Clean Modules has completed the purpose-designed Anthony Nolan Trust Cord Blood Centre, which includes a processing and cryogenic storage facility in the grounds of Nottingham Trent University.
The GBP1.4m centre will provide stem cell donations from umbilical cords and placentas for people with cancer and life-threatening bone marrow conditions.
The trust aims to store 50,000 cord blood samples by 2013.
The fully validated facility complies with the latest EU Good Manufacturing Practice regulation and Good Laboratory Practice requirements.
It houses a 50m Grade D cryogenic storage area with three liquid nitrogen storage vessels with racking systems for the storage of the blood samples, a 25m Grade D distribution area with a Class Two laminar air flow cabinet for the testing of the blood samples and a 25m Grade C processing area for preparing the storage of the blood samples.
Additionally, there is 70m of support areas including technical administration, an archive, a meeting room and a utility area.
To meet with the GLP requirements covering blood storage, Clean Modules installed a complete facility monitoring system (FMS) validated to GAMP4 and CFR21 part 11.
The facility has also been fitted with a trend building management system to control the air handling system, an oxygen monitoring system, a temperature control monitoring system for the liquid nitrogen storage vessels and freezers to ensure conditions are optimised for blood preservation.
The three monitoring systems have been linked in with the facility monitoring system, which is covered by an alarm system in case of any variation outside the set parameters.
