案件

5类飓风保障期间的连续监测Teva Pharmaceuticals

连续监控药品设施
Published: May 10, 2018
Life Science

“After installing viewLinc, we were pleased with the system, but it was during the hurricane that it really proved itself...”
-Luis Johnson,Teva Florida(右)的现场自动化工程师Jose Moure,维护工程师(左)。

Teva是世界上最大的通用制药组织。在广泛的产品中,该公司还开发了肿瘤学和其他治疗类别的生物学和生物仿制药。Teva在世界各地拥有80多个制造和分销设施,每年为地球上的每个人平均生产超过10剂。

当美国的Teva设施决定升级其连续监控系统(CMS),they compared three system vendors. Their existing monitoring system had become expensive and labor-intensive.

Site Automation Engineer Luis Johnson knew the facility needed a fully digital monitoring system. Part of Johnson’s role is to support Teva’s QA/QC teams in ensuring that manufacturing equipment and environments are GxP-compliant and fully aligned with cGMP requirements.

约翰逊说:“我们的设施中有多个应用程序,包括洁净室,仓储,稳定室,冰箱,孵化器以及高效力产品的控制存储。”“为了确保我们可以尽可能高效,准确地监视和记录设备的性能,我们认识到我们需要升级我们的技术。”

Why viewLinc?

在评估了所有三个系统之后,他们选择了Vaisala ViewLinc监视系统。约翰逊回忆起选择选择的三个关键原因:数据完整性,基于浏览器的监视以及快速,简单的报告。在监管要求方面最重要的是连续数据。“这Vaisala数据记录仪在独立模式下记录,无论电力或网络连接如何,”约翰逊说。“在这些环境中,伐木工人在不需要任何外部电源的情况下提供30天的连续数据的能力确实很重要。

约翰逊说:“其他供应商在停电的情况下有不同的方法来实现数据记录,但他们提供了本地化的不间断电源。”“该方法的问题在于,除了传感器之外,它还需要数百个设备……这些设备通常具有较大的电池,并且需要自己的维护。Vaisala数据记录仪内置了每个设备的电池,并且可以在八到十年的情况下监视无外部电源。”

人提出,艾尔玛飓风处置

2017年9月,有记录以来最强大的大西洋飓风飓风袭击了佛罗里达州西南部。超过600万佛罗里达人被撤离有史以来最大的州撤离。总损失估计为640亿美元,使Irma成为有记录以来第五次最大的飓风。尽管Teva设施配备了备用发电机,以确保建筑物自动化系统继续运行,但在整个风暴中,温度和湿度大大增加。

“After installing viewLinc we were pleased with the system, but it was during the hurricane that it really proved itself,” recalls Johnson. “Once we were able to return to work, we began analyzing conditions during the power outage. We were happy to find all records were complete. This gave our Quality team all the data they needed to determine whether products were maintained within required specifications during the storm. We verified and saved product that might otherwise have been needlessly destroyed because of the storm. As a result, our products reached patients without interruption, and the savings were huge.”

出色的可用性和惊人报告

使ViewLinc成为最佳监视系统的第二个功能是基于Web的用户界面。一些监视系统涉及在每个工作站上安装可执行软件包。ViewLinc系统可以在线访问已获得ViewLinc管理员许可的员工。只要他们能够访问公司Intranet,他们就可以查看仪表板,趋势,管理警报和运行报告。约翰逊指出,其他监视系统供应商提供基于Web的监视,但ViewLinc没有的限制。

ViewLinc的第三个优点是该软件能够从无限数量的设备中管理大量数据。约翰逊说:“我们每分钟都有数百种探针进行采样。”“但是ViewLinc压缩了此信息,并占用了服务器上的很少的空间。“例如,我可以在几分钟内进行6个月的查询,并在几分钟内获得完整的报告。那是数百页的数据。那是惊人的。”约翰逊说。

“无论ViewLinc开发人员在设计系统数据库时所做的一切,他们都做对了。”

ViewLinc软件的查询效率来自其轻巧,嵌入式数据库,该数据库没有管理或维护要求。还有其他功能使该系统成为TEVA的正确选择:员工使用与工作站使用的ViewLinc相同的登录凭据;他们可以显示图形(原理图或区域照片),并将传感器位置叠加在图像上,以快速视觉范围。ViewLinc的审核跟踪显示了与系统的每一次交互,从登录到注销。

Another convenience in viewLinc is that users can annotate events with explanations and corrective actions. If a question ever arises regarding an excursion, the software provides an intuitive and secure way to record details about how it occurred and how it was handled. This ensures all activities are tracked and recorded in a way that anticipates an auditor’s questions about events like temperature excursions.


Simple and supported

约翰逊指出,不在自动化行业工作的人倾向于将环境监测系统与SCADA或建筑物管理系统混淆。SCADA/BMS系统可以执行监视系统可以做的任何事情,然后可以做一些,但成本要高得多。通过像ViewLinc这样的系统,功能仅限于监视,令人震惊和报告,成本和验证工作大大减少。

约翰逊说:“ ViewLinc系统非常适合我们所需的东西。”“这比SCADA简单得多。我们只需要可靠的监控,这可以帮助合规,而在电力或网络中断期间永远不会让我们失望。”

It was key for Teva to collaborate with a vendor that supports their products long after the initial startup and training. The team in Florida work with Vaisala’s technical support to ensure all system users get the most out of viewLinc. Although the software is extremely user-friendly, it still takes time to become familiar with all its capabilities.

“We recently installed a viewLinc testing environment so that when we get new loggers, or someone wants to learn the software without going into our live, validated system, we have an environment where staff can practice setting up and running reports, creating alarm thresholds, annotating events and other common tasks.”

尽管Teva具有内部校准部门,但他们还是决定使用Vaisala校准作为维持传感器性能的一种经济高效的方式。通过Vaisala的综合校准软件包,出色的用户体验以及监视遇到灾难性功率故障的数据,ViewLinc Monitoring System提供了一种将继续增长的投资回报。

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