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隔离器的过氧化氢测量系统的现场比较
Life Science
Ardien Consulting Services成立于1994年，为无菌制造，无菌测试和遏制应用程序中使用的设备提供了隔离验证。Rick Nieskes是Ardien的创始人兼首席顾问，目前为全球50多家制药公司提供验证需求。Vaisala向Nieskes提供了Vaisala HPP272 probe与Indigo201 transmitter用于测试目的。
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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）测量设备。第一个主要区别是，他的传感器仅给出每百万读数（PPM）的零件，而Vaisala的HPP272探针则设置了Indigo201发射器，以提供三个值：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.
“With both my standard sensor (based on electrochemical technology) and Vaisala’s HPP272 (based on thin-film polymer sensor technology) placed less than a foot apart in the isolator, I began the decontamination cycle,” says Nieskes. “The electrochemical 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2o2concentration isn’t as important as how relatively consistent it is from cycle to cycle. Both units were consistent throughout the validation.”
虽然浓度值相似，但值的分辨率有所不同。这两个显示单元均以零开始，但是对于电化学传感器，第一个值为10 ppm，随后的值为5。Vaisala Indigo发射器提供了HPP272探针的读数，以1 ppm增量给出了值。
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。
“I use two different devices to measure high and low level hydrogen peroxide concentrations. The low level device gives values between 0.1 and 3 ppm. When the HPP272 was at 2 ppm, the device reading was 1 ppm; and when the HPP272 was at 1 ppm, the device reading was at 0.5 ppm. I was interested to see the consistency between readings, but surprised that in a process that typically requires two different sensing devices for high and low level accuracy, the HPP272 was relatively accurate during all the phases of bio-decontamination.”
Nieskes注意到的另一个差异是在过程中测得的变量数量。“使用Vaisala单元，我会变得湿度（在这种情况下，选择相对饱和值显示），温度以及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认为，了解环境参数以及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。”
从与药品制造商合作的二十年来，Nieskes知道控制成本的压力不断。过程中的每个步骤都必须尽可能高效。Nieskes说：“如果我们能够确保一致的生物污染周期，以更好地了解影响该过程的关键参数，则会导致更有效的制造。”“下游，这不仅可以提高制造商的生产率，而且还可以降低消费者的药物成本，他们仍然可以确保药物在安全，无菌和受控条件下进行处理。”
Nieskes在验证方面工作，已经看到了与假设设备会按预期执行的成本，或者环境环境不断变化不会产生不利影响。
“You use biological indicators and other equipment annually to re-qualify an isolator. Between re-qualifications, you have to assume everything is stable. But if you have a sensor monitoring the isolator for each cycle, you can troubleshoot between re-qualifications. I believe that inline monitoring is useful in isolators regardless of the application. Unfortunately, this is not always done.”
Nieskes了解到没有H2o2sensor monitoring bio-decontamination cycles, ignorance is bliss. “I can’t count how many times I’ve seen companies go into a re-qualification and find biological indicator growth-positives. Then they initiate troubleshooting. With an inline sensor, they’d have historical information that can aid in troubleshooting.
“I have experienced a situation where the injection of H2o2是正常的（即没有警报或中止），但不当蒸发。在这种情况下，有H2o2浓度传感器可能会识别出故障状况。在这里，了解HPP272传感器的相对饱和度和浓度值可能是有价值的。”
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.
“了解凝结的程度或相对饱和％ - 很重要。您仍然达到杀人率吗？我查看客户能够控制和创建最坏情况的条件。很大程度上取决于隔离器的设计，生物污染参数和隔离器周围房间中的条件。”Nieskes指出，某些设备有自己的系统来控制温度和湿度，以在周期中产生一致性。但是，通常唯一的控制是湿度值小于或等于h开始之前的设定点2o2vaporization 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了解到，了解其他因变量可以更好地控制生物污染周期。“如果您在温度波动或湿度的房间内运行一个周期，则可能会影响隔离器的生物污染周期，其微生物效率或充气时间。”
In his comparison of the electrochemical sensing equipment and Vaisala’s HPP272 probe combined with the Indigo201 transmitter, Nieskes identified several advantages in the Vaisala system, especially the superior resolution of ppm measurement and the relative saturation value. It was also helpful that the HPP272 was relatively accurate during all the phases of biodecontamination.
Rick Nieskes received no compensation from Vaisala for his testing of the HPP270 probes or Indigo200.
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