Share via email
Some fields are missing
send eMail

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.

Systems with Logix 5000™ controllers – How you can massively speed up parametrisingSystems with Logix 5000™ controllers – How you can massively speed up parametrising

Add-on profiles considerably speed up the configuration and parameterisation of EtherNet/IP-based components in systems with ‘Logix 5000™’ automation solutions by Rockwell Automation. This saves valuable time for system constructors and integrators after device replacement and when recommissioning complex systems. At the same time, they are supported by helpful functions during configuration and parametrising, which reduces susceptibility to errors and creates significant free space. Find out more in our whitepaper.

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.  

Everything from a single source

From the complete control loop, in which we combine actuators and sensors, to the sub-system or control cabinet solutions – we offer a broad portfolio and the ability to combine it. In addition, you benefit from a single point of contact for all topics.

Reliable processes

You’re on the safe side with Bürkert - whether it is due to solutions for explosive environments, traceability and seamless documentation, or for complete monitoring of your process thanks to a wide range of diagnostic options.

Process automation

Bürkert’s comprehensive portfolio that supports the industry-leading communication protocols and common automation concepts, as well as the user-friendly operation and easy integration of components and systems optimise your processes - even in areas at risk of explosions.

 

Smart Bürkert solutions for manufacturing pharmaceutical ingredients

Purified Water & Steam
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.
Batching
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.
CIP
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.
Process automation
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.
Plant Efficiency
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.
Sustainable Manufacturing Process
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.
Control Cabinet Construction
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.
Safety Integrity
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.

  • Manufacturing ideas

    Experienced consultants, qualified industry specialists and dedicated engineers work directly with you to develop a solution for your requirements for automation processes. Thanks to our network of five Systemhaus locations in Germany, China and the US, you can rely on flexible and efficient project management – from the initial idea to the implementation of solutions for process optimisation in the manufacture of pharmaceutical ingredients.

    Directly to the Systemhaus

Measurably safe, measurably efficient

Steam savings in SIP processes

53 %

Up to 53 % steam savings in SIP processes due to innovative tube valve bodies for diaphragm valves.
 

Compact control cabinets

45 %

Up to 45 % more compact control cabinets thanks to the smart installation concept and greater integrated range of functions of the Bürkert valve islands.
 

Detecting media changeover

66 %

Up to 66 % less loss of product due to accurate detection of media changes via FLOWave.
 

Measuring, controlling, regulating – our highlights for the manufacture of pharmaceutical ingredients (APIs)

Type 8098

FLOWave SAW flowmeter

Type 8098
  • No obstacles inside the measuring tube, compact, lightweight and low energy consumption
  • Conforms to hygienic requirements, CIP/SIP compatible
  • Ideal for liquids with low or no conductivity
  • Digital communication, parameterisation via Communicator, display
  • Optional: ATEX/IECEx certification, II 3G/D
Type 8650

AirLINE Ex – electropneumatic automation system for use in potentially explosive areas

Type 8650
  • 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
Type 2103

2/2-way diaphragm valve with pneumatic stainless steel actuator (Type ELEMENT) for decentralised automation

Type 2103
  • 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.