隔离器的过氧化氢测量系统的现场比较

Founded in 1994, Ardien Consulting Services provides isolator validation for equipment used in aseptic manufacturing, sterility testing and containment applications. Rick Nieskes is the founder and principal consultant of Ardien, currently serving the validation needs of over 50 pharmaceutical companies around the world. Vaisala supplied Nieskes with aVaisala HPP272探针与Indigo201 transmitterfor testing purposes.

After working with early hydrogen peroxide bio-decontamination methods in the 90’s, Nieskes decided to specialize in isolation technology and vaporized hydrogen peroxide systems for the pharmaceutical industry. In his work, Nieskes not only qualifies equipment and environments, he develops bio-decontamination cycles and protocols to help companies ensure the consistency and efficacy of their processes.

当有机会评估Vaisala氢过氧化探针与Indigo201发射机结合使用时，Nieskes将它们与当前的过氧化氢进行了比较（H₂o₂) measurement equipment. The first major difference was that his sensor gave only parts per million readings (ppm), whereas Vaisala’s HPP272 probe with the Indigo201 transmitter was set up to provide three values: H₂o₂PPM的浓度，相对饱和百分比（湿度）和温度。Vaisala提供了两个用于过氧化氢测量的探针。HPP271探针仅测量H₂o₂concentration in ppm and the HPP272 probe can measure several parameters, including H₂o₂concentration in ppm, relative saturation, relative humidity, temperature, dew point and vapor pressure.

Nieskes说：“借助我的标准传感器（基于电化学技术）和Vaisala的HPP272（基于薄膜聚合物传感器技术）在隔离器中距离不到一英尺，我开始了净化周期。”“电化学H₂o₂浓度传感器最初的响应更快，但是在大约五到十分钟的时间内，两个传感器基本上读取相同的值。但是，以我的经验₂o₂浓度不如从周期到周期相对一致的重要性。在整个验证过程中，这两个单元都是一致的。”

While the concentration values were similar, the resolution of the values differed. Both display units began at zero, but for the electrochemical sensor, the first value was 10 ppm, with subsequent values in increments of five. The Vaisala Indigo transmitter, which provided the readings of the HPP272 probe, gave values in 1 ppm increments.
Nieskes回忆说：“这在充气期间变得非常有趣。”“在净化阶段结束时，两个单元给出了几乎相同的读数。电化学传感器在705 ppm处，HPP272为710 ppm。在曝气阶段结束时，一旦HPP272在2 ppm处，我使用了用于低级PPM的不同设备进行了阅读。

“我使用两种不同的设备来测量高水平和低水平的过氧化氢浓度。低级设备给出0.1至3 ppm的值。当HPP272在2 ppm时，设备读数为1 ppm；当HPP272以1 ppm为单位时，设备读数为0.5 ppm。我有兴趣看到读数之间的一致性，但惊讶的是，在通常需要两个不同的传感设备以提高高水平和低水平精度的过程中，HPP272在生物污染的所有阶段都相对准确。”

Another difference Nieskes noticed was in the number of variables measured during the process. “With the Vaisala unit I’m getting humidity (in this case relative saturation values were selected to be displayed), temperature, along with H₂o₂专注。这为发生的事情提供了更完整的了解，这对于验证至关重要。看到温度和相对饱和值以及过氧化氢的水平，不仅对于合格的设备很重要。对于设备重新配置之间的故障排除可能非常有用。”

Nieskes believes that knowing the environmental parameters along with H₂o₂ppm values can save time and ensure cycles are effective. “Say that some undetected situation occurs with the HVAC system. If it’s winter, the temperature in the room might decrease. As a result, the ppm during the decontamination cycle may be lower than normal. You might have to do a lot of investigation to figure out that the root cause is the HVAC system.

“与此同时，隔离器中可能会有更多的凝结，这导致了较低的读数PPM。如果您在不了解环境中的其他变量的情况下运行一个异常的PPM读数周期，则必须花费一些时间来调查问题。如果您可以看到实时影响该过程的其他参数，则可以立即了解发生的事情：其中一个变量更改。”

From over two decades working with pharmaceutical manufacturers, Nieskes knows there is constant pressure to control costs. Every step in the process must be as efficient as possible. “If we can ensure consistent bio-decontamination cycles with a better understanding of the critical parameters that affect the process, it leads to more efficient manufacturing,” says Nieskes. “Downstream that can result not only in improved productivity for a manufacturer, but also reduced drug costs for a consumer who can still be assured that the drugs are processed in safe, sterile, and controlled conditions.”

Working in validation, Nieskes has seen the costs associated with presuming that equipment will perform as expected, or that a changing ambient environment won’t have a detrimental impact.

Nieskes了解到没有H₂o₂传感器监测生物污染周期，无知是幸福。“我无法计算我看到公司进行重新资格并找到生物学指标的生长申请的多少次。然后他们启动故障排除。借助内联传感器，他们将拥有可以帮助故障排除的历史信息。

“我经历了注射H的情况₂o₂是正常的（即没有警报或中止），但不当蒸发。在这种情况下，有H₂o₂concentration sensor would have likely identified the faulty condition. This is where knowing the relative saturation and concentration value from the HPP272 sensor can be valuable.”

Nieskes新的参数之一是相对饱和百分比。相对饱和表明双方h的空气的湿度₂o₂vapor and water vapor. Under the conditions in this case, Nieskes noticed the onset of condensation occurred around 82%RS. Decades of experience have brought Nieskes to the conclusion that some degree of condensation is necessary for an effective bio-decontamination with hydrogen peroxide vapor.

在使用HPP272之前，Nieskes使用了他为此目的创建的二进制冷凝传感器。经验告诉他，一个无法实现冷凝的周期可能会导致生长阳性的生物学指标。凝结物通常是可潜在的 - H₂o₂在周期中的各个位置，蒸气在不同程度的两个状态下，作为气体和液体（冷凝水）。

“In the ideal biodecontamination cycle, the isolator temperature and humidity would be exactly the same each time,” says Nieskes. “Since you can’t do that, you have to ‘validate through’ meaning; incorporate room temperature during validation. This shows that you are able to destroy microorganisms through environmental variations. You change the ambient conditions and document the effect.

“Knowing the degree of condensation – or Relative Saturation % – is important. Do you still achieve the kill rate? I look at what the client is able to control and create worst-case conditions. A lot depends on the design of the isolator, the bio-decontamination parameters and the conditions in the room surrounding the isolator.” Nieskes notes that some equipment has its own system for controlling temperature and humidity to create consistency in the cycle. However, usually the only control is a humidity value less than or equal to a set-point prior to the start of H₂o₂vaporization and the amount of H₂o₂vaporized. “This is limited information, at best,” says Nieskes. “Say for example you add 120 grams of hydrogen peroxide, for a given duration; what are the other conditions in the isolator? You need to understand the humidity and temperature values throughout each cycle to understand and control it.”

Nieskes has learned that knowing the other dependent variables allows better control of biodecontamination cycles. “If you run a cycle in a room with fluctuating temperature or humidity, it may have an impact on the isolator’s bio-decontamination cycle, in terms of its microbiocidal efficacy or aeration time.”

Nieskes在比较电化学传感设备和Vaisala的HPP272探针与Indigo201发射器结合使用时，确定了VAISALA系统中的几个优势，尤其是PPM测量的优质分辨率和相对饱和值。在生物污染的所有阶段，HPP272相对准确，这也很有帮助。

里克·尼斯克斯（Rick Nieskes）因对HPP270探针或Indigo200的测试而没有获得Vaisala的赔偿。

阅读更多有关传感器的比较在Rick Nieskes博客上的隔离器的周期开发验证期间使用“Inside the Isolator”

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