PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the June 2011 edition from Meissner and Telstar.
Filter system reduces cleaning requirements
Meissner’s inline UltraCap H.D. assembly is a ready-to-use, integrally sealed filter and housing system. The system’s filter element is welded into a disposable polypropylene housing unit to form an assembly without O-rings. The assembly’s absence of O-ring materials and its construction from natural polypropylene material help reduce extractables and leachables.
The UltraCap H.D. assembly is completely disposable, thus reducing cleaning and cleaning validation costs and enabling faster and more convenient change-outs than traditional cartridge and filter housing systems. In addition, the inline capsule filter was designed to withstand higher temperatures and operating pressures than conventional high-capacity capsule filters. The unit’s inline flow configuration is intended to provide high flow rates by reducing housing pressure loss.
The UltraCap H.D. filter is available in lengths from 10 to 50 in. and pore sizes ranging from 0.04 through 99 µm. Users can choose the new inline version or the existing T-style version of the system depending on their requirements.
System loads and unloads lyophilized vials
Telstar’s new automatic vial-loading and -unloading system operates under aseptic conditions and is compatible with conventional cleanroom and barrier technologies. The vial-loading technology incorporates mechanisms driven by a set of three flexible, curved steel bands that make it compact and easy to clean. The entire system is situated outside the lyophilizer when not in active use. The lateral curvature of the bands gives them high stiffness, which reduces requirements for guidance and makes system elements accessible for cleaning.
The system can be configured in a pass-through layout that makes it possible to segregate loading and unloading in areas in terms of aseptic classification and degree of operator protection. The system integrates easily with isolators designed to separate operators from toxic chemicals. Under isolated conditions, operators can access all working areas easily and safely using gloves for activities such as changes of format and sampling.