Sterile Contained PM8 Micronizing systems
FPS Food and Pharma Systems is a leading company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of Fine Size Reduction machines and Containment Solutions (Sterile and Highly Potent API).
With a customer portfolio from all over the world, FPS has been delivering tailor-made machines to all the major pharmaceutical, fine chemical and cosmetic industries for over 15 years.
FPS guarantees quality and support in all activities: consulting, engineering, manufacturing, testing, validation, maintenance and assistance are executed according to cGMP requirements within an ISO9001 certified quality system.
One of the most important projects of this year has been the construction of a production scale sterile contained micronisation system that was delivered to a pharmaceutical manufacturer in Spain last July.
The equipment, designed to be installed across different floors, is composed of a glovebox to discharge the batches from a filter dryer without affecting the product sterility; a jet mill isolator provides a confined environment in which the product is micronised; downflow booths are integrated on the airlocks of the pack-off isolator to guarantee the high sterility grade.
The system is fully automated. FPS internally develops the software that controls all the equipment functionalities. The machine is sterilised with both hot steam and VHP.
The ground-breaking unit will allow the customer to complete different phases of a sterile production of APIs avoiding the risk of contaminating the product and reducing the operator’s exposure to the potent compound.
FPS R&D and Test centre, (recently re-modernised and expanded with a new test center equipped in order to execute short to medium duration micronisation technical tests) is available for all possible kind of collaborations. The availability of 3 controlled contamination rooms ISO8 - if required - allows product and operator protection.
Safety devices and interlocks for operations under controlled Nitrogen atmosphere.
As an alternative, it is possible to execute test at our Customers premises. This is desirable when particular process conditions need to be met. We can rent the equipment and assure the necessary technical support. FPS Glovebox is also available for inert or toxic testing. Our commitment is not only to improve our own know-how and process equipment, but also to face your new challenges to serve the chemical and pharmaceutical world.