The entire experimental process of using a microscopic counting method insoluble particle analyzer for the detection of insoluble particles in pharmaceutical stoppers

Test sample: Medicinal rubber stopper

Testing items:Insoluble particle inspection

Detection method:Microscopic counting method

Reference standard:2015 National Drug Packaging Material Standard: YBB0027204-2015 Packaging Material Insoluble Particle Determination Method Microscopic Counting Method

Operation process:

Experimental instruments:

Microscopic Counting Insoluble Particle Analyzer (Model: YH-MIP-0103)

Technical advantages:

A fully automated testing system that automatically scans, counts, and issues reports to reduce human error;

√ Fully automatic detection system to reduce eye damage to testers during use;

√ Can distinguish particle properties and identify the source of insoluble particles, whether they are metals or fibers;

√ Complies with the requirements of various pharmacopoeias such as the Chinese Pharmacopoeia, the United States Pharmacopoeia, the European Pharmacopoeia, and the Japanese Pharmacopoeia for insoluble particle testing.

Experimental process:

TIPS: All operations must be carried out in a clean workbench.

1. Take several rubber plugs (with a total surface area of about 100 cm) to be tested, place them in a triangular beaker, add an appropriate amount of water for particle inspection, cover the mouth of the triangular beaker with aluminum foil, and place it in an oscillator (rotating horizontally in a circular motion, oscillation frequency of 300 ± 10 r/min) to oscillate for 20 seconds;

2. Place the filter membrane on the suction filter. Carefully remove the aluminum foil from the triangular beaker, pour out a portion of the test solution into the suction filter, rinse the opening and sampling bottle, and then pour the remaining test solution into the suction filter for vacuum filtration. Use water for particle inspection to wash along the wall and filter until the filter membrane is almost dry;

3. Remove the filter membrane and place it in a petri dish, then dry the dish at low temperature;

4. After drying, transfer the filter membrane to the stage of YH-MIP-0103 Micro Counting Insoluble Particle Analyzer using flat mouthed tweezers, adjust the incident light, and magnify 100 times for insoluble particle inspection and counting.

Test results:

1data statistics

Table 1: Number of particles in different size ranges detected by the microscopic counting method for insoluble particles in medicinal stoppers

2Particle morphology

Global image (a) and partial images (b) and (c) of insoluble particle detection using microscopic counting method for medicinal stoppers

Microscopic counting method insoluble particle analyzer allows particles to have nowhere to hide.