In part 2 ( http://wp.me/p7I0V6-1l ) I covered problems with equipment. This post will cover cleaning. As was once told me by my graduate advisor, ‘Cleanliness is next to Godliness’. So, protocols for cleaning are important. Too many times people get accustomed to CIP (Clean In Place) but do not check whether or not the procedure actually works.
There are many tools to check for issues, one is from Hygienia and there are many others. This is a basic test to determine if there are intact bacteria, mold, etc. Then further tests, like culturing, etc. will determine what the microorganism is and what to do about it.
At one particular job, I was working on a project where sterility was important, since we were doing a continuous fermentation to a slow growing culture. It was important that the initial sterility and cleanliness were paramount. All the issues with dead spot, etc. were in place but how to clean was not discussed. We started with a CIP (Clean In Place) system but determined that the system caused issues, namely some Bacillus sp. that was found in the CIP (Clean In Place) material. We had to switch and tried several different vendors until one solution was found of a different make up.
In another instance, a simple brush was found to be the culprit in scoring the inside of a fermentor. It was these scratches, that allowed contamination to build up. We had dismantle the fermentor and polish the inside to remove these scratches before continuing with our process.
Cleaning protocols are not infallible and need to be tested to make sure they work properly.
All 3 posts show how important being observant and diligent in dealing with contamination can be.
David Slomczynski, Ph.D; Geometrick Enterprises