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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.
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.
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.
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.
IQ, OQ, PQ, Calibration certificates, Operations & maintenance manuals, GA & Electrical drawings, Material test certificates, Training to end-users.
Temperature & Humidity Deviations, Door Opening, Component Failure, Mains Failure.
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.
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.
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 system, Time of Alarm transmission, Name of Equipment, Transmitted Message (Equipment Name, Alarm time, Type of Alarm & Limits).
| Temperature Range | -20°C to 50°C |
| Double walled with PUF insulation | SS304 Interior & Exterior of Mild Steel |
| Stainless Steel trays | Metal door with gasket & lock on the outside |
| Forced air circulation for uniform temperature | PU wheels for easy movement |
| U shaped SS tubular heaters | 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 | 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 & Operational Manual | |
Power Supply: 230 volts 50 Hz main supply. Also available with 60 Hz Cycle.
| ICDAS - A Single Software installation for all Newtronic make equipments | Door Access system (Numeric or Biometric) |
| Remote alarm system suitable for upto 4 nos. Newtronic make equipments | Mobile Alert System |
| Model | Capacity | Internal Size | External Size | Trays Qty. | Trays Size | |
|---|---|---|---|---|---|---|
| CuFt. | Liter | (H*W*D) mm | (H*W*D) mm | (W*D) mm | ||
| NLFT7MI | 7 | 200 | 510 x 560 x 700 | 1500 x 720 x 880 | 2 | 540 x 605 |
| NLFT11MI | 11 | 300 | 910 x 560 x 590 | 1955 x 720 x 770 | 3 | 540 x 495 |
| NLFT14MI | 14 | 400 | 910 x 560 x 785 | 1955 x 720 x 965 | 3 | 540 x 690 |
| NLFT25MI | 25 | 700 | 1200 x 800 x 730 | 2120 x 960 x 1020 | 4 | 780 x 635 |
| NLFT34MI | 34 | 1050 | 1200 x 1200 x 730 | 2110 x 1360 x 1020 | 8 | 515 x 635 |
| NLFT54MI | 54 | 1500 | 1200 x 1500 x 830 | 2110 x 1660 x 1120 | 8 | 660 x 735 |
For all your industrial chamber needs or to explore collaboration opportunities, don’t hesitate to reach out. We’re here to assist you in any way we can.
