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.
Decreased capital costs for hard equipment...