Filter dryer for high potency molecules
Solution
3V Technologies:
Filtration and Drying.
3V Competences:
Mechanical design competences and integration with containment devices.
Design:
Design specific customised solutions in order to achieve high containment performances with an integration of the isolator.
Build:
Build the filter dryer with design criteria suitable for APIs production.
Operate:
Integration with isolator device, commissioning & start-up of the system.
Team
3V project team:
3V Tech Project Manager, Customer Technical Director, Subvendors for structures, ancillaries and all other process equiments.
Site of realisation:
Italy.
Audience
Client industry:
Pharmaceutical.
Context
Project context:
High potent API production.
Project goal & client needs:
We were contacted for a project that needs to ensure high containment conditions and operator protection during work and maintenance.
Results
Project execution timing:
1.5 years.
Project complexity:
Develop specific customised solutions in order to have all key components of a filter dryer inside containment devices such as process connections, base bottom and dust filter.
Other information
An HPAPI is a Highly Potent Active Pharmaceutical Ingredient and can be defined as a pharmaceutical compound with a low occupational exposure limit (OEL). 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 health. A specific value of 10µg/m3 is defined as the threshold limit for the definition of an HPAPI. All compounds with a lower OEL are considered highly potent. As the risk of an adverse effect on human health is the product of a hazard and the exposure to such hazard, risk mitigation of handling potent APIs (high hazard) can only be accomplished through the adoption of containment systems (low exposure).
