Final filling: process design considerations

Final filtration and filling of your drug product is one of the most critical points in the manufacturing process. Product quality must be guaranteed to ensure patient safety. In addition, any filtration steps must be capable of satisfying system flow rate and throughput demand.

At Merck, we recognize the importance of final fill as well as ensuring that the design of your flow path meets all requirements. With the increasing popularity of single-use technologies and stringent requirements of sterile filtration, final filling can be complex.

The implementation of single-use technologies in the final filling process is steadily increasing as these technologies can effectively meet stringent requirements with regards to proper assembly design and integration. Of particular concern is flow path sterility and integrity as well as operational safety and efficiency.

An additional critical area of final filling is sterile filtration. There are multiple options in designing a sterile filtration process, as well as regulatory compliance and cost efficiency challenges that require an understanding of the cost-benefits analysis. We are committed to answering any questions you may have as you design your final fill step, helping you weigh risks and benefits, and creating a design that will best fit your needs.

Recently we developed a two-part webinar series examining the challenges of final fill regarding single-use technologies and sterile filtration. Please click the button below.

For more information, please click here

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