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.

[Stability Chamber]

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Standard Features

Double walled modular structure with 3” thick PUF insulation
Inside Stainless Steel and Outside Mild Steel Powder Coated OR Stainless Steel
Interior illumination
Inside full length observation glass door with secure gasket
Handle and hinges for positive sealing with lock and key arrangement
Heavy-duty door hinges and latches to maintain a secure and uniform seal
Racks & trays – Stainless steel with adjustable height
65 mm Port Hole with rubber seal to insert sensors for validation purpose
Interior illumination for working area
U shaped S.S. Nichrome wire air heaters
Humidity system with evaporation tray and reservoir tank with water level arrangement
Compressor with CFC Free R 134 A / R 404 (Eco Friendly) refrigerant having state of art by-pass system for continuous run of compressor
Plc control system with touch screen display coloured screen – 5.7” HMI with Ethernet
Safety controller sensor to cut off the supply in case of overshoot and undershoot of Temperature giving audio visual alarm
Web based online monitoring
Complete with IQ, OQ, PQ, Documents, Operations and Maintenance manuals
Works on 23V AC single phase 50Hz
Complete safety and alarm system

Optional Features

21 CFR Part 11 Compliance Window based communication software for data management
Stand by refrigeration system & Stand by humidity system (Except for 90 Ltrs.)
Scanner 4 point temperature and 4 point humidity scanner complete with sensors and printer interface and data storage facility Door Access Security system
Mobile Alert system
80 Col. Dot Matrix printers along with stainless steel stand

Specifications

Standard Model(S) : Inside S.S. 304 with mirror polish & outside mild steel powder coated
GMP Model(G) : Inside S.S. 316 with mirror polish & outside with S.S. 304 matt buff
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

Thermolab Scientific Chambers are perfectly designed for the high requirements of stability studies and climatic tests. With stability rooms specifically developed to meet FDA / ICH stability requirements generating exceptional control and uniformity of both temperature and humidity. Our chambers feature automated process control, energy efficiency and a vast range of options and are 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.

65% power saving by chilled water refrigeration

95% water saving in humidity system

Flame proof chamber

[Walk-In Stability Chamber]

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Standard Features

Pre-fabricated doubled walled modular panels with PUF insulation
Inside Stainless Steel and Outside GI pre coated or Stainless Steel
Floor panels having extra reinforcement to sustain the movement and sample load inside the chamber
Interior illumination for working area
Multi pane vacuum sealed observation glass window
Heavy-duty door hinges and latches to maintain a secure and uniform seal
Racks & trays made up of Stainless Steel with adjustable height
65 mm Port Hole with rubber seal to insert sensors for validation purpose. Interior illumination for working area
Interior illumination for working area
U shaped S.S. Nichrome wire air heaters
Humidity system with evaporation tray and reservoir tank with water level arrangement
Compressor with CFC Free R 134 A / R 404 (Eco Friendly) refrigerant having state of art by-pass system for continuous run of compressor
Plc control system with touch screen display coloured screen – 5.7” HMI with Ethernet
Web based online monitoring
Complete with IQ, OQ, PQ, Documents, Operations and Maintenance manuals
Works on 23V AC single phase 50Hz

Hydronic refrigeration system by chilled water circulation

Compressor is in off mode more than 50% of the time, saving electrical consumption, heat dissipation in the room and increasing the life of the compressor
Saves 50% of the electrical consumption
System is compact and avoids piping on site as it is factory fitted ready to install, which reduces installation time
Weather proof unit (which can be placed indoors as well as outdoors)
Recovery of cost within 2 years

Smart air distribution system

A separate supply and return duct for ensuring uniformity of set conditions

Efficient water management system

Built-in water recirculation system which saves 95% of water consumption
Reduction in water cost

Safety & Alarms

Safety controller sensor to cut off the supply in case of overshoot and undershoot of Temperature and Humidity giving audio visual alarm
Low water level alarms
Door opening alarms
Emergency bell switch provided inside the chamber
Special door lock provided to open the door from inside
All the alarms are events are logged in the software

Optional Features

21 CFR Part 11 compliance Window based communication software for data management
Stand by refrigeration system & Stand by humidity system
Scanner 4 point temperature and 4 point humidity scanner complete with sensors and printer interface and data storage facility Door Access Security system
Mobile Alert system
80 Col. Dot Matrix printers along with stainless steel stand

Rockwool insulated panels

Specifications

Standard Model(S) : Inside S.S. 304 with mirror polish & outside mild steel powder coated
GMP Model(G) : Inside S.S. 316 with mirror polish & outside with S.S. 304 matt buff
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

Thermolab’s Photostability Chambers are developed according to the ICH 1Qb guidelines keeping in mind that light testing is an integral part of the stress testing. The chambers closely monitor temperature, Humidity (optional) and light intensity on the drug and drug substance.

Standard Features

Double walled modular structure with PUF insulation
Inside Stainless Steel and Outside Mild Steel Powder Coated OR Stainless Steel
Exposure of cool white florescent light for 1.2 mil lux hours and UV-A light for 200 watt hours per square meter on the test samples
Cool white, near-ultraviolet, full spectrum, and dual source cool white/UV banks designed to meet Options 1 and 2 of current ICH/FDA guidelines
Combined light exposure or individual light exposure with automatic light cut off system after exposure is achieved
The light exposure data is captured in the system with respect to date and time along with temperature
Shelf-mounted light tubes providing direct uninterrupted light to test samples
Interior illumination
Inside full length observation glass door with secure gasket
Racks & trays – Stainless Steel with adjustable height
U shaped S.S. Nichrome wire air heaters
Compressor with CFC Free R 134 A / R 404 (Eco Friendly) refrigerant having state of art by-pass system for continuous run of compressor
Plc control system with touch screen display coloured screen – 5.7” HMI with Ethernet
Safety controller sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm
Web based online monitoring
Complete with IQ, OQ, PQ, Documents, Operations and Maintenance manuals
Works on 23V AC single phase 50Hz
Complete safety and alarm system
Automatic door open cut off of UV light as a safety measure

Optional Features

21 CFR Part 11 compliance window based communication software for data management
Humidity system
Stand by refrigeration system & Stand by humidity system
Scanner 4 point temperature and 4 point humidity scanner complete with sensors and printer interface and data storage facility Door Access Security system
Mobile Alert system
80 Col. Dot Matrix printers along with Stainless Steel stand

Specifications

Standard Model(S) : Inside S.S. 304 with mirror polish & outside mild steel powder coated
GMP Model(G) : Inside S.S. 316 with mirror polish & outside with S.S. 304 matt buff
Temperature Range : 20 °C to 60 °C
Temperature Accuracy : ± 0.2 °C
Temp Uniformity : ± 2 °C

Stability Storage Facility

With extensive experience in the manufacturing of Stability Chamber since last 49 years, Thermolab offers one of the best Stability Storage Facility. The storage facility has 16 Walk-In Chambers and 11 Standalone Chambers with the total volume of 3,50,000 liters.

We offer comprehensive stability testing facility to our clients according to ICH guidelines in total completeness comprising of drug product, drug substance storage as well as cGLP compliant analytical laboratory.

[Stability Storage Facility]

Analytical Testing Laboratory

Well-equipped state-of-the-art analytical laboratory offer comprehensive stability testing services as per ICH guidelines and customer specifications. Highly experienced and qualified teams of scientists are responsible for the facility. The laboratory is compliant to GLP requirements. The laboratory facility includes sophisticated instrument lab, microbiology lab and chemistry lab.

The Analytical Testing Laboratory have been granted license by the FDA and currently serving to many Multinational and Indian pharmaceutical companies.

Thermolab Testing Services is one of the leading calibration, validation and testing service providers in India with NABL Accreditation.

We operate with the regulatory requirements of ISO/IEC 17025:2005 & NABL’s specific criteria documents; with the operating procedures as per various IS documents, ISO 14644 – Part 3, HTM 2010 – Part 3 to comply with the requirements for ISO, WHO, FDA, USFDA, MHRA & cGMP audits.

We serve to an extensive client base for calibration and validation of plant, machinery and equipments.

Thermolab Cooling Cabinets are of superior quality and precise control best suited for storage of reference standards, raw materials and vaccine storage . Thermolab Cooling Cabinets feature various safety feature, audio visual alarms, 21 CFR part 11 complaint software and are the preferred choice in cooling solutions.

Standard Features

Double walled modular structure with 3” thick PUF insulation
Inside Stainless Steel and Outside Mild Steel Powder Coated OR Stainless Steel
Interior illumination
Inside full length observation glass door with secure gasket
Handle and hinges for positive sealing with lock and key arrangement
Racks & trays – Stainless Steel with adjustable height
65 mm Port Hole with rubber seal to insert sensors for validation purpose
Compressor with CFC Free R 134 A / R 404 (Eco Friendly) refrigerant having state of art by-pass system for continuous run of compressor
Plc control system with touch screen display coloured screen – 5.7” HMI with Ethernet
Safety controller sensor to cut off the supply in case of overshoot and undershoot of Temperature giving audio visual alarm
Network connectivity via Ethernet for web based online remote monitoring
Complete safety and alarm system
Complete with IQ, OQ, PQ, Documents, Operations and Maintenance manuals
Works on 23V AC single phase 50Hz

Optional Features

21 CFR Part 11 compliance window based communication software for data management
Stand by refrigeration system (Except for 90 Ltrs.)
Scanner 4 point temperature and sensors and printer interface
Data storage facility Door Access Security system
Mobile Alert system
80 Col. Dot Matrix printers along with Stainless Steel stand

Specifications

Standard Model(S) : Inside S.S. 304 with mirror polish & outside mild steel powder coated
GMP Model(G) : Inside S.S. 316 with mirror polish & outside with S.S. 304 matt buff
Temperature Range : 2 °C to 8 °C
Temperature Accuracy : ± 1.0 °C
Temp Uniformity : ± 2.0 °C

The Walk-In Cooling Cabinets / cold rooms are designed according to ICH guidelines, WHO, MCA and USFDA requirements to maintain uniform conditions. They are superior in airflow distribution, temperature control technology, cabinet construction and are manufactured as per cGMP regulations.

Standard Features

Pre-fabricated doubled walled modular panels with 80 mm thick PUF insulation
Inside Stainless Steel and Outside Mild Steel Powder Coated OR Stainless Steel
Floor panels having extra reinforcement to sustain the movement and sample load inside the chamber
Interior illumination for working area
Multi pane vacuum sealed observation glass window
Heavy-duty door hinges and latches to maintain a secure and uniform seal
Racks & trays – Stainless Steel with adjustable height
65 mm Port Hole with rubber seal to insert sensors for validation purpose
Compressor with CFC Free R 134 A / R 404 (Eco Friendly) refrigerant having state of art by-pass system for continuous run of compressor
Plc control system with touch screen display coloured screen – 5.7” HMI with Ethernet
Web based online monitoring
Complete with IQ, OQ, PQ, Documents, Operations and Maintenance manuals
Works on 23V AC single phase 50Hz

Hydronic refrigeration system by chilled water circulation

Compressor is in off mode more than 50% of the time, saving electrical consumption, heat dissipation in the room and increasing the life of the compressor
Saves 50% of the electrical consumption
System is compact and avoids piping on site as it is factory fitted ready to install, which reduces installation time
Weather proof unit (which can be placed indoors as well as outdoors)
Recovery of cost within 2 years

Smart air distribution system

A separate supply and return duct for ensuring uniformity of set conditions

Safety & Alarms

Safety controller sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm
Door Opening alarms
Emergency bell switch provided inside the chamber
Special door lock provided to open the door from inside
All the alarms are events are logged in the software

Optional Features

21 CFR Part 11 compliance window based communication software for data management
Stand by refrigeration system
Scanner 8 point temperature complete with sensors and printer interface and data storage facility Door Access Security system
Mobile Alert system
80 Col. Dot Matrix printers along with Stainless Steel stand

Rockwool insulated panels

Specifications

Standard Model(S) : Inside S.S. 304 with mirror polish & outside mild steel powder coated
GMP Model(G) : Inside S.S. 316 with mirror polish & outside with S.S. 304 matt buff
Temperature Range : 2 °C to 8 °C
Temperature Accuracy : ± 1.0 °C
Temp Uniformity : ± 2.0 °C