NHS Tayside Pharmaceuticals 'Specials' Service Facility

Combining innovation, commercial expansion and production, the building will manufacture medicines that are not commercially available as licensed products. This includes a range of eye drops, injections, infusions, creams, ointments and oral liquids that are required to meet the clinical needs of patients.

After a competitive tender process, T-SQUARED was commissioned to take responsibility for a RIBA Stage 3 design through to technical design and construction of the new facility.

The project consists of:

• Critical areas, each with dedicated environmental control systems
• High standard of room finishes
• Complex project management of a significant number of design and coordination interfaces
• Phased completion of a series of HVAC systems linked to a central utility system
• Site activities within a live, operational hospital

T-SQUARED was responsible for the design, construction and validation of all manufacturing spaces, equating to about 75% of the facility footprint. Through close collaboration with the end-user, we have designed all aspects of the regulated spaces including procurement and integration of some of the client’s manufacturing equipment.

Our scope included:

• Complete design and build, validation, and maintenance
• Flexible design to allow classified areas to be upgraded with minimal disruption in the future
• Enhanced process flows - people, product, waste • Enhanced room adjacencies
• Grade B – Aseptic processing suite
• Grade B – Cytotoxic suite
• Grade B – Microbiology testing
• Grade B – Sterility testing
• Grade C – Manufacturing areas
• Grade D – Packing areas
• Sterilisation facilities and quality control laboratories
• Cleanrooms designed to cGMP standards
• 24/7/365 operation with facilities management responsibility
• MHRA compliant high-quality bespoke finish throughout
• Building Management System (BMS)
• Validated Environmental Monitoring System (EMS)
• Environmental control with terminal high-efficiency particulate air filters
• Highly regulated pressure regime

"T-SQUARED was involved at all stages from cleanroom design through to commissioning and validation of the new NHS Scotland Pharmaceutical ‘Specials’ facility at Ninewells Hospital in Dundee. At all times the approach was extremely professional and inclusive of the client’s views and requirements. At each stage of the project, there was a review of both progress to date and forthcoming milestones.

In particular, I would comment on the following:

Design
During design, meetings were undertaken to understand our requirements, propose solutions and agree the final design. This was all undertaken following a well-managed design programme. Design documents were always of a very high quality and T-SQUARED were always keen to provide additional drawings/documentation that we required.

Equipping
T-SQUARED were tasked with the procurement, installation, commissioning and validation of specialist equipment for the project. Again this was undertaken with the full client involvement and their proposals and options were submitted for approval.

In addition to adhering to our requirements, T-SQUARED offered a number of novel solutions to issues relating to the integration of the specialist equipment into the design. The co-ordination of installation, commissioning and validation was undertaken by T-SQUARED and documentation submitted to us for approval.

Construction
Construction of the cleanroom suites was extremely well coordinated and
T-SQUARED had a constant presence on-site during construction. The construction programme was shared with ourselves and there was always a desire for us to visit site to observe progress.

The management of subcontractors was excellent and we were encouraged to meet with T-SQUARED and subcontractors to discuss areas of concern. The quality of the construction and finishes in the facility is excellent and has been praised by a number of visitors to site (some of whom are experts in the field). We now have a facility that is both state of the art and adaptable to any future cleanroom requirements.

Validation
The T-SQUARED validation team worked very closely with us to develop a commissioning and validation plan that was bespoke for our facility which benefitted us hugely during our subsequent MHRA Inspection. There were numerous client review meetings to ensure that all actions had been undertaken and all results were within specification. The documentation system that was developed for the project was exemplary and was fully GMP compliant.

Summary
My experience of working with T-SQUARED has been an extremely positive one and I know that this is also the case for my staff who worked with them. I have always had the feeling that all T-SQUARED staff are committed to providing an excellent service to their clients. I had numerous meetings with planners, engineers, validation team, project managers and senior executives and what came across at all times was the enthusiasm that the staff had for the project and that they appeared very proud to be part of this exciting project. This resulted in very high-quality work from the whole T-SQUARED team. A high quality, customer focussed team was evident to me from Day 1.

Once the project was complete and the facility handed over, the T-SQUARED involvement did not stop there. They have followed up on a number of occasions to ensure that the facility, plant and equipment is running as planned and there are no ongoing problems or issues.

I have been fortunate to have an excellent relationship with the whole T-SQUARED team during this project and I therefore have no hesitation in recommending them to anyone who is planning the construction or refurbishment of a cleanroom suite."

Dr Baxter W Millar,
Head of NHSS PSS