Aseptic Manufacturing: Packaging for Parenteral Packaging Components
June 20, 2017 at 10:30 am EDT
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In aseptic pharmaceutical manufacturing, the packaging for parenteral packaging components is essential for ensuring proper sterilization and utilization. The importance cannot be overstated. Ineffective component packaging can potentially affect patient safety, and result in significant financial loss. Acknowledging this, West conducts exhaustive testing on its packaging systems to ensure that quality and functionality requirements are achieved.
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.
West Pharmaceutical Services Inc. published this content on 14 June 2017 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 20 June 2017 14:30:10 UTC.
Original documenthttp://westpharma.com/en/blog/2017/June/aseptic-manufacturing-packaging-for-parenteral-packaging-components
Public permalinkhttp://www.publicnow.com/view/282CD2FB7C7920973A0650EB5E3B73D2837754E3
West Pharmaceutical Services, Inc. specializes in the design, manufacture and marketing of components and systems for the containment and delivery of injectable drugs. The group offers packaging, components for syringes, cartridge systems, auto-injection devices, accessories for vials, specialty components, etc. Net sales break down by family of products as follows:
- own manufactured products (81.8%);
- products manufactured under contract (18.2%).
Net sales are distributed geographically as follows: the United States (42.3%), Germany (16.8%), Ireland (8.7%), France (7.5%), Europe (12.1%) and other (12.6%).