The following five points provide a glimpse into the West strategy as it pertains to assessing steam sterilizable packaging, such as the STERILIZABLEBAG™ packaging system commonly used for Westar® and NovaPure® components.
- End-Use Functionality: Sterilizable packaging must withstand the filling, heat sealing, sterilizing, packing/cartoning, shipping, and end-use handling associated with parenteral packaging components intended for aseptic manufacturing.
- Sterilization Capability: Steam must be able to easily ingress and egress the sterilizable packaging.
- Packaging Integrity: Sterilizable packaging must maintain package integrity throughout the established use-by-date or shelf life, including all aspects of processing, handling and shipping.
- Chemical Compatibility: Sterilizable packaging must have no or limited chemical interaction with the parenteral packaging components.
- Packaging Specifications: Sterilizable packaging has a direct impact on the quality of the components packaged within.
Well-designed, validated, and controlled packaging and processes for parenteral packaging components is one of many factors that is critical to achieving success during aseptic manufacturing of pharmaceutical drug products. Assessing end-use functionality, sterilization capability, packaging integrity, chemical compatibility, and packaging specifications is critical to ensure the suitability of component packaging. West’s strategy and extensive testing assure that the quality and functional requirements of its packaging systems are achieved, and thus meet the demanding needs of the pharmaceutical industry.
For additional details regarding West’s assessment and testing strategy of component packaging, please contact West Technical Services.