Freeze Thaw Chambers

Freeze Thaw or Cyclic Temperature stress tests are designed on the knowledge of the product so as to mimic likely storage conditions.

The period of cycle is mostly considered 24 hours since the diurnal rhythm on earth is 24 hours.

Additionally, the distribution environment can vary greatly, especially when a drug product is shipped between various climatic zones. Seasonal changes, mode of transportation, and the number of drop-off points are also variables that should be considered within the pharmaceutical supply chain. Drug products requiring controlled-temperature storage conditions must be distributed in a manner that ensures that the product quality will not be adversely affected. With the exception of short transit times within the same climatic zone, it is virtually impossible to validate a shipping method against all environmental conditions.

Therefore, distribution stability studies are designed to generate additional data to complement preformulation development and routine (ICH) Q1A(R2).

NEWTRONIC Freeze Thaw Chambers control a broad temperature range of -20 °C to 50 °C thereby offering the flexibility to simulate a broad range of conditions. The min temperature, max temperature & cyclic time are all user-settlable thereby allowing the user to program a specific profile for their studies. Automatic cycling between the setpoints enables rapid simulation of conditions & the need to replicate freezing and thawing during product testing.

Features

ETHERNET COMMUNICATION

Offers high-speed data transfer, surpassing serial (RS-485) communication, and adheres to a global standard for communication protocol, enabling data operations from any PC over the LAN without requiring a separate PC interface.

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 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.

Documentation & Training

IQ, OQ, PQ, Calibration certificates, Operations & maintenance manuals, GA & Electrical drawings, Material test certificates, Training to end-users.

Complete Range of Alarm

Temperature & Humidity Deviations, Door Opening, Component Failure, Mains Failure.

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.

Safety

Temperature Overshoot/Undershoot, Delay Timer to safeguard the Compressor, MCB to cut-off over-current supply, Standby Controlling Sensor upon failure of Primary, Emergency Bell switch inside the Chamber,

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.

Mobile Alert

Mobile Alert system, Time of Alarm transmission, Name of Equipment, Transmitted Message (Equipment Name, Alarm time, Type of Alarm & Limits)

Business Sector

Pharmaceuticals

Biotechnology

Cosmetics

Food & Beverages

Features
Temperature Range -20°C to 50°C
Double walled with PUF insulation SS304 Interior & Exterior of Mild Steel
Metal door with gasket & lock on the outside Forced air circulation for uniform temperature
Stainless Steel trays PU wheels for easy movement
CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser Complete Operations driven through PLC with data logging capacity of upto 1000 readings
U shaped SS tubular heaters High speed Ethernet based communication
All operations through a single 7″ Color Touch Screen High-quality PT-100 Temperature sensor
Safety devices: High Temperature cut-off settable thermostats Audio/Visual alarms for deviations
Complete with DQ, IQ, OQ, PQ & SOP & Maintenance Manual
ICDAS – a Single software installation for all Newtronic make equipments Door Access system (Numeric or Biometric)
Remote alarm system suitable for 4 nos. Newtronic make equipments Mobile Access system
ModelCapacity – CuFt.Capacity – LitresInternal Size – (HxWxD) mmExternal Size – (HxWxD) mmTrays Qty. Tray Size – (WxD) mmApprox. Weight – Eqip. KgApprox. Weight – Ship. Kg
NLFT7MI 7 200 510 x 560 x 700 1500 x 720 x 880 2 540 x 605 175 250
NLFT11MI 11 300 910 x 560 x 590 1955 x 720 x 770 3 540 x 495 225 300
NLFT14MI 14 400 910 x 560 x 785 1955 x 720 x 965 3 540 x 690 275 350
NLFT25MI 25 700 1200 x 800 x 730 2120 x 960 x 960 4 780 x 635 300 375
NLFT34MI 34 1050 1200 x 1200 x 730 2110 x 1360 x 1020 8 515 x 635 325 515
NLFT54MI 54 1500 1200 x 1500 x 830 2110 x 1660 x 1120 8 660 x 735 350 660
Temperature Range 20°C to 60°C
Temperature Accuracy ± 0.5°C
Temperature Uniformity ± 1°C
Humidity Range 40% RH to 95% RH
Humidity Accuracy ± 2% RH
Humidity Uniformity ± 3% RH
Double walled with PUF insulation. Stainless Steel trays
SS 304 Interior & Exterior either SS 304 or Mild Steel Full-length inner glass door & metal door with gasket & lock on the outside
Internal LED lights Forced air circulation for uniform temperature
PU wheels for easy movement U-shaped SS tubular heaters
Non condensing steam injection type humidity system with standby heater & auto switch overs CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser
Stand by humidity system with booster humidification Complete Operations driven through PLC with data logging capacity of upto 1000 readings
High speed Ethernet based communication All operations through a single 7″ Color Touch Screen
High quality imported make T/Rh combo sensor with 4-20 mA output Safety devices: Low & high temperature cut-off settable thermostats
Audio/Visual alarms for deviations Complete with DQ, IQ, OQ, PQ & SOP & Maintenance Manual
ICDAS – A Common Software suitable for 20 nos. Newtronic make equipments Door Access system (Numeric or Biometric)
4pt. Temperature & Humidity Scanner Mobile Alert system
Stand by Cooling System with auto switch overs (430 litre & above) Remote alarm system suitable for 4 nos. Newtronic make equipments
ModelCapacity – CuFt.Capacity – LitresInternal Size – (HxWxD) mmExternal Size – (HxWxD) mmTrays Qty.Tray Size – (WxD) mmApprox. Weight – Eqip. KgApprox. Weight – Ship. Kg
NLHC7SI 7 200 800 x 500 x 500 1315 x 660 x 985 3 430 x 460 150 225
NLHC16SI 16 430 1200 x 600 x 600 1715 x 760 x 1155 4 530 x 560 250 325
NLHC26SI 26 735 1500 x 700 x 700 2070 x 860 x 1255 5 630 x 660 275 350
NLHC34SI 34 1000 1500 x 800 x 800 2070 x 960 x 1355 5 730 x 760 350 425
NLHC54SI 54 1500 1500 x 1600 x 600 2070 x 1760 x 1155 10 695 x 560 350 450
NLHC71SI 71 2000 1500 x 1600 x 800 2070 x 1760 x 1355 10 695 x 760 375 475
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