WALK-IN STABILITY CHAMBER
21 CFR Part 11 Compliance Window based communication software for data management
Capacity: from 3,000L to 700,000L
Thermolab Scientific Chambers are perfectly designed for the high requirements of stability studies and climatic tests. With Stability Chambers specifically developed to meet FDA/ICH stability requirements generating exceptional control and uniformity of both temperature and humidity. Thermolab Stability Chambers feature various safety feature, audio visual alarms, 21 CFR part 11 software and a vast range of options and is the most preferred choice for stability studies. Every Thermolab Scientific Chamber repeatedly produces required conditions, structural integrity that keeps the chamber working properly through years of demanding test cycles and measuring equipment’s that precisely records all test data.
Thermolab Stability testing chambers are designed to meet, if not exceed, stringent quality standards recognized internationally. Offering all temperature and relative humidity conditions specified in ICH guidelines as below:
25°C/ 60% RH 30°C/ 65% RH 30°C/ 70% RH
30°C/ 75% RH 40°C/ 75% RH 25°C/ 40% RH
30°C/ 35% RH 40°C/ NMT 25% RH
Today, other than Pharma and Bio-pharma products, stability studies are required for Alternate medicines, Food & Beverages, Medical devices, Cosmetics and other items to check the environmental effects on the product.
- Temperature Range : 20°C to 60°C
- Temperature Accuracy : ± 0.2°C
- Temp Uniformity : ± 2°C
- Humidity Range : 40% to 95% RH
- Humidity Accuracy : ± 2% RH
- Humidity Uniformity : ± 3% RH
- Prefabricated modular structure with PUF/Rockwool insulated panels and reinforced floor panel.
- Interior Stainless Steel and Exterior PPGI/Stainless Steel finish.
- Adequate illumination inside the chamber.
- Glass view panel with specially designed leak proof door.
- Racks & trays made of Stainless Steel with adjustable tray heights.
- CFC free refrigeration systems.
Man, Machine, Product and Environmental Safety
- Safety system to cut off the power supply in case of overshoot and undershoot of Temperature and Humidity conditions giving audio visual alarms.
- Additional safety thermostat to cut off the power supply in case of temperature overshoots.
- Low water level alarm for humidity system.
- Emergency push button inside the chamber to de-energise magnetic lock.
- Panic switch inside the chamber with audible alarm outside.
- Manual unlocking mechanism for door from inside the walk-in chamber.
- Environment friendly processes and refrigerants used.
Hydronic Cooling System
- Thermolab has innovated a unique chilled water circulation system which reduces the electrical consumption by 60% and water consumption by 90%.
- Factory assembled refrigeration system, avoiding on-site piping work.
- This unique design enables maintenance of optimum cooling coil temperatures depending on the chamber conditions and resultant Dew Point.
- The life of compressor increases as the running time of compressor has enormously decreased.
- Compact plug and play design and can be placed behind the chamber or in the technical area.
Meet FDA/ICH stability requirements
21 CFR part 11 software
Complete with IQ, OQ, PQ, Documents
Air Processing Unit (APU)
- Designed to achieve optimum energy utilization with Integrated Cooling, Heating and Humidifying system.
- The airflow is designed to have uniform conditions throughout the chamber.
- Custom designedsupply and return air ducts particularly for chambers having larger storage volumes.
- Sleek APU design resulted in increased storage volume.
- Newly designed control panel as per international electrical safety standards.
- PLC based control system with 7” colour HMI, and front mounted compact design.
- Country specific electrical panel design to comply with local electrical standards.
- Works on 110 / 220 / 440 Volts and 50 / 60 Hz
- Windows based SCADA software for data management having support for 21 CFR Part 11 compliance.
- 100% redundant refrigeration & humidity systems with automatic changeover.
- 8 point temperature and 8 point relative humidity monitoring sensors for online mapping.
- Standby temperature and humidity sensors.
- Printer interface and data storage facility.
- Email and mobile alert systems.
- Ethernet communication protocol.
- Door Access Security system.
- Remote audio visual alarm.
© 2020 • www.pharmastabilitychamber.com • Tel: +8 4918 509 782 • Pharmaceutical Stability Chambers