Relocated, requalified, and back in validated state.
A GMP autoclave and utensil washer moved inside a live AstraZeneca facility, with customized IQ/OQ protocols, a closed-loop cooling-water reuse system, and Annex 1 contamination control, returned to validated state with minimal downtime.
Relocating Validated Equipment in a Constrained Footprint
The project required relocating and integrating an autoclave and a utensil washer within a live GMP manufacturing facility. Multiple utility systems, including water, steam, compressed air, drain, cooling water, and steam heating, had to be reconnected inside a constrained footprint, while the layout simultaneously satisfied EHS requirements for safe maintenance access and clear emergency egress.
Every move risked the validated state of the equipment. The impact on existing qualification had to be assessed precisely to scope requalification correctly, and production downtime kept to a minimum throughout, all while maintaining GMP segregation, contamination control, and close coordination with operations, QA, and external suppliers.
An Integrated Relocation, Utility, and Requalification Package
Damgaard Solutions delivered the work as a single engineering and qualification package rather than a series of disconnected tasks, controlling the requalification scope while improving the layout and utilities at the same time.
1. Structured GMP impact assessment and requalification scoping
A detailed GMP impact assessment was performed at the outset to map every affected system and qualification document, establishing a clear, justified requalification scope and avoiding unnecessary re-execution.
2. Integrated utility design with cooling-water reuse
Utility interfaces were defined and specified across water, steam, compressed air, drain, cooling water, and steam heating. A jacket cooling-water storage and recirculation system, an external tank and pump station, was designed to reuse cooling water, and centralised detergent dosing was introduced across all washers.
3. EHS-driven layout and material flow
New equipment layout and laboratory adaptation drawings were developed with safe service access, maintenance routes, and clear emergency exits. Transfer hatches were added to move materials and loading equipment between classified areas without compromising segregation.
4. Risk-based qualification execution
Customised IQ/OQ protocols were developed for the relocated autoclave and washer, and affected protocols were re-executed only where modifications touched the validated state, returning the equipment to compliance efficiently and with full documentation.
This project was delivered by a senior Damgaard Solutions GMP engineering consultant specialising in equipment relocation, utility integration, and risk-based qualification. The same approach, controlling requalification scope while improving layout and utilities at the same time, is how Damgaard Solutions keeps relocation projects compliant without over-running.