We have developed humidity control oven in result of its own in-house r&d having backing of years of experience and exposure in pharmaceuticals testing to comply with gmp regulations and ich guideline, so as to match the international standards, the need of present globalization. These chambers are used in stability & self life studies. We are determined and committed to provide high quality products and services, to satisfy the customer before, during andafter the sales in total. construction* interior executed in ss-304* exterior executed in ss -304* puf insulation heating systemscustom built stainless steel tubular heaters used as heating element. The stainless steel ensure better heat transfer. cooling systems:hermetically sealed compressor, with evaporation coil and condenser protected with time relay.* non-cfc refrigerant. humidification:humidity is controlled by steam injection method. The boiler tank is used for steam generation; electro-magnetic switch is used for sensing the water level. Float valve is used for controlling the inlet water flow in the reservoir tank. air circulation:suitable capacity blower, circulating air throughout the chamber maintains uniformity of temperature &humidity. chamber lightfluorescent tube light fittings are provided for internal illumination inside the chamber. traysremovable perforated trays are provided, made of 304 stainless steel. controller :microprocessor based programmable pid controller offers fine and accurate control of set parameter. The panel is consisting of data logger capable of storing 5000 records. recommended stability test parameter as per ich guidelines. As per ich guidelines, stability studies are carried out under the following conditions. * long term: at 25c ( 2c) and 60% rh(5%rh)intermediated : at 30c (2c) and 60% rh(5%rh)accelerated : at 40c (2c) and 75% rh(5 % rh) documents dq, iq, oq, &pq and calibration certifications:to comply with the documentation requirements under ich guidelines, we provide dq, iq, oq and pq protocols to be executed before taking the chamber in to for regular use, and support the supply with the following documents with the detail operational and service manual technical data:*temperature range : + 20 c to + 60 c*temperature accuracy : +- 0.5*humidity range : 40% rh to 95% rh*humidity accuracy : 3% rh*alarm : visual alarms. * power supply : 230 v ac, +- 10 %, 50hz data acquisition software window base for acquisition of performance data, and to store andmaintain the data folders for future record as well to view the periodical graphic chart, average and mean results, and many more facility as specified under software with 21cfr part 11 compliance.
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Panvel, Navi Mumbai, Maharashtra