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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

파트 명칭 및 재질

플라스틱 주사기

Clearject® COP

  • 일본 TAISEI KAKO사의 플라스틱 프리필드 주사기
  • 모든 공정 자동화 시스템 (Clean room 진행)
  • Sterilization : 감마멸균 (Barrel, Tip cap, Piston)
  • Barrel : Cyclo Olefine Polymer 소재 (감마멸균)
  • Tip Cap / Piston : Butyl Rubber 소재 (감마멸균)
  • ISO13485 인증 생산시설
  • Damage / Cracking에 우수
  • Siliconization : 12,500cSt. 의료등급 실리콘 사용
  • Inspection : 100% 카메라 검사 수행
  • Packing : Ready-To-Use (RTU) 포장

Cyclo Olefine Polymer (COP)

플라스틱 주사기 재질 특성 비교

감마 멸균 완료 플라스틱 주사기

Barrel(COP)
Cap/Piston(Butyl Rubber)

감마멸균 완료 후
Packing

다양한 멸균 호환 가능
Autoclave
Ethylene Oxide Gas
Electron Beam

감마멸균 진행에 따른 Barrel (COP)의 색 변화

Non-irradiated barrel

25kGy
irradiation

One week has passed

Four weeks have passed

Biological safety test

생물학적 안정성 시험 통과 완료

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

용출물 평가 시험 통과 완료

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 인증 생산시설

ISO 인증 및 FDA 등록 완료

  • 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 포장

TASPACK®

ISO 8등급 환경에서 성형 되고, ISO 7등급 환경 자동화 시스템에서 포장되어, Barrel과 Tip-cap이 결합된 RTU (Ready-To-Use) 상태로 포장됩니다.