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高壓滅菌釜驗證問題

#1
AnnyWuu 發表於 2019 / 09 / 16
想詢問一下 在做微生物挑戰的時候 計畫書的規格寫 滅菌期間每條T-Type Thermocouple之溫度差異應在2度C內,這裡指的2度C是指每一條T-Type Thermocouple的各自平均後的差異還是T1~T6(假設有6條)每個時間點的平均差異呢 因為廠內兩種算法都有人用,若是比較正規的應該採用哪一種呢 再麻煩各位解惑 謝謝
管理員回覆

您好,

應該是指在滅菌期間(sterilization holding time/dwell time)每一個溫度量測時間點, 每一條TC的溫度與滅菌艙的監控參考點溫度的最大差異不超過2度C。請參考EN 285,2015, Chapter 8.2.1.2.3以及Figure C.1.的說明,摘錄如下:
8.2.1.2.3 Throughout the holding time the temperature measured at the reference measurement point of the sterilizer chamber, any temperature measured within the test pack(空氣不易移除的試驗包,內放五支溫度探針) and the theoretical temperature of the saturated steam determined from the measured sterilizer chamber pressure(如果滅菌機量測溫度時可同時顯示壓力,則可依據壓力推算飽和蒸汽的理論溫度,此理論溫度與參考點溫度及試驗包顯示的三個溫度應符合下列規範) shall:
a) be within the sterilization temperature band;
b) not differ from another by more than 2 K.
See also Figure C.1.
The correlation between steam pressure and temperature of saturated steam shall be determined.



From TPDA
2019/10/2
WII 發表於 2020 / 03 / 10
您好! 廠內產品之滅菌方式為溼熱滅菌法,產品之放行擬由每天每鍋改為每週一次之BI結果,並搭配滅菌鍋之每日點檢、機械性監測、真空監測及化學性監測等,且依5M1E法、風險評估擬訂計畫書以做為評估依據,想詢問其可行性及需補充之測試為何
管理員回覆

您好,

先釐清您的問題重點是否為:產品之放行擬由每天每鍋(之BI結果)改為每週一次之BI結果…其可行性為何?
溼熱滅菌只有在滅菌確效時才需要以BI執行微生物挑戰試驗,在日常滅菌通常不放置BI,所以你的問題理論上可以不存在。而且,僅使用BI的結果並不能保證滅菌行程符合標準;產品放行前應審查所有的關鍵滅菌參數以及製程上的要求,確認都符合規格,產品才能放行。
請參考Annex 1draft, 2020條文8.41 Suitable BIs placed at appropriate locations may be considered as an additional method to support the validation of the sterilization process. BIs should be stored and used according to the manufacturer’s instructions. Where BIs are used to support validation and/or to monitor a sterilization process (e.g. for ethylene oxide), positive controls should be tested for each sterilization cycle. If BIs are used, strict precautions should be taken to avoid transferring microbial contamination to the manufacturing or other testing processes. BI results in isolation do not give assurance of sterilization and should not be used to override other critical parameters and process design elements. 最後一段句子的說明。
另外說明,通常加熱(濕熱與乾熱)的滅菌確效要放BI,但日常滅菌時則不用放BI監測;放射線滅菌的確效與日常監測可以不放BI,而氣體滅菌(例如ethylene oxide)於確效以及日常滅菌都要放置BI監控。可進一步參考EP 5.1.2. BIOLOGICAL INDICATORS AND RELATED MICROBIAL PREPARATIONS USED IN THE MANUFACTURE OF STERILE PRODUCTS
 
根據PIC/S GMP Annex 1條文描述,滅菌過程需要透過適當的驗證方式來確認,並依據風險管理計畫的時程進行至少一年一次的再確效。
建議相關風險管理可參照ICHQ9及HACCP(危害分析重點管制點)等風險評估,若有代工等作業須注意議約事項是否符合。
  
註一:請參考PIC/S GMP Annex 1
8.38 The validity of the sterilizing process should be reviewed and verified at scheduled intervals based on risk. Heat sterilization cycles should be revalidated with a minimum frequency of at least annually.

From TPDA
2020/3/27

 

 

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