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Quality Standards | ||||
Component | Material | Quality Standard | ||
Glass Barrel | Neutral Borosilicate Glass | National Standard for Pharmaceutical Packaging Materials--Quality Standard for Borosilicate Glass Tubes of Prefillable Syringes | ||
Needle Shield | Polyisoprene | National Standard for Pharmaceutical Packaging Materials--Quality Standard for Polyisoprene Rubber Needle Shield of Prefillable Syringes | ||
Rubber Stopper | Chlorinated/Brominated Butyl Rubber | National Standard for Pharmaceutical Packaging Materials--Quality Standard for Brominated/Chlorinated Butyl Rubber Stopper of Prefillable Syringes | ||
Needle | AISI304 Stainless Steel | National Standard for Pharmaceutical Packaging Materials--Quality Standard for Stainless Steel Needle of Prefillable Syringes |
Inspection Item | Quality Standard |
Appearance | The glass needle tube shall be free of cracks or fractures, the crimp be free of deformation, and the conehead crimp be free of cracks or breakage; the outer surface of the needle tube shall be free of spots, stains or scratches |
Silicone Oil Content | ≤0.7mg per syringe |
Insoluble Particle | For each syringe, the number of particles with a particle size ≥10μm shall be no more than 60, and that with a particle size ≥25μm shall be no more than 6 |
Bacterial Endotoxin | ≤0.5EU/ml |
Sterility Test | Sterile |
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