Q: We are a large pharma company. We use Alconox detergent in an ISO 8 cleanroom that does not have a floor drain so rinsing in a cleanroom is a problem. We have a form, fill, seal machine with 2 pumps, tubing, and a hopper that have product contact. They are permanently installed. Can we rinse with tap water if we are sanitizing after the rinse? How much rinsing is required?
A: Yes, tap water, in general, can be used or rinsing. As rinsing is a mass displacement event, any reasonable quality of water will suffice. However, it will depend on the requirements you have for the surfaces. Sanitization following the cleaning will reduce/remove bioburden but would not remove salts and minerals if you happen to have hard tap water, and other particulates that may be deposited. Typically, ISO 8 cleanrooms do not have stringent requirements on surfaces (beyond viable and non-viable particulates, etc.). In short, the tap water will indeed rinse as in remove residual detergent and residue-detergent emulsions, but as you might imagine, the best practice would be to use higher quality water. Another way to look at it is the rinse is the last step where the surface is physically impacted in a cleaning process. The rinse water quality should meet or exceed the intended quality of the surface just cleaned.
Three rinses are a good standard for thorough rinsing, but less can be done. Every application, setup, instruments and condition is quite different. How many rinses depends on many factors: temp of water, volumetric flow rate, time, quality of water, and others. A rule of thumb is a single good rinse knocks down detergent residue two orders of magnitude. In cleanrooms, less detergent can be considered to make rinsing easier. The following TechNotes articles will help elaborate:
Practically speaking, achieving thoroughly clean, detergent and contaminant residue-free surfaces will not be difficult. Cleanrooms have been using our products for decades to ensure their surfaces are critically clean, and rinsing in a cleanroom is achievable in a variety of ways. We’d be glad to help!
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