Gesellschaft fur Micronisierung - Micronisation and Refining of Active Pharmaceutical Ingredients

Since it was established in 1985, Gesellschaft fur Micronisierung (GfM) has experienced continuous growth and become an innovative, owner-managed company. Our employees are specialists in their fields, receiving regular internal and external training, and will micronise and refine your active pharmaceutical ingredients, excepients and carrier substances (standard micronisation and sterile micronisation).

Throughout the world, numerous satisfied customers have come to appreciate our flexibility, long standing experience and our adherence to the highest quality and safety requirements. We regard the future and even the most unusual customer request as just another challenge, which we are happy to meet.

Micronisation and refining services

GfM's services include:

• Micronisation
• Homogenisation
• Blending
• Micronisation under aseptic conditions
• Sieving
• Analysis of practical size using laser particle analysis (including Malvern, particle sizing, dry and wet)
• Microscopic image analysis
• Identity testing (FT/IR)
• Water content analysis using Karl Fischer technology
• Surface analysis (BET)
• Scanning electron microscope (SEM) analyses
• Sieve analyses
• Chemical and microbiological purity analysis of raw materials and finished products using PhEur methods
• Transport service for your products

Micronisation – particle reduction sizing

Micronisation (ultra-fine milling) involves the reduction of particles to a size of less than 10μm using special milling processes. This can be used, for example, to increase the solubility or bioavailability of active pharmaceutical ingredients and excipients.

GfM has 15 clean-room chamber systems available to process your active pharmaceutical ingredients (APIs) and pharmaceutical excipients. We identify your product to one of our product groups and then micronise it in chambers specially reserved for these product groups, using a state-of-the-art jet mill. The processing is undertaken under clean-room conditions: Class A for sterile products, or otherwise Class C.

Sterile micronisation

Even sterile products can be micronised under clean-room conditions. There is an adherence to all requirements regarding room and equipment sterility, personnel, monitoring and documentation, including for purity of air/nitrogen atmosphere.

Product sterilisation and sterile micronisation

GfM has been working for well-known pharmaceutical companies in the field of product sterilisation for many years. In this context, we use hot air sterilisation (the method specified by European Pharmacopoeia). After sterilisation your product can either be sterile-packaged and returned to you or subjected to a sterile micronisation process to achieve your desired particle size distribution.

Particle size analysis

The stability, chemical reactivity, flowability, tensile strength, etc. of many materials are significantly influenced by the size and properties of the particles they contain. Measuring the particle size is therefore a vital parameter for our process.

Our test methods include the use of laser granulometers (Malvern/Cilas), microscopic particle size analysis, particle size measurement by means of sieve analysis, surface analyses using BET and REM techniques.

Moisture content analysis and purity testing

Furthermore, we provide analyses of other parameters such as moisture content and FT/R analyses or chemical as well as microbiological purity testing according to PhEur. We can also offer these services on an individual basis.

Our highly qualified personnel are always available to provide help and support to our customers and contacts.

Certified quality

Our company holds a manufacturing licence pursuant to AMG 13, has been GMP-certified according to EU directive 2001/83 and is FDA-approved. GfM was recently also accredited in Japan. These distinctions serve as proof of our high level of quality assurance, which we have established over our many years of operation.