• Temperature Range20°C - 60 °C
• Humidity Range40%RH - 95%RH

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. Optional Features GSM TECHNOLOGY HOOTER SYSTEM Features UV lights get switched off automatically once the door is opened. You can test the samples on Fluorescent light or U .V lights separately as well as simultaneously. Uniform light distribution & high intensity levels allow quick response for forced degradation testing and confirmatory studies. Lights automatically shut off after a specified exposure level or time duration.   21 CFR PART-11 Compliance Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis & Data acquisition.

Design Qualification (DQ) Defines the functional and operational requirement and specification of the instrument and details the conscious decisions in the selection of the supplier. Installation Qualification (IQ) Confirms that all the equipment was installed to specifications. All of the model and serial numbers are documented. Operational Qualification OQ) Verification of operator controls, alarms, software, stand by system & chamber temperature mapping and verification that chamber stays within the humidity tolerances. Performance Qualification (PQ) Confirms that the chambers are meeting the operating set points at stipulated product load. The temperature and humidity accuracy is also confirmed. Calibration & Validation Calibration Calibration is the comparison of an instrument to a known standard. Our equipments are calibrated with multipoint calibrator, which is certified by ERTL (Indian Government Agency) traceable to NABL India and NPL (National Physical Laboratory), Delhi – one that has paperwork showing it compares correctly to a chain of standards going back to a master standard.   Validation Validation of equipment means preparing an authentic report of performance of the equipment,  which establishes the fundamental documentary proof of proper working of the equipment within the specified limits of its performance accuracy and repeatability.

• Temperature Range20°C - 50°C
• Accuracy+ 0.2 °C

• Temperature Range10 °C Above ambient to 250 °C
• Accuracy± 1°C

• Temperature Range20°C - 60 °C
• Humidity Rang40%RH - 95%RH
• Accuracy+0.2 °C / +2.0 % RH
• Uniformity+1.0 °C / +3.0 % RH
• Test suitable for25°C & 60%RH, 30°C & 65%RH,,, 40°C & 75%RH, 30°C & 75%RH

• Temperature Range20°C - 50°C
• Accuracy+ 0.2 °C

• Temperature Range20°C - 60 °C
• Humidity Range40%RH - 95%RH

• Temperature Range20°C - 60 °C
• Humidity Rang40%RH - 95%RH
• Accuracy+0.2 °C / +2.0 % RH
• Uniformity+1.0 °C / +3.0 % RH
• Test suitable for25°C & 60%RH, 30°C & 65%RH,,, 40°C & 75%RH, 30°C & 75%RH

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. Optional Features GSM TECHNOLOGY HOOTER SYSTEM Features UV lights get switched off automatically once the door is opened. You can test the samples on Fluorescent light or U .V lights separately as well as simultaneously. Uniform light distribution & high intensity levels allow quick response for forced degradation testing and confirmatory studies. Lights automatically shut off after a specified exposure level or time duration.   21 CFR PART-11 Compliance Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis & Data acquisition.

• Temperature Range10 °C Above ambient to 250 °C
• Accuracy± 1°C

• Temperature Range2° C to 8 °C
• Accuracy+1.5 °C
• Uniformity+2.0 °C