Upgrade of two modules to improve operability, containment and GMP
(£1.4m Project Management of the Detailed Design and Construction)

Pharmaceutical Pilot Plant North of London

The Problem
The 50L scale modules of this pilot plant lacked working space and relied on open topped

processing methods for filtration and drying. These issues were packaged under remedial works
within the Phase 2 Ergonomic Upgrade.

The Solution
The objective of the work was to make the modules safer and compliant with the requirements of GMP plus the creation of more working space.

In place of the open topped filtration and drying operations BPE proposed a combined operation
within an Isolator. Working closely with the Clients representatives, the concept of a pan filter and vacuum tray dryer contained within an Isolator was developed. The initial concepts became the basis
for design and several vendors were invited to bid for the supply of a package of equipment integrated into a working unit.

This ‘contained’ filtration and drying facility required the development of several new design features
for the individual items of equipment and for the control/operating systems. Of note was a radical change to the dryer doors to permit opening in a restricted space and to provide a 360° swivel
enabling all faces to be thoroughly cleaned. On the control side, the direct connection of pressure equipment to the lsolator presented a number of safety issues that had to be dealt with using fail safe
yet simple user friendly solutions. Two such packages were ultimately purchased.

Increased operator working space was created through the repositioning of walls and the relocation
of stairways. Working to specifications by BPE, Civil Engineering and Architectural designers were engaged to provide detailed design proposals. These became the basis of the installation work which was jointly managed by the client and BPE for continuity.

The completion of this Project brought together a number of design improvements that had been identified and engineered by BPE in a phased programme with the ultimate objective of improving
the time to market of new chemical entities through significantly reducing the batch cycle times.