe powder-coated cleanroom window flush-mounted in a BioSafe Cleanroom with FRP finish.
Framed Double-Flush Cleanroom Window
Framed design encases window panes with 304 Stainless Steel frame on the exterior. Glazing is recessed into the frame for a flush surface with the wall to minimize crevices where contaminants can collect.
BioSafe Window Designs
Framed and frameless BioSafe windows are designed without exposed hardware or crevices where microbes can colonize.
Cleanroom Fire-Rated Doors
UL-listed fire-rated door with wired-glass window, shown with optional mortise locking mechanism and hinges installed. SIngle- and double-door designs available.
Fully automated iris scanner for secure, hands-free access (includes datalogging and optional secondary keycard reader).
The flat touch interface is easy to clean and operated by gloved personnel and impervious to moisture; includes emergency stop.
Door and Window Designs
Terra Universal's Biosafe® Windows
Door, Roll Up; Aluminum, 29.5"W x 42"H finished opening, 110V, Installed
Terra's BioSafe windows are configurable to any wall thickness, easy to install and disinfectTerra Universal's Biosafe® WindowsTerra Universal's BioSafe® windows are quick to install, easy to disinfect and configurable to any wall material or thickness.
Allows transport of carts and large equipment into and out of a facilityDoor, Roll Up; Aluminum, 29.5"W x 42"H finished opening, 110V, InstalledAllows transport of carts and large equipment into and out of a facility.
Multi-room configurations with automated FFU controls automate compliance with ISO standards for cascading pressure gradientsHardwall Modular Cleanroom – Multi-Room ConfigurationMulti-room configurations with automated FFU controls automate compliance with ISO standards for cascading pressure gradients and particle counts.
Cleanroom Roll-Up Door Pass-Through Chambers include interlocked doors for transfer of carts, bulky equipment | 6705-31C displayedRoll-Up Door Pass-Through ChambersCleanroom Roll-Up Door Pass-Throughs with electronically interlocked aluminum doors allow transfer of large equipment without cross-contamination; a sensor detects obstructions and halts motion to prevent injury or damage.
High-speed roll-up doors are ideal for moving carts and large equipment into a cleanroom | 6710-53A displayedHigh-Speed Roll-Up DoorHigh-speed roll-up doors are ideal for moving carts and large equipment into a cleanroom; their fast operation minimizes the chance of cross-contamination between two areas.