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충전공정

삼성바이오로직스의 최신 완제설비는 제품의 무균충전, 동결건조 그리고 포장기능이 모두 하나의 라인으로 연결되어 있으며, 자동화시스템과 제한접근시스템(RABS; Restricted Access Barrier System)을 통해 통합운영 및 관리되고 있습니다. 모든 공정은 cGMP를 준수하며 고객과 규제기관의 요건을 만족시키고 있습니다.

삼성바이오로직스의 완제시설은 무균 완제 의약품 제조에 있어
FDA와 EU Annex 1의 모든 요구사항을 충족합니다.

해동 및 조제 공정

Freeze and Thaw System Specifications
Freeze and Thaw System
Equipment
  • Freeze/Thaw skid for cryovessels
  • Freeze/Thaw skid for cryobags
Capacity/Capability
  • Controlled freezing and thawing
  • Max. capacity: 1 tank per station
  • Temperature Range : -70℃ to 40℃
Freeze and Thaw System Specifications
Freeze and Thaw System
Equipment
  • Freeze/Thaw skid for cryovessels
  • Freeze/Thaw skid for cryobags
Capacity/Capability
  • Controlled freezing and thawing
  • Max. capacity: 1 tank per station
  • Temperature Range : -70℃ to 40℃
  • 동결 융해 시스템 사진 1
  • 동결 융해 시스템 사진 2
  • 동결 융해 시스템 사진 1
  • 동결 융해 시스템 사진 2

부형제 준비와 조제(Excipient Preparation & Formulation)

Excipient Preparation & Formulation Specifications
Plant 1
Equipment
  • Excipient and Formulation Vessels
Capacity/Capability
  • Excipient Vessel Capacity: 20L to 3,000L
  • Formulation Vessel Capacity: 20L to 1,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of Excipient and Formulation Vessels
  • Single Use Solutions Capabilities
Plant 2
Equipment
  • Excipient and Formulation Vessels
Capacity/Capability
  • Excipient Vessel Capacity: 200L to 2,000L
  • Formulation Vessel Capacity: 200L to 2,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of Excipient and Formulation Vessels
  • Single Use Solutions Capabilities
Excipient Preparation & Formulation Specifications
Plant 1
Equipment
  • Excipient and Formulation Vessels
Capacity/Capability
  • Excipient Vessel Capacity: 20L to 3,000L
  • Formulation Vessel Capacity: 20L to 1,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of Excipient and Formulation Vessels
  • Single Use Solutions Capabilities
Plant 2
Equipment
  • Excipient and Formulation Vessels
Capacity/Capability
  • Excipient Vessel Capacity: 200L to 2,000L
  • Formulation Vessel Capacity: 200L to 2,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of Excipient and Formulation Vessels
  • Single Use Solutions Capabilities

바이알 세척 준비와 충전

바이알 준비와 충진 사진 1 바이알 준비와 충진 사진 2
  • 바이알 준비와 충진 사진 1
  • 바이알 준비와 충진 사진 2

바이알 충진

Vial filling Specifications
Plant 1
Equipment
  • Washing, Depyrogenation, Vial Filling
  • Stoppering, Capping, Transfer to Lyo
Capacity/Capability
  • Active RABS
  • Filling Rate : up to 12,000 vials/hr (up to 20cc vial)
  • Filling Operation range : 0.1 ~ 100ml
  • Pump types: Piston and Peristaltic
  • CIP/SIP of Vial Filling Machine
  • 1mL to 100mL vial size
  • GRADE A Over Sealing
  • Adaptable process to include single use or fixed systems
Plant 2
Equipment
  • Washing, Depyrogenation, Vial Filling
  • Stoppering, Capping
Capacity/Capability
  • Active RABS, Piston & Peristatic Pump
  • Max. capacity : 300vials / min (based on 10ml vial)
  • Filling Operation Range: 0.1ml to 100ml
  • 100% Weight Check System
  • CIP/SIP of Vial Filling Machine
  • GRADE A Over Sealing
  • Adaptable process to include single use or fixed systems
Vial filling Specifications
Plant 1
Equipment
  • Washing, Depyrogenation, Vial Filling
  • Stoppering, Capping, Transfer to Lyo
Capacity/Capability
  • Active RABS
  • Filling Rate : up to 12,000 vials/hr (up to 20cc vial)
  • Filling Operation range : 0.1 ~ 100ml
  • Pump types: Piston and Peristaltic
  • CIP/SIP of Vial Filling Machine
  • 1mL to 100mL vial size
  • GRADE A Over Sealing
  • Adaptable process to include single use or fixed systems
Plant 2
Equipment
  • Washing, Depyrogenation, Vial Filling
  • Stoppering, Capping
Capacity/Capability
  • Active RABS, Piston & Peristatic Pump
  • Max. capacity : 300vials / min (based on 10ml vial)
  • Filling Operation Range: 0.1ml to 100ml
  • 100% Weight Check System
  • CIP/SIP of Vial Filling Machine
  • GRADE A Over Sealing
  • Adaptable process to include single use or fixed systems

외관 검사

  • 검사 사진 1
  • 검사 사진 2
  • 검사 사진 1
  • 검사 사진 2

외관 검사

외관검사의 항목으로는 Manual Inspection, Automated Inspection 등 이 있습니다.
Manual Inspection
Equipment
  • Manual inspection booths
Capacity/Capability
  • Comprehensive Visual Inspection Program
  • Operators' manual inspection qualification
  • Product Type: Labeler and Lyophilized
  • Defect Classification Library developed for all product types
Automated Inspection
Equipment
  • Automated inspection line
Capacity/Capability
  • Line Speed: 12,000 vials/hr (20R vial)
  • Uses Charge Coupled Device (CCD) camera system to identify vial defects, product defects, closure defects, etc.
외관검사의 항목으로는 Manual Inspection, Automated Inspection 등 이 있습니다.
Manual Inspection
Equipment
  • Manual inspection booths
Capacity/Capability
  • Comprehensive Visual Inspection Program
  • Operators' manual inspection qualification
  • Product Type: Labeler and Lyophilized
  • Defect Classification Library developed for all product types
Automated Inspection (or Leak Detection)
Equipment
  • Automated inspection line
Capacity/Capability
  • Line Speed: 12,000 vials/hr (30mm dia. vial)
  • Uses Charge Coupled Device (CCD) camera system to identify vial defects, product defects, closure defects, etc

포장

포장 사진
포장의 항목으로는 Packaging 등 이 있습니다.
Packaging
Equipment
  • Automated packaging Line
Capacity/Capability
  • Line Speed: 18,000 vials/hr (30mm diameter vial)
  • Pakaging Type: Labeler, Cartoner, Overwrapper
  • Laser Carton Print System
  • Automatic weight check unit between cartoner and overwrapper
포장의 항목으로는 Packaging 등 이 있습니다.
Packaging
Equipment
  • Automated packaging Line
Capacity/Capability
  • Line Speed: 18,000 vials/hr (30mm diameter vial)
  • Pakaging Type: Labeler, Cartoner, Overwrapper
  • Laser Carton Print System
  • Automatic weight check unit between cartoner and overwrapper