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 RANGE35 TO 95% RH
STABILITY +/- 1% RH
UNIFORMITY+/- 2% RH                                                                                                                        
SHELVESNUMBER OF SHELVES AND STORAGE CAPACITY WILL VARY WITH CHOSEN MODEL,
SHELVING LAYOUT AND NUMBER OF TIERS
ICH COMPLIANCEICH Q1A
LIGHTNINGSERVICE LIGHTS ONLY