Stability Chambers

The Stability Chambers are designed as per ICH Guidelines for precise monitoring of temperature and humidity conditions required for long term, intermediate & accelerated stability studies at chemical, pharmaceutical, agrochemical manufacturing facilities. These chambers are manufactured to comply with GMP requirements. These freezers are available in standard & GMP versions. Performance: Designed as per ICH guidelines to meet, WHO and USFDA requirement Fulfills storage conditions of 25C – 60% Rh, 40C-75% Rh, 30C–65% Rh, 25C–40% Rh Precise monitoring of temperature and humidity conditions Comply with GMP requirements Powerful fan motor for forced air circulation to maintain uniform conditions inside chamber within permissible limit Heating by long life SS tubular heaters Validation protocol with IQ, OQ, DQ Documentation as per ICH guidelines Leading Technology: Microprocessor controller with LCD display & capacitance type sensor for precise control of temperature and humidity 4 Inch attractive LCD display for direct display of humidity & temperature Battery Backup for Controller-12 V, 7.2 Ah sealed maintenance free, Fully charged battery runs for more than eight hours Automatic Calibration of set parameters Self-Diagnosis for errors Power failure and resumption recorded with date and time Machine filled PUF insulation to eliminate void pockets Unique design of thermal barrier for better energy efficiency Hermetically sealed Compressor with CFC free refrigerant User Friendly: Histogram format of 24 hours temperature and humidity recording Settable High/low alarm points with date and time Memory for storage of up to 1000 records Centronic interface to record Temperature, Humidity, Date, & Time by attaching Dot Matrix printer with adjustable print interval Chamber calibration port on side Adjustable trays PC communication with RS-485 and software complying to 21 CFR part 11 as per USFDA guidelines (Optional) Data logger for 8 Point (4 + 4) temperature/humidity recording with sensor, printer interface and software (Optional) Safety: Low water level alarm and power cutoff of boiler tank heater High temperature safety cut off & alarms for high/low set parameters Electrical circuit breaker Time delay for compressor switch on Overload cut off relay for compressor Features of Software complying to 21 CFR part 11: Multiple level alpha numerical password with password ageing Electronic signature and menu entered comment Secured audit trail report Alarm report with mention of alarm condition Mean Kinetic Temperature able to be calculated for any days & alarm deviation report Reports in graphical and tabular form Data Stored in PC server with Lan connectivity and can be monitored on any PC with password authentication Multi chamber data acquisition on single software