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Clean-up Phase and Recovery Time - is there a Difference?

自凈時間和恢復時間 - 有什么不同？

With the new Annex 1 and the ISO 14644 series, detailed guidelines apply to the planning and GMP-compliant operation of cleanrooms and theirHVAC systems. Nevertheless, or precisely because of this, in practice there is often the question of the "recovery time" and the required "clean-up phase". Are these different requirements, or are they the same? Do they only apply to sterile or also to non-sterile medicinal products? Do they have to be measured in operation or at rest?

新版EU GMP附錄 1 和 ISO 14644 系列有詳細的指南適用于潔凈室及其HVAC系統(tǒng)的規(guī)劃和符合 GMP 的操作。然而，或者正因為如此，在實踐中經(jīng)常存在“恢復時間”和所需的“自凈時間”的問題。他們是相同還是不同？它們僅適用于無菌藥品嗎？還是也適用于非無菌藥品？它們必須在動態(tài)還是靜態(tài)時進行測試？

Clean-up phase

自凈時間

The determination of the clean-up phase is a requirement of Annex 1. It is defined as the time that elapses until the ventilation system has cleaned the particle concentration in the operating state "in operation" to the limit value of the particle concentration for the operating state "at rest". Consequently, the clean-up time is measured starting in the operating state "in operation" and ending in the operating state "at rest". The requirement is that the clean-up phase is less than 20 minutes.

自凈時間是附錄1的一項要求。它被定義為在空調(diào)系統(tǒng)將“動態(tài)”條件下的顆粒濃度自凈到“靜態(tài)”條件的顆粒濃度限度之前經(jīng)過的時間。因此，從“動態(tài)”條件開始測量自凈時間，以“靜態(tài)”條件結束。要求自凈時間少于 20 分鐘。

Annex 1 applies to the production of sterile medicinal products, but can also be used for the production of other forms. This is also extremely sensible, as especially in the dusty production of e.g. solid dosage forms, the avoidance of cross-contamination during a product change is essential. Besides cleaning the manufacturing equipment, the premises and the air in the rooms must also be cleaned before a new product is produced. So it must be known how long the ventilation system needs to reach the clean (at rest) state again. The clean-up phase is determined for premises of cleanliness classes B, C and D (not for zone A) as well as in the non-sterile production areas, as far as reasonable (risk analysis or contamination control strategy).

附錄1適用于無菌藥品的生產(chǎn)，但也可用于其他形式的生產(chǎn)。這也是非常明智的，因為特別是在固體制劑等產(chǎn)塵操作中，避免切換產(chǎn)品期間的交叉污染至關重要。除了清潔制造設備外，在生產(chǎn)新產(chǎn)品之前，還必須清潔房間內(nèi)的場所和空氣。因此，必須知道通風系統(tǒng)需要多長時間才能再次達到潔凈（靜態(tài)）狀態(tài)。B，C和D級潔凈區(qū)（不適用于A級）以及非無菌生產(chǎn)區(qū)域的自凈時間在應確定在合理范圍內(nèi)（風險分析或污染控制策略）。

So, in addition to cleaning validation, compliance with the clean-up phase after product changeover is part of the answer to a GMP inspector's question: "How do you prevent cross-contamination?". And it isalso helpful to know the answer in the production of non-sterile, solid dosage forms.

因此，除了清潔驗證之外，產(chǎn)品切換后的自凈時間符合性也是GMP檢查員問題的一部分：“如何防止交叉污染？在生產(chǎn)非無菌固體制劑時也很有幫助。

Recovery time

恢復時間

The recovery time is a requirement of ISO 14644. The recovery time test is performed to determine whether the cleanroom is capable of returning to its specified cleanliness class within a limited period of time after brief exposure to a source of airborne particles. This test is not recommended for low-turbulence displacement flow (as for the clean-up phase, see above). The recovery time is thus measured in the state at rest, after an amount of particles has been added. The recovery time also provides information on the locking times in airlocks. It is therefore not only recommended for production rooms, but for all rooms with turbulent dilution flow. There is no normative requirement for a recovery time; each company is obliged to define a recovery time. Also, no time interval for measuring the recovery time is specified, but it is carried out during the initial qualification (classification) and is repeated in the event of a change in the room or the air change rate.

恢復時間是 ISO 14644 的要求。進行恢復時間測試是為了確定潔凈室在短暫暴露于空氣顆粒源后，是否能夠在限定的時間內(nèi)恢復到規(guī)定的潔凈度等級。此測試不建議用于低湍流度的置換流（見上文，自凈時間）。因此，在添加一定量的粒子后，在靜態(tài)條件下測試恢復時間?；謴蜁r間還提供有關氣閘互鎖時間的信息。因此，它不僅適用于生產(chǎn)車間，而且適用于所有具有湍流稀釋流的房間。對恢復時間沒有規(guī)范性要求；每家公司都有義務確定恢復時間。此外，沒有規(guī)定測量恢復時間的時間間隔，但它是在初始確認（級別確認）期間進行的，并且在房間或換氣次數(shù)發(fā)生變化時重新測定。

Since both measurements are completely different, measurements of both the recovery time and the clean-up phasehave to be carried out.

由于兩種測量完全不同，因此必須同時進行恢復時間和自凈時間的測量。