Binder KBF P 240-UL, Translation Of Original Operation Manual

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KBF P + KBF LQC + KBWF (E6) 11/2016 page 140/189
20. Illumination system
20.1 ICH compliant illumination according to CPMP/ICH/279/95 (Q1B) – KBF P,
KBF LQC
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.
The KBF P and KBF LQC chambers are equipped with BINDER ICH light. Pure cool white fluorescent
tubes (light color 965 Biolux) are used together with the special fluorescent tubes “BINDER Q1B Synergy
Light” available only at BINDER, which combine emission of both radiations UVA and cool white. Combi-
nation of these tubes leads to a spectral distribution according to option 2 of Guideline CPMP/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
“BINDER Q1B Synergy Light” fluorescent tubes, which contain a UVA portion, independently from the
“cool white” fluorescent tubes emitting in the visible spectral range.
•
Optimum homogeneity of the spectral distribution and the intensities in LUX and UVA on the shelf sur-
face, 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 pre-
cise 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 / 23.6 in or 900 mm / 35.4 in . 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 the form of a rod with a tube
diameter of 26 mm / 1.02 in . Length according to chamber size 600 mm / 23.6 in or 900 mm / 35.4 in .
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 chamber on unprotected skin or eye shall not
exceed 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.