Milling Process How a Hammer Mill Fulfills the Quality Demand of a Pharmaceutical Company
The mindset in R&D departments of pharmaceutical companies has changed. There is no longer a question of finding the right machine, but rather adapting the machine to the process and the product to the customer. Read this article about a modified hammer mill, which provides reproducible results under stable process conditions.
According to a study by Ernst & Young in 2012, the world's 19 largest pharmaceutical companies invest nearly 70 billion euros in research & development. There are about 200 projects in clinical development at the pharmaceutical giant in Switzerland. A few points are presented about the new challenges faced by pharmaceutical companies at the conclusion of the study: “Product demand has historically been determined by the physician. Patient product forums have an increasing influence on competition. This transparency leads to increasing price pressure.”
The comment by Dr. Hartmut Klocker, the head of VSS Pharma Siemens, may provide a direction to suppliers to the pharmaceutical industry on how they can respond to increasing price pressure: “The demand for so-called multi-purpose systems to manufacture several substances in one system will increase.” The benefits of a flexible system in the production of very small and small volumes should be shown in a project which has been co-developed by Debiopharm and Frewitt in a collaborative partnership.
The change in the pharmaceutical industry has led to a change in perspective for all participants: In the past, the majority of people at Frewitt discussed machines. Today, processes and the customer´s products are the key areas of focus. That does not make things easier, but does make the issue more exciting. The process is designed during development to be able to avoid quality deviations. Understanding critical quality attributes and process parameters can lead to better control of production processes. Design of experiments (DoE) has become an indispensable tool in determining the relevant process parameters in many cases.
This led Frewitt to a project whose purpose is suggested in the title of this article: Debiopharm, a developer and manufacturer of medicines in the areas of oncology, immunology, metabolic and infectious diseases, contacted Frewitt managers during 2012. Following the first few discussions at a congress, meetings were held to discuss the possibility of changing the Hammerwitt mill to meet customer needs. The machines should be operated under stable process conditions and small quantity (50 g) manufacturing should be reproducible. A further requirement was a modular design for easy assembly and disassembly.
Stable Process Conditions
The term “stable process conditions” is used often in chemistry where reactions must be run at a controlled, stable temperature, and in metallurgy, where the temperature must be raised in a stable manner. A stable temperature increases the precision of the workpiece, thus decreasing rejects. In Debio-pharm's case, the product temperature needed to be stabilized below 0 °C in order to ensure stable flow characteristics and product moisture contents.