Driving Compliance & Quality ③: ISO 14644-7 Final Question – How Does Sensor Accuracy Affect Leak Detection?

After the in-depth interpretations of the previous two issues, we have clarified the pressure setting logic of ISO 14644-7 positive pressure testing and the core of PQ validation for leak size detection. As the final installment of the series, this issue focuses on the "key component" determining test system performance—the differential pressure sensor—answering the industry’s ultimate question: Does sensor accuracy affect the minimum detectable hole size? Why is accuracy a core indicator for evaluating equipment compliance?

Let’s uncover the "mystery" of sensor accuracy and conclude the series perfectly～

In glove integrity testing, pressure drop (ΔP) is the core indicator for judging glove leakage, and the reliability of ΔP directly depends on sensor accuracy. Simply put: The higher the sensor accuracy, the stronger the ability to identify tiny pressure changes, and the smaller the minimum detectable hole size.

Taking two common accuracy sensors as examples, their performance under the 1000 Pa range varies significantly:

Note: Actual detection capability is also affected by system noise, temperature drift, glove material response, and other factors.

Insufficient sensor accuracy directly leads to two serious consequences:

Missed Detection: ΔP signals from small leaks may be masked by system noise, causing the equipment to fail to identify qualified gloves and bringing contamination risks to aseptic production;

False Positives: Excessive system error may misjudge normal pressure fluctuations as leaks, leading to unnecessary glove replacement and increased production costs.

Both scenarios violate the core goal of aseptic manufacturing compliance, making sensor accuracy a crucial indicator in equipment selection.

Astute partners may notice that many test equipment manufacturers prefer to emphasize "resolution" rather than "accuracy" in promotions. The reason is simple:

Resolution can be improved through software algorithm optimization, making it a "beautifiable" parameter; while accuracy is an inherent hardware property of the sensor, directly determining the equipment’s manufacturing cost and core performance, and cannot be easily improved through software. Some manufacturers choose to avoid this key parameter to cover up insufficient accuracy.

Sensor accuracy not only affects test sensitivity but also directly determines the lower detection limit of the test system, making it a core parameter for evaluating whether the equipment truly meets ISO 14644-7 requirements. When selecting equipment, companies should clearly request sensor accuracy indicators from suppliers and comprehensively judge whether the equipment can meet their own production compliance needs based on PQ validation data.

So far, the ISO 14644-7 positive pressure glove testing series has come to an end! In the three installments, we have answered three core questions: pressure setting, leak size detection, and sensor accuracy. We hope to provide practical technical references for your aseptic manufacturing compliance work.

Compliance and quality improvement in aseptic manufacturing is a continuous process of refinement. In the future, we will share more cutting-edge industry technologies, standard interpretations, and practical experience to support the joint development of industry partners. Thank you for your continuous attention—see you in our future content!

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