Device Bioburden / Sterility

Andersen Caledonia provides bioburden and sterility testing at its Bellshill laboratory in compliance with ISO 11737.

Bioburden testing ISO 11737-1 is carried out to determine the microbical level on products prior to Sterilisation. Monitoring products for Bioburden will ensure that the challenge is not too great for the sterilisation and will continually monitor the manufacturing processes.

Bioburden results are split into bacteria, yeast, fungi and heat shock with the option to specifically identify key pathogens. It is recommended by the ISO standard that customer have a bioburden validation carried out before any routine samples are tested to ensure the best revovery method is applied to their product. Bioburden limits for customer can be calculated using historical data if requests by our customers.

Sterility testing is carried out to comply with ISO 11737-2. This is carried out at Andersen Caledonia using the Direct immersion method or Removal of organism methods.

In addition to Andersen Caledonia sterilisation customers we also process samples packed in other cleanrooms which includes Sterile Service department within many Hospitals .