HMI & SCADA Success Stories

COPA-DATA: Consistent and safe – zenon in the Pharmaceutical Industry

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The HMI/SCADA software zenon is an integrated and safe platform for consistent  process and information management. The established special machine builder  Bausch + Ströbel is now using the solution from COPA-DATA throughout the company for machine operation, logging of operational data and control and monitoring  of entire production facilities in the pharmaceutical industry.

The company Bausch + Ströbel from Ilshofen, Germany  manufactures around 300 machines per year – 95 percent of  which are for the pharmaceutical industry. Founded in 1967,  with four employees, the special machine builder now generates  annual revenues of 120 million euros and has around 1,000 employees. More than 90% of the company’s goods are exported.  There are customers on every continent and the company also  has sites and representative offices on every continent.

The challenge of various machinery

Bausch + Ströbel offers both customer-specific individual machines as well as multifunctional production lines for industrial  processing. The range of machines is orientated towards manufacturers of pharmaceutical products in the primary packaging  and secondary packaging fields. This includes products such  as ampoules, disposable syringes, carpules and vials. Bausch  + Ströbel has produced a total of more than 10,000 individual machines for use worldwide. This includes over 130 ampule  lines, over 340 vial or bottle lines, over 100 injection lines (mold  cavity), over 50 injection lines (bulk) and over 40 carpule lines.

Its main working procedures are cleaning, dosing and filling  fluid and powdered products, sealing, labeling, checking and  transporting and storing the above-mentioned containers. The  production facilities of Bausch + Ströbel play a key role in the  processing of high-quality, sterile pharmaceutical products. Furthermore, the company also offers labeling machines. The special machine builder also provides services such as qualification  and validation, customer training and service and support for  all machines.

complex machines,  complex requirements
Up to now, Bausch + Ströbel used two different software systems for the control process and for the management level,  which controlled the machines and used process data from the  machines and equipment. The company also developed its own  functions and add-ons for the SCADA system. “Two separate  systems and additional in-house developments require a large  amount of work to ensure the implementation and validation  of software – as well as for the maintenance and upkeep of the  machines and equipment. Our objective was to stop developing  and configure projects instead,” explains Michael Pratz, who is  in charge of automation, equipment qualification and documentation and the technical IT at Bausch + Ströbel. Bausch + Ströbel  was looking for a system which could consistently operate from  machine level through to management level (SCADA) and which  also offered good performance for the price. “The decision  criteria for an HMI/SCADA solution included comprehensive  user administration and the ability to use Microsoft Windows  as an operating system platform to allow integration into Active  Directory. Furthermore, it was important to us to be able to work  with existing tools and modern, intuitive user interfaces,” adds  Michael Pratz. Another requirement was creating a solution  for the end user that can visualize the entire working process.

In the process, the work can be designed more efficiently and  the likelihood of making errors is reduced. „Our new solution  should make it possible to guide the machine operator intuitively and enable them to work on different machines – without  a long time to learn the process. This is a necessity nowadays. At  the same time, we wanted to increase process safety,” says the  Bausch + Ströbel Manager

zenon – record, visualize and log
The special machine builder Bausch + Ströbel now offers its customers all the important functions for packaging and production processes in the pharmaceutical industry on the basis of  zenon. The new HMI/SCADA application based on zenon aids  lot-based recording, visualization and logging of all data that  is generated during production and processing. Users receive  information on the current machine performance, counter statuses and weight values as a bar chart or in table form with net and tare weight values including the date and time of weighing  etc. In the trend dis play, employees can follow the development  of production data over a longer period of time, recognize possible problems in the production process at an early stage and  instigate measures to counter them. Object-related production  data such as weight values are recorded with high performance  during each machine cycle.

Create a consistent basis for data

An important point for Bausch + Ströbel – and a significant requirement in the pharmaceutical industry – is the integrity of  data, which also decisively influences the product quality. With  zenon, Bausch + Ströbel can consistently write all data from  processes such as temperatures, presses and weight values to  a database, read them again, and evaluate or analyze them, as  well as being able to archive them. The use of an SQL database  and the OPC UA connection also makes it possible to forward  the production results to superordinate systems such as MES  solutions.

Audit trails in zenon – safe from manipulation, reliable, complete

zenon supports machine builders and production companies  optimally in meeting the requirements of the pharmaceutical industry and complying with legally-binding international  regulations such as FDA 21 CRF PART 11 or GMP and – in conjunction with the integrated user administration – creating the  Audit Trails required in the pharmaceutical industry. In doing so,  zenon checks which users are carrying out which actions and  documents this. It is therefore possible to trace all user interventions and relevant results, such as any process events, value  changes or limit values being exceeded, at all times.

A consistent flow of  information in the process of  a batch throughflow

With the start of a new lot and the lot number being assigned,  the start information and production data such as weight values  or messages are stored in an SQL database. The application records all of the data generated in this production and packaging  process in an Audit Trail. This ensures compliance with FDA 21  CRF Part 11. The employees in charge can view the Audit Trails  of the current lot. After a lot has been completed, the lot protocols or trend evaluations are ready to be analyzed, documented  or archived. They contain information on the operating status  of the machines, any system access by employees, changes to  parameters, operational messages, and trends such as temperature, statistics, counter logs etc. Bausch + Ströbel also makes it  possible to log production and downtime during a lot, to display  the key figures graphically and – as an option at the end of a  lot – to print them out.

Increased efficiency thanks to  recipe management

With the zenon Recipe Group Manager, it is possible to keep  individual packaging and manufacturing parameters, target values and commands in a list, which are executed in Runtime with  a single function call. Bausch + Ströbel uses this central recipe  or format management to edit all format parameters for the individual machines or the whole line; to delete, approve, save  and administer. In addition, the customers of Bausch + Ströbel  can integrate CIP/SIP format management. Because recipes allow considerable changes to the equipment, zenon protects this  with well-developed safety mechanisms and access rights. All  changes can also be logged.

Additional modules for  tailor-made solutions

Bausch + Ströbel now offers a variety of modules and functional components so that customers can tailor their own solution  which fully meets their requirements for the filling and packaging of pharmaceutical products. These include, for example, a  module for object logging and for the saving and requesting of  time-driven process data. With the module for time control, users can connect a machine or piece of equipment to an NTP time  server and synchronize times. The backup module ensures that  data is secure and can be recovered.

Acting internationally

Due to the global nature of the pharmaceutical industry and because exports make up more than 90% of its sales, a truly internationally software solution is a fundamental requirement for  Bausch + Ströbel. With the language switching in zenon, users  can switch language or alphabets as desired whilst the program  is running and convert units of measurement – without laborious adaptation being necessary. At the same time, it is ensured  that the selected language is used consistently throughout. The  Audit Trail is thus also stored in the desired language.

Flexibility and professionalism in cooperation

The customer-orientated product development, the clear and  well-thought-out release policy and the open communication  in terms of the planned development stages for future software versions is valued highly by the automation specialists at  Bausch + Ströbel. In addition to the technical solution, Michael  Pratz from Bausch + Ströbel stresses the professional cooperation with COPA-DATA in particular: “COPA-DATA has shown  bausch + ströbel I pharmaceutical  great commitment and shown that the company can quickly  implement our requirements and needs, react immediately to  queries and support us competently on site – and wishes to  go forward together with us.” Bausch + Ströbel has currently  supplied five machines to customers with the new zenon based  application. Sandoz is one of the first users.

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