LSNE (a PCI Pharma Company) leverages digitization to ensure quality, compliance, and data integrity
Photo Source: Lyophilization Services of New England, Inc
Lyophilization Services of New England, Inc.（LSNE，现在是PCI Pharma Services的一部分）是一个合同开发和制造组织（CDMO），可为全球制药，生物技术和医疗设备公司提供服务。在一系列合同制造服务中，LSNE专门从事CGMP无菌填充和缩放冻干应用。
LSNE comprises five FDA-inspected facilities in the U.S. and Europe, with a sixth facility opening in 2022. In support of commercially approved medical devices and drug products to over 30 countries across North America, South America, Europe, Africa, Middle East, and Asia, LSNE’s services fall into three categories: development, manufacturing, and analytical. With the PCI acquisition, the combined companies now offer global end-to-end integrated CDMO services for clients, including development and manufacturing, clinical trial services, and commercial packaging.
尽管LSNE提供多种服务，例如乳液，悬浮液，脂质体以及聚合物或脂质纳米颗粒（LNP）等多种服务，但该公司是冻干（冻干）的行业领导者，通过冷冻和冷冻的过度化稳定生物学物质（冻干）高真空下的水。在溶液中降解的产品（大多数药物或生物产品）受益于冻干，以确保产品功效并延长保质期。使用热量去除水分会降解许多产品。取而代之的是，冻干在真空下使用冰冻条件。LSNE目前是该行业中最大的服务提供商之一，拥有30多个冻干剂。
丹尼尔·加布拉特（Daniel Gabrault）担任LSNE的工厂工程师已有三年多。目前，他为设施，系统，公用事业和设备提供总体支持。当他从公司开始时，有多个不同的监测系统分布在设施之间。2018年，LSNE决定使用Vaisala ViewLinc连续监控系统标准化几个设施的环境监测。
监视多个参数
“Initially, we had Vaisala do the installation and validation for system deployment,” recalls Gabrault. “Now after many years of using viewLinc, we find it’s easy to expand the system on our own.”
Vaisalaoffers安装资格和操作资格协议to simplify validation. Gabrault was able to further streamline the documents for simplicity. “I took the data in the IQ and OQ from Vaisala and customized it for our needs. I simply capture the location, serial numbers, alarms, and function, and it’s a straightforward validation.”
一旦安装和验证了ViewLinc系统，LSNE就可以监视多个环境，包括步入式或拨入的冰柜和冰箱以及洁净室。对于大多数应用程序，他们使用Vainet Wireless数据记录仪 - RFL100。
“I like the wireless RFL100 data loggers because they are easy to place and easy to configure,” says Gabrault. “The RFL100s also have a digital display, so we can quickly check conditions and see whether the device is working properly.”
The viewLinc system is also easy to standardize across applications.
“It was important to us to have as much environmental data as possible in one system,” says Gabrault. “So, we use other devices in viewLinc to monitor parameters theRFL100 loggersdon’t currently include. We also use Vaisala’s CAB100 in our clean suites to monitor ambient temperature, relative humidity, and differential pressure.”
The Vaisala Industrial Cabinet CAB100integrates multiple sensors into a simple, pre-configured instrument panel. While typical parameters include differential pressure, ambient temperature, and relative humidity, the CAB100 can also take a variety of analog inputs, which can also be made intrinsically safe.
“就CAB100而言，根据我过去对洁净室监测系统的经验，我估计大多数系统的空间大约是Vaisala Cab100的四倍。橱柜的小占地面积以及预先配置的事实使其非常方便。
“我们还使用DL4000通用数据记录仪用于诸如废物系统监视中的pH之类的参数。通过ViewLinc中的这些测量，我们确保符合当地对环境保护的要求。”
Monitoring for GMP compliance
To ensure the highest level of quality to client companies and patients, LSNE must undergo regulatory inspections from multiple agencies and host numerous client and Qualified Person audits. This regulatory scrutiny necessitates that the company’s Quality Systems are current, compliance focused, and continuously updated.
“Lately our focus has been on client-specific audits. Every time one of our clients receive a new drug approval, the FDA comes in for that client. Because our clients are seeking FDA approval, the FDA needs to survey everything involved with the product that has been submitted for approval.
“Our clients also audit our Quality Systems,” says Gabrault. “During these audits they appreciate viewLinc’s monitoring capabilities. The system provides data on all environments, for any time they request.”
2016年，FDA发布了数据完整性指南草案, which states: “In recent years, FDA has increasingly observed cGMP violations involving data integrity during cGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.”
“数据完整性对我们非常重要。在ViewLinc中，审核跟踪可确保您无法编辑任何数据。即使要删除设备或设备，数据也会永远存在，这是GMP的理想选择。是的，有时可能会很棘手 - 例如，每次输入密码错误时，都会记录下来；什么都不会被抹去。但是我们需要GMP的这种数据完整性和访问控制。”
具有灵活，可靠的警报的监视
ViewLinc系统可以多种方式发送通知：电子邮件，短信，语音通话，灯光，警报器和继电器到外部系统。这使管理员和用户可以收到其护理区域的远程警报。
Gabrault说：“目前，大多数警报都是通过电子邮件发送的，但我们还设置了重要的警报，直接发送到电话。”“一些用户设置了他们的喜好发送到电子邮件和短信。
The system sends alerts on thresholds and communication failures immediately, without loss of data.”
Gabrault also appreciates viewLinc’s reporting capabilities. “Thealarm reports特别有帮助。您可以轻松地仅了解所需数据。”
User-friendly software
“The viewLinc system has the best user experience of the monitoring systems I’ve worked with. In other systems, I would sometimes have to manually back up the data, but that’s unnecessary in viewLinc. Also, if the system goes down and you don’t receive a notification, it’s very frustrating. I’ve worked with other systems where the devices are excessively large. That can mean extra effort to set them up.”
The viewLinc software was designed to be easy to learn. The user interface is intuitive, with embedded prompts and functional “Tours” to guide users through common tasks, provide onscreen instructions, and embedded tooltips.
“每个人似乎都喜欢使用ViewLinc。不难学习。我们进行了初步培训，并且一次性培训就足够了。从那时起，用户可以制作自己的报告，并仅查看与他们相关的数据。作为ViewLinc管理员，我将所有数据隔离，因此员工只看到他们关心的申请。”
Vaisalaalso providescalibration optionsto ensure sensors maintain their accuracy, including: Vaisala service center calibration, probe replacement service, or software and equipment for in-house calibration.
Gabrault说：“我们有一个校准团队作为工程组的一部分，因此我们内部校准了传感器。”“我们使用Vaisala的MI70sto calibrate the RFL100 probes. Being able to calibrate in-house definitely adds to the usability of the system.”
可扩展，标准化，安全
The viewLinc monitoring system was designed to be easily scalable, a feature that LSNE has leveraged. “We have hundreds of devices over seven facilities, soon to be eight. I like that I can see what’s happening in our facility out in Wisconsin from my location in New Hampshire.
“Before we installed viewLinc, we had several different monitoring methods,” recalls Gabrault. “Some were using chart recorders, or other legacy systems. The viewLinc system gave us a single, centralized solution.”
尽管Gabrault欣赏了ViewLinc的可用性和灵活性，但最重要的功能是ViewLinc的远程令人震惊。警报确保产品24/7保护产品。
“就令人震惊的是，ViewLinc是无情的。在响应时，它不会停止警报。”
