來源：ECA官網
8. Question: For themanufacturing of solid oral forms: Our local authorities still insist that weneed to re-introduce the 10ppm criteria even though PDE-values are availablefor all products produced in our facility. What could be the intention of thisrequirement?
問：對於口服固體製劑的生產：我們的當地藥監局仍然堅持，我們需要重新引入 10ppm 標準，即使我們工廠所生產的所有產品都有PDE 值。這項要求的意圖是什麼？
Answer: Based on the information the only rational behind thisrequest would be that the authority usually complains in this case, and whichwas also addressed in question 6 on Q&A on the "shared"facilities guideline, is the replacement of existing limits (e.g. 10ppm) byPDE-based limits, especially if these are higher:.
答：根據該信息，此要求的唯一合理依據是，當局通常在此情況下提出質疑，在問題 6 中也提到了"共線"設施指南的問答，即，使用基於 PDE 的限度取代現有的限度（例如 10ppm），特別是如果這些限度更高：
"For existing products, manufacturer's historically usedcleaning limits that should be retained and can be considered as alert limits,provided that when taking cleaning process capability into account, theyprovide sufficient assurance that excursions above the HBEL will be prevented.A similar process should be adopted when establishing cleaning alert levels forproducts introduced into a facility for the first-time."
對於已有產品，製造商應保留長期使用的清潔限度，並可作為警戒限，在考慮清潔工藝能力時，它們可以提供足夠的保證以防止超出HBEL。首次引入的產品在建立清潔警戒限度時，應採用類似的流程。
9.Question:If e.g. one out of several swabs is OOS, is it possible to calculate the realcarry-over from the achieved swab values and compare it to the MACO? So thatnot all relative (to surface) values need to be in spec but the final absolutecarry-over value
問：如果幾個棉籤中有一個是 OOS，那麼是否可以從已取樣的擦拭樣品計算實際總殘留並將其與 MACO 進行比較？因此，並不是所有相對（表面殘留）值都需要符合標準，只要最終的總殘留符合就可以？
Answer: No, on of the fundamental assumption that swab samplingcould be performed is that the residues are evenly distributed on the surface.Additionally regulators generally see it critical if some sort of mean valuecalculation is performed (compare microbiological environmental monitoringaccording Annex 1).
答：不，進行擦拭採樣計算的基本假設是殘留物均勻地分布在表面。此外，如果進行某種平均值計算，監管者通常視為嚴重缺陷（與附錄1微生物環境監測要求同理）。
10.Question:What to do first, swab or rinse, if you are doing both?
問：如果擦拭取樣和淋洗水取樣都採用，先取哪個？
Answer: I would recommend to perform final rinse before swabsampling so no interference from swab sampling could affect the rinse sample.
答：我建議在擦拭取樣前進行最終淋洗取樣，這樣擦拭取樣的幹擾不會影響淋洗取樣。
11.Question:Which microbiologic method do you consider more representative/complete:rinsing, plates or swabbing?
問：哪種微生物方法更具代表性/完整性：淋洗取樣、接觸皿取樣或擦拭取樣？
Answer: Based on my experience recovery rates of rinse and contactplate sampling are often higher than those for swabbing. Some colleagues evencall microbiological swabs a "qualitative" sampling. For samplingcurved surface areas I even would recommend flexible contact plates overswabbing.
答：根據我的經驗，淋洗取樣和接觸皿取樣的回收率往往高於擦拭取樣。一些同行甚至稱微生物擦拭為"定性"取樣。對於對彎曲表面區域的採樣，我甚至會建議在使用柔性的接觸皿。
12.Question:For determination of cleaning agent residue: would a conductivity measurementin the final rinse be totally enough for a cleaning validation or should adirect sampling via Swab and TOC analytics be added at least to verify theresults from conductivity?
問：為了確定清潔劑殘留：在清潔驗證中使用最終淋洗水的電導率測試是否完全足夠，還是至少應該增加擦拭和TOC檢驗的直接取樣方法來確認電導率的結果？
Answer: If the composition of the cleaning media is a simpleanorganic acid or base the concentration of it in the media and also finalrinse sample has a high correlation factor to conductivity measurement. This isalso one reason why especially for Biologics and Biotech products NaOH isfrequently used.
答：如果清洗介質的成分是簡單的無機酸或鹼，其在清洗介質中的濃度，以及在最終淋洗樣品中的濃度，在電導率測試方面具有高度相關性。這也是為什麼特別是生物製品和生物技術產品經常使用NaOH的一個原因。
13.Question:What are the regulatory requirements for recovery for swab tests during methodvalidation, is there a percental limit?
問：在方法驗證期間，棉籤擦拭取樣回收率的法規要求是什麼？是否有百分比要求？
Answer: There are no explicit regulatory requirements regardingchemical swab recovery rate. Common practice is e.g. reflected in PDAs TR No.29; Section 6.5.2 "Swab/Wipe recovery":
答：對於化學棉籤擦拭回收率沒有明確的法規要求。常見的做法參考，如PDATR 29 第 6.5.2 節"棉籤/擦拭回收率"：
"An acceptable swab recovery depends on how that swabrecovery is being used. If the recovery is performed to qualify the samplingmethod without correction of either a limit or an analytical result then arecovery percentage such as 70% or more is typically required. If the recoverypercentage is used to correct a residue limit or an analytical result then arecovery of 50% or more is typically required. An upper limit for percentrecovery should be established to deal with studies where the measured recoveryis greater than 100%. Recoveries of less than 50% typically require a writtenrationale of why that percentage is appropriate."
"可接受的棉籤擦拭回收率取決於如何使用該回收率。如果回收率只是用作取樣方法的標準而不修正可接受殘留限度或殘留檢測結果，則通常需要回收率標準（如 70% 或更多）。如果回收率標準用於校正殘留限度或檢測結果，則通常回收率50% 或更多就可以了。應確定回收率的上限，以處理回收率測試大於 100% 的試驗。回收率低於 50% 通常需要書面的理由說明為何該百分比合適。
14.Question:Is it acceptable after CHT is exceeded to carry out only a disinfection of theequipment or isitobligatory to repeat the whole cleaning process?
問：超過潔淨保持時間CHT後僅對設備進行消毒是否可接受，還是必須重複整個清潔過程？
Answer: Generally CHT has nothing to do with disinfection. Also,it is not advisable to disinfect product contact surfaces with potential riskof leaving disinfecting agent residues on the surface. It should be assessed ona risk-based approach if only final rinsing is sufficient or the whole cleaningprocess needs to be repeated.
答：一般CHT與消毒無關係。此外，不建議對產品接觸表面進行消毒，因為產品接觸表面存在將消毒劑殘留在設備表面的潛在風險。應使用基於風險的方法進行評估，只進行最終衝洗是否足夠，還是需要重複整個清潔過程。