In the second half of 2020, BioPhorum Drug Substance will publish a comprehensive set of tools and guidance to help the industry foolproof the transportation, deployment and use of single-use systems. Inspired by the work of Bayer’s Berkeley facility, who over many years reduced leak rates from totally unsustainable 40% to a phenomenal 0.04%, the industry package takes the position that single-use systems are complex delicate objects and you only enjoy high levels of reliability if they are treated with care and intelligence at all stages of their lifecycle. Further the team believe that true reliability, failures measured in parts per million (ppm), can only be be made the new normal, within a framework of industry wide best practice, that in turn need to have a foundation of common terminology and investigative approach to enable users and suppliers to talk, learn and improve together.
The launch package, is being developed by the Disposables Supply Base Reliability team and is due out in Q3/4. This will provide the first parts of the toolkit and overtime build up to include:-
Industry language and knowledge
- Single-use system visual observation library, that will provide clearly defined and aligned single-use terminology to facilitate investigation communication, accuracy of information, and the ability to properly trend defects.
- Single-use system anatomy, will define the commonly used names and descriptions of single-use components
Training program guidance
- Guidance for developing bag handling training, will provide industry aligned guidance on how to provide effective training on the handling and deployment of single-use assemblies and components for manufacturing operators in order to minimize “user error”
Leak response guidance
- Single-use event response checklist, will build on the standard SUS anatomy and look to become the industry standard to capture key information and be used to communicate internally and with suppliers, about issues and failures.
- Single-use leak RCA guideline, will provide a list of questions that are specific to the use and handling of single-use materials that can be used to help provide guidance for the investigation process.
As always with all BioPhorum missions, the publication of the guidance is the start of the journey and not the end. The team realize that this will just be the jump-off point to years of collaboration and work across the industry to get to the ultimate goal of reliability measured in ppm. In reality, this is ambition in non-negotiable; single-use systems are now a fundamental part of life in commercial biomanufacturing and improvement is vital. For end uses, depending on the scale, the group estimate that the reduction of leaks and associated costs can save from $50k for a small clinical operation, to more than $20m for a large operation, once product loses and lost time are included. Add in the the reduction of deviation reporting, manufacturing and supply chain disruptions and the opportunity to streamline investigations through a standardized approach to detecting root causes and the benefits of the industry working in concert and improving are evident.
The benefits of the program are not just for manufacturers, suppliers will also gain. Reliability means happy customers and low complaints means good business. The industry-wide understanding of the common root causes of failures will accelerate development and better designs, and robust and statistically based standards for performing qualification, and in-process/release testing for SU components will build trust and confidence the supply and the product we are all now so dependant on.