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STABILITY CHAMBERS
Product Details:
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