Photostability testing chamber with temperature, humidity and light exposure control, designed for testing under ICH Q1B (and also Q1A) guidelines.
MORE INFORMATION
FITOCLIMA 600 PLH-R PHARMA
Environmental chamber for testing according to ICH guidelines.
The FitoClima 600 PL/PLH-R for Photostability performs ICH Q1B guideline testing in less than 50 hours, with tracking of accumulated UV and Visible light emission and automatic stop function. Light shelves and light sensors can be exchanged by standard wire shelves, transforming it into a Stability chamber for ICH Q1A testing.
Controller and software compliant with FDA 21 CFR part 11 guidelines for data logging. Qualifications IQ, OQ and PQ provided for required on-site quality validations.
PRODUCT DETAILS
INNER DIMENSIONS (H X L X P) (MM)
1340 X 600 X 660
EXTERNAL DIMENSIONS (H X L X P) (MM)
1980 X 730 X 920
INTERNAL VOLUME (LITERS)
600
TEMPERATURE RANGE
0ºC TO 45ºC
HUMIDITY RANGE (rH%)
35 TO 95% rH
VISIBLE LIGHT
26,000 LUX (+/- 6% APPROX.)
TEST ICH Q1B VISIBLE IN APPROXIMATELY 48H
UV LIGHT
30 W/M² (+/- 10% APPROX.)
TEST ICH Q1B UV AT APPROXIMATELY 7H
SHELVES / STORAGE (M²)
ONE SHELF WITH VISIBLE LIGHTS (0.14M²)
ONE SHELF WITH UV LIGHTS (0.14M²)
