|Temperature Range :||Accuracy :||Uniformity :|
|20°C to 50°C||< ± 0.2°C||< ± 1.0°C*|
|Rel. Humidity Range:||RH Accuracy :||RH Uniformity :|
|40%RH to 85%||< ± 1%||< ± 3%RH*|
|Models||Cap. in liter||Internal size in mm||External size in mm||Tray Qty||Tray size in mm||Connected load|
* Measured with high accuracy data-logger at sample storage area with standard Set Point
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:
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:
The study as per the guideline is performed to should 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 silicone rubber gasket on entire perimeter to ensure air tight, leak tight chamber.
Door Operation: Biometric &/or Password protected-from software & HMI
Humidity Control: S S Reservoirs- steam kettles forms 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.