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Pre-Filled Syringe

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Plastic Prefillable

ClearJect® Syringe

Cyclo Olefine Polymer (COP)

Barrel Types & Sizes

Luer Lock Type (LL)

Type O.D.(mm) I.D.(mm) Total Length(mm)
ClearJect 0.5mL LL 10 4.65 64.4
ClearJect 1mL LL 9.4 6.35 64.4
ClearJect 2.25mL LL 11.2 8.65 64.4
ClearJect 3mL LL 11.2 8.65 84.4
ClearJect 5mL LL 15.05 12.45 79

Luer Cone Type (LC)

Type O.D.(mm) I.D.(mm) Total Length(mm)
ClearJect 1mL LC 9.15 6.35 64.5
ClearJect 2.25mL LC 10.85 8.65 64.4
ClearJect 5mL LC 15.05 12.45 79.0

With Needle Type (WN)

Type O.D.(mm) I.D.(mm) Total Length(mm) Needle
Size
ClearJect 1mL WN 8.15 6.35 76.7 22G
–
29G
ClearJect 2.25mL WN 10.85 10.85 84.3

Part name and material

Plastic syringe

Clearject® COP

  • A plastic pre-filled syringe of TAISEI KAKO in Japan
  • Automation system of all processes (Clean room processed)
  • Sterilization: Gamma sterilization (Barrel, Tip cap, Piston)
  • Barrel :CycloOlefin Polymer material (Gamma sterilization)
  • Tip Cap / Piston: Butyl Rubber material (Gamma sterilization)
  • ISO13485-certified production facility
  • Excellent in Damage / Cracking
  • Siliconization: 12,500cSt. Use of medical-grade silicone
  • Inspection: 100% camera inspection performed
  • Packing: Ready-To-Use (RTU) packaging

Cyclo Olefine Polymer (COP)

Comparison of plastic syringe material special features

Gamma-sterilized plastic syringe

Barrel(COP)
Cap/Piston(Butyl Rubber)

Packed after
gamma sterilization

Various sterilization compatible
Autoclave
Ethylene Oxide Gas
Electron Beam

Change in color of Barrel (COP) according to the gamma sterilization process

Non-irradiated barrel

25kGy
irradiation

One week has passed

Four weeks have passed

Biological safety test

Biological safety test

Tested object

  • ISO10993 Biological evaluation for Medical devices
  • External communicating device, blood path, indirect ← 24h

Testing method

  • COP-barrels, Butyl rubber pistons, PTDE-laminated pistons, SUS304-canulas
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

Exractables Assessment

USP1663
  • -Assessment of Extractables Associated with Pharmaceutical
  • -Packaging / Delivery Systems

Tested object

COP barrel, Butyl rubber piston, Teflon-film coating piston

Analysis

Extraction medium : aqueous, organic solvent etc.

Detected compounds

  • γ-Ray irradiation sterilized COP barrel : Total over 34
  • Autoclave-, γ-Ray irradiation- and autoclave-steriliazed butyl - rubber piston : Total over 47
  • Twice autoclave-steriliazed Teflon-film coating piston : Total over 65

Toxicity assessment

Judgement as non-toxic material compared with toxicity data

TAISEI KAKO

ISO13485-certified production facility

ISO-certified and FDA registered

  • License Number: 27B2X00203 (1" Sep., 2015)
    Marketing Authorization Holders for Second-Class Medical Device
  • License Number: 27BZ200369 (21 May, 2015)
    Medical Device Manufacturing License
  • License Number: 27AZ200113 (21 May, 2015)
    License for manufacturer of drugs (Sterile products) by MHLW
  • ISO13485:2016
    Certification Number: JP19/040500
  • ISO 14001:2015 (SGS 14001:2015)
    Certification Number: JP18/071554
  • DMF(Drug Master File) Registration for US-FDA
    Manufacturing of Plastic Syringes: DMF21350
    Manufacturing of Plastic Syringes with Needle: DMF29071

Ready-To-Use Package

TASPACK®

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.