Temperature Sensors for Freeze Drying / Lyophilization
Tempris – Wireless, Battery-free and Real-time Temperature Monitoring System for Freeze Drying / Lyophilization
Tempris has been 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 components are cGMP and the software is GAMP 5 / 21 CFR Part 11 compliant.
Tempris sensor type TL are available for many vial types and filling. With an additional adapter the sensors can be used also in trays and/or inside closed containers (e.g. Lyoguard®, Lyocup®) and double chamber syringes.
Sensor positioning and stoppering
Antennas of the TL sensors are designed for the stoppering process. After stoppering the vials in a freeze-dryer all measurement vials with the sensor antenna will be bent but not destroyed. All sensor antennas are disposable and for single-use. Advantage: the sensors can be placed in the vial with the tip exact at the center at the bottom. It allows to following the exact freezing and drying profile in the vial during primary and secondary drying.
A major advantage of the Tempris technique is the accuracy. It will be ensured over the entire measurement chain.
TL sensors are calibrated and will be offered as follows:
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
Further temperature ranges on request.
Cleanable and sterilizable sensors
TL sensors are sterilizable with saturated steam and cleanable with peracetic acid, hydrogen peroxide, hydrogen peroxide solution, sodium hydroxide solution, isopropyl acohol.
Easily applicable in RABS / Isolators
Tempris is the world’s only sensor technology for measuring product temperature (Tp) in a vial, which 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.
High reliability of data is an important aspect for our clients in Lyphilization. Tempris DataServer (TDS) software offers the possibility to connect the system to the Freeze-Dryer PLC/SCADA system. Two options will be supported: (A) Current Loop Interface like 4 to 20 mA / 0 to 20 mA or (B) Modbus over TCP/IP (Slave or Master).