某医药企业无菌灌装线Pharmaceutical Aseptic Filling Line
医药食品 · 2022 年交付Pharmaceutical & Food · Delivered 2022
医药食品Pharmaceutical & Food
- 项目背景Project Background
- 洁净车间人工操作多，存在交叉污染风险，且人工记录难满足 GMP 合规追溯要求。Cleanroom operations involved much manual work, posing cross-contamination risks, and manual records could not meet GMP compliance traceability requirements.
- 客户需求Customer Needs
- 减少人工接触、满足 GMP 合规、实现批次级全程追溯。Reduce human contact, meet GMP compliance, and achieve batch-level full-process traceability.
- 设备配置 / 实施方案Equipment / Implementation
- 采用隔离器 + 协作机器人完成无菌灌装与转运，配合 MES 批次管理与电子批记录，全程无纸化追溯。Used isolators + collaborative robots for aseptic filling and transfer, combined with MES batch management and electronic batch records, achieving paperless full-process traceability.
落地效果Results
人工接触降低 80%，批记录合规率 100%，产品不良率下降 45%，顺利通过 GMP 复审。Human contact reduced by 80%, batch record compliance 100%, product defect rate reduced by 45%, successfully passed GMP re-inspection.