- 304-grade stainless steel construction is resistant to corrosion, stands up to disinfectants
- Will not produce contaminants during sterilization
- Reduces bio-burden in compounding spaces
• 304-grade stainless steel construction is resistant to corrosion, stands up to disinfectants
• Will not produce contaminants during sterilization
• Reduces bio-burden in compounding spaces
• Free-standing 304 stainless steel structure meets the requirements of USP 800 for negative-pressure containment in hazardous-drug compounding
• Includes exhaust plenum with flanges for connection to the customer-furnished ventilation system capable of drawing out air introduced by the fan/filter units
• Standard layout features a negative-pressure Buffer room (ISO 7 or 5, depending on requirement) and a positive-pressure ISO 7 Anteroom
• Environmental Control System (included) monitors fan/filter units via 3.5" color touchscreen interface for easy air balancing; includes pressure and temperature sensors
• Stainless steel double-wall insulated panels with covered corners product a smooth, easy-clean interior; allow flush-mounting of power outlets
• Exceeds USP cleanliness and aseptic requirements
• Wall structure bolts together and panels snap in place, simplifying installation
• Verify before you buy: Consultation services available to ensure evaluate compliance with USP, cGMP, DQSA and other regulations
• Wall panels can be sealed with silicone caulking to eliminate all cracks and simplify disinfection
• Heavy-duty steel ceiling grid is fully supported by the wall structure; holds HEPA-filtered fan units and LED light panels without need for external bracing
• Specialized pass-throughs can be included for transfer of finished products, minimizing disruptions in your workflow
• Features available for logging and storing room pressures and temperature
• Pressure sensor included in each room
• Individual variable control over all Fan/Filter Units to achieve target flow and pressure levels
• Clock-calendar control of energy-saving setback mode
• Standard configurations are available at affordable prices, or specify custom sizes to fit unique facility requirements; call for a custom quote!
• Standard turnkey configurations include RSR HEPA fan/filter units, LED light panels, duplex outlets, ante-/buffer room panels and ceiling grid; installed on site
• These BioSafe® compounding cleanrooms are designed to the requirements of USP 800 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 suitability for your application
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.
Call or submit a QuickQuote Form for assistance with a modular cleanroom tailor-made to your application!