Case Study

Edge Computing in Pharmaceutical Manufacturing Biotest

How Biotest AG Standardized on Stratus Fault-tolerant Computing Platforms to Optimise Pharmaceutical IT

Challenges

  • High standards in production within the pharmaceutical industry require compliance with stringent quality standards and regulatory requirements
  • These standards require seamless integration of equipment, an SAP system and automation software
  • Complete archiving of all process data in a complex environment

Solution

  • Decision in favour of redundant servers with an availability of 99.999%
  • Stratus ftServer running AVEVA System Platform
  • Deep integration of 40 Stratus ftServers into the production processes

Benefits

  • Increased efficiency: optimisation of production processes through automation
  • Improved compliance: easy adherence to regulatory requirements
  • Cost reduction: minimization of downtime and investment costs
  • Future-proof solution: scalable and adaptable to new requirements

Biotest AG is an international manufacturer of biological medicinal products derived from human plasma used to treat life-threatening diseases such as haemophilia, severe infections, or immune system disorders. The company markets its products in more than 90 countries worldwide and strives to enable people with severe blood or immune disorders to live a self-determined life. Company headquarters and production are located in Dreieich near Frankfurt am Main, where up to 1.5 million liters of blood plasma are processed annually. In order to meet the high quality and safety standards prescribed in the pharmaceutical industry, a powerful and reliable IT infrastructure is critical. For the servers in production, Biotest relies on fault-tolerant computing platforms from Stratus.

Stratus zero-touch computing platforms deliver the highest levels of availability

Stratus fault-tolerant computing platforms have become an indispensable part of Biotest’s IT infrastructure. They are primarily used in production, where 40 platforms are deeply integrated into the production processes. Production at Biotest is carried out in a batch process. This means that the processes are carried out strictly one after the other. Such batch processes are more complex than continuous processes, placing high demands on automation and requiring precise control and monitoring. On the software side, Biotest leverages the widely used AVEVA System Platform automation software. Its modules, installed on the Stratus platforms, link all production processes and provide a uniform view of the overall process. Each Biotest plant has its own computer with the appropriate software. From there, the plants are controlled, monitored, and all processes are logged.

On the commercial side, Biotest uses an SAP system that handles the company’s business processes. Special interface servers – running on Stratus ftServers – enable production data from the AVEVA software to be fed into the SAP system, connecting the two worlds. This connection allows the SAP system to record and process information about batch numbers, production quantities, or quality inspections. Conversely, the connection allows for data transfer from the SAP system to the AVEVA software. Production orders, material stocks, or delivery dates can be displayed with ease – for example – and considered accordingly when planning. This also facilitates the qualification and logging of processes.

A key feature and selling point for choosing Stratus platforms is the ability to deliver continuous availability. In the event of a hardware failure, another server will automatically and seamlessly take over the tasks affected by the failure, ensuring the processes and applications are not affected and there is no data corruption or data loss.

“Stratus and the service of our partner Nonstop Technologies are first choice for us. The fast accessibility and the high reaction speed of their team are really exceptional. That’s why we have been working together in this partnership since 2006 and will certainly not change anything in the future.”

Maxim Befort
Measurement & Control Technology Engineer
Biotest

This exceptional resilience is made possible by the continuous background mirroring of files on all servers. The Stratus platforms fulfil various tasks at Biotest. These are:

Ensuring production: Deeply integrated into the production facilities, they ensure uninterrupted processes.

Connection to SAP: As coupling servers, they support seamless communication between the process plant, AVEVA software, and the SAP system.

Historical records: For compliance with pharmaceutical regulations, the platforms are used for recording and archiving process data.

Delivering consistent and customer-oriented service

Stratus platforms have a reputation for their technical quality and longevity – on average, users keep them in use for ten years – as well as their adaptability and consistent focus on fail-safety. In cooperation with qualified Stratus partners, Stratus platforms can unlock their full potential for the customer. In Biotest’s case, that partner is Nonstop Technologies. The company specializes in high-availability solutions and offers services from planning and implementation to the maintenance of IT systems. Nonstop has been the preferred service provider of Biotest and the pharmaceutical
company’s plant engineers since 2007. Based on service contracts with Biotest, this partner is also responsible for monitoring the servers and providing support. Biotest’s higher-level fault reporting system and a Stratus analysis tool used by Nonstop Technologies monitor the Stratus platforms. This makes it possible to monitor all 40 platforms at a glance and detect problems at an early stage. Biotest is extremely happy with this. Maxim Befort, Measurement and Control Technology Engineer at Biotest, summarizes:

“Stratus and the service of our partner Nonstop Technologies are first choice for us. The fast accessibility and the high reaction speed of their team are really exceptional. That’s why we have been working together in this partnership since 2006 and will certainly not change anything in the future.”

Outlook: Biotest Next Level

As part of the Biotest Next Level (BNL) project, the company has set itself the goal of gradually doubling its processing capacities at the Dreieich site to 3 million liters of plasma by 2026. The project was put out to tender in 2015, and the commissioned plant engineers started work in 2016. BNL’s main goal is to increase production capacity and establish processes that meet the special requirements of the FDA in the USA. And unsurprisingly, BNL also relies entirely on Stratus platforms.

Conclusion

The cooperation between Biotest, Stratus, and Nonstop Technologies is exemplary. The 40 Stratus platforms meet all of Biotest’s requirements and form a powerful and reliable basis for controlling the production processes. At the same time, the company is also equipped for the coming years thanks to the scalable server architecture. The package is rounded off by a partner who is as committed as it is competent, and whose services take care of the implementation of Biotest’s requirements. The result is a stable, future-proof, and fault tolerant IT infrastructure.

The use of fault-tolerant servers offers Biotest numerous advantages.

Availability: Stratus platforms are designed with redundancy so that even the failure of one component cannot affect the overall system.

Reliability: Stratus platforms deliver uninterrupted uptime that exceeds 99.999%.

Longevity: Stratus platforms work productively for an average of ten years. Validation is only required every ten years.

Performance: Modern hardware ensures maximum performance.

Security: Protection through a multi-level security concept, for example through firewalls, encryption and backups.

Flexibility: The platforms are scalable and individually configurable at any time.

Support and Service: Partners such as Nonstop Technologies offer reliable support that can be reached at any time.

“The provision of fail-safe IT infrastructures is our core business. Therefore, fault-tolerant server solutions have been a focus of ours for almost 20 years. The cooperation with Stratus continues because there is nothing better on the market.”

Frank Giesche
CEO
Nonstop Technologies

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