宏虹案例|ELPRO 數位化溫控監測系統,協助頂級醫學中心確保 CAR-T 細胞治療全流程合規
一、引言:生技冷鏈監測的合規關鍵挑戰 在生物醫藥產業中,血液製品、幹細胞與 CAR-T 細胞的保存與運輸,一直被視為高度關鍵的「精密冷鏈工程」。這不僅意味著必須長時間維持 -30°C 至 -80°C …
一、引言:生技冷鏈監測的合規關鍵挑戰 在生物醫藥產業中,血液製品、幹細胞與 CAR-T 細胞的保存與運輸,一直被視為高度關鍵的「精密冷鏈工程」。這不僅意味著必須長時間維持 -30°C 至 -80°C …
一、專案背景:從14台冰箱開始的轉型:生醫溫控管理為何需要升級? 這家位於新北市的生醫公司,多年來致力於細胞治療用細胞培養基的開發與量產,在臨床等級製程的高度規範下,溫控管理向來是該公司最重視的基本工…
Client Profile The client is an important index enterprise in Taiwan's pharmaceutical industry, which has been deeply cultivating the market for more than 40 years, and has a mature R&D team and large-scale mass production capacity. All production bases have passed PIC/S GMP and other stringent quality certificates, and their products are ...
Industry Pain Points During the transportation of power and energy technology equipment, companies are faced with the same key challenge: how to ensure that high-value equipment remains in good condition during long-distance transportation. Whether it's transformers, generators, high-efficiency inverters, or large control cabinets, these devices are often large and...
Preface Maintaining accurate temperatures is not only critical to the quality of pharmaceuticals and food products, but is also a core element of many other products and industrial processes. Therefore, it is important to ensure that temperature data loggers and sensors used in refrigerators, freezers, ultra-low-temperature freezers, cryogenic containers or incubators are in good condition and have been calibrated...