Walk In Stability Chamber

Available Variants:

1. Walk-In Stability Chamber – 2000 Ltr.
2. Walk-In Stability Chamber – 4000 Ltr.
3. Walk-In Stability Chamber – 6000 Ltr.
4. Walk-In Stability Chamber – 8000 Ltr.
5. Walk-In Stability Chamber – 12000 Ltr.
6. Walk-In Stability Chamber – 18750 Ltr.
7. Walk-In Stability Chamber – 23250 Ltr.
8. Walk-In Stability Chamber – 32500 Ltr.
9. Walk-In Stability Chamber – 45000 Ltr.
10. Walk-In Stability Chamber – 50000 Ltr.
11. Walk-In Stability Chamber – 80000 Ltr.

Compliance & Design Requirements:

• CE Certified.
• Designed as per ICH guidelines.
• Designed to meet WHO requirements.
• Designed to meet USFDA requirements.
• 21-CFR Part-11 compliant PC software as specified.
• Electrical wiring as per CE compliances.

Description:

• Walk-In Stability Chamber is designed as per ICH guidelines to meet WHO and USFDA requirements. It fulfills the specified storage conditions of 25°C - 60% RH, 40°C - 75% RH, 30°C - 65% RH, 25°C - 40% RH and 30°C - 35% RH. The chamber is equipped with a PLC and touch-screen HMI system with highly accurate individual control loops for precise temperature and humidity control.
• The chamber is constructed with stainless-steel interiors and exteriors, insulated prefabricated PUFF panels with cam-locks to minimize thermal leakage, and a viewing arrangement for inspection of samples without disturbing chamber operation. It incorporates controlled air circulation, steam-injection humidity generation, heating and refrigeration systems, safety provisions, electrical controls, data logging and 21-CFR Part-11 compliant software features.

Applications:

• Stability testing and controlled storage under specified temperature and humidity conditions.
• Environmental storage conditions required according to ICH guidelines.
• Conditions intended to meet WHO and USFDA requirements.
• Monitoring and recording temperature and humidity conditions.
• Real-time environmental monitoring and data acquisition.
• Generation and maintenance of controlled temperature and humidity environments.

Apparatus Details:

Construction:

1. CE Certified.
2. Designed as per ICH guidelines to meet WHO and USFDA requirements.
3. Fulfills storage conditions of 25°C - 60% RH, 40°C - 75% RH, 30°C - 65% RH, 25°C - 40% RH and 30°C - 35% RH.
4. Equipped with PLC and touch-screen HMI system.
5. Highly accurate individual control loop for precise temperature and humidity control.
6. Interior fabricated from stainless steel.
7. Exterior body fabricated from stainless steel.
8. Toughened glass window for inspecting samples without affecting chamber temperature.
9. Prefabricated PUFF panels with cam-locks to avoid thermal leakage.
10. Electrical wiring as per CE compliances.
11. LED chamber illumination with door switch.
12. User-friendly chamber door and locking mechanism.
13. Facility to open the chamber door from inside in case of emergency.
14. Aesthetic outer appearance and high-quality construction.
15. Supplied with IQ/OQ/PQ documents, calibration certificates and instruction manual.

Air Circulation:

• Temperature is maintained by a quiet-running blower circulating air throughout the chamber. Forced air is circulated vertically downward and re-circulated throughout the chamber to provide uniform temperature and humidity distribution.

Humidity Generation:

• Humidity is created by the steam-injection method. The boiler tank is fitted at the back side of the chamber for better servicing. An electromagnetic switch controls the wet heater and prevents it from burning when the water level is inadequate. A float valve automatically controls and maintains the water level in the boiler tank.

Heating & Cooling System:

• Long-lasting SS tubular heaters are used as heating elements, with stainless-steel fins for better heat transfer. A hermetically sealed, CFC-free compressor using 134A gas is coupled with an evaporation coil and condenser. Refrigeration components include expansion valve, driers, oil separators, pressure gauges and vibration eliminators. Reputed refrigeration systems such as Emerson/Kirloskar make are specified.

Sample Trays:

• Removable stainless-steel rod/perforated trays are provided as specified. The trays are strong enough to withstand heavy loads of test specimens and facilitate better air circulation. The distance between trays is 15–20 cm. Tray quantities supplied include 8, 12, 20, 28, 36, 40, 66, 84, 100 and 200 numbers as provided in the source.

Electrical Controls:

• Relays, contactors, SSR, MCB, mains switch, fan-control switch, compressor ON/OFF switch with indicator, and dry-heater switch with indicator are provided for safe and easy operation.

Electrical Circuitry:

• CE-certified inner circuitry wires are provided with individual number tags for ease of servicing and maintenance.

Safety Provisions:

• Over-temperature thermostat and thermal fuses for the heating system.
• Low-water-level boiler cut-off.
• Electrical overload cut-off.
• Time delay for compressor switch ON.
• Electrical circuit breaker.

Viewing Window & Wiper:

• The viewing window consists of multi-pane toughened clear glass sealed with silicone and separated by spacers to form a completely vacuumed/vacuumised window. A wiper is provided to clear condensed water droplets from the glass.

Advanced Features:

1. 7-inch touch-screen HMI controller and PLC system.
2. GSM module for mobile alert configuration and parameter deviation alerts.
3. Magnetic door-lock mechanism.
4. Password-protected door access system.
5. 21-CFR Part-11 compliant PC software.
6. Audit-trail generation in PC software.
7. In-built data logger with uniformity module.
8. Temperature and RH sensors for data logging.
9. Low-water-level monitoring.
10. Automatic water-filling system.
11. Automatic resume after power failure.
12. Standby refrigeration system in case the main system fails.
13. Standby humidity system in case the main system fails.
14. Automatic switch-over from mains to standby system and vice versa.
15. Calendar option for selecting the days on which either the mains or standby system remains active.

The source also specifies, in one configuration, an email alert system for parameter deviation, a standby sensor in case the main sensor fails, and 5 temperature + 5 RH sensors consisting of 1 main and 4 for data logging.

21-CFR Part-11 Compliance Software Features:

1. Multi-chamber data acquisition software.
2. Graphical analysis of data according to 21-CFR compliance guidelines.
3. File encryption facility.
4. Secure login facility.
5. Password-protected system access controlled by the system supervisor.
6. Limited system access.
7. Limited module access.
8. Password expiration.
9. Bilateral user ID and password identification.
10. Access-failure lockout.
11. System access logs.
12. System audit-trail report.
13. System input/output logs.
14. Mean kinetic temperature calculation.
15. User activity logs including users logged in, login/logout time and changes made to software settings through audit-trail reports.
16. Gap-free records.
17. Reports scheduled through email.
18. Compliance with tough standards.
19. Real-time environmental viewing.
20. Flexible alarm management.
21. Consistent alarm acknowledgements.
22. Highly secure and tamper-proof operation.
23. Protection from data loss.