Westar RU (Ready-to-Use) Stoppers for Meeting Stringent Regulatory Requirements
Industry requirements for the preparation of parenteral packaging components encompass many levels of validation and data. Requirements may include, but are not limited to, endotoxins, bioburden, particles, silicone and sterility. Understanding and providing this information is costly and time consuming.
Why take on the added responsibility of stopper preparation? Why question whether or not your contract manufacturer meets all necessary process validation requirements? You can simply specify Westar RU components with the confidence of knowing your project will not be compromised because of inadequate component preparation. Additionally, specifying Westar RU stoppers from the onset of clinical trials through commercialization helps mitigate risks from variations in stopper preparation.
To view a quick reference guide that connects relevant sections of current industry guidances and documents to specific issues related to the preparation of parenteral packaging components, click here.
Enabling Lean, Efficient Filling Operations
Westar RU sterile components let you make your filling operations lean and efficient - as your company saves time, floor space and money.
Westar RU is a documented, validated process for preparing pharmaceutical components in accordance with international regulatory requirements. Westar RU components can be moved directly from warehouse to sterile fill areas - eliminating work-in-process issues for sterile components. You also eliminate component preparation entirely, leaving you one less area subject to FDA inspection.
West delivers Westar RU components in customer-specified quantities and packaging for easy introduction into barrier systems. The Westar process meets all relevant FDA validation requirements according to CFR 211.94 Drug product containers and closures. To view current industry guidance related to preparation of parenteral packaging components, click here.
Pharmaceutical manufacturers and contract manufacturers can underestimate the validation requirements necessary to meet industry and FDA requirements. West works closely with the FDA to ensure our processes and product specifications meet all requirements outlined in guidances relating to components for parenteral packaging.
The following list includes the industry requirements for proper stopper preparation:
- Maintenance of equipment
- Calibration, change control
- Cleaning, line clears, cleaning validations
- Laboratory controls
- Standards, cultures, controls, lab equipment
- Prewash bioburden and pyroburden
- Operator training
- Maintenance of documentation (SOPs)
- Annual revalidation of processes
- Raw material testing (detergents, packaging, etc.)
- Water system maintenance and testing
- DMF updates: Technical Amendments, Annual Reports
- Out of Specification (OOS) investigations
When you specify Westar RU components, you receive stoppers that have been tested and certified to meet specified bacterial endotoxin reduction, pyroburden, bioburden, particulate levels and sterility. Every wash load of Westar RU product is shipped with a Certification of Analysis (C of A) to provide you with data showing that the product meets all specifications for cleanliness.
During the Westar process, stoppers are:
- Staged in a Class 100,000 clean room
- Washed using USP purified water and detergent
- Rinsed with USP purified water
- Final rinsed with WFI (Water for Injection)
- Centrifuged for drying
- Unloaded in a Class 100 clean room for final packing into double heat sealed sterilizeable bags made of HDPE (high density polyethylene) and Tyvek®, a selective barrier that allows moisture/vapor transmission but prevents microbial ingress.
To contact a West Representative who will provide you with a product you are sure has been prepared to meet industry requirements for component cleanliness, click here. Westar RU provides you with the confidence of knowing your project will not be compromised because of inadequate component preparation.