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.
TLM-3D Software
Product Temperature Visualization during Freeze-Drying
A digital twin of a freeze-drying system visualizes complex process sequences in real-time and time-lapse mode.
Tempris provides the TLM-3D software to develop solutions faster, reduce process transfer time, and maintain quality using data analysis.
Tempris uses the TLM-3D software to support customers with wireless and battery-free sensor technology to scale their processes or for approval processes.
In the future, TLM-3D software, with AI, will offer additional functions and solutions to streamline lyophilization.
Transforming a production machine into a digital twin promotes innovation. 3D data in a digital twin enables better process mapping for the scaling or transfer of lyo products. This leads to improved process optimization and the ability to switch to dynamic processes.
You can easily upgrade your current Tempris software with this application.
Take a Look into the Software
Main Benefits for
Pharmacists in formulation development, transfer or scale-up and regulatory filing
Engineers in tech transfer, MS&T, and CMC in process optimization
Key Features
Tempris will offer additional features in the future.
3D Data Visualization:
We have introduced a graphical 3D analysis tool for visualizing measurement data. This feature enables users to identify Cold and Hot Spots, providing a comprehensive understanding of temperature distribution.
Automated Logging Configuration:
Users can now configure automatic logging initiation at the start of measurements, streamlining the process and ensuring seamless data recording.
Time-Stamped User Comments:
During logging sessions, users have the ability to add time-stamped comments, providing valuable context. These comments will be reflected in both graphical representations and report outputs.
Dynamic Sensor Set Switching:
Introducing a new function that allows operators to switch between active sensor sets without accessing sensor configuration data directly. This feature enhances operational flexibility and efficiency.
Customized User Roles:
Administrators can define personalized user roles in the user management system, tailoring access to specific functions within the Temperature and Logging Management (TLM) system. This ensures a secure and customized user experience.
Improved Signal Processing:
Our updated signal processing algorithms contribute to a more stable system by minimizing temperature outliers, ensuring the accuracy and reliability of your measurements.
Enhanced Backup Log Data:
In addition to temperature data, backup log files now include diagnostic information such as the used antenna and signal strength. This comprehensive data set enhances post-analysis capabilities.
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:
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.
Tempris Antenna MFA – Our Solution for Production Freeze-Dryer
Welcome to the cutting-edge world of MFA Antenna—a revolutionary solution designed to enhance sensor signal acquisition and streamline processes. MFA, short for “Multi-Functional Antenna,” represents the pinnacle of innovation in antenna technology.
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. 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.
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.
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).
Tempris Lyophilization Sensor Accessories and Consumables
The correct measuring position
Only with the exact positioning of the sensor in the vial does the measurement data become comparable and provide the pharmacist with valuable information throughout the freeze-drying process. With innovative accessories such as the Piercing Tool (PIT), Centering Cross (CCP), and Sensor Antenna (S-ANT), it becomes easy to place Tempris sensors reliably and accurately at the desired position.
The New Piercing Tool PIT2
We are excited to announce the release of PIT2 tool, the second iteration of our innovative Piercing Tool series. The Tempris Semi-Automatic Piercing Tool PIT2 offers precise placement of the sensor antenna, accurate compatibility with standard R- and H-vials, and effortless adjustment of the distance between stopper and sensor tip based on vial size.
Tempris TL Stopper Tweezers: Revolutionizing Sterile Room Workflows
Introducing the Tempris TL Stopper Tweezers, an innovative tool designed for efficient handling of vials and Tempris sensors. Easily remove original stoppers and securely place sensor-equipped stoppers directly in the sterile room, streamlining your workflow. Crafted from high-quality PEEK and stainless steel, these robust and durable TL Stopper tweezers are fully autoclavable, ensuring top-tier hygiene and sterility. Available in three sizes to fit common stopper types, they offer maximum flexibility and adaptability. Tempris TL Stopper Tweezers optimize and accelerate your processes while adhering to strict GMP standards, making them the ideal choice for both laboratory and production environments.
See how the PIT2 and the TL Stopper Tweezers work
Piercing Tool (PIT)
With the piercing tool, the sensor, in just a few simple steps, can be combined with the stopper. The sensor is positioned with the centering crosspiece (CCP) at the bottom of the vial. For use in cGMP, the sensor is sterilized together with the stopper and CCP.
The piercing tool includes:
a) piercing needle
b) piercing cap with centering fixation
c) stopper holder 13: suitable for 2R and 4R vials
d) stopper holder 20: suitable for 6R to 100R vials
Centering Cross CCP
The Centering Cross Piece ensures that the sensor is positioned precisely at the center bottom position of the vial. Different CCPs are available for different vial sizes. The disposable CCP is cGMP compliant.
Vial Sizes:
2R | 4R
6R | 8R
10R | 20R
25R | 30R | 50R
100R
30H | 50H | 100H
GPL-1 Vol. 3.0
Customized CCP sizes on request.
Sensor Antenna S-ANT
The disposable sensor antenna is made of thin, flexible stainless spring steel and is cGMP compliant. This antenna is specifically designed to be compatible with the stoppering process.
