This standard is applicable to chlorobutyl rubber plungers for prefilled syringes. There are two types of plungers: plunger with snap lip (PSL) or plunger with thread (PT).
[Appearance] Take several of this product, and carry out visual inspection in the bright place of natural light. It shall be uniform in surface color and free from: stains, impurities, bubbles, cracks, light stock, roughness, rubber thread, rubber shoulders, sponginess and burrs; defects or jaggedness caused by edge removal; and obvious marks caused by the mold. If there is a sprue runner, it shall not protrude from the surface of the plunger.
[Identification] *(1) Cut 2.0g of this product into granulum, place them in a crucible, add 2.0g sodium bicarbonate to uniformly cover the sample, then place the crucible on electric furnace, slowly heat until carbonization, let it cool down, place it on muffle furnace and heat at 300℃ until it is ashed completely, then take it out and cool to room temperature, add 10ml of water to dissolve and filter it, take 1.5ml of subsequent filtrate and place it at a test tube, add nitric acid for acidification, add a drop of silver nitrate solution and white sediment shall be generated.
(2) Take appropriate amount of this product, determine according to the Method IV in YBB00262004-2015 Packaging Material Infrared Spectrometry and the result shall be basically consistent with the reference spectrum.
[Fitness of plunger and push rod], [plunger lubricity], [plunger sliding performance] and [body tightness] shall be inspected according to the method specified in YBB00112004-2015 Assemblages for Prefilled Syringes (with Stainless Steel Needles), and the result shall meet the requirements.
YBB00072004-2015 The following standards are cited：
YBB00072004-2015 Cited by the following standards：
