Rising to the challenge of BioPhorum's small flexible filler URS
This paper provides a seminal example of how BioPhorum can partner with biopharmaceutical suppliers to address the needs of the industry and facilitate positive and lasting change. BioPhorum’s Small Flexible Filler (SFF) URS allowed Groninger to build a line that would otherwise not exist, defining a strategic direction for the future of liquid fill and finish for the biopharmaceutical industry.
The URS lays the foundations of the industry’s expectations of equipment suppliers. It allows industry suppliers to develop appropriate technology and to focus on the areas that are important to its future direction. The URS should also help vendors understand where future technology innovations are most needed.
Key requirements of BioPhorum’s SFF URS
The URS outlines many requirements for small flexible fillers across the main aspects of filling operations. Some elements are considered more important to industry, or more urgent and these elements are listed here:
- Modular plug-and-play capability
- A gloveless isolator, improving sterility assurance level
- A low reject rate of <0.05 percent
- 30-minute changeover time between the last acceptable filled unit to the first acceptable filled unit
- Standardized, ready-to-use components
- No human intervention needed inside sterile areas after decontamination.
Within two and a half years of BioPhorum publishing the SFF URS, Groninger, a German supplier to the industry, has developed a gloveless, robot-based, automated filling line that aligns with the URS and relevant current regulatory expectations. Groninger had already generated a number of ideas independently but needed industry input to answer questions such as What defines a small batch? and What constitutes low speed? The SFF URS provided clear guidance to Groninger on these vital knowledge gaps and allowed them to move forward with their filler developments.
Groninger were keen to meet the requirements of the URS, not only because it meets industry needs, but also because it helps filler developers. Most filler design is fulfilled through bespoke orders. This approach does not lend itself to short lead times or standardization of components, etc. Aligning with industry needs, as detailed in the URS, not only gives industry what it needs, but also provides technology vendors with confidence that a more standardized (and less bespoke) approach would continue to add value through, for example, faster implementation, reduced inventory, and faster response times.
|Rising to the challenge of small flexible filler URS September 2021.pdf|
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- Create Date 29th September 2021
- DOI https://doi.org/10.46220/2021FF005
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