BINDER KBF LQC 240 - Manual (Page 75)

KBF LQC (E5.3) 07/2014 page 75/114
15. ICH compliant illumination according to CPMP/ICH/279/95 (Q1B)
15.1 BINDER ICH light
Drugs are tested according to extensive test procedures and only thereafter are admitted for distribution.
Part of the approval procedure is the proof that the products do not or only minimally change within the
serviceable life. One of the tests to be executed is the photostability test according to ICH guideline Q1B.
For this test, product samples must be exposed to a quantity of light of at least 1.2 million LUX x hours in
constant climate chambers with ICH compliant illumination. To prove the quantity of light a temporal inte-
gration of illumination (LUX) and UV intensity (W/m²) e.g. by optical sensors is needed.
Beside pure cool white fluorescent tubes (light color 640 or 840) the special fluorescent tubes “BINDER
Q1B Synergy Light” available only at BINDER are used, which combine emission of both radiations UVA
and cool white. Combination of these tubes leads to a spectral distribution according to option 2 of guide-
lineCPMP/ICH/279/95 (Q1B).
Advantages of the BINDER light system:
•
Reaching the radiation doses of UVA and LUX requested by Q1B almost simultaneously.
• After having reached the target intensity of guideline CPMP/ICH/279/95 (Q1B), you can turn off the
fluorescent tubes with a UVA portion (BINDER Q1B Synergy Light) independently from the tubes with
visible spectral range.
• Optimum homogeneity of the spectral distribution and the intensities in LUX and UVA on the shelf
surface, even with high intensity values, obtained by the BINDER ICH light and the special lens of the
headlight. This guarantees that all samples receive the same radiation doses, thus permitting very
precise test conditions for photo stability tests.
Fluorescent tube cool white: T8 fluorescent tube in form of a rod with a tube diameter of 26mm. Length
according to chamber size 600 mm or 900 mm. Emissive range in the visible spectral range 400 to 800
nm. The relative spectral distribution meets the F6 standard (cool white) acc. to ISO 10977.
Fluorescent tube “BINDER Q1B Synergy Light”: T8 fluorescent tube in form of a rod with a tube di-
ameter of 26mm. Length according to chamber size 600 mm or 900 mm. Emissive range in the visible
spectral range 400 to 800 nm. Emissive range in the UVA range 320 to 400 nm.
WARNING
UV light hazard.
Eye and skin injury.
∅
Do NOT look directly into the light.
 Minimize skin exposure.
The maximum allowed ultraviolet exposure emitted by this unit on unprotected skin or eye shall not ex-
ceed 7.7 hours per day.
The waste heat of the fluorescent tubes leads to a modification of the temperature - humidity diagram:
When operating the chamber with illumination: Restricted temperature and humidity range 20
°C / 68°F to 60 °C / 140°F , at 20 °C not below 30 % r.H.