Our Cleanroom and Equipment
Austrianova's Cleanroom setup is based on the principles of complete isolation. The Product never comes into contact with the operator during GMP oprations since all operations are carried out in a large interlinked chamber isolator.
The isolator, which is situated in a Class D suite, is completely closed and runs on medical grade triple filtered gasses. Items are brought into the islator through pass-boxes in which they undergo a series of air changes to ensure that no particles or contamination is brought into the isolator, which itself works as a Class A environment.
Our islator contains all equipment necessary for cell biology work, including a heated cell work bench, cell culture incubator, recording microscope, centrufuge, bioreactor, encapsulation machine, filling machine. Each of these machines are fully GMP compliant and are situated in their own isolator segment which is physically seperated from other segments. Further, the gases in the isolator can be adjusted to accomodate the requirements of any cell type.
Our isolator and D-room are part of our larger GMP facilitity with all other necessary ancillary rooms and services. We operate to US FDA, EMA, TGA and PIC/s standards.
Our staff are fully trained in all aspects of our GMP operation including our electronic Quality Managment System. The data generated by this German-made system is stored at separate duplicated secured locations in Switzerland to ensure full data safety and protection.
Our isolator GMP set-up allows us to be up and working much faster than conventional cleanroom setups and this equates to cost savings for our customers.
GMP Cell Production
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