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PharmaPort® 360 FEATURES
Precise 5°C Temperature Control
The PharmaPort® 360 safely maintains internal temperature of 5°C in extreme ambients from 60°C to -40°C and in two modes.
Energy Efficient, Internally Powered in Transport
The PharmaPort® 360 is energy efficient and operates with minimal environmental impact. It maintains internal temperature control and uniformity throughout the chamber over specified hold times and ambient conditions.
- Recharge Mode: When connected to an AC power supply the container functions as a high-performance laboratory refrigerator
- Transport Mode: While operating on internal power the container maintains setpoint temperature for extended hold times of >72 hours @ 30°C, and >100 hours @ 23°C ambient
- Brushless DC fan and compressor motors consume minimal power and offer exceptional reliability over conventional motors
- During transport mode refrigeration compressors are inactive; the regenerative cooling and heating system consumes no external energy and generates no external heat, noise or vapor
- OQ and PQ documentation is available
The PharmaPort® 360 features many redundant systems to protect valuable cargo and significantly reduce the possibility of a temperature excursion in the event that any single system should fail:
Advanced Remote Monitoring and Data Logging
- Two individual refrigeration systems for charging the cooling plate, and maintaining temperature in charging mode
- Two individual heating coils charging the warm plate
- Six ducting fans: two for cooling, two for heating, two for circulation
- Two door latches
- Dual gasket for door seal
The GPS Tracking and GSM Monitoring systems permit 24/7 retrieval, analysis and sharing of system information such as global location, internal and external temperatures, temperature conditioning capacity, and deviations from set point. The PharmaPort® 360’s Pro-Tectic® technology system works together with the remote monitoring to communicate alarm information more than 6 hours before a potential temperature deviation.
Temperature data is independently acquired by the Elpro Libero® data logging system to comply with FDA 21 CFR 11 criteria for incorruptible recording for verification.
- Supports compliance with World Health Organization (WHO) standard Status Alarm/OK, and MKT (mean kinetic temperature)
- User programmable five temperature zones (recommended PDA-39-ICH guideline)
- PDF/A (ISO 19005-1) provides a mechanism for representing visual appearance of electronic documents over time, independent of the systems used to create, store or render such files
- USB compatible; no software required. The PDF/A is automatically generated when the Libero® data logger is inserted into any PC USB port