Sterility Testing by Membrane Filtration

Steritest™ NEO Filtration Devices

For filterable pharmaceutical products, the membrane filtration sterility test is the industry standard, particularly where samples can inhibit microbial growth (e.g. for bacteriostatic, fungistatic compounds or where preservatives have been added). Our closed Steritest™ NEO devices are supplied with detailed certificates of quality, with data gained from rigorous in-process and release testing. The membrane and canisters are also subjected to stringent integrity and microbiological tests.

Steritest™ NEO devices are color-coded for easy identification:

  • Blue base for Products without Antimicrobial Agents.
    Mixed esters of cellulose membrane. This membrane provides an optimal filtration flow rate for standard products. Canisters material: SAN (Styrene-Acrylo Nitrile)
  • Red base for Antibiotics and Products with Antimicrobial Agents.
    Low binding PVDF Durapore® membrane. This optimizes the rinsing of products that inhibit microbial growth. Canisters material: SAN (Styrene-Acrylo Nitrile). 
  • Green base For products requiring increased Chemical Compatiblity
    Low binding PVDF Durapore® membrane. This optimizes the rinsing of products that inhibit microbial growth. Canisters material: polyamide polymer.

Flexible to fit your needs and minimize false results:

  • The closed system reduces the risk of false positives.
  • The elimination of bacteriostatic, bacteriocidal, or fungistatic agents help to remove the risk of false negatives.
  • Configure the Steritest™ to your needs – tailor to your sample, packaging and testing environment.

 

Materials

     
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