ICH-2 Photoreactor Among its line of photoreactors, we had designed a model to comply with ICH guidelines under option 2. This unit is equipped with sixteen T5-8Watt fluorescent lamps providing an illuminated area of about 144 square inches, of which an active area of about 96 square inches (8 x 12 inches) have fluctuations of under 10% in the incident power. While not required under ICH guidelines, the excellent exhaust design of our photoreactors allows the easy exhaust of ozone for users employing UVC lamps at 254 nm.. A number of tools provided as standard in the ICH-2 unit allow control of the irradiation conditions and greatly facilitate photostability work The brushed aluminum interior of our photoreactors ensures quasi-spectrally neutral reflections, thus ensuring that reflected light has essentially the same spectral composition as direct light. The recessed magnetic stirrer facilitates the irradiation of preparative (large) solution samples for product identification and is ideal for stress tests. Complete sets of sixteen UVA and visible lamps are provided with ICH-2 photoreactors. UVB and UVC lamps are optionally available from us. A bulkhead gas connector makes it easy to provide controlled atmosphere (e.g., oxygen or nitrogen) to suitable contained samples. We manufacture an environmental chamber with atmosphere, wavelength and temperature control that fits in our photoreactors. Easily changeable lamps allow users to switch UVA and visible lamps in minutes, or to expose with a preferred combination of lamps. For those choosing to have two separate photoreactors for visible and UVA irradiations, we will advice on how to avoid duplications of options where this is unnecessary, and will provide appropriate credit. A shutdown digital timer permits unattended irradiation for time intervals from a few seconds to 99 hours. A carousel for liquid samples (usually referred as a merry-go-round) allows up to 16 test tubes to be simultaneously exposed, while slow rotation ensures that all samples receive the same average dose. Ideal for actinometry work. A turntable for solid samples also provides exposure equalization. Suitable also for Petri dishes. Driven by the same motor as the carousel above, they can be easily exchanged or removed. Four separate switches allow different sets of lamps to be selected for illumination. Temperature regulation is achieved by controlling exhaust fan operation and heating elements. Temperature stabilization can be achieved at user-selected temperatures starting about 4 degrees above room temperature and up to about 46 Celsius. A power meter, pre-calibrated in the UVA and visible regions allows light intensity determinations in both regions with about 10% accuracy. In order to meet more stringent requirement we can advice customers on other products that may meet their needs. Calculations made easy: we provides all the equations for the calculations to ensure that exposure times are compliant with ICH guidelines under option 2, then all is needed is to set the timer to the specific time required for either visible or UVA exposure. An Excel file (provided) can be used as an ICH calculator. The lamp arrangement of the ICH-2 unit is shown in Figure 1, where the numbers indicate sets of lamps operated with separate control switches. For confirmatory studies lamp sets 1, 2 and 3 (10 lamps) are used, while all lamps are utilized for stress tests. 1 2 1 2 1 2 1 102 2 Relative percent power across the center depth of ICH-2 4 3 3 4 4 4 4 % relative power 101 4 100 99 98 1 3 5 7 9 11 Position (in inches) from lateral edge of chamber Figure 1: Lamp configuration for our ICH-2 model. Typical intensities achievable in the UVA region are between 25 and 30 watt/square meter, requiring around 6-8 hours to achieve the ICH recommended 200 watt-hour/square meter of UVA exposure. Visible light exposure of 1.2 million lux.hour requires about 70 hours. The emission spectra of our UVA and Visible lamps are shown in Figure 2. 1 Normalized data 0.8 Luzchem LZC-Vis lamps (Sylvania cool white) Energy photons 0.6 0.4 Figure 3. Relative light intensity across the center depth of the ICH-2 model. Determined with Sylvania F8T5/CW lamps. The interior of the chamber is constructed of aluminum. Its surface has been designed to avoid specular reflectance of the light, thus providing a mechanism for diffusive reflectance and helping achieve illumination homogeneity. The diffuse reflectance spectrum of the chamber walls is shown in Figure 4. The relative small variations and the fact that reflections only contribute to ≤ 20 % of the light incident on samples minimizes spectral variations across the chamber surface. 0.2 100 Aluminum 0 300 400 500 Wavelength, nm 600 700 80 Figure 2A: Emission spectrum of LZC-Vis lamps. %R 60 40 1 Normalized data 0.8 Luzchem LZC-UVA lamps 20 Energy Photons 0 0.6 200 300 400 500 Wavelength (nm) 600 700 0.4 Figure 4: Diffuse reflactance spectrum of the ICH-2 chamber walls. 0.2 0 300 400 500 Wavelength, nanometers 600 700 Figure 2B: Emission spectrum of LZC-UVA lamps. The ICH-2 has its lamp configuration optimized for best homogeneity of exposure. Figure 3 shows the relative power across the photoreactor, as determined at the half-depth of the chamber, i.e., 6 inches from the front access area. The measurements where made on the ‘floor’ of the chamber, about 9 inches from the lamps. Power distribution is excellent across the chamber, as shown in Figure 3. This ensures that any group of samples placed across the chamber at constant depth will receive essentially identical doses. However, there is some unavoidable drop in power towards the back of the chamber, and near the front, where the door access is located. Samples at these positions are below the electrode region of the lamps, and thus the 2-inch strip nearest the back and front show significant variations, as shown in Figure 5, where the numbers correspond to a 2-inch grid at the floor of the photoreactor. 2 fluorescent lamps. They utilize highly efficient ceramic xenon lamps with built-in reflectors providing, with just 175 Watts, an illumination intensity (34 watt radiant output) comparable with conventional illuminators using lamps with power ratings several times higher. This allows for forced air cooling, avoiding the inconvenience and risks associated with water-cooling. The ‘ozone-free’ lamp is ideal for drug phototesting and solar simulated radiation over 320 nm, while the full UV lamp provides the usual xenon lamp spectrum with significant intensity at 220 nm and up. The ‘ozone- Figure 5: Surface plot of light distribution across an imaginary 2-inch lattice at the floor of the irradiation chamber. Except for the 2-inch strips at the front and back, the remainder of the chamber (an 8x12 inch area) shows variations of less than 8%, with best homogeneity achieved for horizontal strips. Convenient add-ons for other photostability applications (not required for ICH guidelines) UVB and UVC lamps Quartz test tubes for carousels Environmental chamber with atmosphere, wavelength (via cut off filters) and temperature control. Xenon illumination chambers ICH Option 1 compliance, solar simulated radiation or full UV exposure free’ units do not require any special concern, since the cooling air can be readily exhausted in indooratmospheres. Many of the convenient options of other photoreactors will be readily available in these units, including digital timers, power monitors, magnetic stirrers, turntables and temperature control. Basic units, including shutter control and filter adaptors will list for under USD $12,000. Contact us for inclusion in our mailing list for product release information. Our new exposure chambers are based on the successful design of the photoreactors using What’s unique about our ICH2 Photoreactor ? LZC-ICH2 photoreactor is a unique instrument in its design, capabilities and versatility. This instrument comes fully certified for operation under ICH guidelines for drug photostability under option 2; it is supplied with chamber mapping of power distribution and meets our standards for illumination. Add to this the unique characteristic of our lamps, which are sold with full spectral information allowing consistent results in any study undertaken with one of our units. We incorporate recessed magnetic stirrers, carousels and turntables for liquid and solid samples, a digital timer, temperature control, and brushed aluminum interior light-scattering surfaces, which allow quasi-spectrally neutral reflections, thus ensuring that reflected light has essentially the same spectral composition as direct light, while providing a very homogeneous illumination field. These are NOT options. This is all standard equipment 3