USP Compounding Cleanrooms

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USP Compounding Cleanroom Design Details

BioSafe: Pre-Fabricated Cleanroom Parts

How can Terra offer industry-leading lead times and pricing? Our advanced cleanroom design doesn’t require factory pre-assembly; each components fits together perfectly, ensuring seamless on-site installation

Long Running FFU Motors

Terra’s filter fan unit motors are rated for 5 years of continuous, 24/7 operation, if the HEPA filters are consistently replaced. To accurately monitor your HEPA filter’s saturation levels, purchase Terra’s audible and visual filter replacement alarm system.

Smooth Interior Walls

Smooth steel BioSafe cleanroom panels with radius corners simplify cleaning and stand up to biocides and disinfectants. Cleanrooms constructed with medical-grade and USP-compliant material.

Sterile Buffer Room

Swing door separates ISO 7 Buffer room from ISO 8 Anteroom; ceiling HEPA fan/filters meet USP particle and pressure differential requirements.

LED Light Panels

Energy-efficient LED lights provide bright lighting without generating excessive heat inside the cleanroom.

Containment Exhaust Plenum

Negative-pressure containment cleanrooms include exhaust plenums that route air to floor- or ceiling-mount fans, protecting the external environment from hazardous materials inside the cleanroom.

Framed Double-Flush Cleanroom Window for Pharmaceutical Compounding Rooms

Dual-pane window sits flush with wall surface, design is free of cracks and crevices where contaminants can aggregate. Design meets USP and medical-grade requirements.

Available Environmental Control System

Standard cleanroom comes with analog pressure gauge and on/off controls; optional touchscreen FFU controller monitors, controls and logs internal pressure, as well as displaying temperature and RH.

Partitioned Anteroom

Anteroom meets USP pressure and cleanliness requirements while providing a convenient gowning area (shown with optional no-touch hand washer/dryer)

Germicidal UV Lamp Sanitizes Labs, Cleanrooms

UV-C Germicidal Lamp installs on a cleanroom ceiling grid for line-of-sight room disinfection; safety occupancy sensor prevents personnel exposure.

Seismic Safe Cleanroom Design

Terra’s modular cleanrooms are designed with seismic safety in mind. Rigid steel frames and ceiling grids are designed with sufficient factors of safety to provide vertical and lateral strength recommended by professional engineers. Both hardwall and softwall designs can be installed to adhere to local seismic codes. Optional seismic and structural calculations can be drafted and stamped by a licensed PE to help meet municipal permitting requirements.

Highest Standards For Electronic Components

Terra’s electronic components are designed and built to the highest standards required by defense and semiconductor industries for long-term reliability and protection against damage, injuries, and electrical hazards.

4,000 Worldwide Cleanrooms

Since 1976, Terra has designed and manufactured over 4,000 cleanrooms for companies at the leading edge of high technology

Complete Order Transparency

Using Terra’s OnTrak system, our customers can view real-time production updates, receive shipment notifications and track their orders until they arrive at their facility

Comprehensive Service Provider

Terra’s portfolio of services includes white glove delivery, product installation, equipment certification, validation documentation, cleaning and disinfection services, engineering consultation, and structural seismic analysis

Pre-Engineered USP-Compliant Cleanrooms

  • USP 797 BioSafe Stainless Steel Clean Room USP 797 BioSafe Stainless Steel Clean Room
  • USP 797 Hardwall Cleanroom USP 797 Hardwall Cleanroom
  • USP 800 BioSafe Cleanroom for Hazardous Drug Compounding USP 800 BioSafe Cleanroom for Hazardous Drug Compounding
  • USP 800 BioSafe Cleanroom, Stainless Steel USP 800 BioSafe Cleanroom, Stainless Steel
  • Custom USP 797 BioSafe Cleanroom Custom USP 797 BioSafe Cleanroom
  • BioSafe USP 795 Compounding Clean Room USP-795 Compounding Cleanroom
  • Terra Universal IQ-OQ Process
Technical Resources

Tips for Passing ISO, cGMP, FDA and Other Certifications

Know your ISO requirement
Modular Cleanroom Clean Zones 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
Modular Cleanroom Ceiling Grid 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
USP 800 BioSafe Cleanroom, Custom Floor Plan 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
Hardwall Cleanroom Environmental Control System 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.

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