Upgrading Autoclaves for Terminal Sterilisation with CQV Execution from Local SteriTech Engineer's.

Global Medical Client -  Operating out of Cork, Ireland our client is a global medical device manufacturer

They design, manufacture, and distribute diagnostic imaging systems and healthcare IT solutions

Project Duration: 2021 - Present

Equipment Scope Awarded: 

• Supply of 2x Fedegari FOAF Autoclaves with chamber depth of 5.4m.
• Scope includes supply of automatic pallet loading and unloading conveyor system. 

Project Description:
Replacement of ageing steam-air mixture (counterpressure) autoclaves used for terminal sterilisation of fluids in hermetically sealed containers.
Original autoclaves were installed in early 1990s, the new cGMP autoclaves are in compliance with current industry regulations and qualified with existing load presentations.

Project Services: 

• Project Management of autoclave design & build phase, factory testing, shipping and post-delivery sitework.
• Protocol generation for Factory Acceptance Testing (FAT), Commissioning, Installation and Operational Qualification (IQ/OQ).
• GMP Documentation supply including requirements traceability matrix (RTM)
• Sitework execution by SteriTech including:
  • Offloading and Positioning Support
  • Reassembly Works
  • Start-Up, Commissioning & Calibration
  • Site Automation Integration Support
  • Installation & Operational Qualification
  • Training

Outcomes: 

"All activities were executed according to plan with no incidents or accidents incurred. Thanks to all involved in ensuring this activity was performed in a compliant and safe manner.

I’d like to acknowledge the months of work performed by the project team to decommission / demolish and install the new autoclave. All disciplines worked extremely well together which resulted in a job well done. All activities ran according to schedule"