3030226 Rev. D 5-25 Routine Maintenance
5.5 Product Water Microbiological Testing
Product water must meet the AAMI and CSA Standards for both bacteria (AAMI 100
CFU max level (or lower if required by national legislation or regulations)) / 50 CFU
action level (typically the limit will be 50% of the maximum allowable level) and
endotoxin levels (AAMI and CSA 0.25 EU max (or lower if required by national
legislation or regulations)) / 0.125 EU action level (typically at 50% of the maximum
allowable level).
5.5.1 Product Water Culture Procedure
Materials Required:
• Bucket or similar container
• Sterile syringe (30 mL minimum – 2 required)
• Sterile specimen (your lab may require).
LAB CONSIDERATIONS:
• Consult your lab to find out what type of sterile container to use and how much
product (RO) water is required to perform the test and any other specific
requirements of the laboratory.
• Make certain that your laboratory is informed of the correct procedure for
performing a product water culture. A "spread plate method", NOT a "calibrated
loop" technique, should be used with typtone glucose extract agar (TGEA),
Reasoners 2A (R2A) or other media that can be demonstrated to provide
equivalent results. Blood or chocolate agar shall not be used.
• If tested incorrectly, the results may be inaccurate. The sample should be
assayed within 4 hours of obtaining it or be immediately refrigerated and
assayed within 24 hours of collection on a regular schedule.
• Obtain the samples wearing long sleeves and a mask to prevent contamination
of samples; use a “mid-stream”, “clean catch”, type procedure.
NOTES:
Follow facility protocols (gloves, mask, etc.) for collection of samples.
This procedure assumes the RO is connected to power and water and is running in
normal operating condition.
1. Turn on the RO unit. Allow the RO unit to run for 15 minutes.
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