Micronization is a cutting-edge technique that allows the particle size of API, High Potent or an excipient to be reduced.
Micronization is nothing more than a mechanical reduction of a coarse solid material into smaller particles to obtain biopharmaceutical or technological advantages.
The process proceeds by introducing the material into a micronization chamber through a high pressure gas flow.
The particles of material dragged by the fluid at very high speed undergo variations in speed and direction also due to the geometry of the chamber, colliding with each other.
As a consequence, their dimensions are reduced to values predefined by the process operating conditions.
The Milan-based company, since 1973, has specialized in the micronization of active ingredients and excipients for the pharmaceutical industry and has performed out-sourcing activities for the micronization of pharmaceutical powders.
This position, achieved through the vast experience gained over the years, puts IMS SRL as a supplier of Pharmaceutical Chemical Laboratories in Europe.
Our mission is to offer a service, realizing custom-made process solutions, which means that they are customized according to the demands and needs of each client.
In fact, thanks to the continuous research of new technologies, IMS can propose and elaborate made-to-order projects according to the specific needs of its Partners, guaranteeing maximum support during all phases of evaluation, production process, analysis, and after-sales.
IMS’ core competence in this area is the ability to evaluate and determine the best solution for the micronization of an active ingredient or excipient (API, HPAP) by organizing the testing and experimentation for a specific product.
Product processing – considering the complexity of the production and the formulation requirements necessary to produce a drug that complies and fully meets regulations – is carried out by IMS SRL in a careful and meticulous manner.
Because of this, the company operates by giving utmost attention to:
For this reason, the micronization of active ingredients and excipients requires experience, knowledge, and professionalism.
This is why IMS SRL, with its multi-year activity in the field, has made its way over the years by becoming a synonym of reliability, guarantee and competence for its customers.
Feasibility Studies / Quality by Design Services
Batch size: 10 gr – 50 gr
Timelines: about 2-3 days
Development of granulometric analytical methods,
Solid state studies
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.
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. 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.
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.
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:
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