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Contact SupplierThe REMI Photostability Chambers are designed for Photostability Tests as per ICH guidelines Q1B. These conditions require white fluorescent light exposure of not less than 1.2 million LUX hours and integrated near Ultra Violet energy of not less than 200 watt hours/square meter. These chambers are manufactured as per GMP norms.
Advantages
Accessories
Features | Customer benefits | Characteristics |
Positive Air flow technology | Uniform test conditions throughout the chamber, Independent of sample size and quantity. | Constant circulation of air throughout the chamber achieves homogeneous Temperature & Humidity conditions. |
Illumination system | Uniform illumination throughout trays. UV exposure on samples only. | Fluorescent & UV tubes fitted in a proper way. UV tubes of 365mm automatically switched off once the door is opened. |
Humidifier system | Humidity maintained by steam injection from Humidifier Tank. Reservoir Tank for storage of additional water. | Vaporized humidification & capacitive humidity sensors provide early recovery after door opening due to better response time. |
Humidity sensor | Direct display of Humidity. Low drift fast response time & high accuracy. | High technology capacitance type sensor. |
Cooling system | Eco friendly CFC free refrigeration system provides reliable conditions as per GMP/GLP norms. | Powerful Hermetically sealed Emerson compressor coupled with evaporator & condenser delivers the performance. CFC refrigerant reduce carbon footprint. |
Safety Features | Auto switch off of UV tubes once the door is opened. Audio-Visual alarm for temperature & humidity variations along with utility failures. Low water level alarm & power cut off of boiler heater. Every alarm on machine can be extended up to security gate by wire connection. | Float switch cuts off supply to heater in case of low water level in humidifier tank. Electrical Circuit Breaker. Shut off of Humidity & Air heaters in case of temperature over shoots or under shoots. Compressor 'ON' delay timer to safe guard the compressor. Overload cut off relay for compressor. |
Stand-by Cooling system & Humidity system | Dual Refrigeration & Humidifier provides extra uninterrupted functioning of the machine with automatic / manual switch over in case primary system fails. | Complete operative secondary system which can be Auto / manual switch over. |
Controller with LCD display | Intelligent controller with Auto tuning facility. Battery backup for controller. self-diagnosis for errors. Histogram format of 24 hours temperature & humidity recordings. Power failure & resumption recorded. Built in memory of 1000 records. Easy one glance display of utility. Felicitates auto switch over to secondary refrigeration & humidity systems. 4 Inch attractive LCD display for excellent graphics & convenient viewing. | Programmable controller provides versatility of auto switch overs. Password protection. Alarms & all electronic data recordings as per 21 CFR guidelines. Excellent visuals on LCD display. |
Software | As per 21 CFR Part 11 requirements. Secured SQL server database. Password aging. Secured Audit trail reports. Electronic signature. User defined MKT calculations. Alarm Log along with acknowledgement. Graphical Data display. Automatic & Manual backup. Single software for multiple machines. | Remi “DATASOFT” software customized to maintain optimum electronic records with all the alarms & events. Rights based user categories. Software manual & validation protocol. Online & offline records. Data export in PDF format. Remote trouble shooting Support via team viewer. |
Qualification | Documentation as per FDA and GMP/ GLP regulations. Maximum process stability. Onsite validation & mapping. | IQ, OQ, PQ, DQ documents. Traceability certificate of loggers. MOC certificates. |
Accessories and Services | Complete solution everything from one source. All over India Service Centers. | Digital light meter PLC with color HMI. Data Logger with multiple sensors. Software as per 21 CFR Part 11. Biometric Door Access. GSM mobile SMS alerts for variations. |