This year at CPhI, Micro-Macinazione is presenting two new proposals.
Micro-Macinazione has more than 40 years of experience in micronizing pharmaceutical active ingredients. We use our own engineering competencies in designing and manufacturing jet mills and containment systems (glove-box isolators) for internal use and for international sale. We offer a consolidated knowledge in particle size design, which can be applied in the development of pharmaceutical dosage forms.
cGMP contract micronization
We have two separated manufacturing sites (one mile distance), both regularly inspected by FDA and Swiss Medic and certified by Japanese authorities.
We have 21 spiral and seven opposed jet mills installed, together with a number of rigid and flexible glove-box isolators, according to the product’s containment requirements. Any product is classified before processing and a suitable containment system to be used is determined. Installations for micronizing products with an OEL of <1mcg/m³ are currently available.
We offer jet mills of different sizes, where we can process from milligrams batches up to tons of an API. We have dedicated facilities for steroids and a high barrier containment system for handling cytotoxic compounds.
We are able to perform micronization in cryogenic conditions (liquid nitrogen), which can be applied to certain APIs for stability reasons or for managing the solid state during particle size reduction.
Quality assured contract micronization services
Quality is an integral part of our activities and significant resources are devoted to it. The quality system in place ensures that every process is under control, in terms of people training, documentation, equipment qualification, process validation and cleaning.
We think that the favorable results of the inspections by the pharmaceutical authorities (FDA, Swiss-Medic) can be considered a good sign of our quality compliance. As a contract service company, we are weekly exposed to audits by our customers, so that our quality system is continuously under examination.
Particle size analysis and materials characterization
Facilities are available at both sites for monitoring particle size reduction. For this purpose, QC labs are equipped with a range of analytical techniques, mainly based on laser diffraction (wet and dry methods). Additional valuable information on the physical properties of a product can be provided.
Our QC team has knowledge and experience to develop and validate analytical methods according to the standard quality procedures, which include analytical transfer studies based on customers’ requests.
Containment systems for contract micronization
We have a consolidated engineering expertise in developing containment systems, which are used in our cGMP contract micronization facilities or manufactured on request of customers for containment purposes (not only for micronization). In this area, we have developed our own engineering solutions for the containment of highly actives during the micronization process and for flexible containment in powder transferring.
SMEPAC test procedure is regularly applied to verify the containment level.
Sterile micronization of APIs
We have gained experience in the design and manufacture of containment systems for sterile micronization of APIs and for aseptic handling of sterile material. We offer our capability to micronize active pharmaceutical ingredients, maintaining the sterile chain.
Nanoparticles production unit
To get a particle size below 1µm, we offer a nanoparticles production unit, based on the super critical fluid (SCF) technology. After a feasibility study at laboratory scale, a fully cGMP plant is available for running atomization by SCF precipitation. Because of its high barrier isolation, the plant is suitable for HAPI handling and also for sterile processing.
Jet mills and isolators
In our independent engineering building, we manufacture spiral / opposed jet mills and rigid / flexible containment systems which are designed for internal use or tailor-made for our customers and sold worldwide.
The design and manufacture of our equipment is ISO 9000 certified and our engineering team (20 people) includes experts for equipment qualification and for the FAT / SAT activities.
More than 300 installations have been marketed so far in the world.
Particle size design and preformulation studies
We offer our expertise in particle size design to assist our customers in solid state characterization of a product during the pharmaceutical development phase or in the process optimization.
We are often involved by customers in the micronization of trial batches of NCEs, where particle size and the process are to be defined, taking into account the biopharmaceutical profile of the API.
New approaches to micronization are being studied (e.g. co-micronization), in relation to specific preformulation projects.
Established in 1970 as an engineering company manufacturing and selling jet mills, we expanded our competences in pharmaceutical contract micronization service. We are the leader in Europe for our micronization capacity (over 1,000t/year) and are unique in offering a synergic activity between our micronization service and our engineering department, taking advantage of their interaction and exchange of knowledge.