Austin was given the opportunity to develop concept and preliminary study for user and management approval.  The project included refurbishment of existing HVAC plant, resetting of pressure regimes, addition of new HVAC plant, installation of secondary packing machines, provision of new finishes, air locks, redesign of change areas and product of dispensary.

Subsequently Austin were asked to take the project to the next stage which entailed the management and execution of the detailed design, procurement, programming, construction, installation, cost reporting, commissioning, DQ, IQ and OQ qualification through to handover of GMP upgraded solid dose manufacturing areas.

At the heart of this project was an extremely complex phasing strategy.  Hence, the work was divided into 30 separate phases to match the works with production down times within a constantly changing production schedule.

Each phase was independently validated to allow continuous production. Areas in which work was to take place had to be formally handed over to Austin before any work could commence. Work was subsequently carried out and the areas cleaned, works validated and then formally handed back to Novartis with all completed documentation in place, for them to begin production.

Much of this work was out of necessity, undertaken outside of normal working hours due to site manufacturing schedules. Work was often carried out in the evenings or at the weekend with release to Austin at lunch time on Friday and handed back to Novartis for production at lunch time on Mondays.

Flexible attitude, teamwork and quick response required by Austin and their subcontractors to accommodate changing scope and program. Procurement and installation of new plant and equipment was carried out within very short timescales as performance testing of existing systems to establish relevant criteria was not possible before commencement of the project on site. All work was carried out in strict observance of cGMP.

In addition using the Austin Total Air System the high bay warehouse was temperature controlled not to exceed 24ºC with a temperature difference between floor and roof of 1ºC.