Steam Test Sterilizer
(SEA)
Quality control and product testing at the highest level

Our Lautenschläger SEA20 is a new type of steam test sterilizer designed for performance testing of PCDs for small medical sterilizers, developed specifically to meet the requirements for a steam exposure apparatus as defined in EN ISO 11140-6:2023 (Sterilization of healthcare products—Chemical indicators—Class 2 indicators and test specimens for performance testing …).

Steam Exposure Apparatus Dampfsterilisator für Prüfzwecke

Range of Application

  • Testing of chemical indicators for steam sterilization purposes acc. to EN ISO 11140-6

  • Performance testing of process challenge devices (PCDs) für small sterilizers acc. to EN 13060

EN 11140-6 defines very specific requirements for the test sterilizer (Steam Exposure Apparatus) to demonstrate the compliance of newly developed PCDs with this standard. Conventional test sterilizers and resistometers cannot run the required test cycles with sufficient accuracy. The SEA20 is an innovative steam test sterilizer that replicates the test cycles specified in EN ISO 11140-6 – with their widely varying pressure change rates – with the required reproducibility and control accuracy.

  • Chamber size (21 l) comparable to standard small sterilizers on the market

  • Pressure change rate A in fractionation for steam steps and vacuum steps of 450 mbar/min with an accuracy of ±10 mbar/min

  • Pressure change rate B in fractionation for steam steps and vacuum steps of 2500 mbar/min with an accuracy of ±20 mbar/min

  • Pressure change rate after the holding period of 4000 mbar/min

  • Process steps can be combined in any way using the recipe management feature in the Lautenschläger HMI

Resistometer steam sterilizer for testing purposes BIER CIER

The Lautenschläger Steril software allows individual programming of sterilization cycles. Both exposure times (holding times) and temperatures can be freely programmed. Air injection cylinders, leakage valves, sight glasses and many other optional extras are available, allowing product development to be optimized and accelerated.

  • Lautenschläger Sterile software with 21 CFR Part 11-compliant audit trail and user management

  • Programming of processes via recipe management tool

  • Tamper-proof storage of cycle data

  • Database system with extensive search and filter function

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