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
Sensor TL6
| Application | Double Chamber Syringes (DCS) and Vials with very low fill volume <1ml |
| 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 3.5×12 mm |
| Filling Height | max. 6 mm |
| Weight | 0.3 g |
| Conformity | cGMP |
| Sensor Housing | USP Class VI |
| Sterilization, Cleaning | saturated steam, general disinfectants cleaners and sterilants |
| Pressure | 10-5 to 3 bar / 1 to 300 kPa |
| Protection Class | IP68 |
Sensor TL12
| 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 |
Sensor TL18
| 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 |
Sensor TL28
| 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
 |
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
 |
Application: Laboratory Freeze Dryers with Acrylic Plastic Door
System Includes: |
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
configure and activate up to 16 sensors
upload and manage sensor calibration coefficient files
sensor parameter query
sensor-specific measurement range selection
measurement time interval; selection 1 to 600 sec
save or select system configurations
signal strength display option
antenna multiplexing display option
Text View screenshot/printout
sensors to be displayed can be selected
show second trace option for signal-to-noise ratio S/N or antenna selection display
temperature data in Celcius, Fahrenheit or Kelvin
absolute or relative time axis
data point query functions with tooltip data display
zoom and pan functions
plot colors, point styles and line modes/widths selectable
Graphic View screenshot/printout
Log file data authenticity and data integrity secured with encrypted data section checksums, log files protected against manipulation
Online log file processing and log file load function for offline log file processing
Log file reports with user identification and complete system configuration information
Log file report template system with support for up to 10 user-defined data fields
output channel selection
output time zone selection
start and end time selection
output time grid option
Modbus Master (Client) or Modbus Slave (Server) mode
Modbus IP address selection
up to 16 value outputs (Modbus Holding Registers)
up to 16 status outputs (Modbus Coils)
float temperature, float current, 4-20 mA or 0-20 mA value output support
Tmin/Tmax temperature scaling for 4-20 mA or 0-20 mA output
Automation value and status output monitor
up to 4 user levels with granular access rights
unique user names with secure passwords
add or delete users
change/set user passwords
change user group
disable user account option
secure audit trail format
save audit trail actions with UTC time stamp, user name and additional process information
audit trail start/stop date filter
audit trail quick filters for today, this week, and last week
audit trail print preview, page setup and printout functions
secure backup log file format according to FDA 21 CFR Part 11
backup log file format specified for optimized backup media usage
backup log management with functions for listing, downloading and deleting backup logs
secure eject backup media function
backup media free space monitor
automatic backup restart after power failure
sensors checked together, in groups or one-by-one
sensor function check log file generation
sensor function check report output
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