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Industry 4.0: Pfizer opens continuous manufacturing plant in Freiburg

On 23rd May 2017, Pfizer officially opened a modern continuous manufacturing plant in Freiburg, thus setting a new technological standard for tablet production. A groundbreaking ceremony to inaugurate Pfizer’s new PCMM plant was held at the same time. Pfizer is investing around 50 million euros in the Freiburg facility.

The continuous manufacturing technologies (CMT) plant, which was officially opened in May 2017, carries out incoming goods inspection, weighing, dosing, container handling and cleaning all fully automatically. © Pfizer

The core of the modern manufacturing plant is what is known as continuous manufacturing technology (CMT). CMT enables individual manufacturing steps – from the delivery of raw materials to shipment of the finished product – to be added into an overall process without interruption. This is made possible by a technology developed by Pfizer called continuous mixing. A special mixer unit blends all active ingredients and additives into a homogeneous mixture. The new facility helps Pfizer save time, reduce possible sources of error and improve quality. “In close cooperation with regional universities and industrial enterprises, we have developed and established the world’s first CMT facility in the pharmaceutical industry. The step into continuous manufacturing according to Industry 4.0 standards has made Pfizer Deutschland and the Freiburg Pfizer site technology leaders in pharmaceuticals manufacturing,” says Peter Albiez, CEO of Pfizer Deutschland GmbH at the inauguration ceremony.

Glossary

  • Desoxyribonucleic acid (DNA) is a double-stranded, helical macromolecule encoding the genetic information of an organism.
  • Alzheimer's disease (also called Morbus Alzheimer) is a slowly progressing dementia that manifests itself in an increasing reduction of brain functions. This disease mainly affects older people. It is primarily caused by intracellular deposits of a fragment of amyloid precursor protein (APP). This leads to a proceeding loss of neurons and therfore to a loss of brain mass. At the beginning of this disease, the concerned people only show a marginal obliviousness. In later stages, speech, the ability to reason and memory are mainly affected. In the end, the concerned people lose their entire sanity and personality.
  • Good Manufacturing Practise.
The use of big bags helps halve the use of trucks for the delivery of raw materials. © Pfizer

The new CMT facility involved re-designing the entire production schedule and material flow. It is now possible to deliver the starting materials for tablet production in big bags weighing between 500 and 1,000 kg. This helps reduce the number of steps involved, including the transfer of raw materials to pallets and temporary storage on company premises. These big bags are constantly tested for purity and homogeneity during the entire process to guarantee consistent product quality using innovative methods based on near infrared (NIR) spectroscopy. “Ensuring the homogeneity of the material was one of the biggest barriers when switching from conventional batch production to continuous manufacturing,” says Dr. Axel Glatz, manager of the Pfizer site in Freiburg.

Hermann Gröhe, the German Minister for Health, who received a special invite to the opening ceremony, emphasised the importance of pharmaceutical research and production in Germany: "I am not sure that everyone sees self-driving cars in a positive light. However, I am pretty sure that everybody likes the fact that we can study and treat diseases such as Alzheimer's. With its new production facility in Freiburg and its cooperation with many regional companies, Pfizer is sending a strong signal that Germany is a location with a strong focus on pharmaceuticals production.” Healthcare is an important part of the economy of the city of Freiburg. Freiburg’s Lord Mayor Dr. Dieter Salomon summarises: “Health and sustainability are the DNA of the city of Freiburg.”

PCMM – a new technology that makes drug production more flexible

Expansion of the Pfizer manufacturing site in Freiburg - Hermann Gröhe, German Minister for Health, and Dr. Dieter Salomon, Lord Mayor of Freiburg, at the groundbreaking ceremony in Freiburg (from left to right: Dr. Clemens Stief (PCMM project manager), Lord Mayor of Freiburg Dr. Dieter Salomon, Dr. Kirsten Lund-Jurgensen (Executive Vice President Pfizer, New York) German Minister for Health Hermann Gröhe, Peter Albiez (CEO Pfizer Deutschland), Dr. Axel Glatz (site manager), Dr. Axel Knoch (head of Product and Process Development). © Pfizer

On the 23rd of May, the groundbreaking ceremony for the inauguration of a new production plant based on a technology known as PCMM (PCMM: portable, continuous, miniature and modular) was also held on the Pfizer company premises in Freiburg. “Our PCMM plant enables us to accelerate the development of highly potent drugs and make new drugs available to patients faster,” said Dr. Kirsten Lund-Jurgensen, Executive Vice President and President Pfizer Global Supply.

Closed manufacturing units – cleanroom for highly potent medicines

Safety and quality have top priority as far as the production of tablets and capsules is concerned. New drugs, for cancer treatment in particular, are highly “active”. While the CMT plant that was put into operation in May 2017 will generate large volumes of powder mixtures which are subsequently processed into capsules, the PCMM plant will be used for the fully automated production of tablets. This plant is so small that it can be accommodated in a large meeting room and is suitable for producing smaller quantities for clinical and stability samples. However, it is also suitable for producing larger quantities for commercial use. The PCMM plant is expected to open in mid-2018.

The first PCMM plant will most likely go into operation at Pfizer's company site in Freiburg. © GEA

The core of the PCMM plant is the continuous mixing technology developed by Pfizer, which is also used in the CMT plant that opened in May. The PCMM plant is a closed and fully automated manufacturing system enabling continuous and flexible manufacturing processes that will produce up to 30 kilogrammes of tablets per hour. The individual manufacturing steps from weighing, mixing and granulating to tableting are carried out fully automatically. Conventional production requires several devices in different rooms as well as successive work steps. During intermediate stages, a complex transport system is required for powder mixtures and granules. The modular wall system of the PCMM plant ensures that there is a cleanroom environment that corresponds to GMP standards (GMP: good manufacturing practice). This further increases product safety and quality.

Continuous scale-up: run time determines quantity

Thanks to continuous production, complex steps are no longer required to transfer the manufacturing process to a larger scale. The so-called scale-up can be achieved by way of the lifetime of the plant. Production times can be shortened and flexibly adapted to changes in drug quantity requirements. This makes it possible to process orders with volumes of up to 5,000 kilograms. The system runs for two weeks without interruption. The plant is only ever stopped to allow authorities to identify individual orders, known as batches.

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