ISO Class 5 (Class 100)
First manufacturer to comply with ISO Class 5
Lytzen was the first manufacturer of depyrogenation ovens in the world to comply with the ISO Class 5 cleanroom standards for an entire cycle.
ISO Class 5 up to 280 °C
Our depyrogenation ovens are capable of performing ISO 14644-1 Class 5 up to 280 ° C during the entire cycle. We have achieved this, due to our unique chamber construction and filter suspension system, and our never ending work for further improvements.
Lytzen was the first company to be in compliance with the ISO Class 5 standard (equivalent to U.S. Federal standard for class 100) during an entire cycle (heating, sterilizing, and cooling).
Documentation for ISO Class 5 before delivery
The critical phases for maintaining ISO Class 5 are the heating and cooling phases due to the expansion and contracting of the frames around the filters. Particle counting during an entire cycle is therefore a necessity. Particle counting only during sterilization is meaningless.
Lytzen is performing particle tests for all ISO Class 5 depyrogenation ovens and the test result is available to the customer before delivery of the oven.
Lytzen welcomes and recommends that the customer attends FAT before shipment to see the tests and the oven.
The particle counting kit is available from Lytzen.