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PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the January 2012 edition from ACS Valves and Terra Universal.
Rotary airlock valves for regulatory compliance
ACS Valves’s Quick-Clean series of rotary airlock valves is designed to aid users in achieving compliance with regulatory standards. The valves feature the ACS RotorRail design that enables full validation access to the rotor and all internal surfaces of the housing without requiring disassembly of the endplate. The stainless-steel housings are machined to precise tolerances. Internal surfaces are polished to a No. 4 finish, and the ACS Valves’s clean-in-place-ready design eliminates internal crevices and joints, where contaminants can accumulate.
The valves’ inlet–outlet seal is produced with an eight-vane rotor design, which eliminates excess pressure loss through the system, ensures cost-efficient upstream- and downstream-material management, and reduces process energy consumption. The valves are available in 304 or 316 stainless steel, and in sizes from 6 to 16 in. with pressure differentials as high as 15 psig and temperature tolerance as high as 500 °F.
Compounding cleanrooms comply with USP <797>
Terra Universal’s compounding cleanrooms are suitable for compounding sterile injectables and other preparations in accordance with US Pharmacopeia <797> standards. An ISO 5 (Class 100) primary processing area with three high-efficiency particulate air filter–fan units provides a total of 1950 cfm (3315 m3/h) of 99.99% particle-free air (measured at 0.3 µm diameter).
The cleanrooms’ fan–filter units exceed USP <797> particle-count and air-change requirements between the buffer room and the antechamber room. Users have a choice of polycarbonate and static-dissipative polyvinyl chloride panels. A powder-coated steel support frame creates a rigid, durable structure that requires no external bracing or ceiling support. The unit’s sliding vinyl curtain creates a separate antechamber that offers another level of protection to the buffer room from the ambient environment. The antechamber is also under positive pressure, and personnel can don garb or prepare materials, thus leaving the buffer room strictly for needed equipment.