Biological Indicator Testing

Boston Analytical performs definitive biological indicator testing for sterilization validation and lot release to ensure compliance with USP/EP requirements. Our dedicated cGMP compliant laboratory is fully staffed by knowledgeable, experienced scientists and is well-equipped with state-of-the-art instrumentation to tackle a diverse array of projects.

Biological Indicator Testing at Boston Analytical

Biological Indicator Testing Services

Our biological indicator testing services include the full gamut of USP <55> and USP <1035> compliant methods to test for population and resistivity:

  • Spore Suspension
  • Spore Strips
  • Spore Ampoules
  • Metal Disc

Sterilization Validation

We subject the biological indicators to your preferred sterilization method, including steam, low temperature steam formaldehyde, ethylene oxide, propylene oxide, dry heat, chlorine dioxide, hydrogen peroxide, and gamma radiation.

We then test the biological indicator strips for any remaining presence of the spore-borne biological indicator. Since such spores are usually challenging to sterilize, their absence in the final sample validates the method or lot and determines sterility assurance levels.

Biological Indicator Testing Equipment

We take extreme care to minimize the chance of false positive readings, which can trigger expensive re-testing or delay release. Boston Analytical utilizes the state-of-the-art Microseq™ 3130 XL gene sequencer for biological indicator identification and OOS investigation.