As a result, customers are looking to their manufacturing suppliers to help them address the following challenges:
- Regulatory Risks: Because regulatory requirements are becoming more stringent for drug manufacturers, more attention needs to be paid to aging facilities and equipment, inadequate validation and testing, missing documentation, and lack of employee training.
- Streamline Processing: The potential for on-site washing demands on-site expertise leading to higher utility, maintenance, personnel and insurance costs – as well as a larger manufacturing footprint. Often, these additional resources are not an option.
- Increased Costs: Preparing components for use requires more personnel and production planning and allows for potential unforeseen events and shut downs.
Daikyo RSV (ready-to-sterilize validated) and RUV (ready-to-use validated) components allow customers more time to focus on their own drug manufacturing needs. Daikyo RUV components are delivered to customers ready-to-use on their filling lines. The components are manufactured using high-quality elastomer formulations, pharmaceutically washed, 100% camera-inspected and steam sterilized. The Daikyo RUV process is fully validated, filed in Drug Master Files in the U.S. and Canada, and utilizes an overkill method based on ISO 17665-1 to provide a sterility assurance level (SAL) of 10-6 or better.
Each batch of product is provided with specification for bioburden, particulate and endotoxin. Daikyo RUV components adhere to rigorous quality standards and provide customers regulatory acceptance and flexibility.
Additionally, the RUV offering is available in small quantities to meet your clinical trial and scale-up needs and enable manufacturing flexibility.
To learn more about the latest component offering from West, visit our website or contact your Account Manager or Technical Account Specialist for more details.