REMI 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.
SALIENT FEATURES
- Fulfills storage conditions of 25°C “ 60% RH, 40°C “ 75% M RH, 30°C “ 65% RH, 25°C “ 40% RH
- Precise monitoring of temperature and humidity conditions
- Unique design of thermal barrier for better energy efficiency
- Machine filled PUF insulation to eliminate void pockets
- Powerful fan motor for forced air circulation to maintain uniform conditions inside chamber within permissible limit Heating by long life SS tubular heaters
- Hermetically sealed Compressor with CFC free refrigerant
- Chamber calibration port on side
- Adjustable trays
- Output for remote alarm
- Microprocessor controller with LCD display capacitance type sensor
- 4 ” attractive LCD display for direct display of humidity temperature
- Auto tuning of controller
- Battery Backup for Controller
- Settable High / Low alarm points
- Centronic interface to record temperature, Humidity, Date Time by attaching Dot Matrix printer with adjustable print interval
- REMI ‘Datasoft’ data acquisition software complying to 21 CFR part 11 as per USFDA Guidelines (Optional)
- Power failure and resumption recorded with date and time
- PC communication through RS “ 485 with data acquisition software
- High temperature safety cut off alarms for high/low set parameters
- Low water level alarm and power cutoff of boiler tank heater
- Time delay for compressor switch on
- Overload cut off relay for compressor
- Rounded inner chamber for easy cleaning
- Auto door closer
- Attractive door profile
- Data logger for 8 point (4+4) temperature / humidity recording with sensor, printer interface and software (Optional)
- Optional
- Touch screen display ( TFT ) with additional features(Details overleaf)
- Validation protocol with IQ, OQ, PQ Documentation
LCD DISPLAY
- 4 Inch attractive LCD display
- Intelligent Controller helps maintain temperature in case of sensor failure
- Battery Backup for Temperature Controller
- Auto tuning of controller
- Self-Diagnosis for errors
- Histogram format of 24 hours temperature recording
- Power failure and resumption recorded with date and time
- Settable High / low alarm points
- Memory for storage of upto 1000 records
- Centronic interface to record Temperature, Date, Time by attaching Dot Matrix printer with adjustable print interval
- Alarm on equipment / output for remote alarm
- PC communication through RS-485 with data acquisition software
- Remi “Datasoft”™ Data acquisition software complying to 21 CFR part 11 as per USFDA Guidelines (optional)
TOUCH SCREEN DISPLAY
- 7 inch big colour touch screen
- PLC (Programable logic controller)
- Memory of 10,000 records
- Centronic interface to record Temperature, Date Time by attaching Dot Matrix printer with adjustable print interval
- PC communication through REMI Datasoft
- Ethernet port
- Battery backup in case of power failure for display, alarms off-line data logging (optional)
- Programmable cyclic timer for controlling illumination conditions
REMI ‘DATA SOFT’
- Multiple level alpha numerical password with password ageing
- 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 PC with password authentication
- Multi chamber data acquisition on single software
- Communication through RS 485 / TCP IP
- GSM Mobile Alert for six Numbers
OPTIONAL ACCESSORIES
- To be Ordered separately
- Data logger for 8 / 16 Point temperature Humidity recording with sensors printer interface and software
- Seven days circular chart recorder (single channel)
- Software as per 21 CFR Part 11 requirements
- PLC Based Control System with HMI Touch Screen
- Biometrics Magnetic Door Access for Secured Door opening with software to maintain log
- Validation (mapping) consist of one cycle for temperature at any one set point for 24 hours on empty and loaded condition
- Standby Refrigeration System
- Standby Humidity System
- GSM alert through SIM card
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