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What test is required to ensure the quality of sterile product?

We routinely devour eyedrops, injectables, and items that should meet the state of being sterile, yet how could this be accomplished? This trademark is basic for a drug item and should be guaranteed through an appropriately planned and approved assembling process.

Sterility Test

Product sterility is achieved by controlling the bioburden and by using an adequate aseptic technique for the processing. In this sense, the European Pharmacopoeia recommends the Sterility Test to verify if a product complies with this requirement.

How is a Sterility Test performed?

Some vital tests should be recently completed. The first is the Growth Promotion Test, which plans to affirm that the way of life media can advance the development of exceptionally low degrees of microorganisms. Simultaneously, the healthful properties of every medium clump to be utilized are affirmed.

For this purpose, less than 100 CFU of each species stated in the Ph. Eur. must be inoculated in Thioglycollate Fluid Medium (TFM) and Trypticasein Soy Broth (TSB), and also in TSA/SDA as a positive control. Once the incubation is over, the medium is suitable if growth is clearly observed.

The subsequent necessity is the Method Suitability Test, which is done at the same time with the past test to show that the strategy is sufficient to control the item sterility.

The same methods as in the Sterility Test (membrane filtration or direct transfer) are used but the difference is that the product is transferred to each medium, TFM/TSB, and then inoculated with less than 100 CFU of each species.

After incubation, in a visual comparison with a blank (no product), the test is suitable for the product if visible growth is observed. Otherwise, the product possesses antimicrobial activity.

Having referenced the above mentioned, the Sterility Test should be done under aseptic conditions and as shown, by layer filtration or direct exchange. The base and greatest volumes of the item are expressed in the Ph. Eur., just as the technique to be utilized that relies upon the items' inclination:

Sterility Test

The incubation, regardless of the method, must last for 14 days and, after this time, if no turbidity is observed, the product complies with the test.

Only two culture media are necessary? 

Both the Thioglycollate Fluid Medium (TFM)  and the Trypticasein Soy Broth (TSB) are general media with highly nutritious characteristics that allow the growth of a wide variety of bacteria (aerobes and anaerobes) and fungi at very low levels since, under the premise of sterility, a considerable number of microorganisms that may contaminate the product should not be found.

In addition, this method is harmonized with the USP and JP, which is a significant additional advantage.      

In Lab unlimited we have available Condalab media according to pharmacopoeia to perform the Sterility Test without complications as each batch is assessed to comply with high-quality standards to ensure their sterility and performance.

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