对于无菌制剂生产线，究竟哪些区域、哪些设备、哪些操作需要通过气流流型的研究，以证明不存在产品污染的风险？针对这个具体的话题，搜集整理了欧盟GMP附录1<无菌制剂>中相关的内容，具体如下：
Grade A: The critical zone for high-risk operations (e.g. aseptic processing line, filling zone, stopper bowl, open primary packaging or for making aseptic connections under the protection of first air). Normally, such conditions are provided by a localised airflow protection, such as unidirectional airflow workstations within RABS or isolators. The maintenance of unidirectional airflow should be demonstrated and qualified across the whole of the grade A area.（A级区域的单向流应经过气流流型的确认）
The design of open isolators should ensure grade A conditions with first air protection in the critical zone and unidirectional airflow that sweeps over and away from exposed products during processing.
The design of closed isolators should ensure grade A conditions with adequate protection for exposed products during processing. Airflow may not be fully unidirectional in closed isolators where simple operations are conducted. However, any turbulent airflow should not increase risk of contamination of the exposed product. （对于密闭式隔离器，自动化程度较高，不一定完全是单向流的设计，但湍流的位置应证明不会影响产品的无菌）Where processing lines are included in closed isolators, grade A conditions should be ensured with first air protection in the critical zone and unidirectional airflow that sweeps over and away from exposed products during processing.（敞口容器上方的第一气流不应被破坏）
The background environment for RABS used for aseptic processing should correspond to a minimum of grade B and airflow pattern studies should be performed to demonstrate the absence of air ingress during interventions, including door openings if applicable.（采用RABS进行灌装生产时，干预操作应通过气流流型的确认，包括开门干预，证明低级别的空气不会进入高级别区域）
Airflow patterns within cleanrooms and zones should be visualised to demonstrate that there is no ingress from lower grade to higher grade areas and that air does not travel from less clean areas (such as the floor) or over operators or equipment that may transfer contamination to the higher grade areas. Where unidirectional airflow is required, visualisation studies should be performed to determine compliance. When filled, closed products are transferred to an adjacent（临近的） cleanroom of a lower grade via a small egress point, airflow visualisation studies should demonstrate that air does not ingress from the lower grade cleanrooms to the grade B area. （对于已经密封的产品，比如轧盖后，产品通过轨道传输至低级别的临近房间，二个房间之间的鼠洞应经过可视化气流流型的确认）Airflow pattern studies should be performed both at rest and in operation (e.g. simulating operator interventions). Video recordings of the airflow patterns should be retained.
The background environment for isolators or RABS should ensure the risk of transfer of contamination is minimized. For isolator, airflow pattern studies should be performed at the interfaces of open isolators to demonstrate the absence of air ingress.（对于开放式隔离器，二头的鼠洞需要经过可视化气流流型的确认，包括静态和动态）
Where aseptic operations are performed, microbial monitoring should be frequent using a combination of methods such as settle plates, volumetric air sampling, glove, gown and surface sampling (e.g. swabs and contact plates). The method of sampling used should be justified within the CCS and should be demonstrated not to have a detrimental impact on grade A and B airflow patterns. （A级和B级区所进行的环测操作也应该经过气流流型的确认）
