"Last month saw the 5th Disposable Solutions meeting take place over two days in Brussels. We had an excellent mix of presentations not just from suppliers thankfully but more importantly from end users looking at the benefits and challenges of building facilities based around single use systems or integrating them into their operations. In terms of the presentations that really caught my eye were those relating to the implementation of single use systems and staff training. This is something that has been close to my heart given I work for a CMO with single use systems! It’s not always articulated in conferences and seems to be a neglected subject in such meetings.
In general conferences on Single Use Systems are attended by people from highly technical backgrounds, rather than by the people using these systems on a day to day basis. Hence the focus on complex technical issues, such as leachables and extractables, rather than the more mundane topics of, how are we going to use the systems within production facilities?
Alain Pralong from GSK Biologics and Arnaud Schmutz from Sourcin chose to focus their presentation on this latter issue. Alain Pralong made the very important point that prior to the introduction of single use systems there had been an increasing tendency to address quality issues by increased levels of plant complexity and automation. Effectively disengaging operational staff from the manufacturing process; with manufacturing facilities being designed by and built by specialist engineering groups with operational staff having minimal if any input into the plant operations.
The advent of single use systems has turned this approach on its head in many ways and I feel is having a profound impact on the way companies are now looking to operate their production facilities. Firstly, with regards to the design of systems it is apparent that the best people to assess how the systems should be designed and the process ergonomics are the operational staff themselves. I recall from a previous Disposables Solutions meeting an excellent case study given by Nigel Bell from GSK’s Barnard Castle site on how they had implemented this into their fill finish operations where the production staff had been intimately involved in the final design process.
The second area that was covered in Brussels was how to train staff through pictorial and video based tools rather than more conventional approaches; to identify and retain best practice. A final point was made around areas of process improvement and pointedly that in manufacturing industries, such as the automotive industry, there is a very different approach where a much more bottom driven approach to quality is undertaken.
Some years ago when I first started presenting on single use systems, there were remarks that the BioPharm industry should also start looking at learning from other manufacturing industries such as the automotive industry to adopting QdD approaches which were dismissed in the same breadth as single use systems, as being unsuitable for Biopharm production and would never take off. It is interesting to see how much this old fashion dogma has been challenged and the breadth of impact single use systems are having on Biopharm production processes and the industry as a whole. Time will tell how much further single use systems will prove a catalyst to other changes in approaches to manufacturing in the future."
Pharma IQ: Making Tomorrow's Medicines