MICRONIZATION

Micromacinazione has experience in the micronization process with more than 1000 different APIs and handling of more than 200 active ingredients every year.

 

Micromacinazione has 37 cGMP jet mills available, both Spiral / Opposite and Pin Mills. Capacities to micronize batches from a few grams to tons of APIs are offered from our Contract Micronization department. Dedicated areas for steroids and a high containment system for handling of HAPIs are also available.

 

Before processing, every product is evaluated by our HS&E department and a suitable containment system solution is assigned according to the OEL. We are currently revamping our complete production facilities and are implementing a Banding and Product segregation system.

Installations for micronizing products with an OEL ≥200 µg/m³ are also available. Micromacinazione has a number of rigid and flexible isolators to match the containment requirements of the products.

We are able to perform micronizations in cryogenic conditions (-60°C), product conditioning and sieving.

 

Thanks to its skilled team of engineers, Micromacinazione offers a micronization service using equipment adapted to the properties of the product, to improve the performance of each unit.

CLASS 1 API WITH OEL ≥ 100 µg/m³

Open Jet Mill configuration.

CLASS 2 API WITH OEL < 100µg/m³

Flexible Isolator configuration.

CLASS 3 API WITH OEL < 10µg/m³

Flexible Isolator configuration.

CLASS 4A HAPI WITH OEL < 1µg/m³

Glove Box configuration.

CLASS 4B HAPI WITH OEL < 0.1 µg/m³

High Containment Glove Box configuration.

TECHNOLOGIES

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Spiral Jet Mill

 The Jet-Mill generates a supersonic speed vortex into which the material is introduced, utilizing the vacuum created by a venturi-nozzle.

Each particle of material being carried in the air stream is therefore subject to centrifugal and radial forces. The micronization occurs via particle collision.

A static classifier determinates the particle size profile.

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Opposed Jet Mill

The opposed Jet-Mill generates a high energy micronization zone into which the material is introduced across a double valve system creating a fluidised bed.

Each particle of material being carried in the fluidised bed is therefore subject to shear forces, the micronization occurs via particle collision.

The particles directed towards the exit of the mill are selected by a dynamic high speed classifier, which determines a centrifugal field and hence the exit PSD.

Coarse particles are recirculated inside the mill and return to the micronization zone.

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Pin Mill

The pin mill is an equipment for the grinding of medium-fine PSD (30 microns~1 mm).

The grinding is achieved by passing the product through two disks, one of which rotating, both with concentric pin circles and interchangeable depending on the requested particle size.

The distance between the individual pins, together with the quantity of dust inside the chamber at a certain moment (capacity) and the rotation speed of the disks, are the main parameters of the process.

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Cryogenic Micronization

Although if jet milling is a heat free process, certain compounds need to be cooled during micronization due to their low melting point or to avoid the phenomena of polymorphisms.

Micromacinazione offers the possibility to micronize under cryogenic conditions thanks to a heat exchanger that cools the Nitrogen gas that is used as a micronization fluid.

A temperature of -60°C can be reached in non-GMP conditions.

Conditioning

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Conditioning

Jetmilling, depending on the level of grinding energy, could induce amorphous regions on the surface of the material. Issues with respect to particle growth may arise in those instances when the recrystallization of the micronized material proceeds in an uncontrolled manner.

Micromacinazione can offer a conditioning step following the micronization in order to improve the physicochemical stability of the material. During this process, the amorphous parts are converted into crystalline solids under storage conditions that are relative humidity and temperature controlled.

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CIM

The opposed Jet-Mill generates a high energy micronization zone into which the material is introduced across a double valve system creating a fluidised bed.

Each particle of material being carried in the fluidised bed is therefore subject to shear forces, micronization occurs via particle collision.

The particles directed towards the exit of the mill are selected by a dynamic high speed classifier, which determines a centrifugal field and hence the exit PSD.

Coarse particles are recirculated inside the mill and return to the micronization zone.