How does RheaLyo ensure aseptic processing throughout the system?

Spin freezing takes place in an isolator, under grade A conditions. Each vial is spin frozen in
individual cylinders, avoiding disturbances of the unidirectional air flow in the isolator. The isolator itself is decontaminated via VHP and wash in place procedures. Piping for the cold gas flow is subjected to a combination of SIP/CIP.

Transport (via a robot arm) in the isolator is designed to take place without movements over the open vials. The impact on the unidirectional air flow is not disturbed as demonstrated via CFD modeling and with experimental data.

Locations for viable & non-viable monitoring were selected based on a risk assessment and are part of the contamination control strategy.

The load lock is docked to the spin freeze isolator. The interface between load lock and spin freeze-isolator is sterilized by applying a double, inflatable, seal principle. This double sealing method ensures overlap between sterilization via SIP and decontamination via VHP.

The drying chamber is subjected to SIP/CIP, like a traditional batch freeze-dryer.

Stoppering takes place under grade A conditions.

All process chambers are connected with an appropriate pressure cascade.