Sterility Assurance Labratories
SA Labs building

How we can help your business

SA Labs offers an array of microbiological and chemical services including EO, radiation and steam sterilization validations, sterility testing, quantitative bioburden and microbial assessments of medical devices, pharmaceutical preparations, water and fresh produce, also heterotrophic plate counts of water and other solutions for hemodialysis. SA Labs offers analytical services for sterile devices including EO Residuals and Endotoxin testing. SA Labs is ISO-17025:2017 accredited.

Dialysis Water and Dialysate Testing

Water TestingOur Dialysis Water Testing Services Group helps dialysis providers maintain compliance with the Federal Regulations for dialysis water quality. The dialysis water testing procedures utilized by SA Labs ensure that both dialysis water and dialysate quality meet the requirements for both viable bacterial counts and residual endotoxin concentration as established by AAMI Standards.

Currently those requirements are:

  1. a total viable plate count of < 200 cfu/mL for both dialysis water and conventional dialysate, with an action level of 50 cfu/mL for each (AAMI 23500-3:2019 and AAMI 23500-5:2019)
  2. a residual endotoxin concentration of < 2 endotoxin units (EU)/mL with an action level of 1 EU/mL, for each

For dialysate and dialysis water testing, SA Labs utilizes the membrane filtration technique for the capture of viable bacteria, with heterotrophic plate counts after culture on TSA, which is the de-facto reference method as specified in both AAMI 23500-3:2019 and AAMI 23500-5:2019, and the Limulus Amebocyte Lysate (LAL) Reagent technique for the determination of residual endotoxins.

SA Labs is ISO-17025:2017 accredited for dialysis water and dialysate testing.