Photostability Chambers

Thermolab Photostability chambers are designed as per ICH guidelines, Option2 For option 2, the sample should be exposed to both the cool white fluorescent and near ultraviolet lamp.

1. A cool white fluorescent lamp designed to produce an output similar to that specified in ISO 10977 (1993); and
2. A near UV fluorescent lamp having a spectral distribution from 320 nm to 400 nm with a maximum energy emission between 350 nm and 370 nm; a significant proportion of UV should be in both bands of 320 nm to 360 nm and 360 nm to 400 nm.

For confirmatory studies samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter. Additionally the chamber also provides precise relative humidity conditions.

Thermolab’s Photostability chambers are designed to meet, if not exceed stringent quality standards recognized internationally. These chambers are fully automated control systems with HMI complement the chamber performance with highly rated data acquisition, storage and retrieval software.

Standard Features

• PUF insulated enclosure with extra floor reinforcement to sustain the movements and sample loads inside.
• Interior Stainless Steel and Exterior PPGI/Stainless Steel finish.
• Trays made of Stainless Steel with adjustable tray heights.
• Glass view panel on specially designed leak proof door.
• Validation port with seal to insert sensors.
• Air processing Unit (APU) with Integrated Cooling, Heating and Humidifying systems as per client requirements.
• CFC free refrigeration systems.
• PLC based control system with 5.7" colour HMI- Optional. No auto LUX/UV off in case of PLC.
• Complete with IQ, OQ, PQ documents, Operation and Maintenance manuals
• Works on 230/415 volts 50/60 Hz or as per requirement.

Safety Features (Vary depending on parameters under control)

• Overriding safety controller to cut off the main power supply in case of overshoot and undershoot of Temperature and Humidity giving audio visual alarm.
• Additional electromechanical safety thermostat to cut off the main power supply in case of temperature overshoots.
• Low water level alarm for humidity system.
• Alarm if door is kept open for a long period.

Additional features

• Window based SCADA software for data management having support for 21 CFR Part 11 compliance
• 100% redundant refrigeration & humidity systems with automatic changeover.
• 4 point temperature scanners. 4 Point humidity scanner (optional)
• Printer interface and data storage facility, Door Access Security system and mobile alert system.
• 80 Col. Dot Matrix printer along with stainless steel stand.

Specifications

Operation conditions: 250 C and 60% RH (Humidity Optional)

• Temperature Control Accuracy / Uniformity : ± 0.2°C / ± 2°C
• Humidity Control Accuracy / Uniformity : ± 2% RH / ± 3% RH

Prompt After Sales Service (PASS)

A vast network of about 200 technicians around the world with adequate instrumentation is your insurance that stringent requirements of timely Installation, Commissioning, Verification, Qualification, Validation and Documentation are met at site without excessive regulatory oversight.

For more information about photostability chambers, contact Thermolab Scientific Equipments.

Thermolab Scientific Equipments are the lab equipment manufacturers with reach to 50+ countries worldwide.