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Water Quality Test Protocol
We recently had 2 DI tanks installed and would like to put together a testing protocol for microorganisms. I’ve seen the Mikrocount Duo kits which look like a great way to get started. Was just curious how often others are sampling their water (daily, weekly, on tank swap)? Also, at what level do you determine the test has “failed”? Thanks!
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6 Replies
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We use a Siemens System. They do all the testing and maintenance. We keep their test results on file.
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See Purified water
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/high-purity-water-system-793Water systems are operated on alert and action limits rather than specs.
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We use Mikrocount Duo kits and have test results periodically validated by a registered external lab. Our production facility is GMP Certified, and this approach is acceptable to the GMP Auditors.
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Think it’s less the testing than design and operation of couple of DI tanks installed.
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mikethair said:We use Mikrocount Duo kits and have test results periodically validated by a registered external lab. Our production facility is GMP Certified, and this approach is acceptable to the GMP Auditors.
We were looking at those kits as well. Just curious, how often are you testing?
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ledude said:mikethair said:We use Mikrocount Duo kits and have test results periodically validated by a registered external lab. Our production facility is GMP Certified, and this approach is acceptable to the GMP Auditors.
We were looking at those kits as well. Just curious, how often are you testing?
We buy RO water from a local supplier in 19 Kg containers. Plus we have a RO unit in our production facility.We take a sample from every Batch # of the 19 Kg containers of RO water and do a microbial test.With the RO unit in our production facility, the QC Manager tests every two months.Finished products are microbial tested.
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