Vertical integration is a fundamental condition for the implementation of numerous Industrie 4.0 solutions (Industrial Internet of Things). It means, among other things, the creation of a standardized interface between the machines on the shop floor (level 2) and the production management software (level 3). Vertical integration involves creating a fully networked industrial production using the latest information and communications technologies.
New integration concepts
Companies and organizations like ISPE are working on new integration concepts. The goal is to jointly develop a new industry standard in the regulated environment. For example, Werum IT Solutions is about to launch a Plug & Produce solution. It will allow a fast and easy integration of machines and automation systems into a pharmaceutical production environment. Previously, this used to be a highly complex, time-consuming and unproductive task with endless i/o lists, configurations and qualifications.
Similarly to the connection of an electronic device via a USB interface, it will be possible in the future to link production equipment such as a line, system or machine to the network. The manufacturing execution system (MES) then detects the precise type of machine, calls up all relevant information from the equipment and uses it, for example, for master batch records (MBR) and electronic batch recording (EBR).
On the basis of new technologies which are emerging for instance with OPC-UA, communication between systems in production and software functions at the production management level is being redefined from tag-based to message-based communication. The new message-based interface facilitates the secure exchange of structured information with the systems, regardless of whether this is the OEE data on a packaging machine, the Track & Trace data for a line management system or EBR data from a granulator or DCS system.
Open vendor-independent interface
The Plug & Produce solution from Werum will be an open, vendor-independent solution. That means, pharmaceutical and biopharmaceutical manufacturers can use it with any smart equipment such as filter integrity testers and analytical test devices or automation systems such as DCS or SCADA.
Reduced integration workload
For pharma manufacturers using standardized, message-based interfaces offers significant benefits: costs and complexity are reduced. The engineering and qualification efforts for integrating a new machine into the production network are substantially lower. It is also important in the regulated industries, for example in the case of change over to a different medical product, for all process steps to be documented in an accurate way. This previously took an enormous amount of time. With a standardized interface between the machines and the production management system, such changes can be made more quickly and more efficiently – for improved pharma manufacturing.