Newtronic Stability Humidity Chambers
Stability Tests are an important step in the development of new drugs and pharmaceutical substances and an indispensable element in the licensing process defined by federal regulating authorities. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance.
Together with committees from the pharmaceutical industry, experts from the licensing authorities (such as the FDA) have developed the ICH Guidelines for the harmonization of stability tests. These guidelines define standardized storage and batch evaluation as well as the time sequence of the required analytic tests.
According to the ICH Guideline Q1AR2, stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances.
NEWTRONIC offers a range of test chambers to meet these regulatory requirements as well as stability testing requirements for other industry segments of Cosmetic, Food & Beverages, etc.
We offer a centralized solution across all ICH conditions of real-time, intermediate, accelerated & semi-permeable study conditions along with a state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features.
Features
Specifications
Temperature Range | 20°C to 60°C |
Temperature Accuracy | ± 0.2°C |
Temperature Uniformity | ± 1°C |
Humidity Range | 40% RH to 95% RH |
Humidity Accuracy | ± 2% RH |
Humidity Uniformity | ± 3% RH |
Standard Equipment
Double walled with 80mm PUF insulated modular panels with easy on-site assembly | System is made up of split type condenser unit in well-ventilated area to avoid throw of hot air in the room |
SS 304 Interior & Exterior either SS 304 or Powder Coated G.I. | Stand by humidity system |
Stainless Steel Trays | Complete Operations driven through PLC with data logging capacity of upto 1000 readings & email facility |
Full length Inner glass door | High speed Ethernet based communication |
Illuminated working area | All operations through a single 4" Color Touch Screen |
U-shaped SS tubular heaters | High-quality German Make temperature humidity sensor with 4-20mA output |
Forced air circulation for uniform temperature | Safety devices: Low & High temperature cut-off settable thermostats & high humidity cut-off device |
Non Condensing steam injection type humidity system with standby heater & auto switch overs | Audio/Visual alarms for deviations |
CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser | Complete with DQ, OQ, PQ, IQ & Operations & Maintenance Manual |
Power supply: 230/415 volts 50 Hz main supply. Also available with 60 Hz Cycle.
Optional Accessories
ICDAS – A Single Software installation for all Newtronic make equipment. | Door Access system (Numeric or Biometric) |
4pt. Temperature & Humidity Scanners | Mobile Alert system |
Stand by Cooling System with auto switch overs (430 litre & above) | Remote alarm system suitable for 4 nos. Newtronic make equipment |
To contact Biotec Solutions about Newtronic Stability Humidity Chambers use Get a quote.
Stability Tests are an important step in the development of new drugs and pharmaceutical substances and an indispensable element in the licensing process defined by federal regulating authorities. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance.
Together with committees from the pharmaceutical industry, experts from the licensing authorities (such as the FDA) have developed the ICH Guidelines for the harmonization of stability tests. These guidelines define standardized storage and batch evaluation as well as the time sequence of the required analytic tests.
According to the ICH Guideline Q1AR2, stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances.
NEWTRONIC offers a range of test chambers to meet these regulatory requirements as well as stability testing requirements for other industry segments of Cosmetic, Food & Beverages, etc.
We offer a centralized solution across all ICH conditions of real-time, intermediate, accelerated & semi-permeable study conditions along with a state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features.
Features
Specifications
Temperature Range | 20°C to 60°C |
Temperature Accuracy | ± 0.2°C |
Temperature Uniformity | ± 1°C |
Humidity Range | 40% RH to 95% RH |
Humidity Accuracy | ± 2% RH |
Humidity Uniformity | ± 3% RH |
Standard Equipment
Double walled with 80mm PUF insulated modular panels with easy on-site assembly | System is made up of split type condenser unit in well-ventilated area to avoid throw of hot air in the room |
SS 304 Interior & Exterior either SS 304 or Powder Coated G.I. | Stand by humidity system |
Stainless Steel Trays | Complete Operations driven through PLC with data logging capacity of upto 1000 readings & email facility |
Full length Inner glass door | High speed Ethernet based communication |
Illuminated working area | All operations through a single 4" Color Touch Screen |
U-shaped SS tubular heaters | High-quality German Make temperature humidity sensor with 4-20mA output |
Forced air circulation for uniform temperature | Safety devices: Low & High temperature cut-off settable thermostats & high humidity cut-off device |
Non Condensing steam injection type humidity system with standby heater & auto switch overs | Audio/Visual alarms for deviations |
CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser | Complete with DQ, OQ, PQ, IQ & Operations & Maintenance Manual |
Power supply: 230/415 volts 50 Hz main supply. Also available with 60 Hz Cycle.
Optional Accessories
ICDAS – A Single Software installation for all Newtronic make equipment. | Door Access system (Numeric or Biometric) |
4pt. Temperature & Humidity Scanners | Mobile Alert system |
Stand by Cooling System with auto switch overs (430 litre & above) | Remote alarm system suitable for 4 nos. Newtronic make equipment |
To contact Biotec Solutions about Newtronic Stability Humidity Chambers use Get a quote.
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