Binder ICH light module for climate chambers size 260 and 470, photostability test to ICH Q1B, 8012-2441

Photostability tests in accordance with ICH Q1B require defined light doses of visible light and UVA radiation, which in practice are spread over several test days. The Binder ICH light module 8012-2441 retrofits climate chambers of sizes 260 or 470 from the KB PRO, KBF and KBF PRO series (development stage E7) to meet the requirements of this guideline as a photostability test chamber, without the need for a separate test unit.

Design and operation

Each ICH light module consists of a power supply unit, which is mounted on the prepared side panel of the unit, and two light cassettes, one for the visible light (VIS) range and one for the UVA range. The VIS cassette utilises LED technology with spectral characteristics similar to sunlight (SunLike Cool White, 6,500 K), whilst the UVA range employs a special fluorescent tube (Narva PUVA), as, according to the manufacturer, this wavelength range cannot yet be covered in an ICH-compliant manner using current LED technology. Together, the two cassettes reproduce the CIE D65 spectrum required by the ICH guideline, which corresponds to daylight grey under overcast skies. This version, which does not feature light dose control, is connected to the climate chamber via a data cable; the irradiation duration of the two light cassettes can be controlled individually via a time-interval programme on the climate chamber’s control unit. Power is supplied via 120 V to 240 V at 50 or 60 Hz.

Light output and test duration

In sizes 260 and 470, the module achieves a VIS illuminance of 38 klx and a UVA irradiance of 37 W/m² at full light output, measured using spherical evaluation at a distance of 12 cm from the light source. A complete ICH-Q1B test with the required light doses of 1.2 Mlx·h of visible light and 200 Wh/m² of UVA can thus be carried out in 32 hours for the VIS component and 6 hours for the UVA component, totalling around 38 hours or approximately two test days. For flat samples, such as printed materials, the manufacturer states that the required test duration is increased by a factor of 1.5, as the spherical evaluation was originally designed for three-dimensional test specimens.

Without light dose control: time control via the controller

Unlike the LQC variant, this version does not contain any light sensors for automatic dose control. The irradiation duration is set via a time programme on the climatic chamber, based on the known illuminance and irradiance levels. For those who wish to enter the light dose directly on the controller and have the cassettes switch off automatically once the dose has been reached, the ICH-LQC light module with item numbers 8012-2443 (260/470) and 8012-2444 (720) provides the appropriate equipment. For an initial ICH-Q1B test run, the timer function is generally sufficient; for recurring test series requiring documentation, the LQC variant with continuous dose measurement is recommended.

The ICH light module is installed on-site by the customer or a service partner; it is not necessary to return the climate chamber to the factory for this. This allows an existing Binder climate chamber of size 260 or 470 to be retrofitted for photostability testing without having to make additional space for another unit.

Typical applications

• Photostability testing of active pharmaceutical ingredients and finished medicinal products in accordance with ICH Q1B
• Stability testing as part of the regulatory approval process for new active pharmaceutical ingredients
• Light stress tests on packaging and primary packaging materials
• Combined climate and light testing in the same cabinet without a separate test unit

According to the operating instructions, the CO₂ gas injection module cannot be operated simultaneously with the ICH light module, as both accessories occupy the same interface on the climatic chamber. Users requiring both applications should either plan for two chambers or switch between the modules depending on the test series.

Technical details

Contents

• VIS light cassette with connection cable
• UVA light cassette with connection cable
• U-rails for mounting the light cassettes in the climate chamber
• Power supply box with ballasts/power supplies
• Profile rails and bolts for securing the power supply box to the climate chamber
• Data cable
• Mains cable
• Operating instructions

The light sensors for light dose control are not included; this feature is reserved for the ICH-LQC light module.

Customised requirements & procurement service

LT Laborhandel can assist you in choosing between the ICH light module and the ICH-LQC light module, as well as with other accessories for constant-climate cabinets, such as water supply systems or sample temperature control sensors. See our services page for details.