Photostability testing according to ICH Guideline Q1B
Vötsch photostability testing cabinets (VP Series 250-L, 250-LT, 500-L, 500-LT) offer innovative product features, high accuracy, intelligent controls and an exceptional build quality.
VP Series 250-L | 250-LT | 500-L | 500-LT
Vötsch VP Series photostability cabinets come in two sizes and can provide a constant climate (types 250-L and 500-L) or just a constant temperature (Types 250-LT and 500-LT).
The photostability testing cabinets are characterized by an ideal light, UV, temperature and humidity (types 250-L and 500-L) distribution and can thus guarantee absolutely reproducible light, UV and climatic conditions.
The lighting equipment used complies with the ICH Guideline Q1B Option 2 and enables photostability tests to be carried out in less than 100 hours.
One of the most important requirements in photostability tests is the homogeneous irradiation of the specimens. For this reason, all the specimens have to be positioned at the same distance from the light source. The inhomogeneous emission of light by fluorescent lamps is compensated with the help of special light and UV filter systems, thus a homogeneous irradiation of the entire storage area is achieved. For recording of the illumination and UV irradiance this system can be equipped with corresponding light and UV sensors. With this option entering of set-point values in lxh and Wh / m2 e.g. 1.2 Mio lxh and 200Wh / m2 is made possible to have a fully automated and with SIMPATI Pharma also fully documented process.
Standard scope of delivery
- Microprocessor monitoring and control SIMPAC with 3.5“ colour touch panel for entering of set-point values
- Fully integrated user management in the control panel
- Shelves illuminated with UV light
- Shelves illuminated with white light
- Light and UV timer
- Light and UV filter for optimum distribution (EEF) Software temperature limiter for min. and max. test space temperatures
- Alarm system according to GAMP
- Interior fittings are entirely made of stainless steel
- Calibration of 2 temperature and 2 humidity values
- Alarm output (potential-free contact) for monitoring of tolerance band ± 2C ± 5 % r.h.1
- Water storage reservoir with automatic and manual supply of demineralised humidification water
- Door contact switch
- Lockable doors
- Counter for total operating hours
- 4 castors, of which 2 have brakes
- Air-cooled refrigeration unit with low noise emission
- Patented vapour humidification system (SSS Sterile Steam System)
- Capacitive humidity sensor
- Entry port, Ø 50mm, in the right side panel
- Operating manual
- Multi-language touch panel (German, English, French, Spanish, …)
Most important options
- Software package SIMPATI Pharma
- Integrated datalogger for recording and processing of measurement values
- Networking of several systems
- Serial interface RS 232 C
- Integrated UPS to keep the recording alive during a power failure
- Registration of temperature and / or humidity
- UV and Lux sensors with automatic measurement value integration
- Mapping of light distribution
- Additional temperature and / or humidity sensor
- Acoustic and optical warning signal
- Refrigeration unit, water-cooled
- Glass door, heated
- Additional entry ports
- Demineralisation unit with exchangeable cartridges for Shelf with white Lights
- Connection to local water supply
- Qualification documentation for equipment and SIMPATI software
- Special voltages
- Analogue outputs
- Maintenance contracts with defined response time
- Operation at 5°C with full illumination