Wireless and battery-free with real-time data measuring system for Freeze Drying – Lyophilization
The Tempris sensor arrangement and parts are designed for freeze-drying/lyophilization. Utilization scale from laboratory FDs to production FDs with API in a sterile environment for real-time product temperature monitoring.
All Tempris analysis system segments are cGMP, GAMP 5, and FDA 21 CFR Part 11 compliant.
Tempris Lyophilization (TL) sensors are ready for various vial types and fill volumes. You can also get adapters to place your sensors in double chamber syringes or trays. Furthermore, you can use these adapters inside closed vials such as Lyoguard® or Lyocup®.
Sensor Positioning and Stoppering
Placing the sensors inside the vials is simple. There are a disposable sensor antenna and a centering cross piece that come in a set.
Firstly, the antenna supports through the vial stopper. Next, one can set the position to hold the sensor at a specified vertical position. The centering cross piece ensures that the sensor is horizontally center-positioned in the vial. Thus assuring the sensor checking tip is precisely at the center bottom of the vial.
Tempris sensor antennas are composed of thin and flexible stainless spring steel. Therefore it is smoothly bent rather than damaged during the process. It also shields the sensors from losses during the stoppering process.
Sensor Accuracy
The Tempris lyophilization comes with calibration certificates for the following accuracies and temperature ranges:
- Class 1: ± 0.7K @-60°C to +40°C
- Class 2: ± 0.5K @-60°C to +40°C
- Class 3: ± 0.3K @-60°C to +40°C
Extensions to the higher temperature range below -70°C and up to +60°C or +70°C are possible on request.
It is worth seeing that Tempris sensor precision is specified for the entire Tempris measurement system element chain and on the whole temperature range.
Disinfection and Sterilization
You can clean and sterilize the Tempris sensor for Freeze Drying / Lyophilization with saturated steam and clean them with peracetic acid, hydrogen peroxide, hydrogen peroxide solution, sodium hydroxide solution isopropyl alcohol.
Fit for use in RABS / Isolator
Tempris is the world’s only sensor technology that maps product temperature (Tp) in a vial. Moreover, you can add it to the sterile filling area (Isolator and RABS).
Transfer of pre-sterilized sensors via Rapid Transfer Port (RTP) system in the freeze dryer isolator Tempris improves the effectiveness and safety of existing freeze-drying technology. Additionally, the software allows a loading map to place sensors exact on Hot and Cold Spots inside the chamber.
Computerization Interface to PLC/SCADA
High reliability of data is a fundamental aspect for our customers in lyophilization. Tempris DataServer (TDS) software gives an Automation interface choice for connecting the Tempris system to the PLC/SCADA system of your freeze-dryer installation. Tempris Automation option provides you a selection between 4 to 20mA or 0-20mA Current Loop Interface and a Modbus over TCP/IP (Slave or Master) interface.
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