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可否幫我翻譯一下文章呢(生技相關文章)?

可否幫我翻譯一下文章呢(生技相關文章)? 以下為原文...謝

VALIDATION

The first time a product is tested for Antimicrobial Effectiveness, a validation is necessary to show the microorganisms are able to withstand the formulation. A full validation is performed in three independent studies with each of the studies recovering not less than 70% of the growth inoculum versus the control.

It is necessary to revalidate a product whenever a formulation change has occurred, when the manufacturing process has been changed, or when changes in packaging occur.

HOW MUCH PRODUCT IS REQUIRED?

If a product is submitted in liquid form, a volume of not less than 20 mL is preferred. When submitting granular or powdered dosage forms, a weight of 20 grams is preferred. The validation of this product requires an additional 100 mL or grams.

At the time of product submittal, it is necessary to note the category to be tested for the product.

TESTING TIME INTERVALS

Under normal conditions, the turnaround time to perform the Antimicrobial Effectiveness test is 7 weeks due to incubation requirements. However if scheduling arrangements are made prior to product submittal, it is possible to reduce the time needed to prepare the necessary organisms used in testing.

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  • 1 0 年前
    最佳解答

    翻好了

    生效

    第一次一種產品被為抗菌效力測試,生效必要顯示微生物能禁得住公式。 充分的生效被每項研究不少于增長的70% 恢復inoculum 與控制在3 項獨立的研究進行。

    每當當當生產過程已經被改變時,在包裝方面的變化發生時,一種公式變化已經發生的時候,使一種產品重新生效是必要的。

    多少產品被要求?

    如果一種產品被以流動形式提交,一卷不少于20 mL被更喜歡。 當提交粒狀或者給撲粉的劑量形式時,20 克的重量被更喜歡。 這種產品的生效需要另外的100 mL或者克。

    在產品submittal時,注意到種類被為這種產品測試是必要的。

    時間間隔測試

    在正常狀態下,執行抗菌效力考試的周轉時間7 周由於孕育要求。 但是如果安排安排在產品submittal之前被做,降低需要準備在測試過程中使用的必要生物體的時間是可能的。

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