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.

Aseptic DS & DP Lyophilization Production Equipment

cGMP Grade 동결건조기(Auto Loading/Unloading System)

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

Aseptic Biological Product(DP) Production Line Equipment for Injections

Glass Vial, Plastic Vial, Pre-filled Syringe, Bag etc.

Biological Product(DS & DP) Lyophilization Production Equipment

cGMP Grade 동결건조기(Auto Loading/Unloading System)

Biological Product Packaging Line Equipment for Injections

Cell Therapy Production Line Equipment

Gene Therapy Production Line Equipment

Clean Air Equipment for Production and QC Sterility Test
C-RABS, Isolator etc ~~~ PIC/S GMP Annex 1 Compliance

Automatic H2O2 Fumigation System

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

Bio Engineering Solution Service : Conceptual, Basic & Detailed Design

Innovative Modular Engineering & Construction Service

새로운 모듈라 형태의 GMP공장 설계 및 시공 서비스