When performed according to USP <51>, five indicator organisms are utilized for the purpose of challenging the preservative system in a product. Three of the five USP indicator organisms, Escherichia Coli, Pseudomonas aeruginosa, and Staphylococcus aureus, address the growth of bacteria. Candida albicans is the representative yeast, while Aspergillus niger is a mold.
The above listed microorganisms are ATCC cultures and must be harvested under current USP guidelines to assure viability. (Other organisms can be incorporated into the test as customer and product needs dictate.)
A product is inoculated (contaminated) with a number of organisms between 1 x 105 (100,000) to 1 x 106 (1,000,000) colony forming units (CFU) per mL of product. At various intervals, depending on the category, the product is tested to determine its ability to control reproduction or destroy the microorganisms.
A logarithmic reduction is evaluated at each test interval required for the category. By test definition, any growth over the allotted amount for any of the indicated microorganisms renders the preservative in the product not effective.
WHEN DOES A PRODUCT NEED AN ANTIMICROBIAL EFFECTIVENESS TEST?
As part of a stability study, it is beneficial to determine if a preservative system will stand up to the product’s shelf life. It may also be beneficial to determine if the preservative system chosen for a product is compatible with the formulation of the product. The USP procedure is intended for a self-contained finished product.
NOTE: It is necessary to retest the effectiveness of the preservative system any time the formulation is changed or when significant product or packaging changes occur.
- 1 0 年前最佳解答
當依照 USP ＜51> 表現, 五個指示器生物被為了在一種產品中挑戰保存的系統利用。 這五個 USP 指示器生物、大腸杆菌、假單細胞細菌 aeruginosa 和葡萄狀球菌奧里斯 中的三個，處理細菌的生長。 假絲酵母屬白色是代表性的酵母而 Aspergillus niger 是一個模子。
上述的列出微生物是 ATCC 文化而且一定要在對 assu 的現在 USP 指導方針之下被收割