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.

tempris-vial-english

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 TL06

Tempris Temperature Sensor TL06 for Lyophilization

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

Tempris Temperature 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

Tempris Temperature 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

Tempris Temperature 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

TX Sensor Series
for aceton and alcohol


Sensor TX18

Tempris Temperature Sensor TX18
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 3.8×21 mm
Filling Height max. 18 mm
Weight 0.7 g
Conformity cGMP
Sensor Housing Stainless Steel
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 TX28

Tempris Temperature Sensor TX28
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 3.8×31 mm
Filling Height max. 28 mm
Weight 1.0 g
Conformity cGMP
Sensor Housing Stainless Steel
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

Tempris 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 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:
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

CCP Centering Cross Piece

Tempris Sensor - Centered in Vial with Centring Cross Piece (CCP) 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:
2R | 4R
6R | 8R
10R | 20R
25R | 30R | 50R
100R
30H | 50H | 100H
GPL-1 Vol. 3.0

Customized CCP sizes on request

S-ANT Sensor Antenna

Tempris 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

Tempris Measurement Technology - TLAB.scale Application: Laboratory Freeze Dryers with Acrylic Plastic Door

System Includes:
Four sensors with calibration certificates, TDS software for real-time data monitoring, antenna for acrylic door, accessories, installation guide and operating manual. For data visualization, a PC or Laptop (Windows 7 or Windows 8) is required. Simple and quick to operate.

TLAB.transfer

Tempris Measurement Technology - TLAB.transfer Application: Lyo-cycle Scale-up / Lyo-Cycle Transfer

System Includes:
Up to 16 sensors with calibration certificates, external or internal antennae (CIP/SIP), accessories, TDS software, operating manual and installation guide. The measurement data is stored in real-time on the TLAB.transfer unit. The measurement system is mounted with a few simple steps and immediately ready to use.
Options: Compliance with GAMP 5 and FDA 21 CFR Part 11, IQ/OQ documentation, engineering support for system adaptation (URS) and installation, training.

TPRO

Tempris Measurement Technology - TPRO Application: Commercial Production

System Includes:
Up to 16 sensors with calibration certificates, CIP/SIP antenna kit with antenna multiplexer, accessories, PLC/SCADA interface for automation, GAMP 5 and FDA 21 CFR Part 11 compliance, TDS software, operating manual and installation guide, IQ/OQ documentation, engineering support for system adaptation (URS) and installation, sensor handling solutions at RABS/Isolator via RTP, automated loading/unloading, training, etc.
The measurement data is stored directly on the TIRU radio interrogation unit and on the PLC/SCADA computer in real-time.
Optional: Maintenance and calibration service agreement, PQ support for HCS definition.

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
Tempris system configuration
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
TEMPRIS DataServer - Config View
real-time temperature measurement value display temperature value display in Celcius, Fahrenheit or Kelvin
signal strength display option
antenna multiplexing display option
Text View screenshot/printout
TEMPRIS DataServer - Text View
real-time and offline graphical measurement data display
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
TEMPRIS DataServer - Graphic View
Tempris log files compliant with FDA 21 CFR Part 11:
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
TEMPRIS DataServer - Log File
Tempris measurement data export for further processing in spreadsheet applications such as Microsoft Excel.
output channel selection
output time zone selection
start and end time selection
output time grid option
TEMPRIS DataServer - CSV Export
fully configurable automation interface for Modbus TCP communication with PLC (Allen Bradley, Siemens SPS, Opto 22, etc.), SCADA systems and data recorders (Yokogawa, Eurotherm, etc.)
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
TEMPRIS DataServer - Automation Interface
User Management according to GAMP 5
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
TEMPRIS DataServer - User Administration
Audit Trail option according to GAMP 5 requirements
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
TEMPRIS DataServer - Audit Trail
Redundant data backup option according to GAMP 5 requirements
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
TEMPRIS DataServer - Measurement Data Backup
validate correct sensor operation prior to measurement run
sensors checked together, in groups or one-by-one
sensor function check log file generation
sensor function check report output
TEMPRIS DataServer - Sensor Function Check

Image Gallery

cGMP-compliant implementation of Tempris sensors in a commercial production lyophilizer
cGMP-compliant implementation of Tempris sensors in a commercial production lyophilizer
Replacement of original stoppers of filled vials with stoppers equipped with sterilized Tempris sensors
Replacement of original stoppers of filled vials with stoppers equipped with sterilized Tempris sensors
Vials with Tempris sensors are ready to move from loading lines onto the fully automated transfer cart
Vials with Tempris sensors are ready to move from loading lines onto the fully automated transfer cart
Positioning of Tempris sensors on the transfer cart as per the predefined loading plan
Positioning of Tempris sensors on the transfer cart as per the predefined loading plan.
Transfer of filled vials (along with Tempris sensor vials) onto the shelves of the lyophilizer
Transfer of filled vials (along with Tempris sensor vials) onto the shelves of the lyophilizer