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增加温度监测探针的五个原因:增加空间,产品价格或敏感性,温度差异和冷却系统可靠性

保罗Daniel, Vaisala
senior GxP Regulatory Compliance Expert
Published: Jun 24, 2017
Industrial Manufacturing and Processes
Life Science

在本周的博客中,我们的高级监管专家提供了五个情况,您将需要考虑增加探针的数量。另外 - 我们邀请您参加平均动力学温度的网络研讨会。

Dear Paul,

感谢您过去为我们提供的帮助……我有几个问题可以澄清监视温度偏移。理想情况下,您建议每天监测多少个监测探针?监视探针的数量是否取决于该区域?

其次,您是否建议将传感器放置在最温暖或最冷的位置?例如:我们只有一个大型步入式探针,即2-8°C或-20°C。这是我们最大的挑战……

非常感谢您的帮助!

最好的祝福,

s

保罗´s reply

Hi S,

是的,随着空间的大小增加,您会期望在受控空间中看到更多的监视探针。

您还希望看到更多的监视探针是…

  1. 产品的温度灵敏度增加。
  2. The price of the product increases.
  3. 该区域内部/外部之间的温度差异增加。
  4. The reliability of the cooling system decreases.

In the end, it is a risk-based decision. There is no solid rule. However, more warning letters and observations are seen for not monitoring at all, than for not having a high enough density of monitoring probes.

选择一系列探针,使您感到安全和自信。我已经看到人们检查了他们的映射研究,确定距离(通常是任意的),说任何产品不应与探针相比X米不应超过X米,然后根据该逻辑提出探针布局。例如,我知道一个希望所有产品(在环境存储条件下)在监视探针25米以内的分销商。

But for anything under 20 cubic meters, you are generally fine with one probe. It does not need to be at the warmest / coldest spots. But it should be placed at a spot that does take that data into account. Most hot spots/cold spots are inconvenient, expensive, or dangerous to monitor. Find a place nearby that is representative. In the end, almost every manufacturer puts the sensor near the door, out of the way of traffic, in good airflow, and out of the way of spaces that can be used for storage.

最好的祝福,

保罗

Mean Kinetic Temperature Webinar

Vaisala's Senior Regulatory Expert Paul Daniel provides you with 6 clear Do's and Don'ts for using the calculation, including where it is useful in decision-making for regulated industries, and where it is not.

您将离开网络研讨会,将MKT理解为非线性加权平均水平,该平均值显示了温度变化随时间的影响。其中包括一个问答部分,现场网络研讨会参与者在自己的受控环境中询问了MKT的最佳实践。

关键学习目标

  1. MKT计算的参考和资源
  2. arrhenius方程和温度偏移的非线性效应
  3. 监管机构(例如FDA和EC)如何推荐MKT
  4. What data to use when MKT is not appropriate

贡献者

保罗Daniel, Vaisala

senior GxP Regulatory Compliance Expert

保罗·丹尼尔(Paul Daniel)在GMP监管的行业工作了20多年,帮助制造商在广泛的资格项目中运用良好的制造实践。他的专长包括映射,监视和计算机化系统。在Vaisala,Paul负责并指导Vaisala的验证计划ViewLinc环境监测系统. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.

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In addition to editing the Vaisala Life Science blog, Janice Bennett-Livingston is the Global Life Science Marketing Manager for Vaisala's Industrial Measurements business area.

Vaisala前的写作学分包括每月为加拿大屡获殊荣的杂志Alive的“研究手表”的专栏,以及加拿大生活和其他期刊的文章。其他过去的工作:加拿大DDB的文案,商业对象的技术写作以及不列颠哥伦比亚省儿童与家庭研究所的传播专家。

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