We deliver fully integrated turnkey solutions for cGMP-compliant sterile injectable manufacturing plants, covering vials, ampoules, pre-filled syringes, infusion bags and large-volume injection production lines. Following EMA Annex 1, FDA cGMP, PIC/S and ISPE standards, our full-package service covers all stages from site planning, Grade A/B/C/D cleanroom design, process equipment supply, utility system fabrication, installation, automation integration to on-site commissioning and complete CQV validation support.
Our integrated scope includes rational unidirectional flow zoning for personnel and materials, isolator / RABS filling systems, customized HVAC with high-efficiency filtration, WFI & pure steam distribution networks, CIP/SIP circulating pipelines, sterilization equipment, BMS & EMS monitoring systems, as well as packaging and quarantine areas. We adopt a risk-based contamination control strategy to eliminate cross-contamination, particle and microbial risks at the design stage.
Suitable for greenfield commercial factories, modular compact injectable workshops and GMP reconstruction of existing sterile plants, our single-contract turnkey model removes the hassle of coordinating multiple vendors. Upon project handover, we provide full validation documentation, operator training and long-term after-sales technical service, enabling clients to launch audit-ready sterile injectable production rapidly and cut overall project cycle and investment costs.
