Sterilization Validation Testing

Properly designed and executed sterilization validations are critical to ensuring the sterilization process is capable of achieving the intended sterility assurance level (SAL). An SAL of 10-6, meaning there is a probability of only 1 non-sterile device in every 1 million sterilized, is most common with today’s sterilization processes. With over 30 years of experience, Avista Pharma offers superior expertise and high quality testing to support your radiation (gamma/e-beam) and gaseous (Ethylene Oxide) sterilization validations and monitoring. Avista Pharma’s experts have years of experience in sterility, bioburden and ethylene oxide residual testing. Avista Pharma has also fostered good relationships with leading industrial sterilizers and work closely with them on clients’ sterilization projects. This networking makes the sterilization validation process very streamlined.

 

Our testing services include:

  • Bioburden testing: performed per ANSI/AAMI/ISO guidelines. Testing can be performed using pour plate or membrane filtration methods.
  • Bioburden Recovery Factor testing: performed per ANSI/AAMI/ISO guidelines. This testing ensures the validity of the bioburden testing by establishing how much of a control organism can be recovered from the product using the extraction methodology.
  • Sterility testing: per ANSI/AAMI/ISO and USP/EP guidelines. Avista Pharma offers a wide range of vessel sizes that can handle most samples.
  • Bacteriostasis/Fungistasis testing: performed per ANSI/AAMI/ISO or USP/EP guidelines depending on the testing method. This testing ensures the validity of the sterility test by demonstrating that control organisms can be recovered in the presence of the sample.
  • Ethylene Oxide Residuals testing: performed per ANSI/AAMI/ISO guidelines using state of the art gas chromatograph (GC) equipment. Avista also is outfitted with GC/mass spectrometry (MS) equipment, which can be used to test devices that contain compounds such plasticizers. Such compounds can interfere with conventional GC methods.