「英中对照」洁净室暖通设计阶段：有哪些气流设计模型？

During the facility design phase of a new cleanroom project, one of the most critical steps is defining facility flow. This is how personnel and materials will enter, move through, and exit critical spaces.在新洁净室项目的设施设计阶段，最关键的步骤之一是定义设施流程，即人员与物料如何进入、穿行并离开关键空间。

The US FDA, EMA, and other regulatory bodies provide guidance to reduce contamination risk, but they generally do not prescribe a facility layout that fits every application.美国FDA、EMA及其他监管机构会提供降低污染风险的指南，但通常不会规定适用于所有应用场景的设施布局。

Depending on the product type and target market, there may be expectations for segregation of personnel, material, and waste streams within a holistic contamination control strategy.根据产品类型和目标市场，整体污染控制策略中可能会要求对人员、物料和废弃物流进行分隔。

This is especially true for airflow, where the movement of air through a facility is both a reflection of and a driving force behind the broader personnel and material flow strategy; in higher-classification environments such as aseptic fill-finish suites, unidirectional airflow patterns are deliberately engineered to mirror and reinforce one-way movement.在气流方面尤其如此：空气在设施内的流动既是更宏观的人员与物料流策略的体现，也是该策略背后的推动因素；在无菌灌装-完成套件等洁净级别更高的环境中，单向气流模式经过刻意设计，以呼应并强化单向移动。

Here we will look at unidirectional and bidirectional flow下面我们将探讨单向流与双向流

Unidirectional flow单向流

Unidirectional flow is a facility design strategy in which staff and materials move through the cleanroom in a single direction. This design helps prevent finished product from crossing paths with anything that risks contaminating it, including raw materials, waste, kitting areas, or locker rooms.单向流是一种设施设计策略，人员与物料沿单一方向穿过洁净室。该设计有助于防止成品与任何有污染风险的对象发生路径交叉，包括原材料、废弃物、备料区或更衣室。

Layouts that follow this approach often include dedicated supply and return corridors, separate entry and exit airlocks, and a progressive transition through cleanliness zones into and out of critical areas.采用这种方式的布局通常包括专用的供应走廊和返回走廊、相互独立的入口和出口气闸，并在进入和离开关键区域时沿不同洁净区逐级过渡。

Airflow strategy should be selected based on the criticality of the operation and the contamination control strategy.应根据操作的关键程度和污染控制策略选择气流组织策略。

Airflow strategy should be selected based on the criticality of the operation and the contamination control strategy应根据操作的关键程度和污染控制策略选择气流组织策略

For Grade A / ISO Class 5 critical zones where product or sterile components are exposed, unidirectional airflow (UDAF, often referred to as “laminar”) is typically expected, and airflow visualisation studies should demonstrate first-air protection and effective sweep-away behaviour.对于产品或无菌部件暴露的A级/ISO 5级关键区域，通常预期采用单向气流（UDAF，常称为“层流”），且气流可视化研究应证明“第一空气”保护和有效吹扫特性。

Surrounding background areas (e.g, Grade B/C, as applicable) commonly use HEPA-filtered mixed (non-unidirectional) airflow with appropriate recovery, pressure differentials, and verified airflow patterns to support the overall environmental control strategy.周围背景区域（如适用，例如B/C级）通常采用经HEPA过滤的混合（非单向）气流，并具备适当的恢复能力、压差以及经验证的气流流型，以支持整体环境控制策略。

Unidirectional flow eliminates the dual use of airlocks and will often employ certain design features to minimise risk of personnel procedure errors. One useful approach includes magnetic or electrical interlocks to prevent two airlock doors from opening at the same time. That typically avoids use of Wave-To-Open devices on both sides of the door to prevent any personnel from moving back through the entry side.单向流消除了气闸两用的情况，并常采用某些设计特征来最大程度降低人员程序错误的风险。一种实用方法是使用磁性或电气联锁，防止两扇气闸门同时打开。这通常会避免在门的两侧使用Wave-To-Open装置，以防止任何人员从入口侧返回。

When designing for unidirectional flow, it’s essential that your personnel and material entry and exit points are fully integrated into the overall facility layout. Kitting and staging areas should align closely with supply corridors, while material exit points should be positioned near cGMP biostorage, filling suites, or clean shipping areas. 在设计单向流时，必须将人员和物料的出入口完全整合到整体设施布局中。备料区与暂存区应与供应走廊紧密衔接，而物料出口应设置在cGMP生物存储设施、灌装套件或洁净运输区附近。 

Bidirectional flow双向流

Bidirectional flow facilities rely more heavily on HVAC design and air pressure relationships to compensate for the shared movement of personnel and materials through common pathways. Rather than physically separating clean and dirty streams, the airflow strategy recreate this.双向流设施更依赖HVAC设计和空气压力关系，以弥补人员与物料在共用通道内共同移动所带来的影响。气流策略并非从物理上分隔洁净流与脏污流，而是重现这种分隔。

This typically means steeper pressure differentials between adjacent spaces, higher air change rates within cleanrooms and airlocks, and careful attention to the direction of air at doorways and transitions.这通常意味着相邻空间之间的压差更大，洁净室和气闸室内的换气次数更高，同时需密切关注门口及空间过渡处的气流方向。

In bidirectional designs, pass-throughs, whether wall-mounted or floor-cart-based, are a common way to reduce how often doors are opened between zones of different cleanliness classifications, which in turn reduces disruptions to the pressure cascade.在双向流设计中，无论是壁挂式还是落地推车式传递窗，都是减少不同洁净度等级区域间开门频次的常用手段，进而降低对压差梯度的干扰。

Similarly, the shift toward closed RABS or isolators in these environments is partly an airflow decision: these systems create a local unidirectional or contained air environment around the critical zone, reducing dependence on the room-level HVAC.同理，这类环境转向采用密闭式RABS或隔离器，一定程度上是出于气流组织的考量：这些系统会在关键区域周边形成局部单向流或密闭气流环境，降低对房间级HVAC系统的依赖。

Lines of demarcation through gowning and support spaces also serve as a behavioural reinforcement of what the airflow design is already trying to achieve.更衣区与辅助空间内设置的分界标识，也能从行为层面强化气流设计本要实现的管控效果。

Production capacity生产产能

Throughput has a direct bearing on how hard an airflow system has to work and, by extension, which design approach is appropriate.生产吞吐量直接决定气流系统的运行负荷，进而影响适配设计方案的选择。

At lower production volumes, such as those seen in hospital pharmacies or early-stage clinical manufacturing, the frequency of door openings, personnel entries, and material transfers is low enough that pressure cascades and air change rates can recover between disturbances.在产量较低的场景下，例如医院药房或早期临床生产阶段，开门、人员进入及物料转运的频次较低，压差梯度和换气次数在受到干扰后可自行恢复。

Bidirectional flow is more viable in these contexts because the HVAC system is not being continuously challenged.这类场景下采用双向流更为可行，因为HVAC系统不会持续承受高频干扰。

At higher throughput, seen in late-stage clinical or commercial scale manufacturing or in multi-product facilities, the cumulative disruption to airflow from increased activity becomes a meaningful risk.在高吞吐量场景下，例如后期临床生产、商业化规模化生产或多产品生产设施，作业活动增多带来的累积气流干扰会成为实质性风险。

Unidirectional personnel and material flow reduces the number of times cleanroom air boundaries are crossed, allowing the pressure relationships between spaces to remain more stable. It also simplifies the airflow visualisation and qualification picture: when movement through a space is predictable and one-directional, smoke studies and airflow pattern tests are easier to execute and interpret against a defined worst-case scenario.人员与物料单向流动可减少跨越洁净室气流边界的次数，使各空间之间的压力关系保持更稳定，还能简化气流可视化与确认工作：当空间内的移动可预测且为单向时，对照既定最差工况开展烟雾试验与气流流型测试，试验执行与结果判读都更简便。

Facilities designed with future scalability in mind should account for this in the HVAC infrastructure from the outset预留未来扩容空间的设施，应从设计初期就将这一因素纳入HVAC基础设施的考量。

Facilities designed with future scalability in mind should account for this in the HVAC infrastructure from the outset. An early-phase facility built with appropriately sized air handling capacity, return air pathways, and modular ductwork can accommodate the transition to unidirectional flow (and the more demanding airflow requirements that come with it) without requiring a full redesign.考虑未来可扩展性的设施应从建设之初就将该因素纳入HVAC基础设施规划。若早期阶段的设施配置了容量适配的空气处理能力、回风路径与模块化风管，即可在无需全面重新设计的情况下，适配向单向流的转型（以及随之而来的更高气流要求）。

Contamination control污染控制

Personnel movement is one of the leading causes of contamination in the cleanroom, either through the exercise of donning and doffing PPE, gowning errors, or even poor movement in critical spaces.人员活动是洁净室污染的主要诱因之一，污染来源包括穿脱PPE、更衣操作失误，甚至关键区域内的不规范移动。

While certain engineering controls can be integrated into the facility to minimise contamination (strategic low wall return locations, increased Air Change Rates, or timed interlock doors), technicians in the space should follow validated standard operating procedures to ensure compliance. 尽管可在设施中集成特定工程控制措施以尽可能降低污染（如合理布置低位墙装回风口位置、提高换气次数或设置定时联锁门），区域内的操作人员应遵循经过验证的标准操作规程，确保合规。 

Understanding the risk and level of particulate generation during manufacturing/compounding will help guide your SOPs.了解生产/药物调配过程中颗粒物产生的风险与水平，可为SOP的制定提供指导。

It is necessary to design in accommodations for laminar vertical airflow in ISO Class 7/Grade C or cleaner environments. This is typically accomplished by having ceiling-mounted HEPA filters with low-wall return/exhaust grilles to pull air from the ceiling down to the floor.在ISO Class 7/Grade C及更洁净的环境中，设计必须为垂直层流预留配套条件。这通常通过在顶棚安装HEPA过滤器、搭配低位墙装回风/排风格栅，引导气流从顶棚向下流向地面来实现。

This will cause first-pass filtered air to pass cleanly and uniformly over any workstations and processing steps before being removed from the space. 这将使经过初次过滤的空气在排出该区域之前，洁净、均匀地流过所有工作站和工艺步骤。 

It is important that process equipment, such as Biological Safety Cabinets, refrigerators, workstations, etc., do not interfere with this vertical laminar flow by creating “turbulent” airflow. This happens when airflow builds up, gathers potential contaminants, and keeps them in the cleanroom instead of exhausting them out of the space.重要的是，生物安全柜、冰箱、工作站等工艺设备不得因产生“湍流”而干扰这种垂直层流。当气流积聚、聚集潜在污染物并使其留在洁净室内而非排出室外时，就会发生这种情况。

Checking for sources of turbulent airflow should be done during the Environmental Performance Qualification, when static and dynamic smoke tests are performed to visualise the behaviour of air through the cleanroom. Validation and commissioning technicians should mimic actual process steps while performing these smoke studies to verify that the cleanroom conditions will be maintained.
 应在环境性能确认期间检查湍流来源；此时会执行静态和动态烟雾测试，以直观显示气流在洁净室内的运动状态。确认和调试技术人员在进行这些烟雾研究时应模拟实际工艺步骤，以验证洁净室条件将得到维持。