STABILITY TESTING ROOMS
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 |
| ICH COMPLIANCE | ICH Q1A |
| LIGHTNING | SERVICE LIGHTS ONLY |
