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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.

삼성바이오로직스는 액상 제형부터 동결건조 제형까지 모든 제형에 대한 개발 서비스를 갖추고 있습니다. 또한 고객이 원하는 시간 내에 안정성과 유효성을 확보하여 최적화된 형태의 제형을 제공합니다. 또한 해당 제형에 따르는 허가 사항까지 고려한 개발 서비스를 통해 고객 만족을 실현하고 있습니다.

제형 개발

  • 제형 개발 사진 1
  • 제형 개발 사진 2
  • 제형 개발 사진 1
  • 제형 개발 사진 2
Formulation Screening system
Formulation
Screening system
Core equipment
  • Formulation Development dedicate Lab.
  • BSC (Bio safety Cabinet)
  • DLS (Dynamic Light Scattering)
  • DSC (Differential Scanning Calorimeter)
  • HPLC (High-Performance Liquid Chromatography)
  • Manual vial filling system (peristaltic type)
Specialized Capability
  • Biopharmaceuticals
  • Monoclonal antibodies
  • Fusion proteins
  • Bispecific antibodies
  • Packaging (Vials and Pre-filled syringe selection)
  • Proteins
  • Peptides
  • Formulation process optimization based on QbD
Formulation Screening system
Formulation
Screening system
Core equipment
  • Formulation Development dedicate Lab.
  • BSC (Bio safety Cabinet)
  • DLS (Dynamic Light Scattering)
  • DSC (Differential Scanning Calorimeter)
  • HPLC (High-Performance Liquid Chromatography)
  • Manual vial filling system (peristaltic type)
Specialized Capability
  • Biopharmaceuticals
  • Monoclonal antibodies
  • Fusion proteins
  • Bispecific antibodies
  • Packaging (Vials and Pre-filled syringe selection)
  • Proteins
  • Peptides
  • Formulation process optimization based on QbD

해동공정

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

조제 공정

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
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
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