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)
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 […]
