Binder ICH light module for climate chambers size 720, photostability test to ICH Q1B, 8012-2442

Anyone who needs to carry out photostability tests in accordance with ICH Q1B using a larger sample size will find that the 720 size offers more usable volume than the smaller climate chambers. The Binder ICH light module 8012-2442 is designed specifically for this size and fits into climatic chambers from the KB PRO, KBF and KBF PRO series with development stage E7.

Light cassette technology

The module consists of a power supply unit for the side panel of the unit, as well as two light cassettes: one for visible light (VIS) and one for UVA radiation. The VIS cassette utilises LED technology and a spectrum similar to sunlight (SunLike Cool White, 6,500 K), whilst the UVA cassette uses a special fluorescent tube (Narva PUVA), as, according to the manufacturer, current LED technology is not yet capable of reproducing this spectrum in an ICH-compliant manner. Together, both cassettes generate the CIE D65 spectrum required by ICH Q1B, which corresponds to daylight grey under overcast skies. Control is via a data cable connected to the climate chamber; the irradiation duration is set as a time-interval programme on the programme controller. The light module is powered by 120 V to 240 V at 50 or 60 Hz.

Lighting values and test duration for size 720

In size 720, at full light output, the module achieves a VIS illuminance of 42 klx and a UVA irradiance of 51 W/m², both measured using spherical evaluation at a distance of 12 cm from the light source. These higher values compared with the smaller sizes 260 and 470 reduce the test duration: 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 be completed in 29 hours for the VIS component and 4 hours for the UVA component, totalling 33 hours. For flat samples, such as printed packaging materials, the test duration is extended by a factor of 1.5 according to the manufacturer, as the spherical evaluation was originally calibrated for three-dimensional test specimens. For pharmaceutical companies with a high sample throughput, this represents a significant time saving compared with the smaller models, without altering the required light doses in any way.

Control system without automatic light dose control

This version has no light sensors and operates with a conventional timer: the required irradiation time is calculated once on the basis of the known light values and stored as a programme. For automatic switch-off once the target dose has been reached, including continuous measurement, the LQC variant 8012-2444 is available for the same model. In both cases, installation is carried out on site by the customer or a service partner, without the need to return the climate chamber.

Typical applications

• Photostability testing of larger batches or sample series in accordance with ICH Q1B
• Stability studies for marketing authorisation dossiers of new active substances
• Light stress tests on primary packaging and packaging materials
• Combined climate and light testing in a single, larger cabinet

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 in the scope of delivery; these are provided as standard with the ICH-LQC light module 8012-2444.

Customised requirements & procurement service

LT Laborhandel’s procurement service can advise you on choosing between the ICH light module and the ICH-LQC light module for size 720, as well as on other accessories for constant-climate cabinets. Details can be found on our services page.