ICH Q1B irradiation chamber BS-02+
The BS-02+ is a compact irradiation chamber for performing photostability tests according to ICH Q1B and VICH GL5 for medical products and active pharmaceutical ingredients. Irradiation is performed with UVA radiation and visible light according to option 2 of the ICH Q1B guideline. With a footprint of 46 x 32 cm and a height of up to 20 cm, the irradiation chamber provides space for samples. The sample chamber temperature during operation is approx. 25 °C, so that thermal damage to the samples is avoided. Due to the high homogeneity of the irradiation, the specimens can be positioned as desired.
In accordance with the ICH Q1B guideline, modern LED light sources with a „Cool White“ emission (ISO 10977) and UVA fluorescent lamps are used. The UVA fluorescent lamps emit a maximum between 350nm and 370nm. The LED light sources emit in the spectral range from 400nm to 700nm. The Cool White light sources and the UVA fluorescent lamps meet the requirements of ICH Q1B and VICH GL5 for photostability testing of medical devices and drug substances.
Both light sources are dimmable without changing the spectral distribution and are automatically turned off after reaching the ICH Q1B target dose of 1.2 million LUX-hours and 200 Wh/m².
The BS-02+ can be used to simulate the resistance to prolonged solar radiation with modern LED light sources. The old fluorescent lamps will be no longer available due to the EU regulation „Ecodesign requirements for light sources“ that becomes effective starting September 2023. For the BS-02+ we offer the irradiation control UV-MAT Touch. The irradiation control measures the UVA and the visible spectral range separately and controls a constant dose independent of aging, contamination or temperature influences.
The measurement is performed with calibrated sensors. For this purpose, the sensor already contains an extremely precise analog-to-digital converter and a temperature sensor. The sensor calibration is performed in our laboratories, for which we are accredited according to DIN EN ISO 17025.
The UV-MAT Touch records the irradiations and temperatures and can be controlled by the PC. Thus the documentation of the irradiation is possible without any problems. In summary, the BS-02+ is thus a high-quality, economical and future-proof investment for the following applications:
- Irradiation of medical products and active pharmaceutical ingredients
- Photostability tests according to ICH Q1B
- Test according to VICH GL5 (veterinary products)
Technical data BS-02+ irradiation chamber for testing of medical products and active pharmaceutical ingredients
|Interior chamber||46 x 32 x 20 cm|
|Dimensions||58 x 40 x 47 cm|
|Weight||~ 40 kg|
|Power consumption||250 W|
|Mains||110 - 230 VAC, 50/60 Hz|
|Operation temperature||10 to 40 °C|
|Humidity||< 80% non-condensing|
|Lamp lifetime||LED up to 15.000 h|
|UVA up to 4.000 h|
|LEDs||4 modules, coole white|
|Number of uv lamps||Typical 4, max 8|
|Sample temperature||25 °C +/- 5°C|
|Irradiance UVA||4 mW/cm²|
|Sample temperature||The cooling uses ambient air|
|typically the temperaure of|
|the samples is ambient + 5 °C|