Westar® RS (Ready-to-Sterilize) 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 and silicone. 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® RS components with the confidence of knowing your project will not be compromised because of inadequate component preparation. Additionally, specifying Westar® RS 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.
In supplying stoppers to the pharmaceutical industry, West maintains state-of-the-art facilities, with Food and Drug Administration (FDA) registration as required. The facilities maintain appropriate ISO certification and operate under applicable CGMP requirements.
The robust Westar® process meets all FDA validation requirements relating to equipment, processes, product, documentation and testing methods according to CFR 211.94 Drug product containers and closures. The Westar® RS process is filed in an approved Type V Drug Master File (DMF) with the FDA. The Westar® DMF is updated annually and supports your submission when filing your application.
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® RS components, you receive stoppers that have been tested and certified to meet specified bacterial endotoxin reduction, pyroburden, bioburden and/or particulate levels. The product is packaged in a double SterilizeableBag™ , which allows for direct introduction into your autoclave. Every wash load of Westar® RS 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.
 Westar® ready-to-sterilize components are delivered in a SterilizeableBag™ suitable for direct introduction into sterilization units. |
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 our Technical Customer Support Representatives click here to provide you with a product you are sure has been prepared to meet industry requirements for component cleanliness. Westar® RS provides you with the confidence of knowing your project will not be compromised because of inadequate component preparation.