GDP Environmental Warehouse Upgrade
Malone Group was retained to manage a distribution warehouse upgrade to GMP and GDP pharmaceutical standards due to change business needs.
The facility contained two warehouses where cross over of air was not permitted due to product contamination issues.
- Client Project Management
- Commissioning and Validation Management
- Construction Management
- Detailed engineering design
- Health and Safety Management
- Overall project management
- Preliminary design including ±10% cost estimate
- Programme Management
- Site Auditing
- Site supervision
- Supply and installation
The facility consisted of two segregated high bay warehouses with static pallet racking storage having multiple daily goods in/out stock movement and control.
The prime objective for this project was to maintain tight temperature and humidity control within all areas and levels of each warehouse on a 24 hour basis.
To achieve this it required the design and installation of new conditioned air handling systems with high velocity air distribution ducts and directional nozzles together with the construction of new air locked trailer loading/unloading bays.
The upgrade included the laying of new resin floors, redecoration, a new mezzanine plant room, new temperature mapping and monitoring systems together with new automatic temperature and humidity control systems.
Temperature and humidity upper and lower limits were advised at the beginning of the project. API was also going to be exposed in one of the warehouses under LAF conditions in which temperature and humidity control limits were tight.
Malone Group carried out a preliminary design and 10% cost estimate, before going into detailed design and implementation. The project involved civil, mechanical, and electrical upgrades to cGMP practice and required a plant shutdown. An extensive qualification activity was then undertaken including IQ, OQ and PQ.