• Application: USP 800 (Sterile HD)
• Frame Material: Stainless Steel
• Height: 8'
• Depth: 10'
• Width: 12'
• Overall Dimensions: 12' x 10' x 8'
• Panel Material: 304 Stainless Steel
• Unit of Measure: EA
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• Containment Room Dimensions: 8'W x 10'D x 8'H (2438 x 3048 x 2438 mm)
• Ante-room Dimensions: 4'W x 10'D x 8'H (1219 x 3048 x 2438mm)
• ISO 7 Compounding room with ISO 7 Anteroom
• Materials: Double-wall, insulated 304 Stainless Steel panels with radius corners provide clean, ISO 5-compatible interior surfaces that are easy to clean and sterilize
• Control panel includes Night Setting switch, to conserve power when room is not in operation
• Requires connection to in-house exhaust ventilation fan (not included); minimum required exhaust - 2730 CFM
• Negative pressure containment system meets requirements USP800 for hazardous drug compounding
• Meets USP compliance with Environmental Control System, which monitors room pressures, temperature and humidity
• Containment system ensures safe handling of hazardous drugs in conformance with USP 800
• Compounding rooms meet ISO 7 particle requirements, in accordance with USP 797 and USP 800
• Request UL Listing Declaration (order separately) for cleanroom electrical system, which helps meet municipal and other permitting requirements that may apply
• Compliance Notice: this clean room is built to the specifications 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 to evaluate suitability for your application
• Includes:
• (1) Duplex Outlet
• (4) 2' x 4' Room Side Replaceable HEPA Fan Filter Units
• (4) LED Light panels and polypropylene ceiling panels in remaining ceiling bays
• (2) Stainless Steel swing doors with partial view windows
• (1) Tempered glass viewing window per compounding room
• (1) Negative pressure exhaust plenum to ensure hazardous drug containment
• FDA-approved silicone sealant for caulking internal seams
• Application: USP 800 (Sterile HD)
• Frame Material: Stainless Steel
• Height: 8'
• Depth: 10'
• Width: 12'
• Overall Dimensions: 12' x 10' x 8'
• Panel Material: 304 Stainless Steel
• Unit of Measure: EA
• Marks & Listings: UL, ULC
• Electrical Specifications: 120 V, 50 A, 1 Ph, 60 Hz
• Weight, Shipping: 1,450 lb
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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* Terra's FasTrak services limited guarantee: to ship on the ESD or date specified OR to refund up to 100% of FasTrak charges. This guarantee covers no direct, special, consequential or other damages and is strictly limited to up to 100% of the amount paid for FasTrak service. When a specified ship date is missed due to factors outside Terra's control (vendor performance, deliveries by shipping companies, etc.) and random factors such as accidents, the credit of up to 100% of the FasTrak 24/7 may not apply. FasTrak service requested after order placement will be quoted and accepted based on available time remaining before required ship date.
