Xi's "triple strategy" to ensure the integrity of low-temperature storage seals of containers

The pharmaceutical industry is emerging with a wave of new high-value biologics thanks to the U.SFood and Drug Administration's (FDA) accelerated approval processthese drugs, which need to be stored at low temperatures of -80c to -180C to maintain stability, pose a new challenge for the industry: How can the container seal integrity (CCI) of the packaging and drug systems be detected and proven at such low temperatures? Photo Provided by West pharmaceutical packaging for this challenge, West Pharmaceutical Packaging is committed to ensuring that Xilin bottle/glue and syringe/piston systems are suitable for low temperature storageMatt Gehrmann, senior scientist at the's Science Communications Division, describes the company's assessment strategy for CCI at low temperatures, by adopting a definitive approach approved by the U.SPharmacopeia 1207 Chapter, "Sterile Product Packaging Integrity Evaluation," West implemented a "triple strategy" to address CCI problems with glass/polymer silin bottle systems with plug/piston components and low-temperature storage of syringe systems: Strategy 1, using improved commercial tracegas (helium) leak detection and evaluation of real-time CCI in low-temperature environments to quickly identify cci systems that may fail, especially for high-pass experimentsstrategy two, using FM spectrum (oxygen) overhead analysis to detect the entry of gas over timeStrategy III, the use of high-pressure discharge to detect and evaluate the sealing integrity of the packaging over time, which is particularly suitable for syringe/piston systems's "triple strategy" helps customers gain a more complete picture of the real-time and time-varying CCI performance of biopharmaceutical container packaging systems and dispensing systemsthis not only meets compliance requirements, but also helps to deliver biopharmaceuticals safely and effectively to patientsWest has a wide range of container seal integrity (CCI) technologies that provide a wide range of packaging and dosing systems to meet the needs of pharmaceutical, biotechnology and medical device manufacturersthe path from product concept to patient application can sometimes be a "windand road", while West's Container Seal Integrity Analysis Team has the resources, expertise, and insight to gain a comprehensive understanding of pharmaceutical packaging systems from packaging development, market launch to lifecycle managementXi's comprehensive and detailed grasp of packaging components, dosing systems and their functionsas a consulting solver, Sie has the insights and capabilities our customers need to ensure that medicines are efficient, reliable and safe from concept to patient applicationso pharmaceutical companies can work with West at every stage of the product life cycle about Xishi Pharmaceutical Packaging West Pharmaceutical Packaging is the world's leading manufacturer of injection container packaging and dispensing systems from product concepts to eventual lying to patients, West works with customers to create products that improve the efficiency, reliability and safety of the world's drug supply headquartered in Exton, Pennsylvania, West, with offices in North and South America, Europe, Asia and Australia, supportcustomers West's net sales for 2019 were $1.84 billion and more than 100 million components were produced daily, with the aim of delivering better healthcare services to patients around the world 1983, Xi's was the first to set up an operations department in Singapore, and in 2009, the company's first injection molding plant was opened in the Qingpu Industrial Zone in Shanghai currently has a digital technology centre in Bangalore, India, three major production sites in Singapore, Shanghai, China and Chennai, India, and seven offices and distribution centers in Australia, China, India, South Korea and Singapore for more information, please scan the QR code below