High containment API and drug processing facility design and project execution
Key Statistics
Client
Takeda Ireland
Year
2019
PM Group Office
Dublin
Size
2,550 sq.m

At its existing Grange Castle, Dublin site, Takeda developed a new high-containment production facility to manufacture its oral solid dosage oncology treatment Ninlaro® for global markets. This integrated facility is unique in that it houses all steps of the production process including API, Drug Product, Primary and Secondary packaging and QA/QC Laboratory processes, under one roof.

Do you have a pharmaceutical project? Talk to one of our experts.

Andy Rayner
Andy Rayner

Pharmaceutical Sector Director

A highly configurable and flexible facility

The facility was designed to meet the regulatory requirements for the sale of product worldwide. It was designed to be configurable and flexible. It provides for the manufacture of chemical synthesis steps including Reaction, Liquid/Liquid Extraction, Separation, Distillation and Filtration steps. These synthesis processes include additions in both solid and liquid phases. Containment levels below 100 ng/m3 are required for many of the steps. This necessitated the design of primary and secondary containment solutions.

Materials handling solutions include isolator technology, split butterfly valves and flexible isolators located throughout the facility (API, DP, Packaging and QC laboratories). Contained waste handling solutions are incorporated in the design for the handing of contaminated waste streams. 

Innovative design features

The building has large glazed sections both on the exterior and within. This allows high levels of natural daylight into each room, providing an enhanced working environment. A visitors viewing corridor facilitates visibility of the manufacturing operations from outside the GMP / high containment manufacturing areas.

Small scale equipment and product operations were facilitated by the use of RTP based handling in API and DP areas, along with selective use split valve canister transfers.  A range of liquid charge solutions were developed for handling the accurate dispensing and charge of hazardous liquids.

A state of the art QA/QC laboratory is incorporated into the facility. The lab contains high containment isolator technology integrated with hybrid isolators and fume cupboards for the handling and testing of intermediate and final product samples.

PM Group services

PM Group’s multi-disciplinary team, including specialists in API and DP manufacturing and process containment, completed the detailed design, equipment and contract procurement services and regulatory submissions.    

PM Group were appointed as Construction Managers for the facility build phase. We also provided Commissioning, Qualification and Validation (CQV) services.

 

 

More about Takeda

Takeda Ireland Ltd, which has had a significant presence in Ireland since 1997, is a subsidiary of the global research-based Takeda Pharmaceutical Company Ltd, Japans leading pharmaceutical company and one of the world's top 100 companies.

Andy Rayner

Pharmaceutical Sector Director