Following all ICH requirements for Stability testing, these stability ‘walk-in’ chambers have unsurpassed reliability in reproducing and maintaining very uniform Temperature and Humidity conditions for both intermediate and accelerated testing.
ICH Q1A compliant, with FDA 21 CFR part 11 data logging and several shelving configurations available for the most efficient use of the available space and internal volume.
Remote monitoring possible with configurable email notifications of any alarms. IQ, OQ and PQ (Installation Qualification, Operation Qualification and Performance Qualification) included for mandatory quality audits.
Common applications include
Features
ICH STABILITY TESTING
PHARMACEUTICALS
COSMETICS
FOOD AND BEVERAGES
VETERINARY
STORAGE AND CONSERVATION
QUALITY CONTROL AND RESEARCH
Environmental conditions controlled with consistent precision through the years
Pre-configured with shelves designed to provide an efficient use of the internal volume
Adaptive future proof design, with height adjustable trays and shelves that are easy to insert or remove depending on storage needs
Content protection features, with configurable high / low temperature and humidity alarms and automatic remote notifications
FDA 21 CFR part 11 compliant software
Compliant and recognized by ICH, FDA, GMP and other leading industry standards
IQ, OQ, PQ and ISO calibration documents
TEMPERATURE AND HUMIDITY WORKING RANGE
Specifications
INTERNAL Dimensions (H x W x D) (MM)
MULTIPLE DIMENSIONS AVAILABLE
INTERNAL VOLUME (LITRES)
MULTIPLE VOLUMES, STARTING AT 5000 LITRES (5M³) UP TO 25.000 LITRES (25M³) OR CUSTOM-DESIGNED ROOMS
TEMPERATURE RANGE (ºC)
15ºC TO 45ºC (TEMPERATURE RANGE EXTENSION AVAILABLE FROM 5ºC TO 45ºC)
TEMPERATURE STABILITY
+/- 0.5ºC
TEMPERATURE UNIFORMITY
+/- 1ºC
HUMIDITY RANGE
35 TO 95% RH
STABILITY
+/- 1% RH
UNIFORMITY
+/- 2% RH
SHELVES
NUMBER OF SHELVES AND STORAGE CAPACITY WILL VARY WITH CHOSEN MODEL, SHELVING LAYOUT AND NUMBER OF TIERS