By Dec Group
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Dec Group White Paper on significance of aseptic and isolated Dual Chamber Syringe Filling
Dec Group, the leading global provider of contained material handling and processing systems, has produced a White Paper guide on the rapidly growing Dual Chamber Syringe (DCS) market and its technological solutions.
The White Paper Dual Chamber Syringe Filling Inside an Aseptic Isolator explores the advantages of DCS technology, manufacturing challenges and how these can be overcome using Dec’s highly adaptable aseptic filling line solution, DecFill®.
The paper explores main drivers of the increasing uptake of DCS, including introduction of advanced isolated filling technologies, increasing demand for lyophilized drugs and high investment in biopharma clinical research emphasizing binary drug delivery systems.
Challenges in DCS production
It shows that main challenges in DCS production include maintaining sterility across the entire filling process to meet demand for pre-sterilized products such as Ready-to-Use (RTU) and Ready-to-Fill (RTF), with consequent technological demands on DCS filling lines. It also discusses implications of the cGMP Annex 1 “Manufacture of Sterile Medicinal Products” that impose changes in Contamination Control Strategy (CCS) to ensure no cross contamination in preparation of the filling, emphasizing need for RABS, isolators or other high containment systems as well as robotic and automation processes.
The White Paper shows how the DecFill® aseptic filling line is the final fully integrated step of an end-to-end solution from the raw material handling to the final aseptic packaging processes, all configurable to accommodate various containers such as RTUs/RTFs, vials, cartridges, syringes, dual chamber systems and multi-container solutions in the same process line all fully cGMP compliant with the revised Annex 1 . It also explains how Dec’s patented BoMa™ technology can transfer simple and complex liquids at any scale with very high installation versatility.
Resource
Click on Dec White Paper: Dual Chamber Syringe Filling Inside an Aseptic Isolator for access to the full White Paper.
Dual chamber syringes combine powdered drug formulation and diluent in one primary package. Pushing on the plunger forces liquid into the chamber housing the drug substance, mixing the dose in the syringe for simplified administration and longer shelf life.
The global market for prefilled dual chamber syringes is expected to show compound annual growth of almost 8% over the coming decade, driven by development of advanced isolation technologies, increasing demand for lyophilized drug products, and increased investment in biopharmaceutical R&D.
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