Technical Specifications of the Tempris Sensors
Here you find the technical specifications for Tempris Sensors – characteristics, application, sizes, compliance and technical details.
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.
Sensors are sterilizable and cleanable.
Application
Real-time monitoring of product temperature in vials, dual chamber syringes (DCS) and bulk in lyophilization / freeze-drying.
Sizes
The TL sensor model is available in five different formats. These are based on packaging materials and filling quantities. The main distinguishing feature is the sensor length. For optimum signal transmission, the sensor antenna must always be positioned outside the liquid. Sensor antenna and sensor centering cross are required for the measurement process in the vial.
Compliance
The sensors with accessories that come into contact with the product meet the following regulatory requirements: FDA compliant, GAMP 5, 2001/95/EC (RoHS).
Amount
Laboratory FD typically 8 per batch.
Production up to 40 per batch.
Sensor Series
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 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.
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.