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 to allow direct comparison to be made between drug substance & drug product.
MACK PHARMATECH’s Photostability Chambers are designed specifically to meet ICH & FDA requirements for Photostability testing. Near UV & visible light testing is Approved Approved performed simultaneously according to ICH Q1B option 2.
21 CFR PART-11 Compliance
|Temperature Range:||20°C - 50°C|
|Accuracy:||+ 0.2 °C|
|Sizes For BOD|
|Features||200 Ltrs||400 sLtrs|
|Width in mm||800||800|
|Depth in mm||500||700|
|Height in mm||600||700|
|Width in mm||940||940|
|Depth in mm||960||1160|
|Height in mm||1175||1325|
|No of Zones||1||2|
|Power Supply||Single Phase, 230V 50Hz|
|Sizes For Humidity|
|200 Ltrs||400 sLtrs|
|Single Phase, 230V 50Hz|
Other sizes also available as on requirement.
|Models||Material of Construction|
|MK1||S.S.304 Mirror Finish||G.I Powder Coated|
|MK2||S.S.304 Mirror Finish||S.S.304 Dull Finish|
|MK3||S.S.316 Mirror Finish||S.S.304 Dull Finish|