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Sterility Testing

All sterility testing is carried out within our fully validated and assured dedicated clean rooms within an ‘A’ grade Laminar Flow cabinet. The clean rooms include a ‘B’ grade room where the LAF cabinet is housed and a dedicated and controlled support room facility. 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.

sterility testing

There are two sterility methods employed at Derby Teaching Hospitals Laboratory: 

Direct Inoculation Sterility Testing - Direct inoculation is used when membrane filtration is not possible. For this procedure the sample is directly inoculated into the media or the device and incubated for 14 days. 

  • Membrane Filtration Sterility Testing - Membrane filtration is carried out using a dedicated Sartorius Sterisart® sterility testing pump. 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 a 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 an industry standard closed proprietary system to eliminate the risk of contamination. For new products and services validation may be required, this is assessed before a new order is initiated.
sterility testing room

Derby Teaching Hospitals laboratory provide Sterility Testing on a range of products, these include:

  • Liquids
  • Solids
  • Parental Preparations including PN (Parenteral Nutrition) products i.e. lipid and non-lipid
  • Non active radiopharmaceuticals
  • Ophthalmic & Other Non-Injectable
  • Preparations
  • Bulk Solids
  • Devices

If you require more information please contact Marc Sutton (Head of QC) on direct telephone number 01332 787950 or via e-mail marc.sutton@nhs.net. Alternatively contact Kate Pegg (Deputy Head of QC) on direct telephone number 01332 787949 or via e-mail kate.pegg@nhs.net

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