Fertile ground for modules

Believed to be the first in the world, the unit includes EU GMP Grade B cleanroom laboratories together with Grade C operating theatres in a layout designed to optimise the complex workflow.

Built in a restricted 270m2 site within the Jessop Wing of the Royal Hallamshire Hospital for the UK National Health Service (NHS) and University of Sheffield, UK, Clean Modules had a difficult brief and very tight 16-week timescale to meet the demands of IVF patients waiting for treatment.

The commission was for the complete package from planning, project management, build and full IQ OQ PQ validation. According to Professor Harry Moore, Chair in Reproductive Biology at the University of Sheffield, the resulting facility will be “the benchmark" for other stem cell research centres worldwide.

Clean Modules used experience, gained through constructing the flagship UK Stem Cell Bank at the National Institute for Biological Standards and Control, to design and build the facility. This included interpreting the standards governing fertilisation and embryology and MHRA approval.

Patient confidentiality was another critical consideration built into the design. Senior embryologist, Rachel Cutting said: “The facility provides our patients with the considerate and straightforward approach, yet behind the scenes there is a complex cleanroom facility delivering a much needed service.”

The finished facility comprises two segregated areas controlled by proximity card access. The clinical side includes two Grade C (ISO Class 7) operating theatres for egg retrieval and embryo transfer with bespoke one way transfer hatches connected to the culture preparation and IVF laboratories.

The research side has six Grade B (ISO Class 5) cleanroom laboratories each dedicated to a specialist task. In the embryology, andrology and micromanipulation rooms, Class 2 Grade A cabinets are used to provide safe clean working environments. The cryo preservation laboratory is equipped with controlled rate freezing and Dewar liquid nitrogen storage to hold stem cells prior to use.

To meet the stringent requirement covering stem cell research, Clean Modules installed a a stand alone air handling system and a complete Facility Monitoring System (FMS) validated to GAMP4 and CFR21 part 11. This sophisticated computer controlled data acquisition and monitoring system continuously checks particle levels, room pressures, temperature and humidity in the cleanrooms. A consequence of the development in monitoring systems is an absence of traditional magnehelic pressure gauges.

The FMS system also monitors the liquid nitrogen storage vessels, freezers, refrigerators, incubators and gas levels to ensure conditions are optimised for cell preservation. Variation outside set parameters is covered by an alarm system monitored 24 hours a day within the main hospital.

Clean Modules says its specialisation in modular construction, enabled the project to be completed quickly, with minimal disruption to other hospital activities and to a cost-effective budget.

The company has expertise in a wide range of life science applications, including pharmaceutical, medical and hospital application and has built up considerable knowledge about modular and mobile facilities including units pre-built and validated off site.

With over 30 hospital and healthcare related cleanroom suites completed in recent years, it can handle a wide range and size of projects, for which it employs specialist, qualified engineers to design and manage projects and three full construction teams on site.