Sterility Test BACT-ALERT

The Sterility Test BACT/ALERT 3D is an automated microbial contamination detection in products that are expected to be sterile. It is an alternative sterility method described in the European Pharmacopoeia (2.6.1).

Regulations:

European Pharmacopoeia 6.0: 5.1.6 Alternative Methods for control of microbiological quality. In the section of methods based on growth and rapid detection of growth, point  2-1-1-3 lists methods for detection of growth as measured by  consumption or production of gas, as is the case for  BACT/ALERT.

European Pharmacopoeia 6.0: 2.6.27 Microbiological control of cellular products. An alternative to traditional sterility control of cell-derived products which include automated reading methods such as BACT/ALERT.

Standard of Good Manufacturing Practice (GMP / GMP)
Detection principle

If the are microorganism in the sample carbon dioxide is generated as the organisms metabolize the substrates of the culture medium. Growth of microorganisms produces CO2, and the color sensor at the bottom of each culture flask changes from a dark color to a lighter one. The detection system provides objective endpoints, which are not affected by sample turbidity. Sampling is not disruptive.

Advantages:

  • Fast results by continued reading and immediate notification of positive samples, maximum 7 days versus 14 days of the traditional sterility test according to European Pharmacopoeia.
  • Reliability of readings by automatic quality control and results interpretation.
  • Minimum sample handling only during loading.
  • Barcoded Culture flasks  for sample identification and traceability.
  • Automatic reading of color-based gas production: less interference from turbidity reading than traditional pharmacopoeia methods.
  • Non-destructive method to confirm positive samples.