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While all major regulatory agencies have expectations regarding the ability of a pharmaceutical wash process to provide a suitable level of pre-sterilization depyrogenation, the United States (U.S.) Food and Drug Administration’s (FDA) requirements appear to be particularly stringent.
Current FDA thinking is outlined in the “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – current Good Manufacturing Practice (September 2004).” This guidance includes the requirement that container closure depyrogenation processes must demonstrate validation of a minimum 3-log reduction in endotoxin levels. The Westar® RS (Ready-to-Sterilize) pharmaceutical wash process developed by West is supported by an ongoing validation program that meets the demanding expectations of the FDA for a broad range of elastomeric products. This information is contained in our portfolio of Type V Drug Master Files (DMFs) with the FDA and Type II DMFs with Health Canada.
In addition, the Westar RS process produces elastomeric components that meet defined specification limits for particulates and bioburden. Process capabilities exist globally at West’s facilities in Eschweiler, Germany; Jersey Shore, Pa.; Jurong, Singapore; and LeNouvion, France. To help support a successful review by the FDA, drug manufactures contemplating a pharmaceutical regulatory submission in the U.S. should consider elastomeric components washed by West.
The transition to the Westar RS process isn’t as difficult as you might think. In June 2010, FDA issued the “Draft Guidance for Industry: CMC Postapproval Manufacturing Changes Reportable in Annual Reports,” which was intended as an adjunct to the existing “Guidance for Industry: Changes to an Approved NDA or ANDA (2004).” The draft guidance identified a new group of changes that are considered to be Annual Reportable including the following:
Use of a contract manufacturing organization (CMO) for the washing of a drug product stopper, provided the applicant certifies that the CMO’s washing process has been validated and the CMO’s site has been audited by the applicant (or by another party sponsored by the applicant) and found cGMP compliant.
West’s recent experience has been that this type of transition can be covered by a Changes Being Effected (CBE-30) submission, however the guidance indicates that the FDA views this kind of change as having minimal potential to impact drug product quality adversely.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar<sup>®</sup> Ready-to-Sterilize (RS) process.
For many years, West has offered several ready-to-sterilize products that are qualified for a minimum 3-log Bacterial Endotoxin Reduction (BER). “Ready-to-sterilize” is known to West customers in Europe as “RS” quality. In other regions, such as South America or Asia, the ready-to-sterilize line of products includes our Superior Clean Product® (SCP) components and Enhanced Performance Products (EPP). These offerings reflect West’s commitment to quality components that support pharmaceuticals and biopharmaceuticals throughout the product lifecycle, while also fulfilling various regional market needs.
Focused on meeting customer needs in different markets and regions, West offers two types of washed Ready-to-Sterilize (RS) rubber closures: Regional-Washed RS and Westar<sup>®</sup> RS.
As customer needs rapidly change to meet these new and unprecedented accelerated timelines, West’s steam-sterilized, ready-to-use Westar<sup>®</sup> and Westar<sup>®</sup> Select elastomer components play a critical role. They simplify component preparation and allow customers to focus on other aspects of the drug filling process.
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
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