ClimatestPharma TH constant clima chamber for stability testing according to ICH
Constant climate chamber Climatestpharma TH has been developed for the stability testing of drugs according to ICH. Our chamber ensures high-precision stability, temperature and humidity conditions when testing the material behavior. Standard-compliant climatic conditions: Climatic zone II: temperature: + 25 ° C +/- 2K; rel. Humidity 60% +/- 4% to 5% RH Intermediate condition: temperature: + 30 ° C +/- 2K; rel. Humidity 65% +/- 4% to 5% RH Accelerate condition: temperature: + 40 ° C +/- 2K; rel. Humidity 75% +/- 4% to 5% RH Climatic zone I: temperature: + 21 ° C +/- 2K; rel. Humidity 45% +/- 4% to 5% RH Climatic zone III: temperature: + 30 ° C +/- 2K; rel. Humidity 35% +/- 4% to 5% RH Climatic zone IVa: temperature: + 30 ° C +/- 2K; rel. Humidity 70% +/- 4% to 5% RH Climatic zone IVb: temperature: + 30 ° C +/- 2K; rel. Humidity 75% +/- 4% to 5% RH Execution: - Chamber dimensions adapted to individual customer needs - Steel interior and housing with antimicrobial powder coating with silver ions - Hygienic corner radius in the inside of the refrigerator compartment - germ formation is effectively avoided - 80 mm insulation - Door with window - Aluminum shelving system with fully hygienic stainless steel gratings ensures ease of construction and supports air circulation in the chamber Air treatment system: - Digitally controlled, precise ultrasonic humidification - Durable cooling device - Powerful and wear-free heating - Highly accurate temperature and humidity sensors for maximum temporal and spatial stability of climatic conditions Regulation and monitoring technology - Intuitive touchscreen controller with freely configurable, graphic and numerical display of the results - Visual and acoustic alarm and (optional) alarm forwarding via SMS or email - Device self-test for comprehensive status analysis - Configurable user management compliant with 21 CFR part 11 - Calibration and adjustment Optional - Cooling unit installed outside the building - Emergency dehumidification system - Networking and central control of multiple devices - Independent, parallel monitoring system (external sensors) with data archiving for controller-independent monitoring - Alarm information via SMS or email - A separate zone for psychotropic drugs in the chamber, with lock or electronically locked - Calibration and qualification documents Sale only to companies.