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准备就绪，蓝牙即将到来…

Bluetooth data loggers in GxP Environments

保罗·丹尼尔（Paul Daniel），瓦萨拉

高级GXP监管合规专家

发布： 2019年3月9日

生命科学

我一直喜欢蓝牙供个人使用。这并不奇怪，因为它首先设计为PAN（个人区域网络）的工具。另外，作为作家，我是一个书呆子，这个名字具有悠久的历史。它来自一个名叫Harald Bluetooth的丹麦维京国王。蓝牙徽标是他名字的两个北欧符文。哈拉德（Harald）以设法团结维京人（Vikings）而闻名。最早为短期无线连接发明蓝牙标准的人是北欧，因此他们以北欧名称向自己的历史致敬。从技术上讲，正是埃里克森（Ericcson）开始从事蓝牙工作，而埃里克森（Ericcson）和弗兰（Vaisala）（芬兰）一样是北欧公司（瑞典）。所以……让我们听到北欧技术进步。（从顽固的维京人的争吵开始。）

One day Bluetooth technology started showing up in my professional world, more specifically: the domain of GxP compliance. The GxP world can be arcane and is often slow to adopt new technologies. So the appearance of Bluetooth not only violated some boundary between my own personal and professional life, it surprised me by the speed of its sudden materialization. Yes, there it was… a Bluetooth Data Logger.

There are currently several flavors of Bluetooth. The one we use for our typical PANs is the most familiar, and with a little analysis, one can see that it isn’t a suitable technology for monitoring in the GxP Environment. First, the Bluetooth protocol is limited to seven devices per node. That’s not enough for most monitoring applications. Second, range is limited to ten meters. Third, the Bluetooth communication protocol is drains batteries pretty fast. When it comes to monitoring, we need battery life in the order of years, not days. (Yes, you could plug the devices in, but I think they lose their attraction when they are wired because there are so many proven wired solutions).

But there is another curious type of Bluetooth that has been making some inroads into the GxP world: Bluetooth Low Energy, or BLE (I pronounce it “Bleh”).

Bluetooth Low Energy overcomes two of the three obvious problems with the standard Bluetooth:
• Number of devices limited to 7 per node
• Short duration battery life

短距离仍然是一个极限，但是可以通过网状网络拓扑来克服。在网格拓扑中，每个设备都可以充当其他设备的中继器。由于BLE与能量相似，因此它可以在不迅速消耗电池寿命的情况下啮合。

Two other advantages of BLE is that it’s inexpensive and devices can have relatively large memories. The technology is being used in innovative ways: in combination with cloud applications, in open API toolkits, and in peer-to-peer cryptocurrency as a way to store data. (Spoiler alert… these benefits don’t actually translate well in a conservative and risk-averse GxP environment.)

促进BLE的人们（用于任何应用程序）列出了其他好处：
•多平台的通信。
•高速配对
•保持更长的连接时间 - （蓝牙掉下来）
• Low implementation costs (Good, but comes with tradeoffs)
• Energy Efficient (up to 5 years)
• Low data rate (great for monitoring) and always off

全部考虑到BLE是蓝牙技术的绝佳进步。但是，在GXP监视应用程序中，这些好处并不重要。在受监管的环境中，多平台的通信是一个坏主意，因为设备绝不应不配对。此外，典型的设备校准间隔为一年，五年的电池寿命超出了必要性。

低实施成本的好处通常会转化为“该设备上的所有东西都很便宜”。这可能意味着低成本设备具有低传感器的精度和流畅的时钟，即使它在具有不错的外形的塑料外壳中充满了便宜的内存。GXP世界是否准备好在不对称弯曲形状中染色的塑料？

That said, BLE probably has a place in Cold Chain and GDP (Good Distribution Practices). Low cost and short range wireless with a multi-platformed communication protocol makes sense in cold chain because of the nature of GDP. Devices need to be cheap because they are often lost or damaged. They don’t need to be highly accurate (± 0.5°C is enough). Companies in this arena are often not integrated, and therefore don’t share networks, so a standard protocol makes sense.

蓝牙低能和GXP符合性

BLE might also have a place in temperature mapping, especially in GDP environments for smaller spaces.
However, I argue that BLE is not the right tool for the core pharmaceutical and biotechnical industries, or mapping those types of warehouses. It could be a good way to remove cost obstacles that might be preventing distributors to start mapping their fridges, freezers, and trailers. We should remember that it was only in 2013 that GxP regulators officially reminded distributors that they were accountable as part of the regulated cold chain.

这还没有足够的时间来进行文化变革。也许可以更便宜，更轻松的映射方法可以帮助过渡。准确性足够好。带有“足够好”设备的映射远不止根本没有映射。
坦率地说，可以使用智能程序来解决大多数反对使用廉价ble登录器映射的论点，以便数据处理可以满足电子记录的要求（第11部分和附件11）。最后，映射是一个简单的过程。我认为我们可以忍受数据方面的一些风险，从而在合规性和控制方面实现很多。

因此，蓝牙很可能会留在这里。尽管标准蓝牙除了网络您的个人设备之外没有太多的GXP应用程序，但BLE可能只是在与该技术功能相匹配的特定角色中发现了一些涉及GXP的信息。