ISO standard clean rooms
SCGT currently offers four purpose-built clean rooms specifically designed in line with ISO 14644 Cleanrooms and Associated Controlled Environments. SCGT has commissioned another three cleanrooms to be qualified in 2015. There is immediately available cleanroom capacity to service new projects.
The cleanrooms are equipped with the necessary production and monitoring equipment supporting validated processes for biological production as required within the GMP standards
SCGT is based in one of Australia’s most extensive hospital and research campuses. There is a wealth of knowledge, experience and access to economic and reliable support services.
Such access includes the largest and most established blood and marrow transplant (BMT) laboratory in NSW. The BMT Service provides a comprehensive clinical service in autologous/allogeneic peripheral blood, bone marrow and cord blood stem cell transplantation for both adult patients at Westmead Hospital and paediatric patients at The Children’s Hospital at Westmead. The service is both NATA and FACT accredited. This may provide a useful resource for cell procurement.
We also have access to two pathology departments which are NATA accredited for microbiology, culture media production, flow cytometry, haematology, molecular diagnostics etc. This is a valuable resource for external clients and can be accessed, by arrangement, subject to availability,
The Bondi Room is a small sized (13.5 sqm) aseptic/biocontained clean room with airlock sink for biocontainment. This provides an extra pressure barrier for higher risk manufacturing. It has dedicated waste removal directly from the suite
The Palm Beach Room is a small sized (13.5 sqm) clean room ideal for autologous manufacture. The room can be transformed into a large suite when combined with the adjacent suite.
The Cronulla Room is a small sized (13.5 sqm) clean room ideal for autologous manufacture. The room can be transformed into a large suite when combined with the adjacent suite
The Balmoral Room is a large (28 sqm) clean room ideal for large scale manufacturing
Human Application Laboratory
Based in the Westmead Millennium Institute, SCGT manages the newly commissioned suite of three ISO qualified cleanrooms.
All rooms are designed to meet GMP guidelines and provides an environment for users that promotes a safe, reliable and reproducible approach for the manufacture of biologicals and cellular therapies.