4.26 Cleanroom classification is part of the cleanroom qualification and is a method of assessing the level of air cleanliness against a specification for a cleanroom or clean air equipment by measuring the total particle concentration. Classification activities should be scheduled and performed in order to avoid any impact on process or product quality. For example, initial classification should be performed during simulated operations and reclassification performed during simulated operations or during aseptic process simulation (APS).
潔凈室分級是潔凈室確認的一部分，是一種根據潔凈室或潔凈空氣設備的標準通過測定總微粒濃度來評估空氣潔凈度水平的方法。分級活動的安排和執行，應避免對工藝或產品質量產生任何影響。例如，應在模擬操作期間進行初步分級，在模擬操作或無菌工藝模擬試驗（APS）期間進行再分級。
4.27 For cleanroom classification, the total of particles equal to or greater than 0.5 and 5 μm should be measured. This measurement should be performed both at rest and in simulated operations in accordance with the limits specified in Table 1.
對于潔凈室分級，應測定等于或大于0.5μm和5μm的微粒總數。應按照表1中規定的限度，在靜態和模擬操作中進行測定。
Table 1: Maximum permitted total particle concentration for classification
表1：各級別允許的最大總微粒濃度
(a) Classification including 5μm particles may be considered where indicated by the CCS or historical trends.
在CCS或歷史趨勢中有說明的情況下，可以考慮包括5μm微粒的分級。
(b) For grade D, in operation limits are not predetermined. The manufacturer should establish in operation limits based on a risk assessment and routine data where applicable.
對于D級區，沒有預先確定的動態限度。生產商應根據風險評估和適用的常規數據建立動態限度。
9.14 A total particle monitoring program should be established to obtain data for assessing potential contamination risks and to ensure the maintenance of the environment for sterile operations in a qualified state.
應建立總粒子數監測計劃，將獲得的數據用于評估潛在污染風險，并確保無菌操作環境維持在經確認的狀態。
9.15 The limits for environmental monitoring of airborne particle concentration for each graded area are given in Table 5.
各級別空氣懸浮顆粒濃度環境監測限度見表5。
Table 5: Maximum permitted total particle concentration for monitoring.
表5：監測最大允許的總粒子濃度。
(a) For grade D, in operation limits are not predetermined. The manufacturer should establish in operation limits based on a risk assessment and on routine data, where applicable.
對于D級，動態限度未預先確定。生產商應根據風險評估和適用的常規數據建立動態限度。
4.31 The microbial contamination level of the cleanrooms should be determined as part of the cleanroom qualification. The number of sampling locations should be based on a documented risk assessment and the results obtained from room classification, air visualization studies and knowledge of the process and operations to be performed in the area. The maximum limits for microbial contamination during qualification for each grade are given in Table 2. Qualification should include both “at rest” and “in operation” states.
潔凈室的微生物污染水平應作為潔凈室確認的一部分進行確定。采樣點的數量應基于書面的風險評估、房間分級結果、氣流可視化研究以及對該區域要進行的工藝和操作的了解。表2給出了各級別確認過程中的微生物污染最大限度。確認包含“靜態”和“動態”條件中。
Table 2: Maximum permitted microbial contamination level during qualification
表2：確認過程中允許的最大微生物污染水平
(a) Settle plates should be exposed for the duration of operations and changed as required after a maximum of 4 hours. Exposure time should be based on recovery studies and should not allow desiccation of the media used.
沉降碟應在操作期間暴露，并在最多4小時后按需要更換。暴露時間應基于回收率研究，并且避免所所用培養基干燥。
9.30 Action limits for viable particle contamination are shown in Table 6
表列出了活性粒子污染的行動限
(a) Settle plates should be exposed in grade A and B areas for the duration of operations (including equipment set-up) and changed as required after a maximum of 4 hours (exposure time should be based on validation including recovery studies and it should not have any negative effect on the suitability of the media used).
沉降碟應在操作期間（包括設備安裝）暴露在A級和B級區，并在最多4小時后按要求更換（暴露時間應基于驗證，包括回收研究，不應對所用培養基的適用性產生任何負面影響）。
- For grade C and D areas, exposure time (with a maximum of 4 hours) and frequency should be based on QRM.
-對于C級和D級區，暴露時間（最多4小時）和頻率應基于質量風險管理（QRM）。
- Individual settle plates may be exposed for less than 4 hours.
-單個沉降碟的暴露時間可以少于4小時。
(b) Contact plate limits apply to equipment, room and gown surfaces within the grade A and grade B areas. Routine gown monitoring is not normally required for grade C and D areas, depending on their function.
接觸碟限度適用于A級和B級區內的設備、房間和潔凈服表面。C級和D級區通常不需要進行常規工作服監測，具體取決于該區域的功能。
(c) It should be noted that for grade A, any growth should result in an investigation.
應注意，A級區域如有任何長菌情況都應進行調查。
