Insitec particle size analyzers allow milling processes to meet specifications
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Case study: Contract Pharmaceutical Milling, Increasing the yield from valuable feed materials

Interview with Hubert Müller of Siemens Axiva GmbH

Insitec helps provide milling results without a delay
Insitec helps provide milling results without a delay

Hubert Müller is a member of the Axiva solids processing group and head of the department for dedusting, sieving, sifting, milling and micronization. "Our team has 6 members. With the help of our experimental equipment we can undertake all kinds of investigations. In addition, we have a complete infrastructure for solids and powder handling. To design processes involving solids treatment, it is necessary to carry out experimental work. This applies to all kinds of products, whether chemicals, pharmaceuticals or polymers."

What is Axiva?

"With annual sales of around €77 million in 1999 and a workforce of about 570, Siemens Axiva GmbH is a leading supplier of process engineering services. Siemens Axiva assists its customers in the process industry, particularly in the chemical and pharmaceutical sectors, with the design, development, construction and optimization of individual production processes. Siemens Axiva offers its customers a wide range of services in all areas of technological development and implementation, project management and process consulting. We adapt flexibly to the starting point of each customer - from development of individual process steps to comprehensive optimization of entire commercial processes.

The company headquarters is in Frankfurt am Main. In addition, the company runs an office in Shanghai (China). Siemens Axiva was formed by the restructuring of the former Hoechst AG. The Siemens Automation and Drives Group (A&D) acquired a majority shareholding in Axiva to build up its strength in the field of process engineering for the chemical and pharmaceutical industries.

For more information please visit our homepage at www.axiva.com".

Does Axiva work with powders?

"Siemens Axiva has various technology groups, which operate all kinds of chemical production steps. One of these groups is the solids processing group. This handles all solids processing steps such as drying, crystallization, granulation, dedusting and micronization. The activities of the group cover process development, optimization of existing production plants and sample provision (of new and modified products)".

How does Axiva use on-line particle sizing?

"We have been using the Malvern Instruments Insitec (In-Process Particle Size Analyzer) for five years now. It is installed in our GMP room for the micronization of drug substances. These materials are very valuable and it is important to reach the desired particle size as fast as possible. With the help of the Insitec, we obtain the result of the milling without any delay. Thus we can react and adjust the milling parameters very quickly.

With some small changes, the Insitec was adapted to clean room requirements. The flexible hose was replaced by a pipe with smooth surfaces. The PC is installed outside the clean room and operated with an infrared keyboard and mouse.

With the help of the Insitec, we achieve our aim of running the mill so that it meets the specification all the time. No product is lost because the particle size misses the specification. We control and document the milling process continually and not just for a moment as you do when you take a sample. That is very important in terms of GMP".

In summary

"Using the Insitec, we save a lot of time and money because the correct milling parameters are found very quickly. This is extremely important because in our case the product very often varies. The yield of the mill was increased. We no longer have the problem of products missing the specification when the mill is started or stopped. These pharmaceutical products are very valuable so each gram saved is a real gain. In short, we can perform much better in a sector where high quality is crucial".