Welcome to Seacross Pharmaceuticals Ltd.
Manufacturing Process
State of the Art facility incorporated with QbD layout designed by GermanEngineering Firm MW Zander.Rigorous GMP compliance in line with EU, FDA and China GMP.
  • Strict unidirectional personnel and material flow.
  • Advanced omniseal RTP for sterile material.
  • Customized equipments by renowned EU brands & cutting-edge technology.
  • Comply with most strict and advanced international quality standards.

Water system
• State-of–art generation system from Finn-Aqua & Steris.
• Fully automated generation & distribution of PW and WFI.
• Class one reverse osmosis membranes, EDI.
• Online TOC, PH, conductivity.        

• Closed system API dispensing.
• RTP charging system of compounding vessels.
• Two stage sterile filtration with on-line integrity detection.
• High precision temperature control, magnetic blending, nitrogen insulation, CIP & SIP system.

Isolator Filling 
• Aseptic filling line of integrated advanced isolator technology with CIP/SIP (VHP sanitizing).
• Integrated with vial washer, depyrogenation tunnel, filler, stoppering, capping line & terminal vial washing and sterilization.
• Online particle and airborne micro-organism monitoring system.
• online weighing.

Automatic Lyophilization 

• Isolator automated loading/unloading system by SRK.
• Automated inspection and leak test, CIP/SIP.
• Advanced auxiliary liquid nitrogen refrigeration.
• Pressure interlock control for door operation.
• No contact nor cross-contamination.

Part 11 and GAMP5 computerized system for the whole filling & isolator line, delivering sterility & lyophilization.

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