FITOCLIMA Walk-In Stability
Description
FITOCLIMA Walk-In Stability
Stability temperature and humidity stability storage rooms
Environmental rooms for stability studies, shelf-life and package testing
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.
Key features
• 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
Product details | |
Internal dimension (H X W X D) (mm) | |
Multiple dimension available | |
Internal volumes (litres) | |
Multiple volumes, starting at 5,000 litres (5 m³) | |
up to 25,000 litres (25 m³) or custom-designed rooms | |
Temperature range (ºC) | |
15ºC to 45ºC | |
(Temp. range extension available from 5ºC to 45ºC) | |
Temperature stability | |
± 0.5ºC | |
Temperature uniformity | |
± 1ºC | |
Humidity range (% RH) | |
35% to 90% RH | |
Stability | |
± 1% RH | |
Uniformity | |
± 2% RH | |
lighting | |
Service lights only | |
Shelves and Lights | |
Number of shelves and storage capacity will vary | |
with chosen model, shelving layout and number of tiers. | |
Electrical connection | |
3/N/PE AC 400V ±10%; 50HZ | |
ICH Compliance | |
ICH Q1A |