High Voltage Discharge Leaking Tester

Leak-HV High Voltage Discharge Leaking Tester is suitable for the sealing integrity test of packaging containers such as infusion soft bag, upright infusion bag, glass infusion bottle, BFS, eye drop bottle, Xylin bottle, ampoule bottle, pre-filled needle, etc. The instrument adopts the test principle of high voltage discharge method and non-destructive testing technology, which meets the ASTM test method. High-precision testing techniques detect leaks in tiny holes. Widely applicable to pharmaceutical enterprises, third-party testing institutions and other units.

Technical Characteristics

1.Selecting the corresponding testing device can complete the sealing test of different packages

2.The test efficiency is extremely high, and the sample can be scanned in a few secondsThe test result is not subjective judgment, no manual participation is required to ensure the accuracy and objectivity of the data.

3. Roller electrode, one click start, automatic detection

4.It is suitable for the detection of small leak holes, and can also identify the sample with large leak holes, and give the judgment of qualified and unqualified

5.A variety of modules can be quickly switched, suitable for different capacity, different dosage forms of packaging testing

6.Double grounding, safety, emergency, detection door triple protection, safety visual

7.Maximum current 20mA, less impact on the sample

8.With full password protection, each operator has a unique combination of login and password to access the instrument operation

9.A comprehensive audit trail system that meets FDA 21CFR PART11 electronic records and electronic signatures requirements

10.Meet the requirements of GMP data local storage, automatic processing, statistical test data, and export in a format that cannot be modified or deleted to ensure the permanent storage of test results Windows

11.The operating system is intuitive and reliable, and the test process contrast curve is clear and clear

12.With error alarm function, power failure memory ability, to ensure the integrity of abnormal power failure data

Detection principle

The emitter and receiver are connected on both sides of the sample respectively, and the set detection high voltage provided by the detection power supply is guided to the emitter. When the sample is not leaking, the capacitance value between the two electrodes is large (due to the partition of the bottle wall, the electrode cannot contact with the liquid medicine, so the capacitance is generated), and the induced micro-current is small; When the sample is leaked (there is leakage at the mouth of the bottle, the bottom of the bottle, and the bottle body), the capacitance between the insulating bottle wall and the electrode disappears, and a loop is formed between the transmitting stage and the receiving stage, and the micro current is larger. As long as the size of the micro current is compared, it can determine whether the sample is leaking. Compare the maximum current value of each drug with the set upper limit. If it is greater than or equal to the set upper limit, the system will be judged as unqualified, otherwise it will be qualified.

Technical parameter

Standard basis

USP 1207.2 Packaging integrity leakage testing techniques

Disposition

Host, control software, computer, measuring head