YBB00232004-2015 Pharmaceutical Synthetic Polyisoprene Gasket

Ash Test Method YBB00262005-2015
HUAREN MEDICAL CPHI Barcelona Oct. 24-26, 2023 (Hall 3 – Booth 3A14)

YBB00232004-2015 Pharmaceutical Synthetic Polyisoprene Gasket

This standard applies to synthetic polyisoprene gaskets (hereinafter referred to as gaskets) assembled in polypropylene composite lids for infusion containers

Appearance: Take a few pieces of this product, and check according to Table 1 to comply with the regulations

Identification: Infrared spectrum* Take an appropriate amount of this product, according to the infrared spectrometry of packaging materials, (YBB00262004-215) the fourth method of measurement, which should be basically consistent with the spectrum.

Use suitability test: Take several pieces of this product and assemble them with the plastic outer cover and inner cover to form a combined cover. Use moist heat sterilization at 121°C±2°C and keep for 30 minutes (if the product is not suitable for 121°C to Sterilize for 30 minutes, use the sterilization conditions used in the production of the product during the test), place it at room temperature, make the test product, and perform the following experiment. :

Fragmentation: Take 10 each of these products, and measure it according to the third method of injection stopper and gasket puncture debris method (YBB00332004-2015). The number of debris shall not exceed 20.

The puncture force is to take 10 test samples, open the pull ring, use a plastic puncture device, and measure according to the third method of the puncture force measurement method for rubber plug gaskets for injection (ybb00332004-2015). The puncture force of the stopper should not exceed 80N, and no rubber stopper should be pushed into the bottle during the puncture process.

Self sealing and preservation of puncture Take 10 test samples and assemble them on the matching plastic infusion container. Fill the container with a marked amount of water for injection and seal it. Use a plastic puncture device (as shown in picture 1) to puncture the marked part of the gasket vertically. The puncture device punctures the gasket and the container is hung upside down. And there should be no leakage at the puncture site