The present application relates to a kind of high-pressure
discharge leak detection methods of double-chamber bag packaging
system, belong to the technical field of
drug detection.The method includes the following steps: preparation contains 3~10 μm pore size double-chamber
positive sample and
negative sample, carry out high-pressure
discharge detection under (7~8) ±0.1KV output
voltage, 250~300Hz frequency, respectively
record minimum positive detection value M min And maximum negative detection value M max , according to formula (M min +m max ) / 2 Calculate leakage threshold (and 1.5m max ≤M min ).The present application breaks through the limitation of traditional step-by-
step detection, realizes double-chamber synchronous
leak detection, avoids the parameter switching and
electrode error caused by chamber detection, is suitable for different pH complex preparation (such as
sodium bicarbonate hemofiltration replacement fluid etc.), can detect ≥3 μm micro leakage, detection efficiency is doubled, result is accurate and reliable, and cost is significantly reduced, effectively guarantees the quality of product and clinical
drug safety.