Photo Stability Chamber

Photostability Studies are prescribed by ICH (International Society for Harmonization) and these guidelines specify that the drug & the drug product must be photo tested to ensure that exposure to light does not cause photochemical degradation of the product & the packaging.

Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use.

In view of the photosensitivity and photo instability of drugs and adjuvants, knowledge of the photostability of these substances and their formulated products is necessary to evaluate the following:

• The intrinsic photostability characteristics.
• The physical and chemical changes upon the exposure to light.

Photostability chambers are specifically designed to perform near UV and visual light testing with fluorescent lamps per ICH Q1B Guidelines.

Allyone offers two choices for your photostability chambers:

• Photostability Chamber (with Lux & UV Light testing) &
• Photostability Chamber (with Temperature & RH Control)

The study as per the guideline is performed to identify precautionary measures needed in manufacturing or in formulation of the product, and if light resistant packaging is needed.

The samples are tested both pre & post photostability studies, i.e. exposure for any changes in appearance, clarity, or colour (physical properties) & for degradation (chemical).

Standard Chamber Features & Provisions:

Construction: Dynamically Designed PUF filled Double walled, Inner Tank & outer body with SS 304, PUF Density 40kg/m³ with 60 mm thickness

Sample Storage: SS Trays.

Door: PUF Insulated External door mounted with imported hinges & locks, Inner glass doors with latches. Door frame is secured with a silicone rubber gasket on the entire perimeter to ensure an air tight, leak tight chamber.

Door Operation: Biometric &/or Password protected-from software & HMI

UV & Fluorescent Lights:

• As per ICH Guidelines-1.2 Million Lux Hours of visible light and 200 watt Hr/m2 of UV light. Auto shut Off after specified exposure level of Lux & UV Intensity.
• Individual Microprocessor based device is provided to start exposure of UV and Fluorescent lights as required.
• UV light is switched off automatically once the inner glass door is opened to prevent hazardous exposure: for Human safety.
• Samples can be tested under Fluorescent light or U.V. lights separately as well as combine as per test requirement.

Optional System:

• Allyone Photostability Chambers can be with Temperature or with Temp & RH (Humidification)
• Lux meter, UV Meter
• Printer Interface (for measuring Lux & UV intensity)

Control System:

1. Ergonomically designed Control Panel.
2. Ferrule printed wiring.
3. Advanced PLC Program with built in processor-based Auto Tuning.
4. 4.3″ HMI Color LED Display.
5. Built in Redundancy & Safety.
6. Advanced High Accuracy “Transmitter Sensors” with output of 4-20 mA.

Temperature Control:

1. Efficient, Reliable, Time tested & Trustworthy Refrigeration Design.
2. PLC Controlled “U” Shaped SS Air Heater Banks.

Humidity Control: S S Reservoirs- steam kettles form a Humidification system.

Safety: Dedicated Thermostats for all key points: Chamber High Temperature, Steam Kettle Element, Utility High Temperature.

PLC Safety Cut Off for Temperature & Humidity: High, Higher & Low, Lower safety cut off