Newtronic - Stability Humidity Chambers Get latest price

Stability Humidity Chambers

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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

• Ethernet Communication
  • High-speed data transfer
  • Significantly faster than serial(RS-485) communication
  • Global standard for communication protocol
  • No need for a separate PC interface
  • Data Operations from any PC over the LAN
• Standby Humidity & Cooling System
  • Completely ready-to-use systems
  • Automatic switch-over upon failure of primary systems to achieve conditions
  • Switch-over also upon detection of HP/LP & Internal fault
  • Scheduled & manual change-overs
  • Recording of all change-overs in the software
• PLC-Based Control System
  • Complete Operations driven through PLC
  • No Data Loss: Data Storage of upto 1000 readings on the PLC itself
  • At an interval of 30 mins, data upto 20 days is stored on the PLC itself
  • Facility to send emails directly from the PLC
• Touch Screen Display
  • All operations through a single 4" Color touch screen display
  • PLC IP Address setting
  • Component Working Hours
  • Standby system change over
  • Password protection for set values and calibration mode
• Email Alert
  • When an alarm is triggered, an e-mail is sent to the registered PC or mobile address
  • *connection to a mail server is required to use e-mail alert.
• Complete Range of Alarms
  • Temperature & Humidity Deviations
  • Door Opening
  • Water Supply Failure
  • Component Failure
  • Mains Failure
• Documentation & Training
  • IQ, OQ, PQ
  • Calibration certificates
  • Operations & maintenance manuals
  • GA & Electrical drawings
  • Material test certificates
  • Training to end-users
• Safety
  • Temperature Overshoot/Undershoot
  • Humidity Overshoot
  • Low water-level
  • Delay Timer to safeguard the Compressor
  • MCB to cut-off over-current supply
  • Standby Controlling Sensor upon failure of Primary
  • In Walk-in chambers door can be open from inside
  • Emergency Bell switch inside the Chamber
• ICDAS Software
  • 21 CFR Part 11 Ready
  • Single software suitable for up to 20 equipment
  • Automatic daily data back-up
  • Alarm logs. Alarm acknowledgement with e-signatures
  • Audit trails
  • MKT Calculations
  • Graphical viewing & data trending
  • Data export in pdf format
• Touch Screen Door Access System
  • Password based access control
  • Restricts access to unauthorized persons
• Alarm Transmission
  • Mobile alert system
  • Time of alarm transmission
  • Name of equipment
  • Transmitted message(Equipment name, alarm time, type of alarm & limits)

 

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

 

 

Read more...

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

• Ethernet Communication
  • High-speed data transfer
  • Significantly faster than serial(RS-485) communication
  • Global standard for communication protocol
  • No need for a separate PC interface
  • Data Operations from any PC over the LAN
• Standby Humidity & Cooling System
  • Completely ready-to-use systems
  • Automatic switch-over upon failure of primary systems to achieve conditions
  • Switch-over also upon detection of HP/LP & Internal fault
  • Scheduled & manual change-overs
  • Recording of all change-overs in the software
• PLC-Based Control System
  • Complete Operations driven through PLC
  • No Data Loss: Data Storage of upto 1000 readings on the PLC itself
  • At an interval of 30 mins, data upto 20 days is stored on the PLC itself
  • Facility to send emails directly from the PLC
• Touch Screen Display
  • All operations through a single 4" Color touch screen display
  • PLC IP Address setting
  • Component Working Hours
  • Standby system change over
  • Password protection for set values and calibration mode
• Email Alert
  • When an alarm is triggered, an e-mail is sent to the registered PC or mobile address
  • *connection to a mail server is required to use e-mail alert.
• Complete Range of Alarms
  • Temperature & Humidity Deviations
  • Door Opening
  • Water Supply Failure
  • Component Failure
  • Mains Failure
• Documentation & Training
  • IQ, OQ, PQ
  • Calibration certificates
  • Operations & maintenance manuals
  • GA & Electrical drawings
  • Material test certificates
  • Training to end-users
• Safety
  • Temperature Overshoot/Undershoot
  • Humidity Overshoot
  • Low water-level
  • Delay Timer to safeguard the Compressor
  • MCB to cut-off over-current supply
  • Standby Controlling Sensor upon failure of Primary
  • In Walk-in chambers door can be open from inside
  • Emergency Bell switch inside the Chamber
• ICDAS Software
  • 21 CFR Part 11 Ready
  • Single software suitable for up to 20 equipment
  • Automatic daily data back-up
  • Alarm logs. Alarm acknowledgement with e-signatures
  • Audit trails
  • MKT Calculations
  • Graphical viewing & data trending
  • Data export in pdf format
• Touch Screen Door Access System
  • Password based access control
  • Restricts access to unauthorized persons
• Alarm Transmission
  • Mobile alert system
  • Time of alarm transmission
  • Name of equipment
  • Transmitted message(Equipment name, alarm time, type of alarm & limits)

 

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

 

 

Read less...

To contact Biotec Solutions about Newtronic Stability Humidity Chambers use Get a quote.