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 TL12

Wireless and battery-free Tempris sensor TL-12 fpr lyophilization
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

Wireless and battery-free Tempris sensor TL-18 fpr lyophilization
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

Wireless and battery-free Tempris TL-28 sensor for lyophilisation
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

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.