Laboratory Services >> Sterile Products Testing >> Viral Penetration Test

Viral Penetration Test

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BACKGROUND:

Globally, there are rising concerns over transmission of infectious agents through barrier materials such as those used in medical gloves and condoms. The users of these protective products (ie. healthcare professionals and ordinary consumers) needs to be assured that the barrier materials and devices can protect them from deadly human pathogenic viruses, e.g. the human immune-deficiency viruses (type 1 and 2), the herpes simplex viruses (type 1 and 2), and hepatitis B virus. Hence, studies have been conducted to understand how best to test the efficacy of various barrier materials.


PRINCIPLE OF TEST:

Viral penetration test is conducted to check the barrier properties of condoms. The test is based on ISO 23409:2011 (Male condoms: Requirements and test methods for condoms made from synthetic materials).

ISO 23409:2011 specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.

This method can be modified to test for other latex products such as clinical and surgical gloves. The sample under test is positioned inside the restraining device (sheer fabric) to restrict the sample from over expansion; the sample is then filled with a suspension of surrogate virus bacteriophage phi X174. The leakage of viral particles through the sample is detected by submerging the sample into the collection fluid. The collection fluid is then assayed for presence of viral particles.


SAMPLE REQUIREMENT:

Normally, 20 units per batch needs to be tested and this has to be conducted on 3 different batches. This may vary depending on the product and test requirement. Contact us to discuss further.


TURNAROUND TIME:

Depending on the product and test requirement, this may vary. Contact us to discuss further.