Reference project Simplified handling despite strict requirementsg
Simplified handling despite strict requirements
The market for blood plasma has never been as successful as it is today. This is mainly due to the increasing demand for medicines for patients with blood clotting disorders or congenital immune deficiencies. However, plasma-based products are also used in intensive care medicine, for example during operations, due to their properties for establishing blood clotting behavior. The pharmaceutical company supported by SpiraTec specializes in the production of vital drugs derived from blood plasma. Using a process known as fractionation, the plasma is split into its individual components and purified using various physical methods, such as centrifugation or filtration. As is usual in the pharmaceutical industry, production here is also subject to particularly strict requirements and regulations – which also vary from country to country.
For this reason, the entire process must be closely monitored and documented so that, for example, certain temperature limits are neither exceeded nor fallen short of. Otherwise, the product could be destroyed or even contaminated in a way that could endanger patients. Thanks to its precise knowledge of the relevant national and international regulations and the complex production processes in the field of blood plasma fractionation, SpiraTec AG was the right address for this project, which entailed two requirements: the design of the new automated process control system and its programming and implementation. For example, SpiraTec AG implemented an intelligent new solution for dispensing point management, which demonstrably ensures continuous circulation and cyclical sanitization at all times.
Project details
- Implementation of a process control system in blood plasma processing
- Compliance with all production regulations and verification requirements
- High degree of automation/user guidance of non-automated processes
Increased effectiveness
Existing concepts and customer requirements were taken into account and optimized, planned and implemented by SpiraTec in compliance with extensive regulations. However, SpiraTec was also able to make recommendations for more effective procedures at any time. Thanks to SpiraTec’s in-depth knowledge of the strict pharmaceutical regulations, all production requirements are complied with at all times, which ultimately ensures the safety of the patients concerned.
PCS 7 multi-project, consisting of several ES-en, redundant OS servers and batch server, 37 clients and 7 AS-en
Batch control with SIMATIC Batch, data storage, evaluation with Process Historian and Information Server
Virtualization from distributed ESXi servers with redundant storage systems (SAN)
Control cabinets and ThinClients (partly for clean room environment)
Automatic instead of manual
Overall, the system now performs a large proportion of the control and documentation tasks for which valuable employee capacity previously had to be made available. The pressure of responsibility for the specialist staff has also been permanently reduced, as many sources of error that occurred during manual processing no longer exist in the new system. Even with non-automated processes, the significantly simplified user guidance ensures fewer operating errors. The automated solution also completes service, maintenance and servicing tasks more reliably, more easily and more quickly. The result: the rare, highly specialized and comprehensively trained employees are able to look after more systems. The extremely limited time buffers in the production process can be used optimally, so that the high quality of the product is guaranteed and the risk of batch loss is reduced.
Effective against skills shortages
The reduction in personnel brought the pharmaceutical company a further advantage: due to the expansion of the site, the company would actually have had to hire numerous new employees, which experience has shown to be difficult to recruit. However, automation reduced the number of new positions to be filled to a feasible level.
“Project durations are getting shorter and shorter. We need someone who knows their way around and doesn’t need to be trained for a long time.“
Project manager on the customer side