8 replies to this topic

[QA Nerd]

Hi Everyone

 

Has anyone conducted a Validation Study on an Ozonated  Bottle Rinser before? If so, please provide me with some tips and to how to go about doing this.

 

The supplier of the equipment could not assist with this as the machine is quite old.

 

Regards,

R

[jel]

by washing with ozonated water I guess the goal is sanitizing the bottle, so it must achieve that goal even in the worst case, ie you must design a robust process.

 

In principle you must consider all factors that could affect the achievement of your goal, as might be pressure washed, the ozone level, speed etc. Which of them are most important? That's something you have to determine, and the best way is to use the experimental design allowing you to evaluate different parameters simultaneously.

 

In the design of experiments you can use either the classic method or the so-called Taguchi Method

[Tony-C]

Hi Everyone

 

Has anyone conducted a Validation Study on an Ozonated  Bottle Rinser before? If so, please provide me with some tips and to how to go about doing this.

 

The supplier of the equipment could not assist with this as the machine is quite old.

 

Regards,

R

 

  R

 

Normally you would validate 'in house' by conducting tests to confirm that during normal operating conditions the rinser achieves the desired microbiological reduction by testing bottles before and after the rinser.

 

Regards,

 

Tony

[Bobwan]

Your validation will be the in-house and third party tests that you conduct on your rinse water and finished product.  The results from these tests will prove or disprove the effectiveness of your sanitizer.  You don't need to validate whether ozonation works as a sanitizer or not.  That is already proven science.

[Charles.C]

Dear QA Nerd,

 

 

I agree with Tony's interpretation.

 

The subjective element may relate to the required bacterial reduction to be achieved by the ozone  "sanitization" procedure.

 

for example, here is the US viewpoint  of the expected reduction  "power" of a chemical which is designated as a  sanitizer -  

 

http://www.foodsafet...-of-prevention/

 

Rgds / Charles.C

[rvazquez]

I performed a rinser validation 3 weeks ago.  This is something we performed as a requirement for our contractors.  We are a co-packer for some customers.

 

They want us to achieve a 3 log reduction from that study.  It has to be in normal operating conditions. 

 

For example, 100 bottles a min, with a concentration of 0.35 of hach reading in your ozonation (this is hypothetically). 

 

You will have to inoculate the bottles with a bacillus to a 10^5 concentration, pass it thru the rinser, collect the bottles, plate it and count the results.

 

As easy process, just a long one.

[SLadd]

I have used the method mentioned by rvazquez, I agree, it's a pretty basic process but time consuming and if the rinser decides to jam up mid run and destroy all your inoculated bottles it can also be infuriating. However, it is an excellent method for validation, just make sure you inoculate plenty of extra bottles.

 

I have a question for Bobwan or maybe for everyone - where can I find the science that proves ozone is an effective sanitizer in a bottle rinser?

[AS NUR]

you can do microbiology test before and after  Ozon process to valdate efectevity of your porcess.

 

Rgds

 

AS Nur

[shipraseo]

Ozonated bottle rinser validation is a critical process in ensuring the safety and efficacy of using ozone gas for disinfecting and sanitizing bottles in food and beverage industries, pharmaceuticals, and other applications.