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
- Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis & Data acquisition.
Features of Photostability Chamber
- 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.
| Technical Specification |
| Photostability with temp : |
| Temperature Range: |
20°C - 50°C |
| Photostability with temp & RH : |
Humidity Range: |
40% RH TO 85% RH |
| Accuracy: |
±3°C |
| Uniformity: |
±5°C |
Standard Features:
- CE Approved
- PLC based Safety Cut - Off
- PLC Control
- Email Alert
- Ethernet Connectivity
- Audio Visual Alarm
- 21 CFR Software
- Documentation
- Colour Touch Screen HMI
- Master & Stand by sensor
Optional Features
- GSM Technology
- Hooter System
- LUX Meter
- UV Meter
| Size |
| Model |
MK*-20PH |
MK*-40PH |
| Capacity |
200 Ltrs |
400 sLtrs |
| Interior Dimension |
|
|
| Width in mm |
800 |
800 |
| Depth in mm |
500 |
700 |
| Height in mm |
600 |
700 |
| Exterior Dimension |
|
|
| Width in mm |
960 |
960 |
| Depth in mm |
970 |
1170 |
| Height in mm |
1320 |
1420 |
| Trays |
|
|
| No of Zones |
1 |
2 |
| Tray |
Perforated Type |
| Power Supply |
|
|
| Power Supply |
Single Phase, 230V 50Hz |
| Power Rating |
2KW |
3KW |
| Warranty |
12 Months |
| Sizes For Photostability with Temperature(◦C) & Humidity (%RH) |
| Models |
MK*-20H |
MK*-40H |
| Capacity |
200 Ltrs |
400 sLtrs |
| Interior Dimension |
|
|
| Width in mm |
800 |
800 |
| Depth in mm |
500 |
700 |
| Height in mm |
600 |
700 |
| Exterior Dimension |
|
|
| Width in mm |
960 |
960 |
| Depth in mm |
1150 |
1350 |
| Height in mm |
1320 |
1420 |
| Trays |
|
|
| No of Zones |
1 |
2 |
| Tray |
Perforated Type |
| Power Supply |
|
|
| Power Supply |
Single Phase, 230V 50Hz |
| Warranty |
12 Months |
Other sizes also available as on requirement.
Photostability with RH also available as on requirement
| MATERIAL OF CONSCTUCTION (MOC) |
| |
INSIDE MATERIAL |
OUTSIDE MATERIAL |
INSIDE FINISH |
OUTSIDE FINISH |
| MK – 1 |
SS 304 |
GI Powder Coated |
Matt Finish |
G I Powder Coated |
| MK – 2 |
SS 304 |
SS 304 |
Matt Finish |
Matt Finish |
| MK – 3 |
SS 316 |
SS 304 |
Matt Finish |
Matt Finish |
Service Center for Photostability Chamber Manufacturer,Equipment Maintenance and Repair
Baddi |
Dehradun |
Delhi |
Haridwar |
Guwahati |
Ahmedabad |
Vadodara |
Vapi |
Pithampur |
Nashik |
Mumbai |
Pune |
Aurangabad |
Goa |
Hyderabad - Chintal, Miyapur , Jadcherla |
Bangalore |
Visakhapatnam |
Chennai - Alathur
