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Micronisation

Micronisation (ultra-fine milling) involves the reduction of particles to a size of less than 10 μm, using special milling processes. This can be used, for example, to increase the solubility or bioavailability of active pharmaceutical ingredients and excipients. GfM has fifteen 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 air jet mill. The processing is undertaken under clean room conditions: Class A for sterile products, or otherwise under Class C. Activated charcoal-filtered, sterile filtrated, cooled, oilfree compressed air, nitrogen 5.0 (pharmaceutical quality) or an inert gas atmosphere are provided during micronisation. We can handle light-sensitive products by using sodium vapour light just as safely as those requiring cooling. Each chamber has its own material and personnel locks and is structurally completely separated from other chambers. In order to rule out cross-contamination, after each production we additionally conduct a verification of the cleaning result, for instance by swab or rinse testing. To ensure that we deliver an absolutely pure product to you, all our chambers and locks have been lined with pharmaceutical quality walls.

Permanent monitoring of room temperature, humidity and positive chamber pressure guarantees consistent production conditions while the results of monitoring are documented. Activated charcoal-filtered, cooled, oil-free compressed air, nitrogen 5.0 (pharmaceutical quality) or an inert gas atmosphere are provided during micronisation. We can handle light-sensitive products by using sodium vapour light just as safely as those requiring cooling.

Batch by batch with consistent top quality
is our motto for quantities ranging from a few grams to several tonnes. Even the smallest amounts of your valuable development products are in the best possible hands in our laboratory and pilot plant systems. Our standard minimum degree of fineness after micronisation is ≤ 2 μm (depending on raw material characteristics). We produce extremely detailed documentation to record the course of processing and the analyses of each product. From receipt of materials through storage, micronisation, sampling, analysis, labelling up to dispatch, monitoring, everything is performed strictly in accordance with GMP, PIC and CFR requirements.