BioDetect should be added to QA procedures to monitor the presence or absence of biofilms in a facility. Here are some basic steps to implement biofilm detection.
1. Establish your facility’s test locations (control points)
Select several equipment / structure / utensils that represent the entire facility
For example: if you have 50 conveyor belts you do not need to test all 50 but one so long as they have the same material type, mechanism, and handle the same products.
2. Record the cleaning chemicals used and concentrations for each item selected.
3. Record the cleaning methods used for each item selected.
4. Once the items have been cleaned as recorded, test with BioDetect.
Spray BioDetect onto the surface and visually inspect the surface treated after application.
- A positive result with BioDetect immediately produces a foaming reaction in the form of white microbubbles. This reaction is visible for at least 15 minutes.
- A negative reaction means the absence of production of microbubbles after the lapse of 5 minutes.
- Rinse the surface abundantly with potable water. Do not dilute BioDetect. Apply to surfaces after cleaning and sanitizing. In case of a positive reaction, refer to internal biofilm removal procedure.
- Be sure to test in both obvious and tricky areas. The same spots should be tested every time. BioDetect can be used to confirm cleaning has been done correctly or for areas that are not cleaned on a regular basis.
- If different products are run on the same item, validation will need to be done after each product type to prove the methods are effective against all product types.
- A minimum of 4 log is required to form a biofilm and a reaction
- When testing surfaces must be clean and free of organic matter
5. Continue this process for a week or two and record success or failure of the test.
- If the test is successful in at least 5 or 6 consecutive tests, the methods are now validated.
- If the test fails make changes to the methods and/or chemicals and re-try validation.
6. Review sanitation procedures if any changes occur to the sanitation program or based on the level of risk of the production.