camara climatica para fotoestabilidade ICHq1b

FITOCLIMA 600 PHOTOSTABILITY CHAMBER

Climatic chamber for photostability testing in pharmaceuticals, cosmetics, or equivalent products, in accordance with ICH Q1b guideline. It can be equipped with UV and visible light sensors for automatic management of photostability tests. Its wide climatic range and the removable and adjustable interior for standard shelves, allow for stability testing as well (as per ICH Q1A).

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FITOCLIMA 600 PHOTOSTABILITY CHAMBER

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)

550

 

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 IN APPROXIMATELY 7H

 

SHELVES / STORAGE (M²)

ONE SHELF WITH VISIBLE LIGHTS (0.14M²)
ONE SHELF WITH UV LIGHTS (0.14M²)

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