The pharmaceutical and life sciences industries are heavily regulated, subject to strict guidelines which they must comply to in every process. In the pharmaceutical industry in particular, drugs and compounds must be documented in batch records in full compliance with GMP standards to ensure that the final product is of the required quality.
Despite the importance of batch records, most pharmaceutical companies rely on paper-based document solutions, with only approximately one third moving to electronic batch records (EBR). EBRs can be implemented using a manufacturing execution system (MES), but there is a wide reluctance to adopt this technology. Reasons for this include costs, the complexity of implementation, and crucially, the challenge of integrating machinery with IT systems that do not have a common interface.
Inter-facing the challenges
There are solutions to the various obstacles in implementing an EBR for pharmaceutical manufacturing. A classical approach is using a centralized process historian to integrate data from both manufacturing machinery and production lines, interfacing both the field and the MES system. A process historian can read values in real time when connected with a programmable logic controller (PLC) or supervisory control and data acquisition (SCADA). This is particularly useful when time-series values are required, for example temperature trends over time.
This system does have its downsides, for instance, it is more complex to collect alarm signals such as GMP exceptions, as the alarm conditions seen in the machines must be recreated by the historian. While this is possible, the historian lacks understanding of the alarm life cycle, and becomes more problematic when integrating the audit trail. At present there is no standardized way to integrate alarms and audit trail which incorporates the metadata needed to comply with data integrity. Instead, it is done machine by machine through file transfers, making the process more time consuming and costly.
MES systems were not intended to exchange real-time data with SCADA and PLC, instead communicating transactionally at the point of production events — for example, sending product data to a machine at the start of batch production, or receiving data on production results or GMP exceptions from the machine at the end of a process.
An effective interface with Werum PAS-X
To address this, Koerber software, the creator of the Werum PAS-X MES system has developed an interface known as Message-based Shopfloor Integration (MSI). MSI interface tackles some of the current issues with OT and IT integrations and, provided the equipment supports the same interface, allows machines and production line systems to communicate bidirectionally to improve data integrity and reliability.
Keeping effective system integration in mind, COPA-DATA’s zenon platform now has a Werum MSI interface to bridge the data gap between machinery and production lines. Developed in collaboration with Koerber software and several leading pharmaceutical manufacturers, the native interface facilitates direct bidirectional communication with the PAS-X MES. It is a GAMP5 SW CAT.4 configurable module, and users can define MSI messages and map message contents to zenon variables and define which zenon alarms they would like to be sent as GMP exceptions to PAS-X.
Using zenon MSI interface with PAS-X enables generation of complete EBRs, providing live information on batch ID, product, recipe and production results, along with an overview of any alarms or exceptions that have occurred. EBRs allow total operational transparency, accurate visualization of processes and compliance to regulations. Though communication between shopfloor equipment and an MES can be a challenge, zenon is an effective integrated solution to provide a reliable and consistent connection.
To find out more about COPA-DATA and zenon, visit the website here.
