CAT Clean Air Technology has finished a cleanroom requalification project for the Joint Stem Cell and Immune Laboratory at the University Hospital Tübingen.
The lab prepares stem cell products for cellular immunotherapy. This is not just for the patients on site, but for clinics around the world through cryopreservation of samples.
The containment control of this area must be strictly maintained. Therefore, twice a year, CAT Group are responsible for the requalification of the GMP areas of this lab.
Cleanroom qualification is a documented process to ensure a cleanroom is designed, installed, and operating correctly to meet its specified performance and regulatory requirements.
Qualification involves Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), which are stages which verify the facility's design, installation, system functions, and ongoing environmental control under both "at rest" and "in operation" conditions.
This duration is due to the scope of the individual parameters that have to be measured in such a sensitive area
The area to be requalified is only about 30 sqm of Grade A, B and C, but it takes about two to three days to requalify.
CAT explained in a LinkedIn post: "This is due to the scope of the individual parameters that have to be measured in such a sensitive area – including filter leakage and tightness tests, recovery time, air volume flow, differential pressure, air purity class as well as microbiological measurements and investigations."
The lab contains a number of highly specialised high-tech devices, such as several CliniMACS Prodigy for semi-automated cell processing.
The CliniMACS Prodigy is a closed, automated, all-in-one system from Miltenyi Biotec that streamlines and standardises the entire process of manufacturing cell and gene therapy products. It automates cell processing, such as separation and washing, as well as cell expansion, activation, and formulation within a single device to ensure reproducible results and compliance with Good Manufacturing Practices (GMP).
Image credit: CAT Clean Air Technology