ISO Class 7 (10,000) Depyrogenation Oven

Lytzen depyrogenation ovens are equipped with a semi-automatic door. The flush-door design is automatically closed and locked by the control unit when you gently push the door into the opening.

For pass-through models, the doors are equipped with an automatic door interlock system to prevent operation failure or contamination through the chamber, even during a power outage. Both doors can never be open at the same time during normal operation. The flush-door is also designed to interface with an isolator.

The ovens utilize forced air convection to rapidly transfer heat to the load. The air distribution plates, combined with the shape and position of the electrical heating element, ensures a consistent temperature distribution inside the chamber.

Temperature distribution is preset and tested before delivery and does not require any adjustments over the lifetime of the oven, eliminating the need for future re-validation and machine downtime.

To obtain ISO Class 7 during the entire cycle, it is important that the chamber is properly sealed. To achieve this, Lytzen depyrogenation ovens are equipped with double door gaskets (FDA-approved) as standard. The double door gaskets ensure there is no leakage between the chamber and the outside environment, while also minimizing the surface temperature of the sterilizer and eliminating any undesired air flow into the sterile area.

With regulatory requirements for quality documentation increasing, emphasis has been placed on providing thorough IQ/OQ qualification and validation documents as standard with the order of any Lytzen depyrogenation oven. Each oven also includes a comprehensive operation and maintenance manual. QA-documentation is also offered.

GAMP
A complete package of qualification and validation documentation based on GAMP5 (Good Automated Manufacturing Practice) is available as an option to help clients save on time and costs during the validation process.

FDA
For clients with production facilities requiring FDA approval, Lyzten depyrogenation ovens are designed and built to meet all FDA guidelines and pass inspection. Lytzen continuously ensures their products are compliant with the latest FDA requirements, and their depyrogenation ovens have never caused a production facility to fail an inspection.

Lytzen’s Lytcon control systems utilize Allen-Bradley or Siemens PLCs and touch screen operator interfaces. The systems provide fully automated cycles and are constructed to comply with the requirements for control of critical production units within the pharmaceutical industry. All Lytcon control systems can be connected to a local factory network and have secure password authentication to comply with FDA 21 CFR part 11 for secure electronic data storage.