Obtained two official patents in the United States and Europe
We are very pleased to announce that Hongke’s LyoPro freeze-drying dedicated temperature verifier has received two official patents in the United States and Europe , solidifying its position as the only solution of its kind on the market. The patents related to the LyoPro temperature recorder are US11340015B2 and EP3742095B1 . The former was authorized on May 24, 2022, and became effective in the United States; the latter was authorized on June 7, 2023, and became effective in Europe. A second patent for the stop clip device is still pending in the US and Europe (US2020/0101188A1 and EP3948128A1). These patents protect and endorse the unique functionality and effectiveness of LyoPro, so you can rely on its superior performance .
In the biopharmaceutical industry, the freeze-drying process is becoming more and more important, and the integrity of the test data of each vial is critical. It carries life-saving pharmaceutical qualities and enormous economic value. We understand the importance of accuracy in this field, and with LyoPro Temperature Validator, you can effortlessly obtain consistent, accurate and repeatable results.
Our goal is to provide pharmaceutical manufacturers with solutions that ensure the smooth implementation of the freeze-drying process and meet compliance requirements , so that you can focus on the research and development and production of drugs that treat diseases and improve the quality of life.
Hongke LyoPro Advantages
① Does not affect the input and output of the freeze-drying machine: wireless real-time transmission, no human operation risk, no need to open the RTD valve; (It has been tested on the freeze-drying machines of Tofflon, Chutian, and Aoxing, confirming that the signal transmission is smooth)
Wireless real-time transmission, built-in storage function, no data loss
② Does not affect the neat discharge of vials: the special recorder shape and base design (similar to vials) perfectly fit the dimensions of the vials when the freeze-drying push rod is automatically put in and out of the box, and is suitable for 2R-100R vials
The bottle-shaped shape design ensures that the vials are arranged neatly, adapts to vials of different specifications, and accurately measures the temperature of certain points in the vials
③ Accurately record and analyze the temperature between the product and the plate layer: The temperature of the vial, product and plate layer can be measured simultaneously. The test probe tip is very small and does not affect the temperature of the product itself. The advanced stage verification report can conduct detailed product and plate Layer temperature gap analysis.
Measure product temperature
Measure board temperature
Application of Hongke LyoPro
① R&D and trial production: It may be in the same location, or it may be in a completely different location/country, or even outsourced. Ply and product temperatures need to be verified for small batches.
②Technology transfer stage and initial IQ/OQ/PQ: Verify board layer and product temperature.
③Periodic re-validation: Usually only the board temperature is verified, and most of LyoPro's sales are verified for normal board temperature.
④ Troubleshooting of product quality problems: Possible design changes in freeze-drying technology, raw materials, vials, any changes, verification of plate layer and product temperature may be required.
⑤Batch control: This is a new additional application of Ellab and LyoPro, which may have risk compliance issues. LyoPro can be used to design/optimize batch control and place a certain number of recorders in each batch.
Hongke-Environmental Monitoring
Hongke Environmental Monitoring Division is the industry's leading solution partner in the field of environmental monitoring and temperature verification of the pharmaceutical supply chain. It cooperates with Swiss ELPRO and Danish ELLAB, which represent the world's top level and high-end quality, to provide users with comprehensive monitoring of all aspects of the pharmaceutical supply chain. Environmental monitoring solutions, temperature and humidity loggers, verification systems and calibration systems, and other related services .
As a professional environmental monitoring and temperature verification solution provider , we will help you:
● Improve verification work efficiency, reduce costs, improve sterilization and freeze-drying processes, and improve design process
● Provide professional customer support plan, including technical support, IQ/OQ service, GxP service, on-site and factory calibration, etc.
● Realize environmental monitoring of the entire life cycle of drugs, effective management of data information, ensure compliance with drug transportation and storage, and provide safe drugs to patients.
Once you start applying Hongke's environmental monitoring and temperature verification solutions, our team will provide a series of professional services and support with rich industry experience and regulatory knowledge, and provide you with products with reliable quality and stable operation for your verification and monitoring journey. Protect and protect.