उत्पाद विवरण
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 25oC -60% RH, 40oC - 75% M RH, 30oC - 65% RH, 25oC - 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 Â 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 मोबाइल 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
Technical Specification
| SC-6 Plus | SC-10 Plus | SC-12 Plus | SC-16 Plus | SC-19 Plus | SC-28 Plus | SC-35 Plus |
Internal volume(liters) | 200 | 280 | 370 | 450 | 540 | 800 | 1000 |
No. of tray | 2 | 3 | 4 | 5 | 6 | 8 | 7 |
Internal dimension W x Dx H (mm) | 660 x 655 x 450 | 660 x 655 x 650 | 660 x 655 x 850 | 660 x 655 x 1050 | 660 x 655 x 1250 | 800 x 800 x 1250 | 800 x 800 x 1580 |
External dimension W x Dx H (mm) | 800 x 1095 x 1020 | 800 x 1095 x 1220 | 800 x 1095 x 1420 | 800 x 1095 x 1620 | 800 x 1095 x 1820 | 960 x 1370 x 1950 | 960 x 1370 x 2270 |
Temperature range & accuracy | 10°C to 60°C 1°C |
Humidity range (Rh accuracy | 40% to 95% ±3% |
Temperature & humodity control | Micriprocessor with capacitance type sensor |
Display | 4'' LCD screen , large size display for ease of reading |
Power failure alarm | Visual alarm |
Door open alarm | Audio visual alarm in case door open for over one minute |
Humidity/ temperature variation alarm | Set humidity ± 3% Rh set temperature ± 1°C audi visual alarm |
Illlumination | 8 watts fluoresent tube |
Internal body material | I stainless steel -316 grade |
External body material | Stainless steel -304 grade |
Insulation | 70 mm minimum for body & 80mm for door, CFC free polyurethane foam |
Noise level | Less than 65 db(A) |
Recommende voltage stablizer | VS-04 | VS-07 | VS-07 |