Continuous production is steadily gaining momentum as a practical strategic option for pharmaceutical manufacture — The market is actively looking for technical solutions and equipment manufacturer Glatt presented a new continuously operated process system at Achema which addressed the topic of Traceability and showed a solution which guarantees the operator a high level of pharmaceutical safety.
Continuous production is slowly but surely coming to the pharmaceutical industry. Pharmaceutical process equipment suppliers have done their homework and are poised strategically with devices and systems to meet the growing demand. For a while Glatt observed the market and then launched its engine of development to present a continuous system, which will further boost the market.
The Glatt continuous manufacturing solution is called Modcos (Modular Continuous System). The system offers flexible configuration and what was exhibited at Achema consists of dosing feeders and a dry mixer for powder or microgranulates followed by granulate production, drying in a Glatt fluidized bed system with the new rotary chamber followed by a tablet press, which can be supplemented with an extra a dry mixer if required.
The system has a supervising control system with PAT for (critical) quality attributes or process parameters such as particle size and moisture. Development manager Dr. Jochen Thies explains that while Glatt is a little late to the field of continuous production for pharmaceuticals: “Based on longstanding experience from other industries, for example food and fine chemistry, the topic of continuous production is not new for Glatt.”
Continuous Fluidized Bed Processes
The sister company Glatt Ingenieurtechnik located in Weimar has been engaged since 1981 in the use of continuous fluidized bed processes in fine chemical products and food production. And more than ten years back, Glatt developed a three compartment, quasi-continuous fluidized bed system together with the pharmaceutical institute of Basel University and Swiss pharmaceutical company.
The system was a technical success and was produced in Basel for a long time but was not heavily adopted as the pharma industry were just not ready for continuous manufacturing back then, states Thies who is the pioneering figure when it comes to continuous production. It was an experience which the company from Binzen shared with the developers from other companies. Today the situation has changed dramatically.
Today it is about the competition from emerging markets, shrinking margins, increasing quality requirements, warning letters and patient safety. In the USA there are already continuously operated process plants approved by FDA and slowly this trend is coming to Europe. The turning point can be marked by the construction of the CMT-system in Freiburg: For the recent ground-breaking development, Pfizer rolled out the red carpet.
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