Temperature Measurement Technology

Tempris has developed a unique temperature measurement technology for use in the freeze-drying process. This wireless, battery-free, and real-time technology allows for the measurement of product temperature during the freeze-drying process. Thus temperature measurement technology provides amazing opportunities for process optimization and product quality improvement.

Below you find further information to the Tempris software and hardware.

TLM – Tempris Lyophilization Monitoring Software

The Tempris Lyophilization Monitoring Software TLM is used to control the measuring unit, record data, set all parameters, visualize and export data. TLM complies with GAMP 5 / 21CFR Part 11.

  • 40 sensors simultaneously

  • Sensor function test for robot-assisted loading

  • Visualization of the measured data

  • Sensor positioning plan (loading plan)

  • 3D representation of the sensor positions
  • Input primary packaging – size, capacity, type, etc.
  • Modern Windows design
  • Selection of different languages
Screenshot of the Tempris Lyophilization Monitoring Software (TLM)
Screenshot of the Tempris Lyophilization Monitoring Software (TLM) - Close-up

Tempris Hardware

Tempris Interrogation Unit TIRU3

The Tempris provides wireless and battery-free, long-term- and real-time product temperature measurement. The key component of our new measurement system is the control unit, which principally allows for an unlimited number of Tempris sensors.

The main features of our new product generation are:

  • Substantially higher data throughput with improved signal analysis and optional extended data analysis in the lyophilization process
  • Spectral analysis for continuous monitoring of interfering frequencies – such as WiFi and Bluetooth – and automatic switching to alternative frequencies
  • Integrated multiplexer for controlling innovative antenna systems
  • Simplified cabling through Power over Ethernet (PoE)
  • Suitable for complete automation in the SCADA / PLC with sensor identification for loading and unloading
  • Digital identification of sensors via radio signal in combination with the proven quartz sensor technology (pat. pend.) for up to 40 sensors with digital calibration
  • Support of additional frequency bands
  • Designed for ATEX application
  • Features to assist the operator
Image of the Tempris Temperature Interrogation Unit TIRU
Image of a vial with inserted wireless and battery-free Tempris sensor

Tempris Sensors

The TL sensor model, short for “Temperature measurement lyophilization,” is designed for measuring temperatures in R-vials, H-vials, and injection vials in conjunction with the original stopper. These sensors can also be applied to additional formats such as bulk vials, sealable membrane bags, or even double-chamber cartridges using suitable accessories. Up to 40 sensors can be utilized simultaneously in each run. The TL sensor model comes in five different formats based on packaging materials and filling quantities, with the primary distinguishing factor being the sensor length.

  • Containers: Vials, DCC, Lyoguard, trays, bulk
  • Fill volume (min): e.g. 2 R vial 0.3 ml
  • System Accuracy: ± 0.3 K to ± 0.7 K (standard)
  • Autoclavable: +122°C or +134°C
  • Re-useable design: approx. 50 cyles

Tempris Antenna MFA

The MFA Antenna System is a robust solution for continuous freeze-drying operations, addressing hot and cold spots to ensure compliance with design space requirements. It monitors temperature, humidity, and pressure, facilitated by TLM software. Optional features enhance sterility and prevent condensation.
In terms of performance, the system allows doubling the number of antennas per interrogation unit, improving signal illumination and sensor positioning to identify hot and cold spots accurately, and optimizing the lyophilization process.
The system’s configuration is considered during freeze dryer design, integrating it into cleaning simulations for successful cleaning validation. Materials and surfaces meet CIP/SIP standards and FDA requirements.
Lastly, the MFA Antenna System’s modular design facilitates easy commissioning, maintenance, and service.

  • Continuous Operation: Designed for uninterrupted freeze-drying in challenging conditions
  • Process Monitoring: Monitors and controls product temperature, addressing hot and cold spots
  • Environmental Sensors: Monitors temperature, humidity, and pressure for reliable operation
  • Enhanced Performance: Doubles antennas per unit, optimizing signal illumination and sensor positioning
  • Cleaning Validation: Integrated into freeze dryer design for efficient cleaning validation
  • Sterility Features: Optional sterile filter and air-drying cartridge for cleanliness
  • Modular Design: Facilitates easy commissioning, maintenance, and service
Image of the Tempris MFA-Antenna
Tempris Antenna ANT-PH1 for production freeze-dryer

Tempris Antenna ANT-PH1

The Tempris ANT-PH1 antenna is a passive module designed for cGMP-compliant freeze-drying processes in API pharmaceutical production. It is specifically recommended for flexible retrofitting in various freeze-drying chambers. All antenna components adhere to CIP/SIP standards, ensuring suitability for continuous operation.
Installation occurs within the chamber using a separate holding rod, fixed, for instance, to the CIP/SIP lance with different clamps. The Tempris team customizes the number and position of antennas based on individual chamber geometry and available flange positions.
Regulatory compliance is ensured, meeting FDA 21 CFR, GAMP 5, and 2001/95/EC (RoHS) standards. The ANT-PH1, with its related accessories, provides an adaptable antenna solution that fits a broad range of freeze dryers. The pre-assembled set includes a single antenna for CIP and SIP applications, along with an angle adapter and clamping rings suitable for a 15 mm diameter rod.

  • Number of ANT-PH1 type antennas: 2 – 8
  • ISM Frequency band: 2.4 GHz
  • Storage Temperature: 0°C … +60°C
  • Operating Temperature: -70°C … +140°C
  • Humidity (max.): < 100 % RH
  • Protection Class: IP68

Tempris Antenna ANT-P3H for Laboratory Freeze-Dryer

The Tempris ANT-P3H antenna is specifically designed for use in laboratory freeze dryers within the pharmaceutical production and development of Active Pharmaceutical Ingredients (API). It is intended for adhesive attachment to an acrylic glass door. To optimize reception quality, users can position sensors within the chamber, adjust plates for desired placement, and easily monitor sensor reception on a PC display. Horizontal and vertical displacement helps find the optimal position, and the antenna holder is then fixed accordingly. Additionally, signal strength can be enhanced by stretching aluminum foil over the acrylic door, commonly employed to reduce radiation strength. The antenna complies with regulatory requirements outlined in 2001/95/EC (RoHS).

  • Storage Temperature:0 °C … +50 °C
  • Operating Temperatur:-20 °C … +60 °C
  • Protection Class:IP43
  • Maximum applicable ANT-P3H per freeze dryer: 2 (depending on amount of sight glasses)
  • Cable Length: 1.20 m
  • Frequency: 2400-2500 MHz
  • Gain: 8 dBi
  • Horizontal Beam Width: 75 degrees
  • Vertical Beam Width: 65 degrees
  • Impedance: 50 Ohm
Tempris Antenna ANT-P3H for laboratory freeze-dryer