Process Monitoring in Pharmacy - latest publication on b.sure

Nothing is more important in the production of pharmaceuticals than a flawless and smooth process flow. Due to the networking of processes and applications, digitalisation is also becoming increasingly important in the pharmaceutical industry. However, the desired, all-encompassing monitoring and an optimised production process pose considerable challenges for manufacturers, users and, of course, suppliers. Especially because many processes are still completely analogue.

Practical experience shows that as production processes become increasingly automated and interlinked, fewer and fewer employees are required to monitor complete production lines. When constantly travelling between the individual operating and control panels of the machines, operators reach their physical limits.

However, plant operators must have access to the control panels at all times in order to recognise deviations in Process Parameters or error messages at an early stage. Due to the arrangement of the systems in different rooms, this is not always possible. Up to now, error and warning signals from the systems have often only been displayed using status indicators. However, if the machine operator does not have a direct or permanent view of the status light, the system can come to a standstill unrecognised in the event of an error or continue to run with incorrect parameters and produce a faulty batch.

Permanent information about the production status

The Ennigerloh-based company L.B. Bohle Maschinen und Verfahren solves this problem with the new process monitoring application b.sure. The app avoids downtime or faulty production by sending and processing operating data and parts of the process data to a communication server in real time.

All systems with programmable logic controllers (PLC) already collect a wide range of process and operating data, which is immediately available at the machines. The customer or system operator can therefore keep an eye on their processes at all times on authorised end devices or at their PC workstation. The application informs the operator about

• Machine name with serial number,
• Operating status (process active),
• Remaining time of the process,
• Batch data, batch number and recipe,
• Process values (e.g. force, gap width and Throughput),
• Errors and status messages (e.g. emergency stop or when ACTUAL
• Values run outside the permitted specified range) and
• Maintenance mode with notification function.

In contrast to other process monitoring solutions on the market with an external cloud solution, L.B. Bohle's b.sure takes into account the special features of the highly sensitive pharmaceutical environment and processes the data in the customer's network. This means that the data cannot be communicated outside the company and cannot be stored permanently.

After analysing the available parameters, L.B. Bohle developed a communication server that can be easily integrated into the company's existing IT infrastructure. The data is then processed on this internal platform so that it can be further processed via app or email. This means that the user receives the latest status reports from any location via mobile devices and Wi-Fi throughout the company.

The application is flexibly configurable and the user can individually define which information is to be recorded from which system and in which form it is to be analysed. The next step is to define which signals or warnings (acoustic and visual warnings in the event of a fault/alarm) are forwarded to whom and with what content. With b.sure, both data and Process Safety are given absolute priority.

Authorised operators monitor the process

In the event of a fault/error, the corresponding message is sent to the end devices via an e-mail service. The app is web-based and can be opened on the respective end device or via the e-mail sent; this means that the user is not tied to a workstation.

The system operator is not only informed by message in the event of a system error, but also if the parameters are outside the set values. This has the advantage that the operator can monitor several systems in parallel and react quickly. This saves valuable time in the event of a fault in order to guarantee the quality of the product.

B.sure is particularly secure because systems and authorised operators must be created on the communication server by an administrator in advance. This prevents unauthorised access. Monodirectional communication provides further protection against incorrect interventions in the process control, as the user has no way of directly influencing or controlling the process using the end devices.