We deliver full-turnkey cleanroom design, engineering, construction and qualification services exclusively tailored for biopharmaceutical manufacturing plants, upstream cell culture workshops, downstream purification areas, sterile filling zones, QC laboratories and warehouse classified areas, fully aligned with global cGMP, EU GMP, FDA and NMPA regulatory standards.
Our full-service scope covers partition & ceiling enclosure system, high-efficiency air filtration HVAC system, purified water & pure steam utility piping, interlocking airlocks, pass-through hatches, differential pressure monitoring, cleanroom flooring, integrated lighting, disinfection distribution system and automatic environmental monitoring (EMS) platform. Hygienic modular sandwich panels with smooth seamless joints avoid dust accumulation and microbial retention, supporting frequent CIP/SIP and routine sanitization operations.
Each zone is strictly graded as Class A/B/C/D according to aseptic process layout, with precise control over cleanliness class, temperature, humidity, room differential pressure, air change rate and particle concentration. The design adopts people-material separation workflow to prevent cross-contamination, and embeds complete data acquisition and traceability functions to satisfy data integrity requirements for regulatory inspections and product filing.
We provide one-stop solutions from conceptual layout drawing, detailed construction, on-site installation to third-party validation support, issuing complete qualification documents including DQ/IQ/OQ/PQ. Mature biopharma project experience enables seamless coordination with bioreactors, chromatography skids, filling lines and process equipment suppliers, shortening overall workshop delivery cycle. Suitable for new greenfield factories, plant expansion and cleanroom renovation projects for vaccines, mAbs, cell therapies and injectable drug manufacturers worldwide.
