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Butyl rubber stopper

Specification 20#
Quality Standards The appearance, dimension and biological and chemical properties should comply with relevant standards
Remark Should provide Registration Certificate of Drug Packaging Materials and Containers

Quality standards of butyl rubber stopper
[material] butyl rubber
[color] grey
[biological property]
1.Exfoliation after being puncturing Exfoliation of the stopper should be no more than 5 pieces.
2.Puncture force  Force required to puncture the stopper should be no more than 10N.
3.Self-tightness     The stopper should be perfectly fitted with its matched bottle.
4.Self-tightness  After three times of puncture, the stopper should meet the requirements for self-tightness test, methylene blue solution should not be penetrated into the bottle
5.Hardness   The Shore A Hardness should not exceed the specified value by ±5 degree.

1.No stains or impurities on the surface.
2.No air bubbles or flaws on the surface.
3.The surface should not be rough with hungry joints.
4.The surface should not be spongy with plastic residues, plastic debris and burrs.
5.No fragmentation or jag due to deflashing
6.No sharp traces created by mould
7.The color of the surface should be even.

[Biological property]
1.No pyrogen
2.No acute toxicity
3.Hemolysis rate should be less than 5.0%

Diameter of the crown 18.5±0.2mm  
Diameter of the neck 13.3±0.1mm
Thickness of the crown 3.3±0.1mm
Height of the slot 7.3±0.1mm
Total height 14.6±0.3mm
Weight  2.7±1g

[Reaction of chemical properties] Comply with 20% of the following requirements 

Items Index
volatile sulfur compounds (calculate by the Na2S/20cm2 rubber surface) , µg No higher than 50
ultraviolet absorbancy degree(220~360nm) No higher  than 0.2
reducing matter(volume of 0.01 mol/L of 1/5KMnO4 consumed by the 20ml of leach solution), ml No higher than 7.0
Conductivity, mS/m No higher than 4.0
Turbidity/ turbidity level No higher than 3.0
PH change value No higher than 1.0
Heavy metal (calculated in Pb2+) , mg/L No higher than 1.0
Ammonium (calculated in NH4+) , mg/L No higher than 2.0
Zinc (calculated in Zn2+) , mg/L No higher than 3.0
Nonvolatile matter (per 100 ml leaching solution), mg No higher than 4.0


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