"During recent meetings I have attended on single use systems it is apparent that whilst there is the acceptance that single use systems are now mainstream, there are still “growing pains” within the industry. These seem to arise from expected areas such as cost of goods and supply chain timelines, but also from the transition from their use for the production of materials for clinical evaluation to long term in-market supply products. Underlying much of these discussions is the concept of standardisation of products, whether it is; system design, connectivity, product testing and manufacturing standards. Clearly the concept of standardisation is a laudable one and one that has been applied successfully in a number of industrial and service area sectors. However it would seem from the discussions I have been involved in that this is a much more difficult concept to achieve in the single use field than it would appear at face value.
The perceived benefits and potential areas for standardisation of single use systems are clearly different, depending upon the area of the industry whether it be those working in clinical development or in-market supply, between equipment manufacturers and end users, and between small and large companies at either end of the supply chain. Clearly these differing needs and expectations need to be recognised if standards are to be universally adopted.
There is an ever increasing range of single use products being developed for an ever increasing range of applications, and one critical aspect that has to be considered is what is to be standardised and what will be the impact of the standardisation. Two obvious areas are the mechanical performance of systems in terms of integrity and strength of bags and connection systems, the other is the leachable and extractable performance of the plastic films and the components. Such standards are likely to bring benefits to suppliers and end users and also establish basic performance requirements for new products and suppliers to achieve. More contentious to me seem to be the development of standard bag designs and connection systems, it is clear that suppliers having invested significant monies into some product designs may be reluctant to give these up in favour of a standard connector or bag design.
The second aspect of this is who would set the standards. There would appear to no shortage of bodies working on the generation of standards; large multi-national corporations, whether suppliers or end-users have extensive standardisation within their organisations. They appear to be very keen to have industry wide standardisation based on their own standards, which are inevitably different from other large corporations, so there clearly needs to be compromise. Additionally, there are several industry wide bodies such as the PDA who have been working on generating guidelines for a number of years. The process of generating standards is further complicated by the fact that it would appear that there are multiple standardisation bodies within multiple territories looking to develop their own standards with no group taking an obvious lead in the area or routes to harmonise the guidelines or standards that may emerge from these various groups.
So for the time being, from my perspective, whilst I am sure these debates will continue for the time being I think we will see continued adoption of single use systems and both suppliers and end-users will apply there own “standards” until a resolution is achieved."
Pharma IQ: Making Tomorrow's Medicines