Production Freeze Dryers Meet 21 CFR Part 11 Requirements
Line of production freeze dryers meets the rigid criteria of the FDA’s 21CFR Part 11 regulation and GMP’s. Systems are available with options for sterile processing and offer a broad range of control features. All systems include a radiant heat plate above the top shelf for uniform drying on all shelves. For pharmaceutical/biotech applications, all internal surfaces are constructed of 316L stainless steel and offer a polish of 20 Ra or better. For the fastest drying rates either an internal condenser or an external condenser with the optimum sized vapor port is supplied. Depending on the application, either a coil or plate style condenser is used. Hot water, hot gas or steam defrosts the condenser when drying is complete. Fluid filled hollow shelves with a serpentine fluid path provide the most uniform shelf temperature possible and results in consistent and repeatable drying. All units come with product trays, either a removable bottom or bulk. For processing vials, hydraulic stoppering is provided for maximum stoppering power.
