Automationen in der Pharmaindustrie

1. Pharmaceutical Bulk Production Process Management System
2. The Tasks
3. Material flow monitor - Process data management
4. Systems and Languages

The qualification of installations agreed by the FDA demands that the pharmaceutical production process is documented as completely as possible.

In this context automation removes the demands made on customers by menu and grind and mix operation.

SYSTAG looks after the entire project from planning to commissioning, training and validation.

We have been able to profit from our experience in the programming of management systems, development of micro processor systems and the conception of data banks and networks.

The most obvious solution from a technical viewpoint is not always the best one for the programme options listed at the right hand.

Approximately 1000 batches are taken annually through this installation for sieving, grinding and mixing. Approximately 100 different products from different origins are processed. These must be identified and registered. A bar-code reader checks at the start of each installation whether the recipe uses the defined products. The container used at the exit is also labeled and checked.

Further technical data for this installation are:

• 11 sift, grind and mix installations
• 9 bottling plants
• 15 PLC Siemens S5 115-U for control of installations
• 6 Scales for bottling
• 1 Scale for checking of entry products
• 2 Bar-code printers

All data, such as recipes, containers, product and installation conditions, process data, alarm messages etc., are continuously stored in a data bank. Through forms and messages information can be recalled, printed and archived.

• Software: FIX DMACS V 5.1, MS-Access V2.0 and MS-Visual-Basic
• PLS with 1000 input/output data points, 60 View-screens; Data bank with approx. 30 tables; FIX DMACS SCADA Node and Manager View Node

In order to optimize the validation effort, the following criteria are fixed during the implementation of this installation:

• Operating systems, tools and programming languages already used in validated systems are utilised
• As many tasks as possible are processed with purchasable, professional tools
• The development and installation documentation is drawn up in accordance with internal guidelines on the installation operator
• A test plan is drawn up for each partial task, against which the operator and manufacturer together check the functions

The FIX DMACS process control software from Intellution, Visual-Basic and MS-Access from Microsoft are used as the software components for data management. Microsoft Windows for Workgroups is offered as operation system for production monitoring on the basis of its user friendliness and compatibility.