Reliable monitoring, measurement and control technology for manufacturing active pharmaceutical ingredients (API)
Safe, timely provision of quality pharmaceuticals is a major challenge. An indispensable matter here is the availability of active pharmaceutical ingredients, or API for short. The manufacture of these takes place under increasingly stringent controls whilst complying with the highest quality standards and documentation requirements. At the same time, high productivity is necessary to ensure cost-effectiveness - whilst keeping the use of resources to a minimum. Intelligent monitoring, measurement and control technology from Bürkert aids in the automation and optimisation of processes. You benefit from reliable processes, reduced CO2 emissions and ultimately, consistently high product quality.
Automation solutions for API production
When it comes to the manufacture of chemical and biological APIs, there is a focus on product quality and also on the safety of the production process - namely ATEX zone 1 or FM. For this reason, there are stringent explosion protection requirements regarding the components that have been installed.
Also, implementation of digital systems, such as centralised process automation via valve islands or distributed automation systems such as feedback and control heads are subject to this requirement - whilst also reducing overall risk due to advanced diagnostics. Quality improvements can be achieved in both the end product and operating procedures.
Digitalisation for efficiency and sustainability
The use of digital system solutions such as for WFI loop batching ensure for automation, accuracy and repeatability, meaning that perfectly coordinated formulations are produced. Furthermore, total costs fall considerably due to the use of turnkey sub-systems, speeding up the implementation of projects. Operating costs can consequently be reduced by optimising processes and reducing product losses. In addition, progressive energy and waste management considerably improves environmental targets.
Smart Bürkert solutions for manufacturing pharmaceutical ingredients
The challenge: consistently high water quality - regardless of the quality of the inlet water.
The Bürkert solution: broad portfolio of control and measuring technology for utility water management backed by skilled experts and standardized offering. For example our state-of-the-art type 8906 online analysis system and its analysis sensors mean that the inlet water can be continuously monitored in an efficient manner, therefore ensuring the required water quality.
The challenge: automatic dosage of ultrapure water from WFI loops whilst satisfying the most stringent hygiene requirements to ensure process reliability.
The Bürkert solution: modular sub-systems for point of use for flexibly designed batching solutions consisting of a controller, valve and sensor - all from a single source.
The challenge: ensure process reliability and process efficiency.
The Bürkert solution: Process safety is ensured by direct safety integration, FLOWave and the matching valves. Process efficiency is ensured, for example, by media changes that are recognised quickly. This allows for acceleration of processes.
The challenge: flexibly implementable automation solutions - even in explosive environments - to increase process stability and enhance product quality.
The Bürkert solution: Bürkert is the only supplier with the comprehensive portfolio of valve islands and automation units for the realization of decentralized and distributed automation concepts - and can therefore provide neutral advice.
The challenge: avoid waste in order to protect environment and resources.
The Bürkert solution: compact system solutions with the lowest possible dead volumes reduce the risk of contaminated ultrapure water. This means the waste of WFI water, which requires a lot of energy to produce, can be reduced.
The challenge: reduced CO2 emissions for maximum sustainability.
The Bürkert solution: innovative tube valve bodies, produced in a resource-friendly manner, ensure sustainable production processes and offer potential to save energy. In addition, benefit from accelerated processes thanks to quicker heating up/cooling down.
The challenge: customised control cabinets that are suitable for the specific requirements of the application.
The Bürkert solution: decades of experience in control cabinet construction enables realisation of customised control cabinet solutions for your application - even in explosive environments.
The challenge: full control of the pressure in the mixing tank.
The Bürkert solution: our compact system solution for fully automated shielding gas overlay ensures the highest levels of process reliability and safety, and therefore maximum productivity.
Bürkert Systemhaus – open for your fluidic challenges in the manufacture of pharmaceutical ingredients
Benefit from the know-how of the fluidics specialists at Bürkert: you will work more efficiently with our digital fluid systems and modern measurement technology for the manufacture of pharmaceutical ingredients. We listen, analyse and develop forward-looking solutions up to series production. You and your projects are always welcome in the Systemhaus – on site, by phone or virtually.
Measurably safe, measurably efficient
Measuring, controlling, regulating – our highlights for the manufacture of pharmaceutical ingredients (APIs)
AirLINE Ex – electropneumatic automation system for use in potentially explosive areas
- For use in potentially explosive areas (Zone 1/21)
- Developed in cooperation with Siemens
- Electrical connection via PROFIBUS® DP-is, electrical I/O functions via Siemens SIMATIC ET 200 iSP™ module
- NEW REV.2 makes new integrable functions like pressure sensor or pressure switch possible
2/2-way diaphragm valve with pneumatic stainless steel actuator (Type ELEMENT) for decentralised automation
- Valve body and diaphragm are available in various materials and variants
- Wetted surfaces from Ra ≤ 0.38 µm...≤ 1.6 µm (optionally electropolished)
- Available in all common connection sizes and variants
From practice: smart Bürkert solutions for the manufacture of active pharmaceutical ingredients
Find out more about our products and solutions – or speak directly to our experts.
