Ampoule bottle powder injection bottle microbial invasion sealing tester

Ampoule bottle powder injection bottle microbial invasion sealing tester

Ampoule bottle powder injection bottle microbial invasion sealing tester

The LSSD-01S Microbial Invasion Sealing Tester is suitable for microbial invasion sealing tests and is widely used for sealing testing of various materials such as penicillin bottles, ampoules, pre filled needles, and sterile packaging bags.

Product features

7-inch touch screen control, stylish and convenient human-machine interface

Automated testing reduces operation time and provides a smoother user experience

Multiple experimental project options to meet the vast majority of industry applications

Large scale program design to meet the testing needs of more experimental materials

The measurement system has high accuracy, good linearity, fast response, and sensor over range protection

The motion drive system operates smoothly and with high precision

Automatic zero point calibration upon startup, supporting manual sensor calibration, and automatic shutdown upon completion of the test

The product complies with GMP user multi-level permissions

Experimental data is automatically saved, historical records can be queried, data cannot be changed, and can be audited and tracked

Single and grouped statistical analysis of experimental results can be conducted

Micro printer, capable of printing test statistics results at any time

Equipped with standard serial communication interface

Specialized computer communication software for real-time display of experiments, analysis and processing of data, and data storage

Test Principle

Microbial invasion test method, also known as microbial challenge method, is a common sealing integrity testing method, usually conducted simultaneously with simulated filling. By simulating the filling of the culture medium according to the simulation filling verification plan, followed by plugging and capping, the visual inspection is qualified. After sterilization in the validated sterilization cabinet, the sealing surface of the container is immersed in a high concentration of bacterial solution, so that the culture medium in the sample container fully contacts the inner surface of the seal. The neck of the sample and the outer surface of the seal should be immersed in the bacterial suspension for a certain period of time, and then removed. After regular cultivation, check for microbial invasion to determine the integrity of the container sealing system. At the same time, a positive control test needs to be conducted to confirm the growth promoting ability of the culture medium. Vacuum or overpressure challenge conditions are usually used in testing.

This instrument complies with multiple national and international standards: GB/T 10440、GB/T 18454、GB/T 19741、GB/T 8368、YY/T0681、YY 0285、ASTM F1140 wait

Test application

Basic Application

Suitable for sealing testing of sterile packaging bags such as penicillin bottles, ampoules, and pre filled needles

technical indicators

test scope90kPa to 400kPa

resolution0.001 kPa

air supply pressuremanual adjustment

holding time0 ~ 99999 s

air source interface6mm polyurethane pipe

power supplyAC 220 V 50 Hz

Net weight23 kg

Product Configuration

Standard configuration: host, mini printer

Note: The air source interface of this machine is a Φ 6mm polyurethane pipe; The gas source should be provided by the user themselves.