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有關動物製劑PIC/S GMP規範之充填凍乾背景環境設置

#1
Q 發表於 2022 / 06 / 15
想請教 半成品充填凍乾區域 其背景環境設定為C級區是否可行?? A in C?? 是否有違無菌操作處理未在具有B級背景區域的A級環境中執行風險??
管理員回覆
 
您好,
 
1.根據Annex 1 draft,2020,如果無菌操作是在經過適當驗證的、密閉的A級環境(例如Isolator),其背景環境可設定為C級區。
摘錄相關條文如下供參考:
4.21 For RABS used for aseptic processing, the background environment should meet at least Grade B. The background environment for open isolators should meet Grade C or D, based on a risk assessment. Airflow studies should be performed to demonstrate the absence of air ingress during interventions, such as door openings.
4.22 The background environment of a closed isolator should correspond to a minimum of Grade D. The disinfection/decontamination programme should be included as a key consideration when performing the risk assessment for the CCS of an isolator. Where additional process risks are identified, a higher grade of background should be considered. The decision as to the supporting background environment should be documented in the CCS.

2.半成品充填凍乾區域作業,包括無菌充填、半封塞、移轉至凍乾機、凍乾、封膠塞、卸載,封蓋等作業如果都在密閉的A級環境(Isolator),則其背景環境可為C級區。另外,封蓋作業可以使用無菌操作(aseptic process)或潔淨操作(clean process)。
請參考Annex 1 draft,2020
8.25 Vial capping can be undertaken as an aseptic process using sterilized caps or as a clean process outside the aseptic core. Where the latter approach is adopted, vials should be protected by Grade A conditions up to the point of leaving the aseptic processing area, and thereafter stoppered vials should be protected with a Grade A air supply until the cap has been crimped. Where capping is a manual process it should be performed under Grade A conditions either in an appropriately designed isolator or into Grade A zone with a Grade B background.

​From TPDA
2022/6/27

 

 

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