High containment filtration and drying superskid
Solution
3V Technologies:
Filtration and Drying.
3V Competences:
Mechanical engineering, civil works, piping design, control, electrical.
Design:
As turn-key solution, we’ve designed a skid system with a full integrated plant with filter dryer assembled inside a metallic structure together with isolators, stairs, ladders, platform, piping, valves.
Build:
Fabricate the filter dryer within Pharma criteria and realise full assembly of the skid in house.
Operate:
Deliver the skid at customer site and complete final installation within the room, perform commissioning and start-up of the plant.
Team
3V project team:
3V Tech Project Manager, Customer Engineering Company, Technical Client Director, all Subvendors for structures, ancillaries and all other process equiments.
Site of realisation:
Ireland.
Audience
Client industry:
Pharmaceutical.
Context
Project context:
High potent API production.
Project goal & client needs:
The intervention aimed to ensure high containment conditions during all production steps, from filtration to packaging, including some main maintenance operations that can be handled under containment conditions. Making the operation even more challenging was the need to install the whole system in an existing room with tight space constraints.
Results
Project execution timing:
2.5 years.
Project complexity:
Acting as an EPC, coordinating all sub-vendors involved in the project, we’ve delivered a turn-key system that had been successfully installed in a tight pre-existing room. The success of this specific project triggered other similar projects with the same client at other company’s premises.
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 his or her 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).
