What were the challenges to be solved and what specific benefits were achieved?
Fast, efficient, high-quality, sustainable: Pfizer's "continuous production technology" (CMT / Continuous Manufacturing Technology) is based on its own development for tablet and capsule production. Around 50 million Euros have been invested in the development and technical adaptations at the plant in Freiburg. Pfizer is the first major pharmaceutical company using continuous production - it was previously only used in the food industry.
Lengthy laboratory were abolished thereby. The result was a manufacturing facility in the sense of “industry 4.0”: highly automated, regulated, monitored and controlled by a state-of-the-art, digitized technology and networked computer systems. Adapted visualization systems (Pro-Vid; VINCC) allow employees to easily monitor and control these complex systems in the simplest visual way. This ensures that all phases of the production cycle of a drug are documented and monitored - from the delivery of the raw materials to the distribution of the final product to the market.
In close cooperation with regional universities and industrial companies, we have developed and built the world's first plant based on the concept of continuous production in the pharmaceutical industry. "Pfizer Germany and the Freiburg plant are thus the technology leader in the production of drugs in an intelligent production environment according to Industry 4.0 standards," says Peter Albiez, Chairman of the Board of Pfizer Germany
How can the Industrie 4.0 approach be described?
Continuous Manufacturing Technology (CMT) - a new process flow in three steps:
Supplying: In the future, the active ingredients and auxiliaries will be made available in very large containers, so called "big bags", and can be used directly in production without further intermediate steps. The big bags were developed by Pfizer and have a quality control window. Manual sampling is no longer required.
Dosing: The active ingredients and auxiliaries are fed into the production process via a fully automatic conveyor system and precisely dosed according to the drug composition.
Mixing: A mixer unit mixes the active ingredients and excipients to a homogeneous mixture, which can be further processed in capsule filler for example. The throughput rate of the continuous mixer ranges from 5 to 1000 kilogram per hour. With this high level of flexibility, we can respond quickly to market demand. We use it to produce what the patient needs. One of the core components of continuous manufacturing is the online quality measurement using process analysis technology (PAT). It integrates quality assurance into the ongoing process and thus ensures the transparency of information. Through the use of digitization, 100% traceability and online monitoring of material transport is possible all the time.
What could be achieved?
The plant in Freiburg relies on Pfizer’s development work in Groton, Connecticut, USA. This is where the substances for the production of clinical samples and market goods, that are developed and produced in Freiburg, come from. The conception of the implementation design for the research and development scale into an industrial scale was carried out in cooperation between the Freiburg plant, professors and students of the universities of Offenburg, Freiburg and Sigmaringen and industry partners.
What can others learn from it?
One of the success factors are the international and national cooperation between the Pfizer locations as well as science and industrial partners.