1. Cleanliness and Sterilization: The non-porous platinum-cured silicone provides an ideal surface for use in cleanrooms because it is impermeable to biofilm. No residue can be trapped within the silicone surface, and the potential for aggressive cleaning (CIP/SIP) using even the most aggressive cleaning agents (e.g., alcohols, peroxides, bleaches) and the potential to high-pressure wash down is an irrelevant concern due to the structure of the material. Most importantly, there is no degradation through repeated steam sterilization catheterization (e.g., autoclaving) and all other methods of sterilization (e.g., VHP, gamma), a key feature for aseptic processes, assuring consistency of delivery to product. Further, its extremely low out-gassing has minimum risk that volatile contaminants can fall into sensitive product under vacuum decreasing contamination of valuable or sensitive products through releasing more volatile contamination concerns from systems demonstrated sensitivity to sub-perceptual volatilization levels in the vacuum systems.
2. Superior Temperature Uniformity: The heating elements are high-accuracy etched metal foils integrated into the silicone sheet which assures that every heater surface area is heat balanced at the same watt distribution and density. Somewhat unique to the heater design is the highly flexible laminated nature, allowing it to completely conform to the freeze dryer shelf (i.e., eliminating insulating air pockets). This
3. Regulatory Documentation & Compliance: Respected manufacturers provide complete documentation as validation, to support safety requirements within pharmaceutical construction in the environment. They supplied material certifications (USP Class VI biocompatibility), RoHS/REACH documentation, electrical safety certification (UL, CE), complete traceability. Documentation of state of the art certification and validation will always be critically important for regulatory requirements ie. FDA (21 CFR Part 11), EMA GMP, and other private and public worldwide monetary authority.
4. Durability & Safety: Silicone elastomers are chemically inert and will not crack, age, or penetrate from extreme thermal cycling (from cryogenic freezing to high sterilization temps), and will also not diffusion / permeation or chemical breakdown. This means that that downtime will be less impactful and years of service will be based on a acceptable cost life time; if not incurring damage. Other built in safety features such as:for electrical safety in expected environments requiring higher electrical safety standard; double insulated, or grounded planes/braids; and low leakage current.
