FPS Food and Pharma Systems has developed software, which controls equipment functionalities of a sterile micronisation system.
A manufacturer and installer of its own range of fine size reduction machines and containment solutions, FPS Food and Pharma Systems has a worldwide customer portfolio. It delivers tailor-made machines to all the major pharmaceutical, fine chemical, and cosmetic industries for more than 15 years.
FPS Food and Pharma Systems guarantees quality and support in all activities, including consulting, engineering, manufacturing, testing, validation, maintenance, and assistance. These are executed according to current good manufacting practice (cGMP) requirements within an ISO9001 certified quality system.
One of the most important projects this year was the construction of a production-scale sterile contained micronisation system, which was delivered to a pharmaceutical manufacturer in Spain last July.
The equipment has been designed to be installed across different floors, composed of a glovebox to discharge batches from a filter dryer without affecting the product sterility, a jet mill isolator providing a confined environment for micronisation, and downflow booths, which are integrated on the airlocks of the pack-off isolator to guarantee the high-sterility grade.
The machine is sterilised with both hot steam and very high pressure (VHP). The unit will allow the user to complete different phases of a sterile production of active pharmaceutical ingredients (API) avoiding the risk of contaminating the product and reducing the operator’s exposure to the potent compound.
FPS Food and Pharma Systems’ research and development (R&D) and test centre was recently re-modernised and expanded to execute short to medium duration micronisation technical tests. Three controlled-contamination rooms ISO8 are now available, which allows products and operators protection.
As an alternative, it is possible to execute tests at a client’s premises. This is desirable when particular process conditions need to be met. The company can rent the equipment and assure the necessary technical support. FPS Food and Pharma Systems’ Glovebox is also available for inert or toxic testing.