• Application: USP 800 (Sterile HD)
• Frame Material: Stainless Steel
• Height: 8'
• Depth: 12'
• Width: 12'
• Overall Dimensions: 12' x 12' x 8'
• Panel Material: 304/316L SS
• Unit of Measure: EA
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Watch Terra's Portable HEPA Filtration System Video Custom USP Stainless Steel BioSafe® Cleanroom for Pharmaceutical Compounding ISO 5 USP 800 Containment Clean Room
This image captures the outer transition area to a cleanroom, equipped with secure stainless steel doors, environmental monitoring systems, and keycard access. The cleanroom's glass windows offer a view into the sterile environment beyond
A clean, sterile room with stainless steel surfaces and a sink workstation, used for laboratory or industrial processes.
A quiet, sterile room with stainless steel surfaces and a large sliding door for controlled entry.
A pass-through chamber located between cleanroom areas, allowing safe material transfer without contaminating sterile spaces
A sterile cleanroom section with a pass-through transfer chamber and refrigerator, likely in a hazardous materials or compounding room
A stainless steel cleanroom entryway showing a glovebox isolator, an emergency stop button, and a motion-sensing door control.
A cleanroom transition area designed for gowning and preparation, featuring stainless steel benches and observation window for controlled access
An airlock or gowning room entry point with a stainless steel door, observation window, and control system for secure access
Negative-pressure containment room is designed for compounding hazardous drugs to USP 800 requirements; ante-room maintains positive pressue to prevent contamination.
The layout of the USP 800 Hardwall cleanroom can be modified to include a negative-pressure storage room adjacent to the Buffer room. A dedicated HD storage room provides a convenient, USP 800-compliant receiving/unpacking area for HD shipments that does not require cleanroom garb. ISO classification is not required for HD storage rooms; air must simply be exhausted at a rate of 12 air changes per hour (ACPH). The storage room exhaust can often be integrated with the Buffer room exhaust for maximum efficiency.
USP 800 also cautions against placing HD refrigerators in the Buffer room, as the refrigerators tend to harbor contaminants and release significant numbers of particles. The designated HD refrigerator can instead be placed inside the HD storage room.
Adding a HEPA-filtered pass-through in the HD storage room allows operators to easily transfer the HD bag into the cleanroom for manipulation. Prior to compounding, operators can pull the necessary items from storage and place them in the pass-through chamber. The HD ingredients can remain in the pass-through, ready for receipt, until the compounder has gone through gowning and finished all other preparations. Following compounding, the final HD product can be safely transferred back into the HD storage room.
According to USP 800, non-sterile HD compounding must also take place within a negative-pressure room that is physically separated from other areas. An exhaust system (directed to the outside of the building) must be used to ventilate the contaminated air and create a slight vacuum (negative-pressure).
The key difference for non-sterile HD compounding is that it does not require HEPA filtered airflow, which can significantly reduce the cost and complexity of building a containment room. Existing HVAC systems can provide fresh air to replace the air removed by the exhaust system.
Because HD contamination can be difficult to clean, non-sterile HD compounding rooms share the same construction features with sterile compounding cleanrooms. Surfaces must be smooth, made of non-shedding materials, and minimize crevices where contamination can collect.
Please contact Terra Universal for quotes regarding USP 800 cleanrooms without the HEPA-filtered FFUs.
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