Stability Chambers

Whether your testing is for R&D, clinical trials or ongoing stability, the “TEMPO” stability chamber provide a stable temperature & humidity condition environment for worry-free operations with a control system that is easy to operate. “TEMPO” make stability chamber is designed as per ICH guidelines and are manufactured to comply with requirements in the industries. Stability testing is an integral part of formulation development. It helps to generate information, which permits well-considered proposals to be made for the shelf life of drug substances and products and recommended storage conditions.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or product under recommended storage conditions. Hence, the pharmaceutical stability chamber serves as an important quality attribute for the product.

Standard Models
Inside S.S. 304 with mirror polish & outside mild steel powder coated.

GMP Models
Inside S.S. 316 with mirror polish & outside stainless steel 304 with the dull buff finish.

Construction
Double-walled construction with backside triple-walled 3” thick PUF insulation ensures stable temperature with humidity & reduced energy consumption. Motorized Blower is fitted at the backside of the chamber.

The unit is provided with an adjustable stainless steel rod mesh tray. The equipment is mounted on caster wheels for easy movement.

Technical Specification

• Controlling System : Two separate imported microprocessors based autotune PID controller with CE mark & dual display of set value & process value for temperature & humidity with direct %RH.
• Air Circulation : The motorized blower at the backside of the chamber develops a unique air ow system which ensures max. uniform temperature & humidity condition inside the chamber.
• Heating System : High-quality U shape S.S. tubular heater is used for better heating.
• Humidity System : Steam injection system (Non-condensing type) & reservoir tank with water level arrangement with indicator.
• Refrigeration System : CFC Free hermetically sealed Emerson Copeland make compressor for better cooling with R134 A (Eco Friendly) refrigerant with a time delay to safeguard compressor system.

Features

• 50 mm validation porthole with silicon rubber seal to insert sensors for validation. Full view observation Acrylic door with a gasket to observe the sample inside the chamber. Interior illumination for working area.
• Specially designed stainless steel rod trays ensure uniform temperature distribution.

Safety Features
Additional safety thermostat to cut of dry heater supply in case temperature of overshoot. Float switch to cut off the wet heater supply in case of low water level. Audio & visual alarm. Compressor ON delay timer (2 min.) to safeguard the compressor.  Inbuilt overload protector provided for a hermetically sealed compressor.

Optional Features

• PLC for auto change over for standby refrigeration system with HMI
• CFR 21 part 11 compliance software for PLC with RS 485 or ethernet communication
• Stand by refrigeration and humidity system
• Data logger
• CFR 21 part 11 compliance software for data logger
• Data scanner complete with sensor
• SMS mobile alert system
• Door access security system
• Safety digital temperature controller
• Timer

“TEMPO” make photostability chamber is used for confirmatory studies, the samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter to allow direct comparison to be made between drug substance & drug product.

Standard Models
Inside SS 304 with mirror polish & outside mild steel powder coated.

GMP Models
Inside SS 316 with mirror polish & outside stainless steel 304 with the dull buff finish.

Construction
“TEMPO” make photostability chamber are made of double walled construction with backside as triple walled. The fluorescent light & UV light fitted on the top side of the chamber. Full view inner tough glass door & a front door with magnetic gasket & lock. The motorized blower is fitted on the backside for uniform temperature & humidity. The 3” thick PUF insulation to ensure stable temperature & humidity. The unit is provided with the adjustable stainless steel rod trays. The equipment is mounted on caster wheel for easy movement.

Technical Specification

• Controlling System : Two separate imported microprocessors based autotune PID controller with CE mark & dual display of set value & process value for temperature & humidity with direct %RH.
• Air Circulation : The motorized blower at the backside of the chamber develops a unique air ow system which ensures maximum uniform temperature and humidity condition inside the chamber.
• Heating System : High quality U shape SS tubular heater is used for better heating.
• Humidity System : Steam injection system (non-condensing type) and reservoir tank with water level arrangement with indicator.
• Refrigeration System : CFC Free hermetically sealed Emerson Copeland make compressor for better cooling with R134 A (eco friendly) refrigerant with a time delay to safeguard compressor system.

Features
50 mm validation porthole with silicon rubber seal to insert sensors for validation. Full view observation acrylic door with a gasket to observe the sample inside the chamber. Interior illumination for working area. Specially designed stainless steel rod trays ensure uniform temperature distribution.

Safety Features
Additional safety thermostat to cut of dry heater supply in case temperature of overshoot. Float switch to cut off the wet heater supply in case of low water level. Audio & visual alarm. Compressor ON delay timer (2 min.) to safeguard the compressor.  Inbuilt overload protector provided for a hermetically sealed compressor. After opening the door UV light is automatically switch off.

Optional Features

• PLC for auto change over for standby refrigeration system with HMI
• CFR 21 part 11 compliance software for PLC with RS 485 or ethernet communication
• Stand by refrigeration and humidity system
• Data logger
• CFR 21 part 11 compliance software for data logger
• Data scanner complete with sensor
• SMS mobile alert system
• Door access security system
• Safety digital temperature controller
• Timer

Whether your testing is for R&D, clinical trials or ongoing stability, “TEMPO” stability chamber provide a stable temperature & humidity condition environment for worry-free operations with a control system that is easy to operate. “TEMPO” make stability chamber is designed as per ICH guidelines and are manufactured to comply with requirements in the industries. Stability testing is an integral part of formulation development. It helps to generate information, which permits well-considered proposals to be made for the shelf life of drug substances and products and recommended storage condition.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or product under recommended storage conditions. Hence, pharmaceutical stability chamber serves as an important quality attribute for the product.

Standard Models
Inside S.S. 304 with mirror polish & outside mild steel powder coated.

GMP Models
Inside S.S. 316 with mirror polish & outside stainless steel 304 with the dull buff finish.

Construction
Double walled construction with backside triple walled 3” thick PUF insulation ensures stable temperature with humidity & reduced energy consumption. Motorized Blower is fitted at the backside of the chamber.

The unit is provided with an adjustable stainless steel rod mesh tray. The equipment is mounted on caster wheels for easy movement.

Technical Specification

• Controlling System : Two separate imported microprocessors based autotune PID controller with CE mark & dual display of set value & process value for temperature & humidity with direct %RH.
• Air Circulation : The motorized blower at the backside of the chamber develops a unique air ow system which ensures max. uniform temperature & humidity condition inside the chamber.
• Heating System : High-quality U shape S.S. tubular heater is used for better heating.
• Humidity System : Steam injection system (Non-condensing type) & reservoir tank with water level arrangement with indicator.
• Refrigeration System : CFC Free hermetically sealed Emerson Copeland make compressor for better cooling with R134 A (Eco Friendly) refrigerant with a time delay to safeguard compressor system.

Features
50 mm validation porthole with silicon rubber seal to insert sensors for validation. Full view observation Acrylic door with a gasket to observe the sample inside the chamber. Interior illumination for working area.
Specially designed stainless steel rod trays ensure uniform temperature distribution.

Safety Features
Additional safety thermostat to cut of dry heater supply in case temperature of overshoot. Float switch to cut off the wet heater supply in case of low water level. Audio & visual alarm. Compressor ON delay timer (2 min.) to safeguard the compressor.  Inbuilt overload protector provided for a hermetically sealed compressor.

Optional Features

• PLC for auto change over for standby refrigeration system with HMI
• CFR 21 part 11 compliance software for PLC with RS 485 or ethernet communication
• Stand by refrigeration and humidity system
• Data logger
• CFR 21 part 11 compliance software for data logger
• Data scanner complete with sensor
• SMS mobile alert system
• Door access security system
• Safety digital temperature controller
• Timer

When your testing requires a walk in rooms choose “TEMPO” controlled temperatures solution. Our test rooms feature automated process control, energy efficiency and a vast range of other features and options. Every “TEMPO” environmental room features equipment that reliably produces required conditions, structural integrity that keeps the room working properly through years of demanding test cycles, and measuring/monitoring equipment that precisely records all test data.

Standard Models
Inside S.S. 304 with mirror polish & outside mild steel powder coated.

GMP Models
Inside S.S. 316 with mirror polish & outside stainless steel 304 with the dull buff finish.

Construction
Double walled constructed PUF modular panels ensure easy assembly at site. The leak proof door with a full gasket and airtight mechanical lock ensures there is no leakage through the chamber. The observation window (30 × 30 cm) is provided for viewing the sample inside the chamber. The unit is provided with perforated stainless steel trays.

Technical Specification

• Air Circulation : The motorized blower at the backside of the chamber provides the recirculation of air which ensure the maximum uniformity of temperature and humidity inside the chamber should be maintained.
• Heating System : The high quality SS tubular heater made from the nichrome wire sheathed in SS tube is used. The special arrangement of heaters avoids the direct rendition of stored samples.
• Humidity System : High-quality U shape S.S. tubular heater is used for better heating.
• Humidity System : Steam injection system with water level arrangement is provided. A low pressure boiler tank and reservoir tank with duly argon welded is fitted with a float valve. When the water level in the tank is low the switch cut off. The ISI marked heating elements are used with the inbuilt stand by humidity system with auto change over the facility.
• Refrigeration System : The CFC Free hermetically sealed Emerson Copeland make compressor is used for better cooling with eco friendly refrigerant. The cooling system is made up of split type and the compressor is coupled with the condenser unit in a well ventilated area to avoid the hot air throw inside the chamber.
• Control System : The microprocessor based PLC (logging capacity of 1000 readings) with HMI touch screen 4.3″ colour display, which gives the direct display, the process value and the set value of temperature and humidity inside the chamber. The sensor (transmitter type 4-20 ma) which will accurately measure the temperature and humidity is provided with a high speed ethernet communication. The internal working area is illuminated.

Features
The sturdy design and long lasting finish ensure the minimum maintenance is required. The tongue and the grooves are moulded to close tolerance ensuring there is a tight fit between the panels. These prevent the condensation from forming on the foam a which minimizes the heat transfer. The high quality hardware like hinges and handles used in panels are indigenous and are imported.

Safety Features

• Audio visual alarms are used for temperature and humidity variations.
• If the temperature increases above the 60°C the system will automatically cut off the dry heater, wet heater and the compressor.
• The float switch is used to cut off the wet heater supply in case of the water level in the tank goes below.

Optional Features

• CFR 21 part 11 compliance software for PLC with RS 485 or ethernet communication
• Data logger
• CFR 21 part 11 compliance software for data logger
• Data scanner complete with sensor
• SMS mobile alert system
• Door access security system