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.
How to safely do In-Process Quality Control for High Potent powder, tablets or capsules? What are the issues? How to protect the QA team during in-process testing when: High Potent tablets are dusty High Potent Capsules can break open or leak Highly Potent API powder must be checked How to make an isolator fit in […]
An HPAPI is a Highly Potent Active Pharmaceutical Ingredient and can be defined as a pharmaceutical compound with a low Occupational Exposure Limit. The occupational exposure limit defines the maximum quantity of product an operator can be exposed to within a defined time frame to avoid the risk of short and long term effects on […]
Why do people use it? To transfer potent in-process API from a process vessel into drums or bags, through a sieve What are the issues: Api is highly toxic (OEL 10 µg/m3) Particle size can be uneven: there could be some abnormally large particles Possible solution (open process): Vibrating screen fixed at the bottom of […]
How can OSD facilities safely dispense HIGH POTENT products? Can containers and IBCs of very different sizes be used for the dispensed product? Process: Load drums, weight & dispense Highly Potent API into various containers or IBCs What are the issues? Highly Potent APIs (CPT < 300 ng/m3) Large variety of incoming drum sizes (5-20 […]
