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藥廠微生物實驗室管理研討會Q&A (27)

#1
TPDA 發表於 2021 / 05 / 27
1.抗微生物效能試驗所製備的試驗菌種是否一定要調整菌液濃度至1x108 CFU/mL,因黴菌很難培養出1x108 CFU/mL的菌液濃度,是否有培養1x108 CFU/mL黴菌的方法?

2.抗微生物效能試驗中,1~3類產品接種的菌種菌液濃度藥典(中華藥典、USP)是寫添加1x105~1x106 CFU/mL,是否可以如上課講義中所寫的添加105~106 CFU/mL菌液即可?
管理員回覆
 
您好,
 
1.首先若是因適用性需要增加稀釋倍數時,為了仍能測得大於3.0 log的減少值,所以建議較高菌液濃度,若檢品無抑微生物活性,則可無須較高菌液濃度。因為接種後最終產品中培養/調整菌液濃度至105~106 CFU/mL,而欲加入的試驗樣品體積若為100 mL,則接種菌液須達到107~108 CFU/mL,最終產品中菌數濃度才能符合法規方法要求。**可參照講義E-12。
若要增加製備黴菌的濃度,可增加用於繁殖的培養皿數量來收集更多黴菌孢子,離心後,再來調整菌數濃度至所需的黴菌菌液濃度。

2.USP藥典所述為接種後最終產品中的菌種液濃度1 × 105 and 1 × 106 CFU/mL。因此藥典最終產品中的菌種液濃度是寫1x105~1x106 CFU/mL,或是寫成105~106 CFU/mL,不論哪種都需要在試驗時進行接種菌數的計數試驗,確認初始時各項接種的菌數值。
USP<51>內文中Testing of Products …the final concentration of the test preparation after inoculation is between 1 × 105 and 1 × 106 cfu/mL of the product.
**可參照講義E-12、E-15、E-17、E-20和E-21,CHP<7016>抗微生物效能試驗法和USP<51>內文中 Suitability of the Counting Method in the Presence of Product和Testing of Products所述。
Suitability of the Counting Method in the Presence of Product
The ability of the procedure to measure preservative efficacy may be compromised if the method suitability requires significant dilution (102 or 103) as this will affect the measured recovery (e.g., it may be difficult to measure a 3 log unit reduction for a 105–106 inoculum). If no suitable neutralizing agent or method is found and method suitability requires significant dilution, a higher level of inoculum (e.g., 107–108) may be used so that a 3 log unit reduction can be measured. Reported recovery cannot be less than 1 cfu/plate on average (or 100 cfu/mL if 1 mL is plated in duplicate at the 10 dilution).
Membrane fltration may be used to filter larger volumes of dilutions to overcome this difficulty or to assist in the neutralization of antimicrobial properties.

From TPDA
2021/5/31

 

 

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