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Stability Chamber
Prominent & Leading Exporter from Mumbai, we offer photostability chambers 200 ltrs 2 tray, walk-in stability chamber and stability chambers.
Photostability Chambers 200 Ltrs 2 Tray
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Product Details:
| Chamber | standardized |
| Brand | WADEGATI |
| Material | standardized |
| Capacity | standardized |
| Color | standardized |
| Temperature Accuracy | standardized |
Wadegati offers a wide range of stability testing chambers that satisfy ICH Q1B guidelines. A state of the art Photostability chambers are available. This chamber has the capability to provide fluorescent light intensities from 1,000 to 10,000 Lux hour. Samples stored at 10,000 Lux can satisfy the ICH guidelines for light exposure in as little as five days. The UV study is done simultaneously. Separate switches are provided for incandescent & UV light sources.
The current ICH guidelines specify that drug and drug products must be phototested to ensure that exposure to light does not cause photochemical degradation of the product or packaging. The product under test must receive a measured dose of both UV-A (200 watt-hours per square meter) and visible (1.2 million lux-hours) optical radiation exposure. This requires both radiometric and photometric measurements in terms of illuminance in lux and UV-(315 to 400 nm) irradiance in W/m2 multiplied by exposure time in hours.
Storage Conditions
- 25°C Ambient Humidity.
- 30°C Ambient Humidity.
- Photostability…. 1,000 to 10,000 Lux (ICH Option 2).
Sequential and simultaneous ageing test. In addition to the temperature ageing, the short period photo-ageing is separately carried out with extremely strong light having a defined lighting specifications or the simultaneous ageing with temperature lighting in accordance with ICH guidelines.
- Construction as per cGMP regulations.
- Consisting of refrigeration, air handling, humidification, dehumidification,
temperature/humidity controlling - Microprocessor based 2 channel multifunctional PID Temperature / Humidity ( RH) controller for simultaneous control of temperature and % RH. OR PLC based system for chamber control and auto changeover of standby system
with touch screen display. - Printer interface & PC interface for data storage
- Standard networking via Ethernet.
Light sources option 2 :
- UVA intensities = 1.5 w/m2 (require about 133 hours)
- VIS intensities = 10,000 lux (require 120 hours)
Validation :
DQ/ FAT /IQ / OQ / PQ documentation with test and calibration certificate.
Safety Features :
- Special software incorporated in the controller to give ‘FAULT’ indication in case of failure of any control system.
- Audio alarm to signal variation in set temperature.
- A safety thermostat is provided to switch off the illumination if temperature overshoots.
- Door switch to switch off the UV light when door is opened.
- Safety digital temperature controller for main controller : In the event of failure of Micro- PID Controller the high accurate safety controller will take over temperature controlling.
- Over load Protector for compressor.
Temperature Range | : 20°C to 60°C |
Accuracy | : ± 0.2°C |
Temperature uniformity | : ± 1°C. |
Power supply | : 1 Phase, 230V ±10% AC, 50 Hz |
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Walk-in Stability Chamber
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Product Details:
| Usage/Application | standardized |
| Chamber | standardized |
| Brand | WADEGATI |
| Temperature Range | standardized |
| Humidity Range | standardized |
| Phase | standardized |
Leveraging on our skilled pool of industry professionals, we are involved in the manufacturing, supplying and exporting Walk-in Stability Chambers. Highly reliable, these stability chambers are pretested in the prevailing industry standards. These chambers are used for passing FDA and ICH Q1A compliance standards. But these could exceed these guidelines for long term, intermediate and accelerated stability studies.
Application Area:
- Used in the big industries
- Used for passing FDA and ICH Q1A compliance standards
Features:
- Designed to be used for long period of time
- Splendid functionality
- In built over load protector provided for hermetically sealed compressor
Specifications:
- Capacity : 2000 Litre to 1 Lac Litre
- Temperature Range: 20 °C to 60 °C
- Accuracy: ± 0.2 °C
- Temperature uniformity: ± 2 °C.
- Humidity Range: 40% to 95%
- Accuracy: ± 2% RH
- Humidity Uniformity: ± 3% RH
- Power supply: 1 Phase, 230 V ± 10% AC, 50 Hz. OR 3 Phase, 440 V
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Stability Chambers
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Product Brochure
Product Details:
| Minimum Order Quantity | 1 Number |
| Brand | WADEGATI |
Stability test chambers are especially built to pass FDA and ICH Q1A compliance standards and have a reputation for reliability, quality and performance. Exceed FDA / ICH guidelines for long term, Intermediate and Accelerated Stability studies.
Features:
- Construction as per cGMP regulations.
- Consisting of refrigeration, air handling, humidification, dehumidification, temperature/humidity controlling
- Microprocessor based 2 channel multifunctional PID Temperature / Humidity ( RH) controller for simultaneous control of temperature and % RH. OR PLC based system for chamber control and auto changeover of standby system
with touch screen display. - Printer interface & PC interface for data storage
- Standard networking via Ethernet.
- Standard temperature & RH configuration.
25°C / 60% RH
30°C / 65% RH
40°C / 75% RH - Specially designed chambers are available to carry out stability studies at low temperature and low humidity conditions such as
25°C / 40% RH,
40°C / 25% RH,
30°C / 35% RH,
40°C / 15% RH,
55°C / 20% RH and
55°C / 75% RH.
Data Acquisition system complying to US FDA 21 CFR Part 11
- Data records & process control systems have Electronic Signature & Electronic Record capability. The controllers have a lockout feature that permits changes through a 21CFR Part11 compliant operator station, thus providing the necessary audit trail.
- Mean Kinetic Temperature value.
- Password security for log in and door operations.
- Operators need to enter user name and password before taking any action.
- Report search option using date and sample name.
- Secure computer generated, time stamped runtime audit trail of batch stop/start, alarm acknowledgements, logins, signature details, configuration changes.
- User actions with signing and authorization.
- Access control according to authority level.
- Export conversion facility to Excel.
Temperature Range | : 20°C to 60°C |
Accuracy | : ± 0.2°C |
Temperature uniformity | : ± 2°C. |
Humidity Range | : 40% to 95% |
Accuracy | : ± 2% RH |
Humidity Uniformity | : ± 3% RH |
Power supply | : 1 Phase, 230V ± 10% AC, 50 Hz. |
Temperature and RH Data Logger :
8 channel (4 temperatures + 4 humidity) or 16 channel (8 temperature + 8 humidity), calibrated data logger to print date, time, temperature and humidity set and process values for mapping and auto validation. Features like printer and PC interfacing.
Standby Systems:
Standby refrigeration, humidity and RH sensor
Validation :
DQ/ FAT /IQ / OQ / PQ documentation with test and calibration certificate.
Safety features :
- Audio alarm provided to signal variation in temperature and relative humidity.
- Water level alarm & indicating device :
- Safety digital temperature controller.
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