Micronization

WHAT IS MICRONISATION?

What is micronization?

Micronization is an advanced technique that allows to reduce the dimensions of particles of an active pharmaceutical ingredient or an eccipient.

How is micronization carried out?

The material is injected under high pressure in a griding chamber using gas flow ( compressed air or nitrogen). The particles of the material dragged by the flow at very high speed, due to the geometry of the chamber, are subjected to speed and direction variations with auto collision and consequent dimension reduction to values settled by the operative condition of the process.

Why micronization is used?

Micronization is used to follow the particle size requirements for the active ingredient and /or excipients, necessary to fit the formulation parameters on the final dosage form.

OUR OFFER

1- Feasibility Studies

Batch size: 10 gr – 50 gr

Apparatus: labmill

Timelines: about 2-3 days

2- Scale -up

Batch size: 100 gr – 10 kg

Apparatus: jet mill Ø 100, 200mm (4, 8 inch)

Timelines: about 1 week

3-Full production

Batch size: 1Kg – 1000 kg

Apparatus: jet mill Ø 100, 200, 300 mm (4, 8, 12 inch)

Timelines: 1-2 weeks

4-Analytical services

Our equipment

To meet our customer’s needs, IMS can counts on a large number of GMP qualified equipment, just to guarantee the top flexibility for quantity and/or activity. We can offer our services starting from few grams to 15Kgs in Glove Box isolator.

Request from R&D labs can be complied thanks to a new Ø 4” equipment for 1 or 2 gr. tests

We aim to quality:

A complex HVAC system regulates the temperature, humidity and overpressure inside the production department. The particle contamination in the production areas is Class 7 (at rest) according to ISO 14644-1 (10000 Federal Standard). To avoid cross-contamination each box and its own SAS have a dedicated air inlet and expulsion group. Each box has an independent conditioning system. In each system the air is introduced through the EU14 HEPA filters (eff. D.O.P. 99.999%). The air extraction takes place through grates with prefilter EU9 (eff. 95% calorimetry), and subsequently with EU13 filters (eff. D.O.P. 99.997%); lodged in a canister with bag in – bag out device. Each box is kept in depression respect to the SAS. This geometric arrangement has been studied with the aim to avoid cross-contamination and leakage of the dust from the system.
The compressed air generated by a compressor, is filtered, oil free, dried and distributed to the working areas through a stainless steel line Ø 3 “.
The liquid nitrogen is stored in a 30,000 liter tank.
After evaporation through the heat exchanger, it is distributed to the working areas through stainless steel line Ø 2 “. The gases are filtered before use through a HEPA filter. The system has been qualified and air and nitrogen quality is constantly monitored
In the CQ laboratory , where highly skilled and trained staff work, we can perform particle size powders analysis by dry and wet laser technique. Laboratory instruments and equipment are qualified and regularly calibrated. Powders can also be examined using optical microscope and the data collected are processed through an image analysis software. The quality of the micronized material is constantly monitored during the production process. QC establishes sampling plans and analytical methods to verify that products conform customer specifications. All laboratory tests are performed and documented at the time of performance, deviations from written procedures are documented and justified. Particle size analysis is conducted on each production batch by laser diffraction technique, particle size is performed on starting material, IPC and final product. To determine satisfactory conformance to established specifications .
Identified reserved samples of startingmaterial and representative of each micronized batch are retained for six years according to internal procedure. Analytical methods are validated according ICH2 and follow the customer requirements.
Quality Assurance carries out periodically self-inspections to check the strict observance to GMP and ISO, sets up the Quality system logics and philosophy , defines the procedures that regulates the Quality System.
All operations are documented in a quality assurance plan that requires that:
· processe, cleaning procedures and analytical methods are validated;
· Equipment, utilities and HVAC system, are qualified;
· All processes are fully documented.

Pharmaceutical plant

Production

apparecchiature

Analytical Laboratory

labo

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The company IMS  has extensive experience in the field of active ingredients and excipients micronization , with a large  portfolio of non-european and european customers.

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