The calibration specifications for glove integrity testers need to be developed based on relevant standards and actual application scenarios to ensure the accuracy, reliability, and compliance of test results. Calibration is a crucial step in maintaining equipment performance and should be carried out in accordance with regulatory requirements, technical parameters, and operating procedures.

‌Calibration basis and regulatory requirements

‌Calibration work should follow international and national standards, such asISO 14644-7Regulations on glove leakage testing for isolation systems, and2020The annual edition of the Chinese Pharmacopoeia requires data traceability, permission management, and electronic recording requirements for glove integrity testing in sterile isolation systems.‌

InGMPIn the environment, equipment calibration must comply with drug production quality management standards to ensure that the operating process can be audited.

‌For exported products, further consideration is neededFDAorEMAWaiting for institutional requirements.‌

‌Calibration frequency and period‌

The calibration frequency should be determined based on regulatory guidelines and risk assessment. For example,NMPAThe "Guidelines for Sterile Preparations" recommend conducting glove integrity testing before each batch or production cycle, and calibration can refer to similar frequencies, such as6Perform pressure sensor calibration once a month.‌If the equipment is frequently used or in high-risk environments (such as sterile production), the calibration cycle needs to be shortened; On the contrary, the cycle can be extended based on the verification results.‌

‌Calibration methods and steps‌

Calibration should be centered around pressure sensors and compared using standard pressure sources. Typical steps include:‌Pressure range verification‌Covering the common range of devices (such as0–5000 Pa）Check the indication error through a standard pressure gauge to ensure that the deviation is within the allowable range (e.g±2 Pa）.‌

‌Sensitivity confirmation‌Using a needle with a known aperture (such as an equivalent aperture)0.01 Pa·m³/s）Simulate leakage and verify whether the equipment can detect minor damages.‌

‌airtightness check‌Before calibration, it is necessary to check the pipeline connection and sensor sealing to avoid external leakage affecting the results.‌The calibration process requires recording raw data and generating calibration reports for easy traceability.‌

‌Calibration parameters and standards‌

The key calibration parameters include inflation pressure (usually20-30 kPa）Testing time（1–8Minutes) and pressure drop value (pressure change per unit time).‌The calibration standard should refer to the reference values provided by the equipment manufacturer and be combined with the pressure drop range allowed by regulations (such as±5 PaInternal stability).‌For high-precision demand scenarios, it is necessary to choose a resolution better than0.1 PaVerify the linearity and repeatability of the equipment.‌

‌Calibration records and maintenance‌

After calibration, electronic or paper records must be saved, including calibration date, parameters, results, and operator information, to meet audit tracking requirements.‌Daily maintenance includes regular cleaning of equipment, checking sensor status, updating software, and retraining operators to ensure calibration effectiveness.‌