I am working on cleaning validation for Automated parts washer. Its qualified and now we are establishing load studies etc…
Another CV project is validating the manual cleaning process of small parts which are not loaded into the automated parts washer such as flow meters, pressure gauges, unusual shaped items.
I am having difficulty understanding how to validate manual cleaning for parts. The Manual cleaning process begins with WFI pre rinse, soak or scrub parts with 1% liqui Nox or NaOH, and final WFI Rinses. Is it possible to validate manual cleaning?
I know the rinse and swab method which I used regularly to validate the COP washers and CIP equipement.
My difficulty is applying that method consistently with a manual cleaning that will vary among operators. Every operator scrubs and clean differently. I am not sure how to properly capture manual cleaning with the same clarity that a COP process or CIP, where the process steps are measurable and specific.
Hello wes77,
I had the same issue, though it was related to validation of lab glassware manual cleaning procedure.
If you want to know more how I managed it I can give you some directions.
Regards
As you may know, general principle of process validation can not be used to validate the manual cleaning process. But we are able to design, so to speak, “a scientific rationale” using “worst case” conditions. First of all you should determine acceptable criteria for your object(s). In case when using WPI for rinsing you should set value for last rinsing (e.g. absence of detergent which has been used for cleaning). In case when WPI used for rinsing you should set value for last rinsing (e.g. absence of detergent which has been used for cleaning). Personally I used pH-meter, conductivity meter, TOC and UV-spectrophotometer to prove rinsing water meets to acceptable criteria (e.g. 0.5 ppm TOC, absence peak of detergent components in UV-spectra). Thus I proved (in 3 times) that cleaning procedure of Lab Glassware (predetermined quantity of units and quantity of water for rinsing) is able to meet determined target (after cleaning procedure LGW is chemically clean). Bingo, Autorities were satisfied!.
P.S. I beg your pardon for my clumsy English. I am still trying to improve my skills. (I am from Ukraine).
Comments and questions are expected.
@wes77 To add on to all the wise comments, you can actually have times and temp. to go with the rinse. Ex: rinse with usp water for 10 minutes. scrub using the dedicated brush for 3 minutes. rinse with water until no visible detergent is observed or when the water is clear or when no foaming is observed. All this can be part of an SOP that you can train the operators on and take their signatures that they are trained. Also, have a data sheet for recording times and temp. of the rinse. Hope this helps.
