An inside look at CO.DON AG: The cleanroom facility

In our highly specialised cleanroom laboratories we isolate chondrocytes from the original material and propagate them in the patient's own serum. The culture of this kind of sterile products is highly sensitive. Autologous cell transplants are sensitive to heat, so they cannot undergo final sterilisation before use.

Conventional cleanrooms are at risk of contamination due to action taken by employees or to cross-contamination (from one product to another).

In response to these particular hygiene requirements co.don AG has developed Integrated Isolator technology (IIT®).

Double isolation for maximum hygiene

This "cleanroom in a cleanroom" integrates the entire equipment necessary for transplant culture and quality control in cleanroom Class A isolators. This includes heating cabinets, freezers, coolers, centrifuges and microscopes as well as accessories for production and microbiology.

The production rooms where the isolators are situated are also subject to the specifications of cleanroom classification and are only accessible via airlocks. Pressure differences between the different rooms prevent contamination between one room and another.

All the necessary materials are brought into the isolators via separate, monitored airlocks in which they are decontaminated.

Work there is carried out using specially made gloves, which are attached to the isolator with safety rings.

Only finished products leave the isolator, packed and ready for shipping. 

Strictly monitored and documented

The central control system for the Integrated Isolator Technology (IIT®) manages all process parameters such as air-conditioning and pressure. The isolator and the combined attachments are fitted with fully automatic monitoring and alarm systems.

Special computer sites guarantee the statutory documentation of all data during the manufacturing process and make it impossible to confuse data.