FITOCLIMA 600 PLH / PLH-R STABILITY CHAMBER
Description
FITOCLIMA 600 PLH / PLH-R
Photostability Testing Chambers
Environmental Stability chambers for storage and testing according to ICH guidelines with unsurpassed stability and uniformity of climatic conditions.
Performs ICH Q1B guidelines tests for photostability in less than 50 hours, with tracking of accumulated UV and Visible light emission and automatic stop function.
Controller and software compliant with FDA 21 CFR part 11 guidelines for data logging. Qualifications IQ, OQ and PQ provided for required quality on-site validations.
Key features
• Ready to use. No assembly needed
• Minimal footprint, for efficient use of laboratory space
• Future proof design. The interior can be reconfigured at any time for the most efficient use of the available storage space and content dimensions
• Content protection, with configurable high / low temperature and humidity alarms and automatic email notifications
• Remote diagnostics, allowing a fast and accurate technical support
• FDA 21 CFR part 11 compliant software
• Compliant and recognized by ICH, FDA, GMP and other leading industry standards
| Product details | |
 |
Internal dimension (H X W X D) (mm) |
| 1340 X 600 X 600 | |
 |
Exterior dimensions (H x W x D) (mm) |
| 1980 X 730 X 920 | |
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Internal volumes (litres) |
| 600 | |
 |
Temperature range (ºC) |
| -5ºc to 45ºc (Light Off) | |
| 5ºc to 45ºc (Light On) | |
|
Temperature uniformity |
| ± 1ºC (Light Off) | |
| ± 2ºC (Light On) | |
 |
Humidity range (% RH) |
| 35% to 90% RH (Light Off) | |
| 40% to 80% RH (Light On) | |
|
Uniformity |
| ± 2% RH (Light Off) | |
| ± 5% RH (Light On) | |
 |
Visible light |
| 26,000 LUX (+/- 6% APPROX.) | |
| ICH Q1B Visible light test in approximately 46H | |
|
UV Light |
| 30 W/M² (+/- 10% APPROX.) | |
| ICH Q1B UV Light test in approximately 7H | |
|
Shelves and Lights |
| 1 shelf with visible lights (0.17m²) | |
| 1 shelf with UV lights (0.17m²) | |
| photostability shelves and light banks can be | |
| removed and replaced by multiple wire shelves (optional) |
|
| for stability testing with a greater storage area | |
 |
Electrical connection |
| 1/N/PE AC 230V ±10%; 50HZ | |
|
ICH Compliance |
| ICH Q1B (Photostability testing) | |
| ICH Q1A (Stability testing) | |
