Important decisions must be based on evidence, and we have to build a shared understanding of the problem and an agreement on the best solution throughout the process.
see what we see?”.These can broadly be clustered as follows:.
The perceived immaturity of the state-of-the-art.There is a belief that the technology involved in intensified chemistry is not very mature and therefore carries substantial risk.Some of the small-scale hardware has not been fully industrialised, the developing data collection, process and quality control approaches have not been fully tested with regulatory authorities..
Complicated supply chain.Pharmaceutical manufacturing of a single product through its lifecycle spans multiple functions and sites within each organisation and spans multiple organisations through product acquisitions and contract manufacturing.
Thus, the breadth of what needs to be changed to deploy a new platform technology is significant.. Resistance to challenging accepted practice.
Regulatory and patient safety risks are always high up the agenda for the pharmaceutical industry.However, trades at different points in the process don’t necessarily have access to the early decision-making rationale, so there can be unanticipated consequences of these forced ad hoc changes.. For example, façade installers have reported that they spent 40% of their time undertaking site surveys and using shims and packers to fill in the gaps between their manufactured unitised systems and traditionally built superstructures.
This example is particularly pertinent given the crucial role façades play in fire stopping and compartmentation..If the BSA onus is on ensuring the design doesn’t change from specification to delivery, then the exactness of the design and the tolerances is crucial..
The higher degree of accuracy and innovation in platform components ensures that what was designed and modelled is much more likely to be what is installed on site, with no need for site based problem-solving/adaptions vs. what has been designed and tested..Platform components create superstructures, which, while a relatively small proportion of the cost, are critical in maximising the accuracy of the installation.
(Editor: Top Skincare)