Products / Stability Chambers / Climacell ECO & EVO (ICH)
Climacell ECO & EVO (ICH)
Patented Forced Air Convection with Humidity
CLIMACELL® stability test chambers are designed to create exact reproducible simulations of a wide range of environmental conditions through precise control of temperature and humidity. CLIMACELL® test chambers are suitable for ICH Q1A stability testing of drug products and stubstances, material quality and durability testing, and shelf life studies. The CLIMACELL® also meets the requirements for ICH Q1B photostability studies when equipped with the EVO advanced controller and fully programmable fluorescent shelf lighting.
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Specifications
Heat Technology:
Patented Forced Air Convection System
Patented Forced Air Convection System
Chamber Volumes:
111 (4 ft³) • 222 (8 ft³) • 404 (14.3 ft³) • 707 (25 ft³) 1212 (43 ft³)
111 (4 ft³) • 222 (8 ft³) • 404 (14.3 ft³) • 707 (25 ft³) 1212 (43 ft³)
Temperature Range:
ECO: 0°C up to 100°C (10°C up to 95°C with humidity)
(optional -10°C minimum temp with automatic defrost)
EVO: 0°C up to 100°C (10°C up to 95°C with humidity)
(optional -20°C minimum temp with automatic defrost)
ECO: 0°C up to 100°C (10°C up to 95°C with humidity)
(optional -10°C minimum temp with automatic defrost)
EVO: 0°C up to 100°C (10°C up to 95°C with humidity)
(optional -20°C minimum temp with automatic defrost)
Refrigerant:
R 134a
R 134a
Sterilization Cycle:
160°C dry heat sterilization (EVO Only)
160°C dry heat sterilization (EVO Only)
Controlled Humidity:
ECO 10% up to 95% – controlled in 1% increments
EVO 10% up to 98% – controlled in 1% increments
ECO 10% up to 95% – controlled in 1% increments
EVO 10% up to 98% – controlled in 1% increments
- Active dehumidification for precise humidity control as uniform as 2.5%
- water tank with pump for water supply included
- Wastewater vessel water pump to remove condensate
ICH Guidelines:
ICH Q1A stability
ICH Q1B Photostability – (EVO models with ICH Q1B lighting equipped only)
ICH Q1A stability
ICH Q1B Photostability – (EVO models with ICH Q1B lighting equipped only)
Control System:
Fuzzy Logic enabled ECO digital controller or upgraded EVO advanced digital controller
Fuzzy Logic enabled ECO digital controller or upgraded EVO advanced digital controller
Chamber Construction:
AISI 304 Seamless Stainless Steel with rounded corners
AISI 304 Seamless Stainless Steel with rounded corners
Lighting:
ICH Q1B flourescent shelf lighting and door lighting options (EVO Only)
ICH Q1B flourescent shelf lighting and door lighting options (EVO Only)
Electrical Data:
230V 50/60hZ
230V 50/60hZ
Certifications:
CE, UL, CSA listed
CE, UL, CSA listed
Chamber Construction
The CLIMACELL® is equipped with a pharmaceutical grade AISI 304 stainless steel chamber with a double wall construction to prolong life expectancy. The inner chamber features a seamless, rounded corner design and is fully removable for easier cleaning and sterilization. The door of the chamber employs a patented 4-point closing system that seals the door to the chamber gasket and enables hands-free opening and closing.
- AISI 304 stainless steel chamber – 316L stainless steel option available
- Double wall chamber construction with 5 layers of insulation for more uniform internal chamber conditions
- Removeable inner chamber with seamless, rounded corner design for easier cleaning & sterilization
- 4-point closing system that seals the door to the chamber gasket – automatic or key door lock options availabe, door sensor and alarm option available
- Inner glass door allows viewing into the chamber without affecting internal conditions
- (2″) 50 mm stainless steel port – (1″) 25, (2″) 50, (4″) 100 mm access port options available
- Shelf brackets that do not penetrate the chamber walls – brackets are molded into the inner chamber walls 2.8″ apart
Digitial Controllers
The CLIMACELL® comes standard with BMT USA’s ECO controller with the option to upgrade to the advanced EVO controller for more functionality and features. Both the ECO and EVO controllers utilize fuzzy logic to assess process data, including operation temperature, chamber size, and other controlled elements. Based on the assessed data, the controller can make continuous adjustments to input values, such as heating intensity or cooling, to optimally regulate internal chamber conditions. With the goal of minimizing the time required to meet set process parameters, the ECO and EVO controllers can quickly ramp up to the exact temperature set point without overshooting. The result is reduced overall cycle time, power consumption, and recovery times after opening the chamber door(s).
ECO Digital Controller
3″ LCD display
Fuzzy logic enabled microprocessor
9 programs each with up to 2 segments for varying loads and parameters up to 99 cycles
Real-time programming and cycling – optional temperature ramping settings
LED indicator of device operation
Constant monitoring of chamber conditions
USB port
RS 232 port
Optional Ethernet port
Delayed heating start & stop function
Digital safety thermostat
Acoustic and digital alarms
Keypad lock
optional integrated data logger for temperature measurement and recording
EVO Advanced Digital Controller
5.7″ color touchscreen – glove friendly operation
Fuzzy logic enabled microprocessor
100 programs each with up to 100 segments for varying loads and parameters
Real-time programming and cycling plus temperature ramping settings
Graphic display of cycle parameters
LED indicator of device operation
Constant monitoring of chamber conditions
USB port & SD card slot with Microsoft Excel formatted data storage
RS 232 port
Optional Ethernet port & WiFi connectivity
Delayed heating start & stop function
Digital safety thermostat
DIN 12880 digital safety thermostat
Acoustic and digital alarms
Multi-level secure user authentication – FDA CFR 21 Part 11 compliant
Integrated data logger – FDA CFR 21 Part 11
Remote access
Heat Technology
BMT Patented Forced Air Convection System
BMT’s patented force air convection system moves air vertically and horizontally inside the chamber for precise temperature uniformity and fast heating and cooling times. The process of heating from the bottom of the chamber to the top mimics natural airflow, allowing for more precise simulation of climatic conditions.
ICH Q1B Lighting
Climacell EVO ICH Q1B Lighting
The CLIMACELL® offers a wide range of lighting options to suit your specific application, including ICH Q1B Photostability. Available options for lighting placement, light sources, and intensity controls allows the CLIMACELL® to meet even the most demanding requirements for exposure lighting applications.
- Fluorescent door lighting and fluorescent ICH Q1B shelf lighting
- Fully programmable time and intensity, microprocessor dimming 0 – 100%
- UV-VIS light sensors usable from 10°C up to 70°C
Optional Equipment
Shelving
Stainless steel wire shelf
Stainless steel perforated shelf
Suspension system for hanging samples from the ceiling of the chamber
Construction
Automatic key and door lock
Door sensor and alarm
Adjustable feet or casters with smooth travel and extendable leveling feet
Rolling cart with casters (swiveling/locking and swiveling/leveling)
Window with 3 layers of insulating glass for observation of samples inside the chamber – complimented by interior lighting with mechanical switch
Interior light – heat resistant with mechanical switch or an electronic switch that is automatically activated when the door opens
Waterproof 115V or 230V electrical socket inside the chamber
PT 100 flexible sensor
Stainless steel exterior
Stainless stacking frame for model 111 & 222
316L stainless steel chamber
Functionality
Oxygen control – 1% up to 19%
Inert Gas or aeration connection
Lighting control, VIS
Lighting control, UV
External printer
Compliance
IQ/OQ validation documentation with temperature mapping – DIN 12880
Warmcomm software – FDA CFR 12 Part 11 compliant
Building management monitoring system
Region specific electrical plug