how to perform sterility method validation for open method for oily injectables
I couldnt understand open method?
sterility anlysis performed by two methods
open method
and close method
open method there is chances of more contamination as well as more difficulty to proceed analysis as compared to close method… so if u have any ides by open method please give me feed back now…
I think there is membrane filtration and direct inoculation method.
If you mean direct inoculation method as open method its really cheaper and easy to perform. U just directly inoculate your product to the medias (FTM and TSB).
But u may only use it for products that u cant use membrane filtration because of the nature of the product.
“After transferring the contents of the container or containers to be tested (for catgut and other surgical sutures for veterinary use: strands) to the culture medium, add an inoculum of a small number of viable microorganisms (not more than 100 cfu) to the medium.
In both cases use the same microorganisms as those described above under Growth Promotion Test of Aerobes, Anaerobes, and Fungi. Perform a growth promotion test as a positive control. Incubate all the containers containing medium for not more than 5 days.
If clearly visible growth of microorganisms is obtained after the incubation, visually comparable to that in the control vessel without product, either the product possesses no antimicrobial activity under the conditions of the test or such activity has been satisfactorily eliminated. The test for sterility may then be carried out without further modification.
If clearly visible growth is not obtained in the presence of the product to be tested, visually comparable to that in the control vessels without product, the product possesses antimicrobial activity that has not been satisfactorily eliminated under the conditions of the test. Modify the conditions in order to eliminate the antimicrobial activity, and repeat the validation test.
This validation is performed (a) when the test for sterility has to be carried out on a new product; and (b) whenever there is a change in the experimental conditions of the test. The validation may be performed simultaneously with the Test for Sterility of the Product to be Examined.”
USP <71>