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Benefits of Single Use Technology in Commercial Filling Operations
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•White Paper: Benefits of Single Use Technology in Commercial Filling Operations
Product Path Considerations
Typical filling equipment has a product path constructed primarily of stainless steel. Operation of hard systems requires cleaning and sterilization operations. The product path needs to be disassembled for offline cleaning and autoclaving of product contact parts. This is a highly labor intensive operation that reduces the life of parts due to wear and breakage. System disassembly also increases the chance of leakage and subsequent product contamination when piping is misaligned or connections loosened. Online, automated CIP and SIP operations can be used to supplement or replace manual cleaning. However, CIP and SIP are a drain to utilities and are expensive to operate.
Neither of these processes is necessary with an appropriately designed pre-sterilized, single use system. The product path assembly is attached to the filling system and connects to the product stream via sterile plug-and-use connections. No preparatory steps like cleaning, assembly and disassembly, autoclaving, CIP or SIP are required. Once the fill process is completed, the product path assembly is removed. The presterilized assembly can be replaced as needed before or during the filling process, thus reducing the impact of leaks or other failures.
Another trend in product filling operations is the need for a non-reactive product path. Certain products react adversely with metallic surfaces. The product potency, efficacy and safety can be negatively affected during the filling operations. A non-metallic product path is required for successful filling operations of certain drugs.
Reduced ExpensesDecreased capital costs for hard equipment, as well as elimination of high-cost process steps like CIP and SIP, are primary drivers for conversion to disposables. The typical product path for filling operations includes a bulk product tank, supply piping, a product surge tank, filter housings, a product manifold, dosing system parts, supply tubing and filling needles. Several sets of product path components are needed to support a filling line. Multi-product filling operations often require dedication of equipment, which adds to the number of sets of equipment on hand. Hard equipment also has a limited useful lifetime due to normal wear, particularly the dosing system parts. The operation of piston pumps, for example, can change over time as they wear or when they are scratched, dropped, or otherwise damaged.
Click Here To Download:•White Paper: Benefits of Single Use Technology in Commercial Filling Operations
