Parameter Generation & Control, Inc. 30 CU. FT. Photostability Temperature and Humidity Chamber Series 9134

THREE-SHELF 30 CUBIC FOOT PHOTOSTABILITY CHAMBER Air-cooled internal refrigeration system. Door latch allows for a pad lock. System will be capable of operating in the range defined below: Minimum air temperature of 5°C (with no RH control) Minimum air temperature of 15°C (with RH control) Maximum air temperature of 30°C Maximum dew point of 25°C Minimum dew point of 8°C Temperature and relative humidity tolerance will adhere to International Conference on Harmonization (ICH) Guideline for Stability Testing over the defined operating range. Temperature ± 2°C Relative humidity ± 5% Digital high grade, thin film temperature compensated RH/temperature sensor/transmitter which allows for very convenient, low cost calibrations. Safety devices including over-temperature safety switch, high and low refrigeration pressure switch and low water cutoff. Three adjustable-intensity , lighted shelves Any combination of shelves (visible verses UV) can be selected at the time of order. The ballasts for the visible and UV lamps are interchangeable. The lamps can be replaced to convert from one type of light source to another. (If the automatic light control feature is purchased the light sources are not interchangeable). Each shelf will adhere to photo stability requirements as defined in the International Conference on Harmonization (ICH) Guideline Q1B entitled Guidance for Industry Q1B Photo Stability Testing on New Drug Substances and Products Maximum usable height from light source to process area bottom will be 14”. This includes riser and light sensor area if so equipped. Basic light source includes a manual dimmer for light intensity control. See OPTIONS for automatic light intensity control. FLUORESCENT SHELF Light source as defined by ISO 10977 16′ long, 4 pin base, compact fluorescent 4000° Kelvin color/temperature Light uniformity better than 10% RSD over defined, usable area of each shelf. Light source will be isolated from the individual product shelf by a clear, acrylic barrier. ULTRA-VIOLET SHELF Light source as defined by ISO 10977 358 nanometers peak wavelength 16′ long, 4 pin base, compact fluorescent Light uniformity better than 10% RSD over defined, usable area of each shelf. Light source will be isolated from the individual product shelf by a clear, acrylic barrier. OPTIONS Light Intensity Controller NIST traceable light sensor Steady state light intensity controller Automatic light intensity control from 15% to 100% light output Cumulative lamp life time (manually reset) Light cycle timer Automatic or manual light control Chart Recorders Temperature and RH Chart Recorder Future Design Controls DR5000 2-pen 10′ round with pre-printed charts recording dry bulb temperature in the range of 0-100°C recording Rh in the range of 0-100%Rh Recorder is supplied with 24-hour or 7-day chart drive. Light Intensity Recorder (1-color with thermal paper) Honeywell DR-4500 Trueline 3 channels Thermal printing (all 3 channels are same color) Self-printing chart Temperature and RH Chart plus Light Intensity Recorder Future Design Controls VR06-4500-121-610 FDA 21 CFR Part 11 compliant data file Paperless digital recorder Data is stored on compact flash memory. Memory can be removed for PC access or data can be transferred via serial or Ethernet connection. 5 channels Serial port (RS-232/RS-485 or Ethernet) Capable of recording dry bulb temperature, RH and light intensity on three separate shelves.