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滅菌鍋冷點

#1
發表於 2020 / 03 / 02
最終滅菌產品在執行滅菌確校時,發現滅菌鍋排水口位置溫度並非最低溫,且最低溫位置並非固定為鍋內任何位置,想請問在無菌試驗冷點抽樣時的位置如何選擇?有規範可參考嗎?
管理員回覆

您好,
排水口位置溫度有可能並非最低點,所以確效時必須根據不同滅菌裝載,例如在liquid load大型輸注液(LVP)的內部,或porous load 複雜且多孔的過濾器組合的過濾器後端,可能是最冷點。應根據確效結果找出最冷點,作為日後例行滅菌時要放置控制與記錄溫度的探針位置。
當確效結果發現最冷點並非鍋內的某一固定位置。則必須根據實際的數據進一步評估:如果各次試驗的溫度差異性很小(例如<0.5℃),表示滅菌製程穩定,可根據數據分析結果,選擇一最具代表性的冷點。如果各次試驗的溫度差異性很大,應進一步調查,檢討滅菌機的性能、純蒸汽的品質、滅菌鍋洩漏試驗、空氣排除效果、裝載型式、溫度分布試驗等因素是否正常,找出根本原因,解決問題。必要時得考慮重新開發滅菌製程。
請參考 Annex 1 draft, 2020 條文8.50 The position of the temperature probes used for controlling and/or recording should be determined during the validation which should include heat distribution and penetration studies and, where applicable, also checked against a second independent temperature probe located at the same position.
以及條文10.6 The sterility test should be performed under aseptic conditions. Samples taken for sterility testing should be representative of the whole of the batch but should in particular include samples taken from parts of the batch considered to be most at risk of contamination, for example:
  1. For products which have been filled aseptically, samples should include containers filled at the beginning, middle and end of the batch and after any significant intervention (e.g. interventions where the integrity of a barrier is breached (open door)) or an operator intervention into critical zones.
  2. For products which have been heat sterilized in their final containers, samples taken should be representative of the worst case locations (e.g. the potentially coolest or slowest to heat part of each load).
  3. For products that are lyophilized, samples taken from different lyophilization loads.
Note: Where the manufacturing process results in sub-batches (e.g. for terminally sterilized products) then sterility samples from each sub-batch should be taken and a sterility test for each sub-batch performed. Consideration should also be given to performing separate testing for other finished product tests.


From TPDA
2020/3/11
發表於 2020 / 03 / 12
管理員你好,廠內滅菌製程算是穩定的,這樣代表性冷點的選擇會建議以甚麼當依據呢?確效時出現最低溫的次數?接近排水口?接近溫控點? 目前我們的做法是每年依據去年該滅菌條件執行熱滲透時的數據選擇最低溫的位置當作當年度每鍋滅菌後例行的冷點抽樣位置,每年的抽樣位置未必相同,這樣適當嗎?
管理員回覆
 
您好,
 
滅菌釜/鍋之的最冷點位置可能不盡相同,可因機台性能差異、滅菌物件差異等因素造成冷點轉移。若冷點的溫度都在規格內,且溫差範圍很小,應該沒有問題,只要合理說明即可。可依據過去滅菌歷史資料佐證冷點之選擇。
但須定期進行再確效。以確保滅菌釜/鍋的滅菌效力符合預期規畫之效力。
 

From TPDA
2020/3/27

 

 

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