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Project Background
A pharmaceutical enterprise's solid-preparation workshop has a Class C clean zone with a high air-change rate and enormous exhaust volume.
Challenges
Exhaust air is hot and humid; direct discharge wastes energy and disturbs the temperature/humidity balance of adjacent zones.
Solution
Integrated inside the AHU:Rotary Heat Exchanger, recovering exhaust energy to pre-treat the fresh air and reducing the fresh-air handling load.
Results
Fresh-air treatment energy reduced by 25%, while the chiller load drops in tandem and the clean-zone parameters become more stable.
制药洁净车间排风改造
制药洁净车间换气次数高、空调能耗大。在确保压差与洁净度不受影响的前提下,对排风进行热回收可降低新风处理负荷。改造需重点评估交叉污染风险与漏风率,选用符合洁净要求的密封结构,详见规格型号清单。
合规前提
改造须满足 GMP 对压差与洁净度要求,热回收不应破坏房间梯度压差,建议由具备医药洁净经验的单位设计与验证。
合规前提
改造须满足 GMP 对压差与洁净度要求,热回收不应破坏房间梯度压差,建议由具备医药洁净经验的单位设计与验证,确保合规与能效兼顾,不影响药品生产质量。
洁净改造的验证应覆盖静态与动态工况,确保各状态均满足规范;验证报告应归档,作为后续审计与复检的基准。
建议把改造后的压差与洁净度验证列为验收硬指标,并保留动态工况下的测试记录,作为合规审计与后续复检的可靠基准,确保长期符合要求。
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