Clean Modules has completed a facility that combines stem cell research with clinical in vitro fertilisation (IVF) treatment.
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 NHS and University of Sheffield, Clean Modules had a difficult brief and a 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.
'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,' said senior embryologist, Rachel Cutting.
Clean Modules utilised the experience gained constructing the UK Stem Cell Bank (UKSCB) at the National Institute for Biological Standards and Control (NIBSC) 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.
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 stem cell laboratory, embryology, andrology and micromanipulation rooms, Type 2 Grade A safety 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, including a stand-alone air handling system, Clean Modules installed a complete facility monitoring system (FMS) validated to GAMP4 and CFR21 part 11.
This 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 the 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.
