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Autoclave確效中的BI規範

#1
Kris 發表於 2018 / 10 / 25
您好 請教用於Autoclave的滅菌裝載確效中的BI 除了USP中規範的D value, Population外 需將此BI計算FBIO value大於12列為acceptance criteria嗎? 如acceptance criteria已設定F0大於15 FBIO還需要列入考量嗎? 謝謝
管理員回覆

滅菌製程確效除了物理性的殺菌力(FPhysical),也要驗證微生物的殺菌力(FBiological)。所以二者都要列入考量,設定規格。例如BI(Geobacillus stearothermophilus  )的D值為2 (通常為1.5- 2.5),孢子數量為106,滅菌後所有的BI都未生長,其F Bio>6,可推斷 D值為1的負荷菌其殺菌力F Bio為> 12 (2 * 6)。此結果必須與F Phy比對,例如最冷點的F0值(F0=13.5滅菌期間不同溫度換算後相當於121度C的累積滅菌時間13.5分。
對濕熱的過度滅菌(overkill),EP與USP有不同定義:
1. EP是規定濕熱過度滅菌的條件為:121度C,15分鐘。
2. USP 1229對過度滅菌的定義如下:
Overkill sterilization can be defined as a method in which the destruction of a high concentration of a resistant microorganism supports the destruction of reasonably anticipated bioburden present in routine processing. That objective can be demonstrated by attaining any of the following:
1. a defined minimum lethality;
2. a defined set of method conditions; or
3. confirmation of minimum log reduction of a resistant biological indicator.
另外,PDA TR 01對過度滅菌的定義為
Overkill Design Approach: A sterilization design approach where minimal information is required about the product bioburden. A worst-case bioburden assumption is used to determine the delivered lethality needed to achieve a PNSU of 10-6on or in the items being sterilized. When using this approach, the qualification program must demonstrate that both the F bio and F phy are greater than 12 minutes.
 
FROM TPDA
2018/12/28

 

 

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