RUMED® stability test cabinets allow durability tests for determination of the usability period according to the ICH Guideline Q1B(2R). For long-term tests, temperate climate (I), subtropical Mediterranean climate (II), hot and dry climate (III), hot and humid climate (IVa) and hot and very humid climate (IVb) can be simulated, depending on the respective storage place. Additionally, accelerated stability tests with 40 °C and 75 % relative humidity can be executed. The Control2015 touch with intuitive operation is equipped with a screen recorder, a logbook with user management and digital signature complying with 21CFR, part 11. Due to the USB and Ethernet interface, external data evaluation is possible.
Models
| SPS-P210 Stability Test Cabinet | SPS-P350 Stability Test Cabinet | SPS-P530 Stability Test Cabinet |
| Temperature Range 0 to +50 °C Humidity Range 20 to 95 % r. h. Test Room 210 Litres ICH Guideline Conformity Control2015touch with User Management Screen Recorder with Logbook Digital Signature 21CFR part 11 compliant | Temperature Range 0 to +50 °C Humidity Range 20 to 95 % r. h. Test Room 350 Litres ICH Guideline Conformity Control2015touch with User Management Screen Recorder with Logbook Digital Signature 21CFR part 11 compliant | Temperature Range 0 to +50 °C Humidity Range 20 to 95 % r. h. Test Room 530 Litres ICH Guideline Conformity Control2015touch with User Management Screen Recorder with Logbook Digital Signature 21CFR part 11 compliant |
| SPS-P850 Stability Test Cabinet | SPS-P1060 Stability Test Cabinet | SPS-P1700 Stability Test Cabinet |
| Temperature Range 0 to +50 °C Humidity Range 20 to 95 % r. h. Test Room 850 Litres ICH Guideline Conformity Control2015touch with User Management Screen Recorder with Logbook Digital Signature 21CFR part 11 compliant | Temperature Range 0 to +50 °C Humidity Range 20 to 95 % r. h. Test Room 1060 Litres ICH Guideline Conformity Control2015touch with User Management Screen Recorder with Logbook Digital Signature 21CFR part 11 compliant | Temperature Range 0 to +50 °C Humidity Range 20 to 95 % r. h. Test Room 1700 Litres ICH Guideline Conformity Control2015touch with User Management Screen Recorder with Logbook Digital Signature 21CFR part 11 compliant |