Climatic Test Chamber with temperature control and relative humidity, for stability tests according to ICH Q1A directive (R2) Stability Testing of New Drug Substances and Products.
Possibility to adapt the climatic test chamber for photo stability study according to ICH Q1B policy, Photo stability Testing of New Drug Substances and Products, option 2.
The walk-in Chambers are the best solution for storage of large batches of pharmaceuticals.
Possibility to manufacture the climatic test chamber with special measures.
Insulation panel of polyurethane foam, covered by two sheets of galvanized steel and high strength coating.
INSULATION
- Medium density: 42-44 kg/m³.
- Coefficient at all points: A group according to UNE 41950.
- 100 mm. floor thickness in all range.
- 70 mm. wall and roof thickness (100 mm optional).
FINISHED
- Roof and walls in White lacquered steel. There is the possibility of finishing in AIS I 304 or AIS I 316L stainless stee l .
- Reinforced floor and non-slip surface, Withstand 8000Kg./m2 of uniformly distributed static weight and 400Kg./m2 of dynamic weight, 4-point rolling (hand truck)
Standard equipment
- PID temperature controller with automatic and precise control.
- Capacitive measuring probe.
- 1850 x 800 pivot door, opening to the left or right as needed. Depending on the model, can be sliding door. Door opening from inside.
- Safety lock. The door has a window.
- Ø25 or Ø50 mm access port, with watertight cap (Possibility of different access port diameter).
- Shelving perforated polypropylene trays (food grade) on tube structure AISI 304 stainless steel. The trays can be adjusted in height, with a maximum of 9 levels.
- Interior lighting.
- Refrigeration equipment mounted on a bench. This equipment can be located above the chamber, on the false ceiling or in the engine room to avoid annoying noises.
- Low power consumption.
- Separate thermostat for over temperature with shutdown of the heating system.
- Warning lamp of lack of water in the humidifier.
- Deviation alarm band temperature and / or humidity.
- Prolonged door opening alarm
- Maximum and minimum pressure switch in condensing unit installed.
- Alarm process configuration at different security levels associated with acoustic buzzer and / or light beacons.
- Detection system of phase change.
- PLC fault management in the system, with fault indicator screen on the chamber.
- CFC and HCFC free refrigerant, under international environmental regulations.
Optional equipment
- Additional trays in stainless steel (plain or perforated).
- Fluorescent tubes UV/VIS/VHO/IR battery light on removable tray for photo stability according to ICH Q1B directive. Photo stability Testing of New Drug Substances and Products, option 2.
- RS232 Serial Port with RS485/232 converter for connection to computer.
- Communications via Ethernet.
- Dashboard protected by transparent door with security lock.
- Auxiliary feed water system using 80 liters tank with pump.
- Demineralization system (inverse osmosis, mixed-bed ion-exchanger, decalcification).
- Motorization system through Videotape recorder with 5,5″ VGA or 12,1″ XGA: Customizable graphical display. Remote viewing and setting. Batch functions. Adaptive recording. Mathematical functions. Totalizers, timers and counters. Time Synchronization (SNTP). Audit trails, Electronic signatures and Security Manager. FTP Client and Server. Communications via Ethernet. Serial communications. Event inputs. Compliance with U.S . FDA guidelines , and 21CFR Part 11. Complies with AMS2750D standard.
- Motorization system with Computer software: visualization of the average values, automatic storage of measurement data, display of the measured values, automatically generating adjustment protocols, calibration and configuration, user creation protected by password, visualization of active alarms, alarm message by e-mail, electronic registration, electronic signature, audits trace. Compliance with US FDA: 21CFR part 11 guidelines and EU Guidelines of Good manufacturing practice of medicinal products.
- Validable monitoring system (Videotapes as in software): demonstrative delivery documentation according to CSV, also ERES requirements according to regulation GxP (see [A11] and [21CFR11], and recommendations described in [PI011]). Installation qualification IQ with cross-reference to the Standard Functional Specifications and description of the test performed by CLIMATRONIC. Operational qualification OQ made at customer premises.
- Climatic Chamber validation, with delivery of documents DQ, IQ, OQ y PQ.
- CFC and HCFC free refrigerant, under international environmental regulations.