BS-02+ photostability chamber to ICH Q1B
The BS-02+ is an irradiation chamber for documented photostability testing to ICH Q1B. Separately controllable visible and UV exposure allow both exposure components to be captured deliberately. Assigned sensors monitor the quantities relevant to the test procedure. This page describes the standard scope, the test procedure, the measurement concept and the available options of the chamber.
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 × 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 and UVA fluorescent lamps are used. The UVA fluorescent lamps emit a maximum between 350 nm and 370 nm. The LED light sources emit in the spectral range from 400 nm to 700 nm. 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 to DIN EN ISO/IEC 17025:2018-03.
- Irradiation of medical products and active pharmaceutical ingredients
- Photostability tests according to ICH Q1B
- Test according to VICH GL5 (veterinary products)
How the chamber meets the test requirement
| Test requirement | Implementation with the BS-02+ | Evidence document |
|---|---|---|
| Defined light and UV exposure | Separately controllable radiation sources (UVA fluorescent lamps and cool-white LED) | Test record |
| Reproducible measurement | Assigned, calibrated sensors | Calibration and instrument data |
| Documented endpoint | Dose- or time-based control via the UV-MAT Touch | Export and record |
| Sample safety | Closed chamber, sample compartment temperature approx. 25 °C | Operating and safety documentation |
The normative framework – options, minimum exposures and test planning – is covered under pharmaceutical photostability to ICH Q1B. Standard scope, options and accessories are listed separately in the sections below.
Equipment in detail
The BS-02+ has a modular design and can therefore be adapted to different test tasks. These functions are always part of the scope of delivery:
 | Dose control The irradiance is measured continuously; the UV-MAT Touch ends the irradiation once the set target dose is reached. UVA and the visible range are recorded separately. |
 | Sensors Suitable materials give the sensors excellent long-term stability. They are traceably calibrated, can be recalibrated and are supplied with a factory or ISO 17025 calibration certificate. Sensors in IP65 as well as further measuring and spectral ranges are available on request. |
 Similar to illustration | Sensor holder The sensor holder fixes two radiometer sensors at the side of the chamber. For measurements on the sample the sensors can be removed, so that the irradiance can be determined at the required position. The UV-MAT can be adjusted to this by a factor. |
 | Control and dimming Two lamp groups can be controlled and dimmed separately - in the BS-02+ for example four UVA lamps and four cool white LED modules. Dimming reduces the irradiance to about 30 %. |
 | Lamps The UVA fluorescent lamps are easy to change - turning them through 90° is enough. The long-life cool white LED light sources are exchangeable as modules. The BS-02+ takes four UV lamps and four LED modules at the same time, or alternatively eight UV lamps. |
 | Timer As an alternative to dose control the UV-MAT Touch offers an adjustable timer for time-controlled irradiations between 1 s and 999 days. |
 | Irradiation records Irradiations can be recorded with a PC. The UV-MAT Touch also records them to a USB stick without a PC. |
Options
This option is available in addition to the standard equipment:
 | PC software for the UV-MAT Touch Complex, multi-stage irradiations - for example a pre-irradiation with UVA at low irradiance followed by a high-intensity UVC irradiation - can be parameterised with the remote control option. Up to 30 dose- or time-controlled steps and pauses are possible. At the same time the irradiation is logged and stored on the PC. |
Technical data BS-02+ irradiation chamber for testing of drug products and active pharmaceutical ingredients
| Interior chamber | 46 × 32 × 23 cm |
| Dimensions | 58 × 40 × 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, cool white |
| Number of UV lamps | Typical 4, max 8 |
| Sample temperature | 25 °C ± 5 °C |
| Irradiance | ~75.000 lux |
| Irradiance UVA | 4 mW/cm² |
| Sample temperature | The cooling uses ambient air |
| typically the temperature of | |
| the samples is ambient + 5 °C |
Testing photostability of pharmaceuticals to ICH Q1B option 2
ICH Q1B allows two routes for photostability testing. Option 1 requires a source reproducing the daylight spectrum – a xenon lamp or a fluorescent lamp with daylight characteristics. Option 2 separates the two components: one lamp for visible light and one for the UV part, each with its own dose requirement – at least 1.2 million lux hours in the visible and at least 200 watt hours per square metre in the near UV.
The practical difference is demonstrability: with separate sources each dose can be measured and recorded individually. That is what the BS-02+ is designed for – with the UV-MAT irradiation control, which ends the run at a dose reached rather than after a number of hours. That is the difference between a test that demonstrates the required value and one that estimates it: lamps age, and an irradiance assumed constant over weeks is not one.
The same arrangement covers VICH GL5 for veterinary medicinal products. What governs is the current version of the guideline and the sponsor's specification.
The UV-MAT Touch irradiation control
The UV-MAT Touch is operated through a high-resolution capacitive touchscreen. A Cortex ARM processor provides durability and the ability to update - new functions can be installed on site. The device and the PC software are compatible with Windows 10 and 11. Single- and multi-channel irradiations are shown numerically and graphically, together with oscillograms and the settings. Parameters are set directly on the device and are password protected.
| Display | capacitive touch display, 5″ WVGA |
| Display output | irradiance and dose, oscilloscope view |
| Data recording rate | adjustable: 1 s to 1 h |
| Recording period | > 24,000 h |
| Storage interface | 1 × USB stick (up to 32 GB) |
| Sensor inputs | 24 bit, fully digital |
| Number of sensor inputs | 2 |
| Dose setting range | 0 to 1,000,000 J/cm² |
| Dose resolution | 1 mJ/cm² |
| Irradiation time | 1 s to 999 days |
| PC interface | USB 2.0 |
| Sensor recognition | yes |
| Dimensions | 185 × 251 × 100 mm |
| Permissible operating temperature | 5 to 60 °C |
| Spectral ranges | UVA and LUX |
Order numbers, scope of delivery, accessories and versions
| Version | Order number |
|---|---|
| BS-02+ | 860912 |
The chamber meets the requirements of ICH guideline Q1B for photostability testing; it is supplied with lamps, sensor holder and control unit.
| Version | Order number |
|---|---|
| UV-MAT Touch | 820930 |
The chamber is operated by the UV-MAT - either as the UV-MAT with a graphic display or as the UV-MAT Touch with a 5-inch touch display and oscilloscope view. Both measure the irradiance and switch off under dose control.
| Designation | Order number |
|---|---|
| PC software for the UV-MAT Touch | 860901 |
| Designation | Number range |
|---|---|
| Radiometer sensors | 8144XX |
The radiometer sensors carry their own number for each spectral range (number range 8144XX); you will find them under radiometer sensors.
| Service | Order number |
|---|---|
| Factory calibration | 710000 |
| ISO 17025 calibration | 17025 |
Accredited calibration to ISO/IEC 17025 in our own calibration laboratory.
