Global Pharmaceutical Client -  A leading global open-access biologics technology platform offering end-to-end solutions.

In 2018 they announced their intention to construct a new biopharmaceuticals contract manufacturing facility in Dundalk, Ireland.

Client was looking for a large equipment scope including process and clean utility equipment fully compliant to cGMP requirements.

Location: Dundalk, Ireland 

Project Duration: 2018-Present 

Equipment Scope Awarded:  

• Clean Steam generation package.
• Hot and Ambient WFI distribution package.
• Autoclave package for saturated steam sterilisation of process components and decontamination of used materials.
• Parts Washer package for washing of process components.

Project Description: 15 high-performance process machines – GMP washers and autoclaves

• Supply of 8x Autoclaves and 7x Parts Washers designed and manufactured by Fedegari.
• Supply of 2x Clean Steam Generators (3,500 kg/h each), Hot and Ambient WFI distribution skids including pumps, heat exchangers, instrumentation and POU (Point of Use) controls designed and manufactured by Stilmas

Project Services:

• Project Management including single point of contact for design/build phase, user requirements traceability (RTM), support for HAZOP, design review, protocol generation and factory acceptance testing
• Full cGMP documentation supply (turn over package).
• Full post-delivery services delivered by SteriTech local resources including supervision of unloading, installation, re-assembly support, equipment start-up, commissioning, calibration, automation support, site acceptance testing, installation and operational qualification.

Outcomes: "SteriTech team demonstrated ownership of the turnover process and executed as "One Team" with determination to complete the tasks for all the Fedegari supplied equipment. Great work carried out by the whole team!"