PHOTO STABILITY CHAMBERS
PhotoStability Test Chambers are especially designed to conduct stability and shelf life studies on drug and drugs substances. These Chambers are designed to provide high intensity lighting system to comply with ICH guide lines for photo stability conditions with white fluorescent exposure of 1.2 million LUX hours and ultra violet energy exposure of 200 W hours/sq. meters. Chambers conform to International Standards such as ICH, WHO Guideline, and USFDA requirements. Printer interface for LUX & UV meter, automatic shut off after specified exposure level.
CABINET CONSTRUCTION
The cabinet of Chambers is insulated with high density CFC free Poly Urethane Foam. Interior of chambers is mirror finish stainless Steel (304 SS, 0.8 mm thick). The exterior is white powder coated (1.0 mm thick) mild steel and the door has magnetic gasket with a keyed door lock. Stainless steel trays are provided for storage inside. The cooling is effected by hermetically sealed compressor of high quality. GMP models are in total stainless steel (Inside S. S 304 with mirror finish and outside. S 304 dull finish and inner 316 is also available on request.)
REFRIGERATION SYSTEM
The cooling is effected by CFC free refrigeration system with split type condensing unit located outside the room. Condensing units are characterised by high-efficiency heat transfer and low power consumption.
- CFC free refrigeration with time delay to safe guard the compressor .
- Inner grooved copper tubes and slit aluminium fins for superior heat transfer.
- Filter drier for moisture and dirt protection.
- Safety and control devices for better system protection.
- Thermally protected and permanently lubricated fan motors.
- Smaller footprint for ease of handling and installation.
PROGRAMMABLE LOGIC CONTROLLER (PLC) SYSTEM
A programmable logic controller (PLC) is a digital computer used for automation of controlling electromechanical processes, such as control of Temperature, Relative Humidity, Standby systems and event management with less maintenance hence no moving parts.
- 4.3” HMI with color Display and touch screen.
- Configurable access for 72 users.
- Privilege based grouping.
- Multi level Password protected Human Machine Interface (HMI).
- Data storage to record set values, process values, date & time with variable time intervals.
- Display of set value and process value.
- High speed Ethernet connectivity .
- incorrect password attempt and user lock.
- Online data can be printed with date and time stamp.
- Non operational screen auto logout.
- Configurable maintenance reminder pop up alarm .
- Individual Alfa numeric user ID and password.
- User operation will be recorded and saved in memory.
- Online and offline Log reports on HMI.
- Safety cut off for over shoot and under shoot.
- Programmable alarms with event management.
- Precise control of temperature by using PID control Action.
- Data storage capacity up to 200000 readings.
- Self diagnostic system with error messages
SAFETY FEATURES
- Miniature circuit breaker to protect electronic components in case of abnormal power supply
- Audio visual alarm for temperature, humidity variations from set Values
- Safety includes shut off of boiler and air heaters in case of temperature overshoots or undershoots beyond specified limits with alarms
- Low water level alarm and power cut off to safeguard the boiler heater
- Overload load protector to safe guard compressor.
- Provision for mobile alert via GSM technology for any abnormal conditions
- Self closing mechanism ensures that the door remains closed
- Facility to open the door from inside in case of door locked with emergency alarm having switch inside chamber
| Technical Specifications | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Volume | 100 Liters | 200 Liters | 300 Liters | 400 Liters | 600 Liters | 800 Liters | 1000 Liters | 1500 Liters | 2000 Liters |
| Temperature range | 20.0 – 60.0 °C | ||||||||
| Accuracy | ± 0.2 °C | ||||||||
| Uniformity | ± 2.0 °C | ||||||||
| Humidity Range | 40 – 98% RH | ||||||||
| Humidity Accuracy | ± 2 % RH | ||||||||
| Uniformity | ± 3 % RH | ||||||||
| Control System | PLC | ||||||||
| No. of tray | 2 | 3 | 4 | 4 | 4 | 8 | 8 | 10 | 10 |
| No. of Doors | Single | Single | Single | Single | Single | Double | Double | Double | Double |
| Power | 1500W | 1750W | 1750W | 1750W | 2000W | 2500W | 3500W | 3500W | 3500W |
| Voltage | 230V AC / 50/60 Hz | ||||||||
| Dimensions (W x D x H) in mm and weight (kg) | |||||||||
| Internal Dim | 435x400x600 | 505x400x1005 | 565x450x1205 | 635x530x1205 | 745x670x1205 | 1120x600x1200 | 1150x670x1300 | 1300x890x1300 | 1500x1030x1300 |
| Internal Dia | 580x845x1275 | 650x880x1680 | 710x935x1885 | 780x1010x1880 | 890x1150x1960 | 1370x1075x1920 | 1400x1145x1920 | 1550x1365x1920 | 1750x1505x1920 |
| Packing Size | 707x972x1478 | 777x1007x1883 | 837x1062x2088 | 907x1137x2083 | 1017x1277x2163 | 1497x1202x2123 | 1527x1272x2123 | 1677x1492x2123 | 1877x1632x2123 |
| Net Weight | 125 | 150 | 205 | 260 | 285 | 315 | 340 | 365 | 385 |
| Gross Weight | 180 | 230 | 280 | 330 | 355 | 405 | 430 | 460 | 485 |
ELFINPRO SOFTWARE
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
- 21CFR-PART 11 compliance.
- Browser based software
- Multiple chamber data acquisition on single software.
- Reports in Tabular and Graphical form
- Mean Kinetic Temperature Report.
- Automatic Back up Provision.
- Privilege based Group creation
- Privilege based user creation
- Trend analysis report
- Equipment audit trial report
- User ID with Alfa numeric password protection
- Multi user environment (LAN)
- Multiple level password with automatic expiry
- Electronic signature
- Separate reports for alarm and events
- Remote integrations with Control systems
- Software audit trial report
- Email, SMS and call alert in case of system failure
Online and offline trends
