GermanyTemprisTechnical Exchange on Robot Fully Automatic Loading System

1 Brand and Product Overview

Tempris GmbHIt is a German company specializing in process measurement technology. Its core business is to provide innovative temperature monitoring and process control solutions for industries such as pharmaceuticals and biotechnology. The company's main technical route is to develop wireless, passive sensor systems to achieve non-invasive, real-time monitoring of key process parameters such as temperature.

TemprisThe product line revolves around its core wireless temperature measurement technology, with the main products including:

Ø Wireless temperature sensor: The sensing unit of the system, placed inside the product to directly measure temperature.

Ø Sensor antenna: installed inside process equipment (such as freeze-drying machines), used to power sensors and wirelessly transmit data.

Ø Temperature inquiry unit: the data processing center of the system, connected to the antenna and managing the sensor network.

Ø Real time monitoring software: provides visualization, recording, and analysis functions for process data.

Ø Centering cross and sensor bracket: used to ensure the fixed position of the sensor in containers such as medicine bottles.

Ø Puncture tool: used to place sensors into sealed containers under sterile conditions.

Ø Sensor calibration equipment: used for regularly verifying the accuracy of sensors.

Ø Data interface module: used to integrate system data into the upper layerSCADAorMESSystem.

Ø Robot fully automatic loading system: realizing the automation and aseptic loading of sensor carriers.

Ø Process validation service package: provides relevant installation, operation, and performance confirmation support.

II Product Model and Technical Parameters

TemprisThe product models are mainly divided according to their sensor size and applicable container specifications to adapt to different application scenarios. The following are its main model series:

Ø TL10Type sensor: suitable for sample bottles or micro containers with extremely small capacities.

Ø TL12Type sensor: designed for2Rto20RSpecification of penicillin bottles, covering common small volume preparations.

Ø TL18Type sensor: suitable for10Rto30HSpecification of penicillin bottles, used for medium capacity products.

Ø TL28Type sensor: suitable for30Rto100HWaiting for larger specification penicillin bottles for large capacity freeze-dried products.

Ø TL30Type sensor: specially elongated design, suitable for measuring products with high filling height.

Ø TSHSeries bracket: matched with the above sensors to ensure their geometric center positioning in the bottle.

Ø TIU-2Type inquiry unit: Standard temperature inquiry and communication control unit.

Ø Ant-4Type antenna array: an antenna system used for multi-point measurement scenarios such as freeze-drying machines.

Ø ALR-100Type Robot Loading Unit: Integrated into Isolators orRABSThe automated loading robot module inside.

Ø Tempris VisionSoftware Suite: Professional software used for data management and process analysis.

Introduction to Robot Fully Automatic Loading System:

This system is an electromechanical integrated unit that combines industrial robots, machine vision, and specialized fixtures. It is designed for use inAutomatically complete the implantation in a clean environment (such as an isolator)TemprisThe entire process of the sensor's penicillin bottle being accurately grasped from the conveyor belt and placed on the predetermined position of the freeze-drying machine shelf.

Working Principle:

Ø Identification and positioning: The system uses visual cameras to identify rows of penicillin bottles on the conveyor belt and the sensors on each bottle bodyIDThe code.

Ø Path planning: The control software plans the grasping and placement path for the robot based on the predefined freeze-drying machine loading diagram (corresponding to key process temperature measurement points).

Ø Aseptic gripping: The robot uses specially designed sterile grippers to gently grip the bottle body.

Ø Precise placement: The robot transports the bottle to the freeze-drying machine and places it on the designated coordinates of the shelf with millimeter level accuracy according to software instructions.

Ø Data association: The entire process involves physical bottle positioning and bottle sensorsIDReal time binding with process data to achieve full traceability.

Main technical parameter considerations:

Ø Cleanliness level: The overall design complies withGMPrightThe requirements for clean area equipment include materials that are easy to clean and sterilize (such asVHP）.

Ø Positioning accuracy: The repeated positioning accuracy of robots can usually reach±0.1mmEnsure accurate placement within.

Ø Compatibility: Supports communication and mechanical docking with mainstream brand freeze dryers, isolators, and upstream filling lines.

Ø Processing speed: It can be configured according to the production pace to meet different speed requirements from research and development to commercial production.

Ø Regulatory compliance: System design followsGAMP 5Standardized, supporting electronic signatures and data integrity (compliant)FDA 21 CFR Part 11Requirement).

III Core Features

Ø Improving the level of sterile assurance: By replacing manual box entry operations, the risk of contamination caused by personnel intervention in this process has been eliminated, and its design concept is closely aligned with the European UnionGMPAppendix1Waiting for regulatory guidance on aseptic processes.

Ø Enhance the reliability of process data: Automated loading ensures that physical temperature measurement points are consistent with preset values during each operationThe consistent loading diagram eliminates human placement deviation, making temperature data between different batches comparable and providing a reliable basis for process validation and continuous process confirmation.

Ø Digitization and traceability of production processes: from sensorsIDThe bottle position coordinates are automatically associated and recorded with real-time temperature data, realizing the evolution of freeze-drying process from "parameter monitoring" to "full process digital mapping", which facilitates in-depth batch analysis and fault diagnosis.

Ø Improve operational efficiency and flexibility: The robot can work continuously and stably, with a constant and optimizable loading speed, reducing the preparation time during the feeding stage of the freeze dryer. When changing product batches, simply switch the loading diagram in the software to quickly complete the setup.

4 application field

This system is mainly aimed at manufacturing scenarios with high requirements for sterility and data integrity:

Ø Production of sterile injection freeze-drying: especially for highly active tumor drugs and antibody conjugated drugs（ADC）Wait, it is necessary to reduce personnel contact and ensure sterile varieties.

Ø Vaccine manufacturing: In the freeze-drying process of vaccine raw material filling, the use of automated loading can reduce the risk of contamination and ensure vaccine safety.

Ø Cell and gene therapy products: Although the production scale of these high-value, personalized therapy products may be small, they require high levels of sterility and prevention of cross contamination. Automated and enclosed production units are the development direction.

Ø Development and scaling up of cutting-edge biopharmaceutical processes: By using them during the research and development phase, consistent and reliable process data can be obtained, aiding in process understanding and smooth transition to production scale.

Ø Process research requiring high-precision thermodynamic data: for establishing product freeze-drying models or design spaces（Design Space）Ensuring the precise and controllable location of temperature measurement points is a prerequisite for obtaining effective data in research.