Westar® RU
Westar® RU (ready-to-use) components are either steam or gamma-irradiation sterilized giving you the power to transform your pharmaceutical filling operation into a lean, efficient process. Westar RU components are sterilized and delivered to you in integrity-tested packaging systems, which may include rapid-transfer port bags, to ease the introduction of components into your filling line. With RU components, you minimize variability in your sterile operations and may even eliminate component preparation from your plant entirely.
Process Validation
The Westar RU process is fully validated, complies with applicable cGMP requirements and is performed in West's facilities in Europe, Singapore and the United States. All Westar RU products are final-rinsed with Water for Injection and packed in an ISO Class 5 cleanroom.
Validated for Quality Assurance
Westar RU components are prepared using a documented, validated process that helps companies comply with current regulatory requirements. All product lots are tested and come accompanied by a Certificate of Analysis (CoA) as documented evidence of compliance with the specifications.
Risk Mitigation
Westar RU components are available from West's facilities in North America, Europe and Singapore. The facilities meet the applicable cGMP requirements and produce components with specified bacterial endotoxin, bioburden and particulate levels for primary pharmaceutical closures.
Packaging
The standard packaging for Westar RU stoppers is a sterilisable bag in combination with an outer clipped polyethylene bag. Customers may request an isolator bag or other packaging combinations to fit their requirements.
Benefits Westar RU
Choosing Westar RU components can streamline your manufacturing operations by eliminating many of the processes related to component preparation. As a result, you may benefit from:
- Minder tests en validatieonderzoeken
- Grotere verwerkingscapaciteit
- Lagere personeelskosten en onderhoudskosten
- Betere naleving van voorschriften
- Een Drug Master File (DMF) ter ondersteuning van ingediende CMC-documenten (Chemistry, Manufacturing and Controls)
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.