New facilities for medical devices


Refurbishing facilities is often more complex than building from scratch. Paul Morley, Operations Director, Chalcroft Construction, outlines the creation of two cleanrooms in an existing facility at the medical device manufacturer, Bespak

A global supplier of drug delivery devices for injectable and inhaled products, Bespak has contributed to the design and manufacture of some of the world’s leading medical devices. The company employs more than 600 people and produces in excess of 500 million medical devices a year, supporting projects from pilot-scale through to commercial supply. It has many partnerships with leading pharmaceutical and biotech industry clients.

Given the highly-regulated environment in which Bespak, a Consort Medical company, and its customers operate, supply performance is rated by stringent customer-defined measures and product quality is measured on a parts per million defect basis. To meet the requirements of its expanding customer base and to increase its product development and production capability, Bespak needed to create two new, dedicated aseptic cleanrooms to perform to ISO 8 standard in operation and ISO 7 at rest, at its King’s Lynn facilities.

The rooms needed bespoke, energy efficient air handling units in addition to vinyl as well as resin flooring, white walling, and rapid rise- and personnel-doors. Chalcroft also constructed a new goods in/goods out area and refurbished a further extension incorporating new office space, a canteen and welfare facilities.

A proven ability to construct the highest quality cleanrooms was a key factor during the tender process. Chalcroft worked closely with JD Cooling Systems, a specialist in bespoke cleanroom systems technology that was able to offer the full mechanical and electrical build to meet Bespak’s exacting requirements.

The raw material service corridor

The raw material service corridor

Mike Gould, HVAC Technical Manager for JD Cooling Systems, says: ‘A fully bespoke air handling unit was manufactured to meet the specific requirements of the cleanrooms. The unit, which includes Terminal H14 HEPA filters, is served by chilled water services, allowing greater control, while an inverter drive fan improves energy efficiency.

‘A purpose-built control panel includes all the necessary controls for the air handling fans, electric heater batteries and electrode steam humidifiers. It also includes multi-stage cooling and heat temperature controllers with dead band humidity control provided via the Vacpac systems. This enables the air handling unit to be operated independently.

‘In addition, the nature of the product manufactured at Bespak is such that one of the cleanrooms was designed with a no-cascade pressure system, providing a safe and secure containment suite.’

Dave Stringer, Bespak Facilities Manager, says: ‘Another significant consideration in Bespak’s choice of construction partner was Chalcroft’s excellent health and safety record, while it was also essential for the work to be completed with minimal interruption to the day-to-day operation.’

But before work on the build project could get underway, Chalcroft faced some significant challenges. The area being converted, which contained Bespak’s principal high-care production facility, had to remain operational at all times.

The low pressure changing area

The low pressure changing area

Innovative design solutions were also required to overcome challenges presented by the limited floor to ceiling space, along with the safe removal of asbestos from the site before the major demolition work could be carried out. The 25m main supporting wall was then demolished to create the space required for the new cleanrooms.

However, this meant that Chalcroft had to provide new piles for the structural steel that was required in both cleanrooms. The discovery of an existing ring beam, which created an obstruction for the new piles, meant, quite literally, going back to the drawing board. By redesigning the pile location layout and bridging existing tie beams beneath the old concrete floor, Chalcroft got the project back on track.

With an extremely tight timeline, weekly co-ordination meetings with Bespak and sub-contractors, facilitated by Chalcroft, proved essential. Daily management meetings to monitor the workflow also formed an integral part of the construction process.

This collaboration enabled Bespak to start installing production equipment in the cleanrooms prior to the project’s completion, minimising interruption to normal operations and maintaining high care standards throughout.

Reflecting on the complexity of the project, Dave Stringer says: ‘Chalcroft’s experience combined with its collaborative approach proved to be a valuable asset, helping Bespak to complete this important extension of its development and production capability with great efficiency.’