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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.

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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

E-MAIL 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 & maintanance 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 upto 20 equipments
  • 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)

Business Sectors

PHARMACEUTICALS

BIOTECHNOLOGY

COSMETICS

FOOD AND BEVERAGES

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
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
Observation window - 300 x 300 mm 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
Flooring of Linoleum carpet Safety devices: Low & High temperature cut-off settable thermostats & high humidity cut-off device
Forced air circulation for uniform temperature Audio/Visual alarms for deviations
Non Condensing steam injection type humidity system with standby heater & auto switch overs Complete with IQ, OQ, PQ & Operations & Maintenance Manual
CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser

Power supply: 230/415 volts 50 Hz main supply. Also available with 60 Hz Cycle.
ICDAS - A Common Software suitable for 20 nos. Newtronic make equipments 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 equipments
Exterior & Interior is of stainless steel
(SS 304)		 Capacity CuFt Capacity Liter Internal Size
(H*W*D )mm		 External Size
(H*W*D) mm		 Trays Qty. Tray size mm Approx. Weight kg Eqip Approx. Weight kg Ship
NLHC7SI 7 200 800 x 500 x 500 1350 x 630 x 945 3 430x460 150 225
NLHC16SI 16 430 1200 x 600 x 600 1795 x 630 x 945 4 530x560 250 325
NLHC26SI 26 735 1500 x 700 x 700 2050 x 895 x 1205 5 630x660 275 350
NLHC34SI 34 1000 1500 x 800 x 800 2095 x 930 x 1295 5 730x760 350 425
NLHC54SI 54 1500 1500 x 1600 x 600 2095 x 1760 x 1095 10 710x560 350 450
NLHC71SI 71 2000 1500 x 1600 x 800 2095 x 1760 x 1095 10 710x560 375 475

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