ProMill-12 is a production scale unit, suitable for micronizing up to 200 kg per hour.
ProMill-8 is a production scale unit and it is the next step up the scale from research and laboratory units, suitable for micronizing from 500g up to 80Kg/h.
Whenever a HPAPI is produced, it is necessary to ensure maximum operator protection in all planned laboratory activities.
Typical laboratory applications are:
Customized isolator shape allows to maximize the length of the working chamber gives dedicated room for all necessary instruments:
Benefits of FPS Solution:
This type of equipment is best for transferring potent API being processed from a process vessel to drums or bags, through a sieve.
These operations generate a lot of dust and exposure to high-potency APIs. Often the product is an API with highly toxic levels (up to OEL 10 µg/m3) and particle sizes can be irregular and PPE does not provide the required protection (e.g., OEB 5 – 0.1 µg/m3).
The advantages of FPS solutions are:
FPS provides flexible solutions: for less toxic products (OEB3) windows can be opened because the continuous liner ensures sufficient containment with a wide range of bag sizes capable of receiving the processed product (system is on load cells)
Formulation operations involve many processes equipment and need to handle small or large batch size. Integration of containment system with the process equipment is a goal to allow best operator use of the machines while assuring requested quality and productivity.
Typical applications are:
FPS has collaborated with leading OEMs for many years around the world. This experience allows us to offer custom-built systems built around the customer’s equipment that guarantee the high standards of quality and safety.
The purpose of micronization is to obtain very fine powders, with size reduction down to a few μm. Therefore, it is important that all milling operations be effectively contained to prevent operators from breathing dust clouds and coming into contact with HPAPIs (highly active pharmaceutical compounds) caused by the high energy involved in these process operations.
FPS provides different types of mills for laboratory, pilot, or production activities, which can be integrated into isolator:
All mills are available for testing, including in isolator, at the MEC test center.
Micronization and fine grinding activities can be carried out within a containment system even under cryogenic conditions.
FPS also provides hybrid solutions where different micronization technologies (jet mill, mechanical mill) can be combined in one system, with or without containment.
When handling HPAPI or intermediates, all operations in chemical reactors, filters, centrifuges, and dryers must be carried out under absolute containment for the protection of the operator.
The isolation system is designed according to the size of the process equipment and to enclose the system completely or, in some cases, contain only the parts where product transfer occurs.
FPS has gained in-depth knowledge of these types of systems and is able to design customized systems according to customer needs.
Typical applications are:
