Many contract labs perform sterility testing using the traditional method of wiping samples into a Grade A environment. This leads to potential contamination of samples and increases the risk of false positives. At Helvic we have invested in state-of-the-art market leading technology and all of our sterility testing is performed in our purpose built, VHP gassed sterility test isolator, thus eliminating the possibility of false positives.
At Helvic, all sterility testing is conducted in a state-of-the-art GMP Grade A Sterility Test Isolator, incorporating hydrogen peroxide gassing technology in our GMP Clean Room; thus, providing the highest standard conditions for performing a sterility test.
A sterility test may be defined as - 'a test that critically assesses whether a sterilised pharmaceutical product is free from contaminating microorganisms'. The purpose of the test for sterility is to independently provide a means of verifying that any substance, preparation or article is sterile, in accordance with the requirements of the Pharmacopoeia.
Helvic use two methods to perform sterility tests depending on the nature of the product:
Membrane filtration - Sterility Test
For this procedure the test product is filtered through a membrane. Any microbial contamination is retained by the filter. The filter membrane is then incubated in two specific nutrient media for 14 days. This media is then regularly checked for the presence of growth.
Due to the complex nature and skill required to perform sterility testing Helvic utilises an industry standard closed proprietary system to eliminate the risk of contamination. Additionally, all sterility testing at Helvic is performed in our Sterility Test Isolator which incorporates a hydrogen peroxide gas decontamination cycle.
Direct inoculation - Sterility Test
Direct inoculation is only used when membrane filtration is not possible. For this procedure the sample is directly inoculated into the media or the device is placed directly into two specific media and incubated for 14 days.