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Sterility

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.

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. Vaporised Hydrogen Peroxide (VHP) overcomes the problems of ‘spray and wipe’ practice of transferring items into the test area.

Problems with ‘Spray & Wipe’ include:

  • Human factors
  • Difficult to validate
  • Difficult to ensure proper coverage / contact time

Advantages to VHP include:

  • Effective bactericides, fungicides & sporicides
  • Reproducible
  • More robust

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.

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

Industry

  • Pharmaceuticals
  • Biologics & Biopharmaceuticals
  • Medical Devices

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