Photostability test chambers in accordance with the ICH Guideline Q1B options 2
The Vötsch photostability test chambers VP 250-L and VP 500-L have an ideal light, temperature and humidity distribution and is thus able to simulate reproducible light and climatic conditions.
The lighting equipment complies with the ICH Guideline Q1B option 2 and enables photostability tests to be performed in less than 100 hours. All specimens are positioned at the same distance from the light source and are evenly irradiated by a special light/UV filter system.
Features
- Ideal light, temperature and humidity distribution
- Reproducible light and climatic conditions
- Lighting equipment complies with the ICH Guideline Q1B option 2
- Photostability tests can be performed in less than 100 hours
- Specimens are positioned at the same distance from the light source and are evenly irradiated by a special light / UV filter system
- System can be equipped with appropriate light and UV sensors for recording irradiation values
- Patented vapour humification (Sterile steam system)
- Capacitive humidity sensor
Standard Version
- Digital measuring and control system SIMPAC with 3,5" TFT-colour touch panel
- 2 shelves illuminated with UV light
- 2 shelves illuminated with white light
- Patented air filter system for homogenous irradiation of specimens
- Timers for light and UV light
- Counter for total operating hours
- Light and UV filters for optimum distribution
- Lockable door
- Stockable (VP 250-L)
- Water tank 13 l (VP 250-L) and 19 l (VP 500-L) with possibility of manual and automatic water supply
- Patented vapour humidification system (Sterile Steam System)
- Ethernet interface
- Calibration certificate
Options
- UV and Lux sensors with automatic measurement value integration (fully automated process)
- Serial interface RS 232 C
- SIMPATI Pharma software package (complying with FDA 21 CFR Part 11 and EU GMP Annex 11)
- Qualification documentation
- Qualification on site, execution of IQ / OQ, spatial measurements, mapping of light distribution
- Maintenance contracts with response time
- Calibration on site, also DAkkS accreditation