YBB 00232004-2015 Pharmaceutical Synthetic Polyisoprene Liners English
This standard is applicable to synthetic polyisoprene liners (hereinafter referred to as "liners") assembled in polypropylene composite covers for infusion containers.
[Appearance] Take several pieces of this product, and check according to Table 1. The results shall meet relevant requirements.
[Identification] Infrared spectrum* Take appropriate amount of this product, determine according to the Method IV in YBB00262004-2015 The test method for infrared spectrum in packaging material and the result shall be basically consistent with the reference spectrum.
[Use Adaptability Test] Take several pieces of this product, assemble it with the matched plastic outer cover and inner cover to form a combined cover, adopt moist heat sterilization method at 121 ℃ ± 2 ℃ for 30 min (if the product is not suitable for sterilization at 121 ℃ for 30 min, the sterilization conditions used in the production of the product may be adopted during the test), cool it to room temperature to make a test sample and carry out the following tests.
Puncture exfoliation Take 10 pieces of this product each and determine it according to the method III of YBB00332004-2015 Test method for fragmentation of closures. The number of exfoliation shall not exceed 20 pieces.
Punching force Take 10 test samples, open the pull ring, and use a plastic puncture device to determine the punching force according to the method III of YBB00322004-2015 Test method for penetration force of closures. The average punching force shall not exceed 75 N, and the punching force of each rubber stopper shall not exceed 80 N, and the rubber stoppers shall not be pushed into the bottle during puncture.
YBB 00232004-2015 Pharmaceutical Synthetic Polyisoprene Liners English
This standard is applicable to synthetic polyisoprene liners (hereinafter referred to as "liners") assembled in polypropylene composite covers for infusion containers.
[Appearance] Take several pieces of this product, and check according to Table 1. The results shall meet relevant requirements.
[Identification] Infrared spectrum* Take appropriate amount of this product, determine according to the Method IV in YBB00262004-2015 The test method for infrared spectrum in packaging material and the result shall be basically consistent with the reference spectrum.
[Use Adaptability Test] Take several pieces of this product, assemble it with the matched plastic outer cover and inner cover to form a combined cover, adopt moist heat sterilization method at 121 ℃ ± 2 ℃ for 30 min (if the product is not suitable for sterilization at 121 ℃ for 30 min, the sterilization conditions used in the production of the product may be adopted during the test), cool it to room temperature to make a test sample and carry out the following tests.
Puncture exfoliation Take 10 pieces of this product each and determine it according to the method III of YBB00332004-2015 Test method for fragmentation of closures. The number of exfoliation shall not exceed 20 pieces.
Punching force Take 10 test samples, open the pull ring, and use a plastic puncture device to determine the punching force according to the method III of YBB00322004-2015 Test method for penetration force of closures. The average punching force shall not exceed 75 N, and the punching force of each rubber stopper shall not exceed 80 N, and the rubber stoppers shall not be pushed into the bottle during puncture.
