Stability ChambersClimate chambers for stability testing of pharmaceutical, cosmetic, and food products. Comply with all requirements set forth in the International Conference on Harmonization (ICH) and have unmatched reliability in reproducing climatic conditions.
Climate chambers for stability testing with an interior volume of 5,000 liters, up to 25,000 liters, especially for stability tests for pharmaceutical products (ICH Q1A).
Climate chambers with sizes ranging from 5,000 liters to 25,000 liters of internal volume, or even custom-made. Designed to perform stability tests for pharmaceutical products.
C24 According to all requirements established at the International Conference on Harmonization (ICH), these chambers have unmatched reliability in reproducing climatic conditions.
Complies with ICH Q1A (stability). FDA approved software 21 CFR part 11 for data recording. IQ, OQ, and PQ (Installation, Operation, and Performance Qualification) for mandatory quality qualifications.
Features:
• Clave Controlled environmental conditions with consistency. precision over the years
• Preconfigured with shelves designed to provide a uso efficient of the internal volume.
• Future-proof adaptive design, with height-adjustable trays and shelves that are easy to insert or remove depending in storage needs
• Content protection functions, with configurable high/low.
Temperature and humidity alarms and automatic remote control notificaciones
• Software compliant with FDA 21 CFR part 11
• Complies with and is recognized by ICH, FDA, GMP, and others industry-leading standards
• Calibration documents IQ, OQ, PQ, and ISO.
• Construction Exterior: EN 14509 high-density injected polyurethane sandwich.
Modular foam panels, 80 mm thick (other thicknesses available for)
different specific insulation requirements) with galvanized light steel gray plastic finish. CFC-free.
• Walls: Galvanized steel with white epoxy paint.
• Shelves and trays: standard in anodized aluminum structures with polyethylene trays (5 steps); Optional in highly resistant stainless steel.
• Floor: high load capacity plywood finish with slip and wear resistance superficie
• Safety and protection Independent thermostats for maximum and minimum temperature limits.
• Automatic cut-off function in case of excessive heating or cooling.
• Configurable maximum and minimum limits for temperature and humidity.
• Visual and audible alarms for temperature and humidity limits.
• Synoptic diagram function: a self-diagnostic tool that checks all active components of the system allowing for faster procedures and minimizing any possible downtime
• Programmable logic controller exclusively developed by Aralab for FitoClima chambers.
• Monitors every environmental variable available for any specific FitoClima model (Temperature, Humidity, Lights, Airflow, CO2, O2, and connected external devices)
• Easy to use touchscreen interface with multicolor monitor.
• User-friendly program editor for creating 32 Programs of 24 segments each, allowing for the dDesign of complex climates and integral simulation programs.
• Password protection for controller functions.
• Content and research protection feature, with configurable high and low temperature andhumidity alarms and automatic notifications.
• Management, tracking, and recording of all alarms.
• Non-volatile memory, allowing automatic restart of previously defined or ongoing set pointsPrograms for power failure, without losing data.
• Real-time monitoring of all functions and active components of the equipment, allowing pFor quick and accurate diagnosis in case of malfunction.
• Ability to control and program events via external commands and with external devices.
• Graphical view of programs and climatic variables
• RS232 / 485, Ethernet and Wi-Fi to connect computers to the controller
• The functions of the ClimaPlus controller are also available on the PC / Laptop with the FitoLog software package.
Technical specifications
Dimensions interiores (mm) (al x an x p)
2.610 x 3.825 x 4.320
Dimensions exteriores (mm) (al x an x p)
2.040 x 3.610 x 3.210
Volumen interno (liters)
25 000 L
Temperature range
15 a 45ºc (luces off)
Temperature stability
+/- 0,5 ºC
Temperature uniformity
+/- 1 ºC
GHumidity alarm (lights on/off)
35 to 90 % hr (lights off)
Ehumidity stability (%)
+/- 1% rh
Humidity uniformity (%)
+/- 2% rh
Iluminacion interna
Recessed LED lights installed in the ceiling. The light can be operated by a manual switch, triggered by door opening, or integrated (programmable) controller
Shelf
Shelves with 5 levels each. Anodized aluminum structures with polyethylene trays. The storage capacity will vary with the final implementation design and number of levels in each rack.
Airflow
Uniform 0.2 m/s through the shelves. Adjustable by setpoint% in the controller interface
Electrical connection
3/N/PE AC 400V ± 10%; 50HZ
Shipping Content:
01 x Phytoclimate Chamber 25,000 PLH
02 x 3 niveles
01 x User instructions
01 x Calibration certificate
More information:
ACCESORIOS
2. FitoLogView: is a working tool for processing data.Recorded by the FitoLog program. One can view, print, and export the log content to other file types, and analyze the data in other data management software (Excel, Star Office, Access, or others).
2. FitoProgram: this application simplifies creation of programs and their integration into the chamber. ClimaPlus controller. Up to 32 programs, each with 24 segments, designed and linked to create pDetailed environmental profiles and simulations.s).
SOFTWARE FITOLOG
El FitoLog software package The FitoLog® software package for PC/laptops allows data monitoring, logging, andoperations management directly on a computerIt is a set of applications designed to facilitate the management, monitoring, and recording of programs and data from the FitoClima chambers. It consists of 3 applications: FitoLog, FitoLogView, and FitoProgra
1.FitoLog: Records and displays in real-time all data and details related to set points, operating variables, and equipment behavior. It also retrieves information about the active components of the chamber, ongoing processes, errors, alarms and allows the configuration of periodic or alarm-triggered remote notifications (via email or SMS, depending on the cconnections and accessories).
SHELVES OR GRIDS
Additional stainless steel wire shelves
LUZ BLANCA
luz visible 26,000 Lux (uniformity of ± 6% approximately)
LUZ UV
UV 30 W/m2 (approximately, ± 10% uniformity)
QUANTUM LIGHT METER
Radiation intensity control with internal quantum light sensors.
EXTERNAL WATER TANK
External water tank of 20 liters with electric pump and safety valve.
OBSERVATION WINDOW
Observation window on the door.
SHELVES AND RACKS
Additional shelves and racks
ESTANTES
Shelves made of stainless steel AISI 304.
CALIBRATION CERTIFICATE
ISO 17025 Temperature and humidity calibrations.
TEMPERATURE RANGE
Extended temperature ranges
PC CONNECTION
Ethernet / Wi-Fi / Other connections for computer connection
DOCUMENTATION IQ, OQ, PQ.
IQ, OQ, PQ procedures and documentation.
DATA LOGGER
Wireless / portable data loggers for monitoring temperature and humidity in external areas
TOMA ELECTRICAS INTERNAS
Internal electrical connection terminals.
CONDUCTIVITY METER
Conductivity meter, for water quality control.
INPUT PORT
Additional side entry port.
OSMOSIS INVERSA
5-stage reverse osmosis with pre-softening system.
Includes:
** 2-year warranty.
** Discounts for the sale of two or more Stability chamber Fito climate.
** Metrological calibration certificate for Stability chamber.
** Preventive maintenance, corrective (repair), technical service, and spare parts.
** Sales, maintenance, calibration, certification, and technical service 24 hours.
Envios a:Argentina, Bolivia, Brasil, Chile, Colombia, Costa, Rica, Cuba, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Puerto Rico, Dominican Republic, Uruguay, Venezuela.