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    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 also provides NIST traceable calibration services and offers analytical services for sterile devices including EO Residuals and Endotoxin testing. SA Labs is ISO-17025:2017 accredited.

Dialysis Water and Dialysate Testing

Our 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 RD62:2006 and RD52:2004 rev. 2009)
  2. a residual endotoxin  concentration of < 2 endotoxinunits (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 RD62 and RD52, 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.

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Clients can also access their dialysis water testing results utilizing our internet based remote access database which includes continuous updates of the historical trends of the results for each client.

For clients located within the State of Arizona, SA Labs also offers a  courier pick-up service that allows for the delivery of the refrigerated samples to our facility in Tucson within 12 hours of sampling, a critical parameter for ensuring the most representative  results for the client’s process.