Stability Chamber - N-Wissen
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Stability Chamber
Stability Chamber:
All Aralab Pharma Stability chambers are designed to simulate and reproduce the climatic conditions required by the ICH Q1A Guideline for climatic Stability and execute data logging according to FDA 21 CFR part 11. The 600 PLHR chamber is also able to perform both the ICH Q1A and Q1B (Photostability) with automatic start and stop of the necessary UV and VIS irradiation required.
In compliance with all international requirements, the standard accessories for Aralab Pharma chambers include: IQ, OQ, PQ and MQ qualifications; FDA 21 CFR part 11 compliant controller and software, and ISO 17025 calibrations.
Common Applications:
- Pharmaceutical Products stability
- Medical and veterinary
- Cosmetics
- Food and Beverages
- Storage and Conservation
- Quality control and Research
FitoClima 600 PLH/PLHR
Climatic chamber for photostability tests of pharmaceuticals, cosmetics or equivalent products (ICH Q1B compliant). Removable interior shelves allow for also running stability tests (ICH Q1A compliant).
Walk-in Room
From 5.000 To 25.000
Climatic stability chambers with sizes ranging from 5.000 liters of internal volume up to custom designed solutions, specially developed for Temperature and Humidity Stability testing of pharmaceutical products (ICH guidelines), cosmetics, food & beverages or quality control applications.
FitoClima 600 PH & FitoClima 1200 PH
Temperature and Humidity chambers with 600 or 1200 liters of internal volume, designed for Stability testing under all ICH conditions. Developed for the pharmaceutical industry stability requirements, but also suitable for cosmetic products, as well as food & beverages companies.
Features / Advantages:
- Best price-quality relationship in the global market
- The most advanced technology in climate control with ultrasonic generator and capacitive sensor
- Internal aerodynamic optimization to ensure uniformity of climatic conditions
- Silent functioning
- Adaptive future proof design, with height adjustable trays and shelves that are easy to insert or remove depending on storage needs
- Pre-configured with shelves designed to provide the most efficient use of the available internal volume
- Content protection features, with configurable high / low temperature and humidity alarms and automatic remote notifications
- Equipped with programmable CLIMAPLUS™ touchscreen controller with customizable alarms and software for data logging in accordance with FDA 21 CFR part 11, for real-time monitoring and managing all operation data
- Capacity for creating 32 programs of 24 segments each
- 0,1°C temperature resolutions
- 0,1% RH humidity resolutions
- Possibility of performing specific testing conditions with external commands and instruments
- Wired and wireless outputs for connecting device
- Compliant and recognized by ICH, FDA, GMP and other leading industry standards;
- IQ, OQ, PQ and ISO 17025 calibration procedures and documentation
- Reduced investment, low maintenance, reliable and accurate performance.
| Model | FitoClima 600 PH | FitoClima 600 PLH | FitoClima 1.200 PH | FitoClima Walk-In 25.000 PHARMA |
Internal volume (L) | 600 L | 1200 L | 25000 L (*) | |
Temperature Range | 5 °C to 45 °C | |||
Temperature Stability / Uniformity | ±0,5 °C / ±1 °C | |||
Humidity Range | 35 to 95% RH | 35 to 85% RH | ||
Humidity Stability / Uniformity | ±1% RH / ±2% RH | |||
ICH Compliance | Stability Q1A | Stability & Photostability Q1A & Q1B | Stability Q1A | |
Shelving & Storage | 4 Shelves 1,3 m2 | 2 Shelves 0,7m2 | 8 Shelves 2,6m2 | 5 Shelves 35m2 |
Internal Dimension (HxWxD) in mm | 1.340 x 600 x 660 | 1.340 x 1.320 x 660 | 2.400 x 3.600 x 3.200 (*) | |
External Dimension (HxWxD) in mm | 1.980 x 730 x 920 | 1.980 x 1.450 x 810 | 2.650 x 3.810 x 3.410 (*) | |
(*) other Walk-In sizes (Dimension) are available on request