连续监控系统带来了安心

“失去股票只是冰山一角。
这意味着损失研发投资，丢失客户承诺，
并错过了商机。
最重要的是，新系统让人安心。”

李·塔顿
设施和公用事业主管
包装协调员Inc.

（PCI）PCI选择Vaisala监控设备以确保质量。

包装协调员Inc.（PCI）总部位于美国费城，是药品包装解决方案的全球领导者。Partnering with global pharmaceutical manufacturers, PCI offers packaging services from early phase clinical studies through to commercial launch, and on-going supply.Due to the unique requirements of a new project, PCI’s UK facility in Hay on Wye had a need to upgrade its environmental monitoring system for one of their warehouses. The redefined system needed to provide real-time temperature information and reliable alarm and reporting capabilities, whilst also eliminating manual processes for reviewing and archiving data. System upgrade required PCI prides itself on reliable and flexible operations, working with customers to ensure their needs are met. “The new project prescribed that drug product was monitored at temperatures as low as -80°C,” explains Lee Tatton, Facilities and Utilities Supervisor at PCI. “We needed a system that could monitor conditions remotely when the site was not manned and we also wanted to ensure that the data was safe and segregated. The current system was not able to manage all the customers’ requirements, and as such we considered it the right time to invest in an upgraded system which could eliminate manual processes, have reliable alarm and reporting capabilities, and provide easy and accessible real-time temperature monitoring in critical areas. We also wanted to ensure the chosen system would meet any future needs, for example regarding electronic signatures.”

确保故障操作的新系统

PCI审查了各种可以满足其挑战的监测系统。在评估可用的期权之后，同意Vaisala的连续监控系统可以满足公司的所有需求，并授予合同。塔顿先生说：“在制药市场中，监管合规性至关重要。”“但是，这不仅与合规性和提供必要的数据有关，还与该数据的访问程度有关。基于浏览器的访问允许用户按需创建自定义报告，而经常运行的报告可以自动通过电子邮件以设定的时间表生成和交付。对于监管审计师来说，也可以快速，轻松地生成报告，他们全年经常访问PCI。PCI的关键要求之一是使用无线监控。由于经常质疑无线系统的可靠性，因此公司需要确保其数据始终安全。PCI选择使用Vaisala的关键原因之一是其无线数据记录仪具有板载内存的可靠性，并且无论网络连接如何，它们都独立运行。由于数据已在本地记录，即使在停电期间，它也是安全的。 Data is then automatically backfilled to the server and client PCs, ensuring gap-free data. The Vaisala monitoring system supports PCI’s business model and is intuitive to use. “The system will become even more valuable as our teams become more familiar with the system and the data it provides,” says Mr. Tatton. “Thanks to the system’s remote monitoring capabilities, personnel no longer have to collect data manually, reducing workload and ensuring resource efficiencies.”The Vaisala system supports laboratory, storage and distribution, and production personnel in their day-to-day work, readily identifying issues, supporting customer requests, and ensuring compliance with regulatory requirements.

合作取得成功

PCI的项目时间表具有挑战性，并且在将冰柜安装到仓库中之前，必须进行许多背景安装，包括连续监视系统。Vaisala与PCI合作，草拟了该项目推出的全面安装计划，并开展了一系列员工培训课程。PCI本身执行了系统验证，采用了Vaisala的验证过程和协议。验证专家蒂姆·戴维斯（Tim Davies）说：“这是一个非常大的协议，这要归功于Vaisala和分步说明的帮助，很容易遵循和完成。”塔顿先生指出，利用可用的最可靠和创新产品来满足您的项目需求。在谈判期间，该项目的范围发生了变化，因此解决方案已扩展到涵盖寒冷房间，实验室，稳定室和制造区域的站点范围的系统。前进的塔顿先生确信该系统将继续为PCI提供创新和范围，以满足其未来需求和客户的需求。