3M Health Care Limited

This project provided 3M with the opportunity to fulfil a strategic decision to remodel the interior of their Pharmaceutics Pilot Plant Building, while allowing production to be maintained without disruption.

The original Pharmaceutics Pilot Plant was a small, but mainstream, manufacturing suite of rooms, based in an existing c1966 building on the 3M site at Loughborough. To complicate requirements for the new challenge, the existing manufacturing facility and specialised plant was sited within the building which could not be temporarily moved or shut down during the proposed upgrade.

The upgrade would provide a new process facility complying with current GMP recommendations and Good Engineering Practice, together with achievement of the following objectives:

• Improved temperature control for operations
• Improved quarantine storage space
• Improved segregation of materials and equipment

Provision of a suite of clean rooms, clean corridors and material and personnel change areas.

Austin to provide a full design service, project planning, project management, H&S planning supervisor, and on-site supervision to coordinate, inspect and validate the construction and services work.

The Austin Company was involved from the beginning, instigating detailed discussions with the users to ascertain their detailed requirements (URS)

During the subsequent design stages from concept/feasibility through preliminary design and finally detailed design, an ongoing dialogue was maintained with the users as their requirements, both for the upgrade works, and the ongoing production requirement, were continually changing

The resultant design was developed in phases to allow the site work to be undertaken with limited impact on the existing production activities. The new facility comprises Class 10,000 and 100,000 areas being a mix of both positive pressure rooms and negative containment rooms.

The installation of a temporary change area and airlocks allowed production to be maintained in a safe cGMP environment whilst the upgrade works continued around them. This included the creation of a plant room above the clean room ceilings.

Managed construction cooperation between client, Austin and subcontractors, created a positive attitude on-site, resulting in early identification of possible problems and solutions.

Carried out Validation of the facility up to completion of Operational Qualification, including preparing the VMP, DQ, IQ & OQ documents.

Austin completed the project within the requirements of 3M Health Care brief.