Wireless, Battery-free and Real-time Measurement
Tempris: The new freedom in lyophilization process monitoring
Tempris was developed for lyophilization in collaboration with leading pharmaceutical companies and universities in Europe and the USA. The same Tempris sensors used in laboratory scale can be used in pilot and production freeze-dryers under cGMP guidelines to obtain directly comparable data.
Experience the new freedom of wireless, battery-free and real-time measurement of product temperature Tp during the freeze-drying process. Tempris as a PAT tool provides the most important information about Tp in the freeze-drying process and thus amazing opportunities for process optimization and product quality improvement.
Technical Specifications
Characteristics of Temperature Sensors:
Wireless, battery-free and real-time measurement, unlimited data storage; measurement data is provided in real-time for storage on a connected PC or SCADA system.
Application:
Real-time monitoring of product temperature in vials, dual chamber syringes (DCS) and bulk in lyophilization / freeze-drying.
TL Sensor Series
Application | Vials 2R, 4R, 6R, 8R, 10R, 15R, 20R |
Temperature Range | Calibrated Measurement Temperature Range: -60°C to +40°C / extended: -70°C to +70°C (Permissible Ambient Temperature Range: -200°C to +140°C) |
Accuracy | Class 1: ± 0.7K / Class 2: ± 0.5K / Class 3: ± 0.3K with Calibration Certificate |
Calibration Interval | annually |
Measurement Interval | 1 sec to 600 sec, adjustable with the Tempris DataServer software |
Geometry | DxL 4.8×14 mm |
Filling Height | max. 12 mm |
Weight | 0.5 g |
Conformity | cGMP |
Sensor Housing | USP Class VI |
Sterilization, Cleaning | autoclavable; cleanable/sterilizable with general disinfectants cleaners and sterilants |
Pressure | 10-5 to 3 bar / 1 to 300 kPa |
Protection Class | IP68 |
Application | Vials 10R, 15R, 20R, 25R, 30R, 30H |
Temperature Range | Calibrated Measurement Temperature Range: -60°C to +40°C / extended: -70°C to +70°C (Permissible Ambient Temperature Range: -200°C to +140°C) |
Accuracy | Class 1: ± 0.7K / Class 2: ± 0.5K / Class 3: ± 0.3K with Calibration Certificate |
Calibration Interval | annually |
Measurement Interval | 1 sec to 600 sec, adjustable with the Tempris DataServer software |
Geometry | DxL 4.8×21 mm |
Filling Height | max. 18 mm |
Weight | 0.7 g |
Conformity | cGMP |
Sensor Housing | USP Class VI |
Sterilization, Cleaning | autoclavable; cleanable/sterilizable with general disinfectants cleaners and sterilants |
Pressure | 10-5 to 3 bar / 1 to 300 kPa |
Protection Class | IP68 |
Application | Vials 30R, 50R, 100R, 30H, 50H, 100H |
Temperature Range | Calibrated Measurement Temperature Range: -60°C to +40°C / extended: -70°C to +70°C (Permissible Ambient Temperature Range: -200°C to +140°C) |
Accuracy | Class 1: ± 0.7K / Class 2: ± 0.5K / Class 3: ± 0.3K with Calibration Certificate |
Calibration Interval | annually |
Measurement Interval | 1 sec to 600 sec, adjustable with the Tempris DataServer software |
Geometry | DxL 4.8×31 mm |
Filling Height | max. 28 mm |
Weight | 1 g |
Conformity | cGMP |
Sensor Housing | USP Class VI |
Sterilization, Cleaning | autoclavable; cleanable/sterilizable with general disinfectants cleaners and sterilants |
Pressure | 10-5 to 3 bar / 1 to 300 kPa |
Protection Class | IP68 |
Tempris Lyophilization Sensor Accessories and Consumables
The correct measuring position
Only with the exact positioning of the sensor in the vial, the measurement data becomes comparable and provides the pharmacist with valuable information throughout the freeze-drying process. With smart accessories such as PIT, CCP and S-ANT, it becomes easy to place Tempris sensors reliably and accurately at the desired position.
PIT Piercing Tool
With the piercing tool, the sensor in just a few simple steps can be combined with the stopper. The sensor is positioned together 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: |
CCP Centering Cross Piece
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The Centering Cross Piece ensures that the sensor is positioned exactly at the center bottom position of the vial. Different CCP’s are available for different vial sizes. The disposable CCP is cGMP compliant.
Vial Sizes: Customized CCP sizes on request |
S-ANT Sensor Antenna
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. |
Measurement Technology
Tempris Hardware
TLAB.scale
TLAB.transfer
Application: Lyo-cycle Scale-up / Lyo-Cycle Transfer
System Includes: |
TPRO
Application: Commercial Production
System Includes: |
TDS – TEMPRIS DataServer Software
- Tempris system configuration
- Real-time data monitoring
- Online or offline data visualization
- Data logging and log file reports
- User Administration
- Audit Trail
- Backup
- CSV Export
- Fully configurable automation interfaces to PLC, SCADA, data recorders
- Sensor Function Check
- cGMP/GAMP 5 and FDA 21 CFR Part 11 compliance