Abstract:
In the medical device industry, software has become a more integral
component of the manufacturing process, which in the main, consists of
discrete manufacturing equipment. As these software systems control the
equipment that manufactures the medical devices, they are required to be
validated to comply with the regulatory bodies requirements. As software
systems become more complex coupled with more enforcement from the
regulatory bodies, medical device manufacturers are investing additional
resources to maintain compliance. This research project examines a case study
of how a medical device manufacturer implemented a new software standard to
reduce the software development and validation costs of new discrete
manufacturing equipment.
The ISA-88 standard was evaluated as the basis for the software standard. This
standard, which has it roots in the batch process industry, has had a major
impact on the way batch process automation is engineered. S88 has been a
focal point for defining and automating batch processes for over a decade; its
acceptance within the batch processing community is widespread. While ISA-
88 has achieved general acceptance in the batch process industry, it has not yet
enjoyed widespread use in discrete manufacturing equipment applications.
This research examines how the S88 design standard was applied to discrete
manufacturing equipment and the benefits of applying the software standard at
a medical device manufacturing organisation. This was complemented with a
survey of similar organisations that had recently implemented the ISA-88
design philosophy.
The final deliverable of this research was to develop a useful decision tree that
should provide practical guidance to engineering professional investigating the
option of implementing S88 at their organisation.
