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:
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 […]
How to safely discharge a Spray Dryer and mill the potent API? Process: Feed slurry into the Spray Dryer, collect the potent dry powder, micronize if necessary, weight and dispense (for pilot application: max 5 kg) What are the issues? Staff comes in and out of the lab very frequently: Each time they lose 3 […]
How can a lab safely weight & dispense toxic APIs and liquid solutions? How to get more protection than the current flexible isolator? Process steps Introduce bags of potent API, weight & dispense in smaller bags Bring in flasks, add solution and dispense in smaller flasks Test samples of potent powder or liquid Challenges of […]
Filter Dryer Isolators are commonly installed on the discharge port of the Filter Dryer. The main goal is to protect the operators during the discharge operations of potent compounds. This can be acceptable for OEB3 and OEB4 products. It requires special procedures and PPEs for activities such as filter vacuum or filter plate/cloth replacement after […]
