SwiftDetect Pharma

Culture-free sterility testing in under six hours.




What is SwiftDetect?

SwiftDetect is a super-sensitive PCR test that can detect down to a single microbiological cell in any sample volume in a variety of pharmaceutical samples and yields results in under six hours. This rapid test eliminates the need for traditional microbiological culturing methods, saving valuable time and money whilst increasing accuracy and reliability.

Why is SwiftDetect needed?

In the world before Microgenetics SwiftDetect, it was accepted that in order to quantify and identify the number of bacteria present in the environment, the only option was to culture them.

Bacteria can only be observed when their colony size becomes greater than 0.1 millimetres in diameter or they replicate to such an extent that the solution in which they are contained culture medium becomes turbid. To observe this growth, cultures must be incubated for anything between 24 hours and 14 days.

For manufacturers releasing products and relying on the outcome of this data, this delay poses a significant cost. This is a problem experienced by every pharmaceutical manufacturer and compounder throughout the world.

SwiftDetect in under 6 hours

Fast detection of microbial contaminants

  • Determine bioburden in less than 6 hours with our rapid PCR-based methods.
  • SwiftDetectis 56 times faster than conventional testing methods like direct inoculation and membrane filtering for analysis of samples.
  • Eliminate the need for traditional microbiological culturing methods, saving money and time.

Maximise manufacturing output

  • Ultra-sensitive bioburden analysis of large volumes and will significantly speed up microbiological testing in the pharmaceutical manufacturing industry.
  • Processing of samples for broth testing, sterility testing and total viable count testing of water systems takes a fraction of the time.
  • Rapid sterility testing of pharmaceuticals means on-time batch release, so products can be dispatched with verification of safety and sterility.

Access your results online

  • Results are accessible through our online portal within 24 hours after sample collection.
  • Seamless integration with SmartControl systems.

Single cell detection

Reliable detection of low-level contamination

  • SwiftDetect makes use of the polymerase chain reaction (PCR), which is the gold standard for rapid presence/absence detection of microorganisms. However, low level sample contamination can be missed with most PCR test kits.
  • Our revolutionary methods have enhanced sensitivity, allowing detection of contamination comprising a single cell.

Advanced microbiological testing

  • For pharmaceutical manufacturers, where the presence of a single viable cell can have disastrous consequences, this unique test will revolutionise the way microbiological testing is performed.
  • The SwiftDetect test is capable of identifying microbial contamination in a wide range of samples or tests used within the pharmaceutical sector, including: saline/IV solutions, water/sterility tests, in-process simulations, operator broths, and advanced cellular and gene therapeutics (including viral or T-cell reprogramming).
  • All our scientists are trained in correct handling procedure and aseptic technique.

A SwiftDetect revolution

Fully validated and compliant

  • Utilising our patent-pending hybrid-PCR technology, SwiftDetect testing will revolutionise the way microbiological sterility testing is performed.
  • Compliant with good laboratory practice (GLP) and good manufacturing practice (GMP) guidelines.

Custom-built testing facilities

  • Our state-of-the-art lab space houses a sterile isolator designed specifically for SwiftDetect testing.
  • Automation of key steps in the testing process minimises handling errors and contamination risk.

Data integrity

  • Secure and encrypted data storage in our SmartControl cloud enables multi-site system access.
  • Stay in control of your data, with customisable permissions for unique user profiles.