Science-based skincare benefits from continuous monitoring & efficient validation
Established in 2000,Crown Laboratories是一家全球公司，研究，开发和生产从非处方局部疗法到医疗设备和处方配方的护肤产品。Crown Laboratories参与了正在推进皮肤科科学的临床试验。他们的产品分为四个主要类别：美学，高级护肤，治疗和处方。
Environmental monitoring data for regulatory compliance
Even for lower risk categories like cosmetics, the manufacturing and distribution of cosmetics differs around the world and each nation oversees regulation individually. In the European Union, the EU Cosmetics Directive requires that manufacturers maintain complete technical dossiers of products, which are reviewed by local authorities. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA), which has regulatory authority under the Food, Drug and Cosmetic Act, specifically FDA Title 21 Chapter I Subchapter G Cosmetics. The FDA conducts inspections and collects samples to verify product safety.
在日本，根据《药物事务法》（第145号法律），化妆品通过卫生，劳动和福利部受到监管。在加拿大，加拿大卫生部的国家机构有一个化妆品计划，其中包括美学从业者使用的产品以及批量产品。实际上，每个国家都试图通过监管监督来保护最终用户。为了满足这些要求，制造商确保他们收集有关处方和非处方药，医疗设备和化妆品的条件的数据。
近年来，许多化妆品制造商增加了对设施，技术和人力资源的投资，以确保产品安全，有效且符合法规。此外，一些公司还进行科学研究，并雇用化学家，毒理学家，微生物学家和其他专家。这些投资不仅可以确保质量和安全性，而且还可以为科学支持的化妆品和皮肤疗法创新。
良好的制造实践提供最先进的护肤品
Mary Gilbert is the Senior Quality Engineer at Crown Laboratories. She is experienced in Validation and Equipment Qualification and is an expert at creating test plans, writing, and executing validation protocols, and assessing or reviewing Validated or Qualified systems and equipment under Change Control.
在她的Crown Laboratories角色中，她管理着关键的实用程序和受控系统项目以及变更管理。这包括系统配置，适用的计算机系统验证，环境条件和系统设备的质量监控和映射以及文档评论和批准。
“Our portfolio offers skincare solutions throughout our lifetime skincare journey, from infancy to older adults. A good example is the“Blue Lizard® line of sunscreen products。We have a baby formulation, a kids’ version, and a sport sunscreen that is water repellant,” says Gilbert. “But the products are wide-ranging; for instance, we have a micro-needling device,Skinpen®精度。”该产品是FDA清理设备的第一个临床证明，可改善颈部皱纹和面部痤疮疤痕。”
Crown Laboratories maintains cGMP-compliant manufacturing operations to provide services that include research and development, lab-scale formulation, manufacturing and packaging, analytical labs, method development and validation, testing for uniformity, hold-time, and ICH stability.
“We are audited by the FDA and firms for whom we manufacture,” says Gilbert. “No matter who is conducting the audit, they want to see data from our monitoring system and sometimes the entire validation package data. It depends on the application. For instance, as a medical device, SkinPen® Precision hasICH湿度要求and is audited by a 3rd party forISO 13485 certification。Because our products are regulated, our operations must adhere to Current Good Manufacturing Practice as well as to applicable certifications.”
环境监测确保质量
皇冠实验室使用Vaisala Viewlinc连续监视系统确保其受控区域在适当的环境条件下运行。吉尔伯特说：“我们从稳定室中的ViewLinc监测系统开始。”“后来，我们扩展了ViewLinc，以监视仓库和实验室。”
2018年，Crown将Vainet Wireless数据记录仪添加到其ViewLinc Monitoring系统中。Vainet技术独立于Wi-Fi和其他无线设备运行，减少了其他网络上的负载。VaiNet AP10 network access points可以支持32个无线数据记录仪，从而消除了每个受监视位置的专用以太网连接的需求。
吉尔伯特说：“该系统很容易设置。”“一旦配置了AP10网络设备，它就会自动连接RFL100数据记录仪。例如，昨天我将RFL100的探测器放入冰箱中。您只需获取AP10即可检测数据记录器，而AP10将数据发送到ViewLinc。”
Early Detection Saves Costs
The viewLinc monitoring system sends remote and local alerts of out-of-specification conditions to designated personnel. Alerts can be sent via email, SMS, voice call, lights, and buzzers.
“Recently we had an event on a stability chamber where viewLinc helped us determine a problem before it became destructive,” says Gilbert. “Whenever a new product is developed it needs stability data to support its approval. For instance, if you use a different tank or filler, or you need to change an ingredient, anything that might affect its efficacy, it requires stability testing.
“在这个特定的腔室中，ViewLinc中的趋势数据显示湿度降低。一看到这一趋势，我就联系了我们的维护线索。他检查了房间，并确定加湿器上的加热器失败了。我们迅速将产品转移到另一个房间，直到维护可以维修为止。”
“我很乐意提醒稳定团队，以便他们在会议厅发出警报之前可以确定根本原因。ViewLinc中的实时数据可让您掌握设施中发生的事情。这些数据使我们能够在研究受到影响之前切换到备份室，并给我们时间安排维修。”
皇冠实验室高级质量工程师玛丽·吉尔伯特（Mary Gilbert）
数月的数据可以保留在每个ViewLinc数据记录器的记忆中。自动数据回填以查看LINC的服务器可确保网络或电力停电期间的无差距数据。
“We sometimes experience brief power outages,” says Gilbert. “Although we have all critical equipment running on a backup generator, it’s good that the AP10s will send a communication alert that it has lost connection. Once power is back, the AP10 automatically re-connects and backfills the data to viewLinc from the battery-powered data loggers.”
Flexible Parameters
ViewLinc系统可以将无限参数与Modbus TCP/RTU和模拟设备集成。
“In 2021, I contacted Vaisala to see if devices with a 4-20 mA signal could send on/off readings to viewLinc,” says Gilbert. “Our engineering team needed a way to study compressed air usage. We used Vaisala’sDL4000通用输入数据记录器收集两个流仪的数据。此信息已提供给工程公司，以设计升级的压缩空气系统。该项目还使用了Vaisala DMT152露点传感器，用于监视和警觉的干燥剂压缩空气。”
用ViewLinc映射
Although viewLinc is a monitoring system, mapping studies can be performed with the software and data loggers. In both monitoring and mapping applications, environmental data is collected at regular intervals. The primary difference is that in monitoring, the data loggers are permanently deployed in a location and the data can be viewed live. In a mapping study, the data loggers are typically deployed for shorter periods in locations that change from study to study.
“In previous mapping studies we used Vaisala DL-series data loggers withVaisala的Vlog软件吉尔伯特说。“在2021年，我们的IT团队将计算机过渡到新的操作系统。作为持续改进的一部分，为了确保稳健的备份和数据安全性，Vaisala的Helpdesk的Curtis Unger建议我们取代在较旧的操作系统上验证的视频博客，以查看映射研究。
“使用ViewLinc进行映射具有一些真正的好处。首先，我们现在只有一个可以验证的软件。其次，我更熟悉ViewLinc的界面，因为我每天使用它，而我每年使用3次视频博客进行验证。当我使用视频博客时，我将运行五到六个报告，其中三个在具有低，中央和高端值的视频博客中，而在ViewLinc中进行了两个或三个，以捕获我的监视日志记录仪。对于仓库映射，我的传感器将放置低，中央和高尺寸用于映射和监视。要使用ViewLinc获取相同的数据，我只需将映射记录仪添加到软件中即可。现在我只打印三个报告。很方便我可以将伐木者保留在我想要的位置，在不映射时使它们失活，然后激活它们以进行学习。”
当使用ViewLinc从映射记录器下载数据时，ViewLinc的回填过程是一个优势。一旦数据记录器在映射研究后连接到ViewLinc，该软件将数据记录器视为暂时断开连接，并自动开始下载存储在Logger本地内存中的数据。使用ViewLinc进行映射是基于热电偶的设备，数据采集系统和较少可靠的数据记录仪的有效替代品。该软件可用于绘制任何典型的GXP存储环境，包括稳定室，冰箱，冰柜，孵化器，仓库，环境环境和其他环境。
“I use the Site Manager in the viewLinc software to keep monitoring and mapping data separate,” says Gilbert. “This keeps the interface clean and focused on monitoring. I simply disabled the configuration and communication alarms for the mapping loggers to avoid nuisance alarms when we are not performing mapping studies.”
“The data provided by viewLinc allows us to make a data-driven decisions.”
皇冠实验室高级质量工程师玛丽·吉尔伯特（Mary Gilbert）