Photostability Test Chamber

We design, build and install stability test chambers for pharmaceutical use (Drug and Medicine Tests). These Photostability chambers are specifically designed to perform near UV and visual light testing with fluorescent lamps per ICH Q1B Guidelines, Option 2. Designed matching with international standards ICH, WHO Guideline, and USFDA Standards our stability chambers have appreciated by industry experts worldwide and recommended for laboratories, universities and pharmaceutical research labs. These chambers provide uniform temperature control, low maintenance and allow quick response for forced degradation testing and confirmatory studies.

Our stability test chambers are easy to install, use and calibrate. Lamp replacement is safe, quick and easy to perform. The whole unit is mounted on casters helping in mobility of the equipment anywhere in laboratory. We have supplied these stability test chambers to major laboratories from India, Asia, Africa and Middle East countries at factory price. We also produce GMP compliant photo stability chambers that are supplied with IQ, OQ, PQ, & DQ documentation complete with reports, calibration and test certificate.

Capacity:

Standard models are available with capacity 100 Liters, 170 Liters, 255 Liters, 450 Liters and 1000 Liters.

Temperature Humidity Range:

Temperature range from 10°C to 50°C with accuracy of ±0.1°C - ±1°C. The humidity range is 20% to 90% RH with accuracy of ±2%RH - ±3%RH.

Illumination:

Equipped with ICH-compliant illumination ideal for photostability testing and provides clear and meaningful test results, according to ICH guideline Q1B, Option 2).
A cool white florescent light for 1.2 million LUX hour's exposure
UV-A lights for 200 watt hours/square meter exposure
Both the lights have independent control to avoid over exposure

Control System:

Imported Microprocessor based PID controller with direct display of SET and Process value of temperature and humidity. The control panel consists of circuit breaker, dry / wet heater and compressor with indication lamps. Non-volatile memory to allow chamber to return to original set point when power is restored in the event of power failure.

Construction:

Come with double walled construction, with a choice of customers the external chamber can be made of Mild Steel, 304, 316 or 316L grades stainless steel with painted or power coated finish. The internal chamber is made of 304 grades stainless steel with mirror finish. The gap between two chambers is filled with thick CFC free PUF insulation which minimizes heat loss and helps in low energy consumption. The whole unit is mounted on caster wheels for easy mobility.

Doors:

With inner glass door user can easily view samples inside without any botheration. Outer door is solid and made of M.S, 304 or 316 grades stainless steel. Door is fitted with magnetic gasket and locking system.

Heating and Cooling:

For highly efficient heating these equipment use U shaped stainless steel jacketed heating element. An automatic temperature limit keeps the system safe from over-heating due to workload. For cooling high capacity industrial cooling system is used which keeps set temperature and RH values unaffected. Superior cooling performance is achieved through hermitically sealed compressor which is CE marked and of reputed brand. Uniform air distribution system helps in maintaining steadiness in environment.

Humidity Generation:

Heater based humidity generator with float valve controlled water reservoir. Steam is conducted into the inner chamber by means of conduits from the Humidity Generator. An additional device, water failure protection is fitted for flawless performance. This device disconnects heater supply in case of water supply failure and starts automatically when the water supply resumes.

Pre-Installation Requirements:

Pharmaceutical Test Chambers or Photostability Chambers require essential checks before installation.
Below 30°C room temperature
Adequate power supply with stabilizer, MCD and Earthing
Continuous DM or Distilled Water Supply
Air conditioned or cross ventilated environment

Validation:

Each stability chamber is validated before delivery to the customer. We offer complete validation with document evidence showing that the installed equipment meets the specifications of manufacturer, user and the applicable regulations. We also provide services to validate stability test chambers for our customers so they have complete documentation citing that their equipment will function properly according to IQ, OQ and PQ protocols. We also offer on-site validation services to satisfy FDA guidelines for qualification verification of equipment.