Pharma IQ have kindly asked me to chair the forthcoming Disposable Solutions meeting next February in Munich, the meeting will focus as much on discussion sessions as it will on the more formal presentations. As a lead into this meeting, I would like to focus my next two Blogs on topics of the planned discussion sessions and I would very much encourage those of you who come along to engage and contribute to these sessions so that participants and vendors get as much as possible out the meeting. The two areas I will look to focus on are, flexible facilities and the current economic drivers behind the adoption of single use systems.
In this Blog I will focus on the area of flexible facilities. It is quite clear that this is currently a “hot” topic with a number of presentations and meetings being solely focused on this area. It has been clear for a number of years that single use systems have opened up a whole new area of possibilities with regards to facility requirements and operational models and that we are now seeing this concept turning into reality.
The initial impression I get from looking at these meetings and articles is that a lot of the discussion and debate to date very much hinges on the economic drivers behind the concept and also facility designs and layouts that may be adopted. However, it seems to me that if we are to make the most of the opportunities that these technologies offer it will be essential that we look at how these facilities will be operated.
One of the criticisms that can be raised against single use systems in the past and potentially a reason for the reluctance of some groups to adopt single use systems was the lack of engagement with the broader manufacturing community with regards to implementation and quality aspects around single use systems. To be able to make the most of these new generation of facilities we will need to look beyond the bricks, mortar and bags.
The notion of flexible multi product facilities has always presented significant challenges to the industry not only with regards to regulatory compliance and quality systems but also with regards to the skills, training requirement and management systems required. It soon became apparent in the early days of single use systems that engender a greater reliance on operational staff for day to day production, but also a greater reliance on the design of process systems and fluid trains.
So for me the key element going forward with flexible facilities will not just be a design and build process, but also to leverage the lessons we have learnt over the last 10 years around single use system; to engage at all levels across organisations , to develop the management and quality systems and, most importantly of all, the skill base required to implement these manufacturing approaches.
Pharma IQ: Making Tomorrow's Medicines