Terra manufactures USP-compliant cleanrooms that meet requirements for sterile drug compounding (USP-797) and both sterile and non-sterile hazardous-drug compounding (USP-800). Turnkey rooms are designed for efficient ordering and operation; contact a Terra Product Specialist for custom floorplans.
Hardwall pharmacy compounding rooms feature HEPA-filtered ante-chambers and buffer rooms made of polypropylene, a durable material that resists damage from sterilizing agents such as IPA. BioSafe® hardwall rooms are manufactured using double-wall, insulated stainless steel, featuring radius corners to simplify cleaning and reduce sites that may harbor contaminates.
503A Traditional Compounding Pharmacies and 503B Outsourcing Facilities: Optimize Your Compounding Cleanroom for FDA Inspections
As a result of the 2013 Drug Quality and Security Act (DQSA), all traditional compounding pharmacies and outsourcing facilities are subject to FDA oversight. Since enactment, the FDA has taken aggressive steps to strengthen enforcement and implement stricter standards for sterile compounding. Any “insanitary conditions” are in direct violation of Sections 501(a)(1) and (a)(2)(A) of the FD&C Act (Title 21 CFR), which gives the FDA inspectors broad discretion for determining what constitutes sterile conditions.
Because adverse events and sterility test failures are a surefire way to attract the undivided attention of the FDA and State Board of Pharmacy, experts in the field of pharmaceutical compounding strongly recommend using an ISO 5 cleanroom to substantially lower the bioburden of the cleanroom environment and restrict the number of colony-forming units (CFUs) introduced into the critical areas.
Specify the following for compliance with cGMP requirements:
1 additional FFU in the Buffer Room
1 additional FFU in the Ante-Room
Tier II Environmental Control System
Please contact us to add these options to your compounding cleanroom.
Clean Rooms Optimized For Outsourcing Facilities (Section 503B)
The FDA enforces standards for outsourcing facilities referred to as Current Good Manufacturing Practices (CGMPs), which are a strict set of quality assurance requirements intended to prevent potentially deadly contamination of CSPs. All 503B compounding pharmacies must comply with CGMP standards (21 CFR Parts 210 and 211) and will be inspected by the FDA upon registration. In addition to satisfying quality assurance requirements, the FDA also expects all pharmaceutical compounders to comply with national industry standards (i.e. USP 797 and 800). Outsourcing facilities must also comply with any applicable state regulations, including licensing requirements.
In order to best ensure compliance with CGMP standards, experts in the field of pharmaceutical compounding strongly recommend using an ISO 5 cleanroom to substantially lower the bioburden of the cleanroom environment and restrict the number of colony-forming units (CFUs) introduced into the critical areas. A "cleaner" compounding cleanroom will help prevent sterility test failures (e.g. viable air sampling and fingertip sampling) and avoid additional scrutiny from the FDA and State Boards of Pharmacy.
Terra's designs reflect these recommendations for non-sterile-to-sterile (high-risk) compounding and for outsourced compounding operations.
These BioSafe® compounding cleanrooms are designed to the requirements of USP 797 as published in USP 40-NF 35. However, because practice standards vary from state to state and depend on compounding operations, Terra recommends consultation with our compounding experts to evaluate suitable for your application.
A USP compounding cleanroom is a pressure-controlled environment for compounding, packaging, and preparing sterile and non-sterile drugs. Sterile preparations such as injectables and IV bags require aseptic workflows and positive pressure rooms to isolate biologically sensitive compounds from contaminated surfaces, air, or personnel. Facility and engineering controls are carefully designed to prevent airborne contaminants, enable easily cleanable conditions, and optimize the placement and movement of both people and products.
For FDA accredited facilities, Terra's All-Steel Pharmaceutical Cleanrooms include double-wall, all-steel, gapless panels that minimize cracks, gaps, and crevices where germs collect and colonize. The standalone system includes UL-listed fan filter units, lights, windows, doors, and a power control system with night service mode for easy permitting and repeatable installation. Additional options include BioSafe doors and smart-enabled configurations for data logging, remote air balancing, and complete automation and monitoring via MODBUS® integration. Upgrade to room-side-replaceable (RSR) fan filter units for faster filter swapping and installation; RSR fan filters do not require ceiling access or removal from the ceiling grid.
USP 797 BioSafe® All-Steel Cleanrooms offer the ultimate aseptic cleanroom suite for compounding, packaging, and sterile preparations. Terra's cleanrooms include an ISO-rated anteroom for support tasks. Fully furnished turnkey cleanroom packages are available with a wide selection of pass-throughs, benches, laminar flow hoods, and laboratory equipment.
USP 800 BioSafe® All-Steel Cleanrooms provide outstanding operator protection for hazardous environments and precise maintenance of room-to-room pressure cascades. Negative-pressure plenums and exhaust fans accommodate USP 800 hazardous materials.
USP 797 and USP 800 Hardwall Cleanrooms provide an economical alternative to fixed-installation cleanrooms while providing the rigidity and durability of a freestanding room. Lightweight polypropylene or acrylic cleanroom panels are cost-effective and easier to install than stainless steel.
For those who require assistance with cleanroom design and installation services, Terra Universal provides in-house engineering, application support, equipment outfitting, and a network of trusted installers from a single point of contact. Call or submit a QuickQuote Form for assistance with a modular cleanroom tailor-made to your application!
ISO 7 buffer room is physically separated from ISO 8 anteroom and protected by cascading positive-pressure levels; internal partition with two-way swing door allows for gowning and hand-washing prior to entering the buffer room
USP 800 (Sterile HD)
Negative-pressure, ISO 7 buffer room ventilates cleanroom air through exhaust system; buffer room is isolated by adjacent ISO 7 positive-pressure anteroom; Tier II Environmental Control System allows enhanced control of FFUs, simplifies pressure balancing, and provides traceable environmental history
Terra’s modular designs allow versatile configurations using standard components, whether you need a small compounding enclosure or a multi-suite processing facility (shown: Stainless steel USP 800 multi-room hazardous materials cleanroom with plastic hardwall ISO 8 transition room)
Versatile plug-and-play Power Distribution Modules allow addition of ceiling fan/filter units and lights to meet any cleanliness requirement or to upgrade ISO levels or lighting levels after installation
Modular frame and panel designs, in several application-specific materials, adapt to any floor plan requirement
Automated fan controls simplify pressure balancing, Building Management System (BMS) integration, and certification of large, multi-suite facilities
Stand-alone A/C modules or integration with existing air handling system
Consultation services available to meet USP 797 and 800 and FDA/cGMP requirements
Terra’s full engineering services adapt designs to accommodate unique equipment or facility integration challenges
Call or submit a QuickQuote Form for assistance with a modular cleanroom tailor-made to your application!
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.
Anteroom meets USP pressure and cleanliness requirements while providing a convenient gowning area (shown with optional no-touch hand washer/dryer)
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 Hardwall Cleanroom
USP 800 BioSafe Cleanroom for Hazardous Drug Compounding
USP 800 BioSafe Cleanroom, Stainless Steel
Custom USP 797 BioSafe Cleanroom
USP-795 Compounding Cleanroom
Terra Universal IQ-OQ Process
USP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer roomUSP 797 BioSafe Stainless Steel Clean RoomUSP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer room (floor not included); shown with optional hand cleaner, biosafety cabinet.
USP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer roomUSP 797 Hardwall CleanroomUSP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer room (floor not included); shown with optional hand cleaner, laminar flow hood.
USP 800 BioSafe Cleanroom for bio-hazard containment | 2899-06-SS displayedUSP 800 BioSafe Cleanroom for Hazardous Drug CompoundingUSP 800 BioSafe Cleanroom for bio-hazard containment includes ISO 8 ante-room, ISO 7 buffer room; optional hand cleaner, biosafety cabinet, flooring.
USP 800 BioSafe cleanroom with ISO 8 ante-room, ISO 5 compounding and containment suitesUSP 800 BioSafe Cleanroom, Stainless SteelUSP 800 BioSafe cleanroom with ISO 8 ante-room, ISO 5 compounding suites and negative-pressure containment suite, surrounded by a standard hardwall cleanroom frame for enhanced biohazard containment
BioSafe cleanrooms blend in with facility constructionCustom USP 797 BioSafe CleanroomBioSafe cleanrooms blend in with facility construction and can tie to existing A/C and other utilities.
Several modular cleanroom styles meet USP-795 requirements for non-sterile compoundingUSP-795 Compounding CleanroomSeveral modular designs meet USP-795 requirements for non-sterile compounding; shown: ISO 8 BioSafe cleanroom with FRP wall panels
This video describes the IQ/OQ process for Equipment and CleanroomsTerra Universal IQ-OQ ProcessThis video describes the IQ/OQ process for Equipment and Cleanrooms
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.
Compounding pharmacists face a challenging regulatory environment that is rapidly evolving as state standards move into compliance with FDA and USP mandates. Because licensing and accreditation procedures differ from state to state and from year to year, it’s important to work with an equipment supplier that understands these complexities.
When you work with Terra Universal, you work with Chris Munoz, PharmD, a leader in the field of pharmaceutical compounding. Dr. Munoz is available for one-hour consultative meetings to help facilities understand the impact of the USP regulations on their business.
Dr. Munoz teaches pharmacy compounding at the University of Southern California (USC) School of Pharmacy, and serves on the California Pharmacists Association's Policy Committee and Board of Directors. Following Chris's earlier work in compounding pharmacies and for pharmaceutical companies, he began a consulting ﬁrm specializing in the business of, and regulatory affairs for, pharmacy compounding.
Chris is an active member of the International Academy of Compounding Pharmacists. He earned his Doctor of Pharmacy degree at the University of Southern California, and his Masters of Business Administration at Chapman University's George L. Argyros School of Business and Economics.
Call or email Terra Universal for Dr. Munoz’s expert assistance in the selection of cleanrooms, isolators, laminar flow cabinets and other equipment appropriate to your process and certification requirements.
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