我们依托自有工艺开发,遵循 DbA®(Design by Application)产品开发理念,配备工艺装备与深耕生物制药行业多年的技术应用专家团队;围绕下游分离纯化与流体管理场景,提供涵盖工艺开发、自动化定制、合规验证、运维保障的全周期专业服务,适配从实验室研发、中试放大到规模化生产的多阶段需求,助力客户推进项目落地,保障工艺稳定合规运行。
Full-Lifecycle O&M Support
Scheduled inspections & maintenance —on-site health checks, consumable part reviews, and routine upkeep that catch issues before they become problems
Software upgrades —continuous feature updates and version improvements that keep your equipment running at peak performance
Technical training —hands-on training for operators, maintenance teams, and process engineers, tailored to your equipment and workflow
Fault response support —fast, expert support when something goes wrong, so you're back up and running with minimal downtime
End-to-End Technical Support
Process parameter optimization — flux analysis and process matching, from TMP and membrane flux screening to cassette lifetime assessment and cleaning
Process system development — buffer system selection and ultrafiltration protectant screening, tailored to your specific feed stream and purification goals
Customized adaptation —on-demand hardware modifications and software customization that fit your unique process scenario
Acceptance testing support —factory acceptance testing (FAT), site acceptance testing (SAT), and performance validation to ensure compliant, worry-free delivery
Automation Integration & Customization
Unit-level workstation integration — linking multiple devices into local automated work cells for end-to-end automation of a single process step
Production-level system integration —connecting to plant SCADA, factory MES, and other systems for seamless data flow and coordinated production control
Turnkey cell development — full-lifecycle customization of automation cells, from solution design and testing through deployment
Hardware & software adaptation —hardware customization and interface optimization, with LIMS integration for the lab and SCADA/MES integration for production—all built for full data traceability
Lifecycle Validation & Compliance
Installation/Operational Qualification (IQ/OQ) —installation verification and functional testing performed per protocol, with complete validation records that meet delivery compliance requirements
Preventive Maintenance Validation (PM) — periodic calibration, inspection, and performance verification, with compliant maintenance records that keep your equipment aligned with operating standards
Instrument Requalification — comprehensive performance verification and compliance reconfirmation for periodic re-inspection, site relocation, and major repairs—so your equipment stays audit-ready
Digital Validation Documentation —tandardized electronic validation files that meet data traceability requirements and make compliance audits straightforward
Every service is performed by certified engineers and comply with GMP, FDA 21 CFR, and other applicable regulations and industry standards.
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