Temperature Sensors for Freeze Drying / Lyophilization
Tempris – Wireless, Battery-free and Real-time Temperature Monitoring System for Freeze Drying / Lyophilization
The Tempris Lyophilization system and components are designed for freeze-drying applications ranging from laboratory FDs to production FDs with API in a sterile environment for real-time product temperature monitoring. All Tempris measurement system components are cGMP, GAMP 5 and FDA 21 CFR Part 11 compliant.
Tempris Lyophilization (TL) sensors are available for different vial types and fill media. Adapters are available for positioning the Tempris sensors in double chamber syringes or in trays and/or inside closed containers such as Lyoguard® or Lyocup®.
Sensor Positioning and Stoppering
The Tempris sensor is positioned inside the vials with the help of a disposable sensor antenna and a Centering Cross Piece. The sensor antenna feeds through the vial stopper and can be vertically adjusted to position and hold the sensor at a defined vertical position. The centering cross piece ensures that the sensor is horizontally center-positioned in the vial. Thus the Tempris sensors can be reliably positioned inside the vial with the sensor measuring tip exactly at the center bottom of the vial.
Tempris sensor antennae are made of thin, flexible stainless spring steel. This ensures that the sensor antennae is smoothly bent rather than destroyed during and that the sensor is protected from being damaged during the stoppering process.
Tempris Lyophilization are offered 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 above temperature range down to -70°C and up to +60°C or +70°C are available on request.
It is worth noting that Tempris sensor accuracies are not only specified for the complete Tempris measurement system component chain but also over the full temperature range.
Cleaning and Sterilization
Tempris Lyophilization sensors are sterilizable with saturated steam and cleanable with peracetic acid, hydrogen peroxide, hydrogen peroxide solution, sodium hydroxide solution, isopropyl acohol.
Suitable for use in RABS / Isolator
Tempris is the world’s only sensor technology that measures product temperature (Tp) in a vial, which consequently can be introduced into the sterile filling area (Isolator and RABS). Transfer of pre-sterilized sensors via Rapid Transfer Port (RTP) system in the freeze dryer isolator Tempris helps to enhance the effectiveness and reliability of existing freeze-drying technology. The software offers a loading map to place sensors exact on Hot and Cold Spots inside the chamber.
Automation Interface to PLC/SCADA
High reliability of data is an important aspect for our clients in lyophilization. Tempris DataServer (TDS) software provides an Automation interface option for connecting the Tempris system to the PLC/SCADA system of your freeze-dryer installation. Tempris Automation option gives you the choice between 4 to 20mA or 0-20mA Current Loop Interface and a Modbus over TCP/IP (Slave or Master) interface.