Speaking on ‘Polymer solutions for drug product manufacturing process’, Rajendra Vidwans, Technical Consultant, Ami Polymer, said that there are two types of curing agents used in silicones – one is peroxide that generates bi-product and the other is platinum that has no bi-product. Regarding peroxide silicone, he also said that there is no risk of potential hazardous peroxide impurities, as it retains higher transparency and has higher shelf life.
“Material of construction and components along with sealing, welding capabilities and validation package should be kept in mind while choosing a tubing,” he said.
Next, he talked about thermoplastic elastomer tubings for tablet coating application and imaliner tubing, which has got a specially formulated inner layer for preservatives resistance. He also talked about FKM tubing for complex injections, wherein corrosive solvents are used for microsphere-based complex injection drug processing and extractable study available limited pump life. Later, he spoke about FEP/PTFE tubing for corrosive fluid transfer. “It is compatible with all corrosive solvents and SIP, and is used for non-pump applications,” he informed.
He further stated that there are over nine colour coding options for product dedicated fluid flow systems and ink-free USP Class-VI-certified silicone-based colour coding. Towards the end of his presentation, Vidwans explained about seamless manifolds such as cable tied manifold and over-molded silicone manifold.
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