Plastic Prefillable
Cyclo Olefine Polymer (COP)
Plastic syringe
Comparison of plastic syringe material special features
Barrel(COP)
Cap/Piston(Butyl Rubber)
Packed after
gamma sterilization
Non-irradiated barrel
25kGy
irradiation
One week has passed
Four weeks have passed
Biological safety test
Evaluation items | Judgement |
---|---|
Acute toxicity test with rats | Accepted |
Skin sensitization with guinea pigs | Accepted |
Cell toxicitytest with rabbits | Accepted |
In vitro hemolysis toxicity test with rabbits blood | Accepted |
Intradermal skin test with rabbits | Accepted |
Pyrogen test with rabbits | Accepted |
Exractables Assessment
COP barrel, Butyl rubber piston, Teflon-film coating piston
Extraction medium : aqueous, organic solvent etc.
Judgement as non-toxic material compared with toxicity data
ISO-certified and FDA registered
It is molded in an ISO 8 grade environment, packed in an ISO 7 grade environmental automation system, and packed in RTU (Ready-To-Use) state with barrel and tip-cap combined.