The pharmaceutical industry is one of the industries with the highest level of responsibility and quality awareness. Products and their quality data must be traceable and verifiable from manufacture to delivery and even years after use. The guidelines for this are primarily legal regulations and provisions, which are summarised in the principles of GMP (Good Manufacturing Practice) and GAMP (Good Automation Manufacturing Practice).

The American Food and Drug Administration (FDA) serves as the executive body, validating systems in accordance with FDA standards, in particular the Code of Federal Regulation CFR Part 11. In order to achieve successful validation, these standards must be taken into account from the plant design stage right through to subsequent production operations. This was the approach taken by Drücker Steuerungssysteme GmbH, based in Neuhausen near Stuttgart, during the development, installation and commissioning of a new, complete filling line, “Rack Pack II Line 16”, at a leading manufacturer of diagnostics.

Individual diagnostic vials are separated from pallets on the filling line, sorted, labelled and combined into so-called rack packs with the aid of a neck filling unit. Depending on the batch, these rack packs contain 1 to 3 diagnostic vials. The vials are fed in via three independently operating palletisers. The bottles are transported further via a conveyor belt to a rotary indexing table. Here, the bottles pass through various processing stations. Labels are affixed and a camera compares the matrix barcode and its correct position.

Another camera checks the bottles and caps for the correct colour. These RackPacks are then transported onwards and packaged. This entire production process is initiated, operated and monitored from start to finish by a visualisation system and logged seamlessly in the database.

The authorised operator enters the process data, such as product selection, batch number and the quantity to be produced. Due to FDA regulations, all actions performed by the operator are logged and cannot be changed.

A wide variety of aspects played a key role in putting together the components for the plant concept. Not only should simple, intuitive operation make work more comfortable and therefore more efficient for the operating personnel. Where possible, the operator should be guided and not left alone with options. However, compliance with FDA regulations and the resulting data security were of central importance. This is achieved through the use of the InTouch visualisation component from Wonderware. All data is stored in the database with the help of the IndustrialSQL Server, also supplied by Wonderware.

The connection to the PLC is established via Wonderware I/O servers. These offer the desired functions ‘out of the box’ and can be further customised as required. The operating system used is the server version of Microsoft Windows 2000. A second, identical Wonderware system is used to increase availability and data security. This second, redundant system is located in a separate room.

It continuously synchronises its data every second with the first system, the master system. By means of a handshake between the master and standby systems, the standby system detects when the master is no longer active. The standby system automatically switches to master mode. This ensures seamless failover. Both systems can be fully integrated into the company network without any problems, and the data can be evaluated across the entire group.

Among other things, FDA guidelines require complete traceability of product data in terms of "who did what and when‘. However, this requires clear identification of the ’who", i.e. the user. The operating system's own user management system offers a solution. With the help of InTouch, it can be managed easily and conveniently without the operator even coming into contact with the operating system. It is also possible to transfer user management from a stand-alone solution to a higher-level company network and integrate it.

User systems already in place across the company could continue to be used seamlessly. Since users are already set up at the operating system level, only one user system is required for end-to-end security from the operating system to visualisation. This is a significant advantage over proprietary user management systems. Users identify themselves by logging into the visualisation. Depending on their user level, they are authorised to perform certain actions.

In the RackPack II line, such actions include all operation-related data such as creating/changing product and process data, starting/interrupting/ending a batch, but also important actions such as creating/changing a user profile. Due to the traceability requirements of FDA guidelines, the user must confirm an action with their user name and password in order to approve it. An ‘electronic signature’ is created, along with an audit trail. System overview Product data management.

This electronic signature now links the user's name to the action they have initiated, including a timestamp. A unique and irrevocable entry is made in the database, known as the audit trail. The data records stored in the audit trail can be viewed and printed out at any time by authorised persons. However, it is not possible to change or delete the data records.

The use of Wonderware software products such as InTouch, IndustrialSQL Server and I/O Server brings users in the manufacturing centre advantages and benefits in the following areas:

DRÜCKER Steuerungssysteme GmbH

Albstrasse 10
D-73765 Neuhausen a.d.F.

+49 (07158) 96668-0
info@druecker.de

© 1985 – 2025 | DRÜCKER Steuerungssysteme GmbH

Imprint, AGBs, Data privacy policy