우리의 취급 서비스 및 품목 요약(Our Service & Items Summary)

System for Chemical Drug(Turnkey Project)

 - Aseptic Drug Product(DP) Production Line Equipment for Injections, Eye Drop & Liquids

[Autoclave - H₂O₂ Fumigation System ] +
[Preparation & Formulation System – Sterilization by filtration] +
[Vial Washer – Tunnel Sterilizer – Aseptic Filing Machine – Aseptic Lyophilization Machine (Auto Loading/Unloading System) - Capping Machine] +
[C-RABS or Isolator]
[Vial inspection M/C + Leak Tester + Labelling M/C + Packaging Equipment] +
[Process Control & Monitoring Computerized System]

 - Glass Vial, Plastic Vial, Ampoule, Pre-filled Syringe, BFS, Bag, Bottle etc.
 - PIC/S GMP Annex 1, 21 CFR Part 11 and Data Integrity Compliance.

 - Aseptic DS & DP Lyophilization Production Equipment

 - cGMP Grade 동결건조기(Auto Loading/Unloading System)

 - Drug Product Packaging Line Equipment for Injections, Liquids, OSD…

 - OSD Production Line Equipment : Tablet Press Machine / Capsule Filling Machine / Softgel Encapsulation Machine / Coating Machine / Dryer / Granulator / Mixer / Pulverizer / Screening Machine / Assistant Machine

 - Oral Liquid Filling Line Equipment

System for Biological Drug(Turnkey Project)

 - Biological Product(Drug Substance, DS) Production Line Equipment

 - USP Production Line Equipment : Cell Culture or Fermentation, Harvest & Clarification ~~~ Stainless Steel & Single Use System
 - DSP Production Line Equipment : Purification, Diafiltration & Concentration + Bulk Formulation & 1^st Packaging + Freezing(Option)
 - Process Control & Monitoring Computerized System
 - PIC/S GMP Annex 1, 21 CFR Part 11 and Data Integrity Compliance

 - Cell Therapy Production Line Equipment

 - Gene Therapy Production Line Equipment

Equipment

 - Clean Air Equipment for Production and QC Sterility Test

 - C-RABS, Isolator etc ~~~ PIC/S GMP Annex 1 Compliance

 - cGMP Particle Monitroing System(TSI)
      Portable Particle Counters / Real-Time Viable Particle Counter / Remote Particle Counters

 - GMP Validator/Data Logger for Thermal Validation
      CGMP Compliance + 21 CFR Part 11 Compliance + Data Integrity Compliance

GEP/Engineering(Turnkey Project)

 - Innovative Modular Engineering & Construction Service
        새로운 모듈라 형태의 GMP공장 설계 및 시공 서비스

• 1) Conceptual Design & URS ---
  2) Project Master Planning ---
  3) Basic & Detailed Design & Technical Specification ---
  4) Design Qualification --
  5) Off-site Fabrication/FAT & Prequalification(Supplier Site) ---
  6) Transportation(From Supplier Site to User Site) ---
  7) On-site Engineering & Construction(User Site) ---
  8) Qualification ---
  9) Handover ---
  10) Maintenance Supporting Service & Requalification Service