Micro-Macinazione, a European specialist in the micronisation of active pharmaceutical ingredients, is expanding its production and storage capacity and establishing new safety standards
The Ticino-based company is investing CHF3m (US$4.67m) in a new banding system and constructing new production units for the micronisation of highly potent substances and cytotoxic products used to treat cancer.
Ultra-high safety standards (high containment) are required during the micronisation of highly potent active pharmaceutical ingredients (APIs) as production involves routine operations such as weighing, charging and discharging powders that are challenging and dangerous.
Employees, the environment and the product must be adequately protected at all times while, at the same time, production must be able to take place as efficiently as possible. ‘That is why we decided to establish a new control banding system,’ explains CEO Markus Arigoni.
In this process, each substance is assigned to a particular risk category. This defines the maximum concentration that may be present in the air, which ensures hazard-free product processing. Regular SMEPAC tests determine the concentration of airborne particulates. ‘This enables us to meet the very highest safety requirements at all stages of production,’ declares Giovanna Libralon, Head of Business Development.
Micro-Macinazione also has a production unit for the micronisation of highly potent substances and cytotoxic products used in the fight against cancer. ‘Our aim is to develop a new segregation strategy for certain pharmaceutical product classes and boost our production capacity in this area,’ says R&D Director Piero Iamartino.
To be able to meet growing customer demand, Micro-Macinazione is also investing in a new jet mill to process very large volumes of highly active ingredients. The new equipment is made of innovative material to improve its ergonomic profile and ensure containment of below 10µg/m3.
In addition, Micro-Macinazione is constructing a new storage facility at its Molinazzo di Monteggio location. This will provide an extra 500m2 of storage capacity for non-micronised and micronised materials. The building will comply with all GMP requirements, meet Micro-Macinazione’s increasing need for storage and help to pave the way for further growth in the business.