7 replies to this topic

[twill]

We’ve received sporadic mold complaints from multiple customers. However, all internal quality controls and retained samples show no signs of contamination:

Initial yeast and mold testing: All results are clean.

Retained product samples: No visible mold; microbiological results are within spec.

Production, storage, and shipping records: Fully compliant with SOPs and regulatory standards.

Air quality and packaging swab tests are also compliant.

Any recommendation for further investigation to determine the root cause?

 

[kfromNE]

What type of product is this. 

[twill]

It's a cultured dairy blend, similar to sour cream.

[Scampi]

I would check your packaging for pin holes

 

You'll have to figure out a way to seal the container and put them under water to check for bubbles   

 

Do you place a film across the top under the lid? Could you have a failure there?

[twill]

I would check your packaging for pin holes

 

You'll have to figure out a way to seal the container and put them under water to check for bubbles   

 

Do you place a film across the top under the lid? Could you have a failure there?

Thank you, I'll give that a try.

The product is packaged in 32 lb HDPE tubs without a film under the lid. 

[JensV]

How much headspace is left in the tubs after filling? Fill it as much as possible.

 

Also, at the level of the customers, if their storage temperature is (slightly) higher than your reference samples, it's more likely to develop molds. This can cause also 'sporadic' complaints.

 

I agree with Scampi; it's possible there’s airflow getting to the product, meaning it wasn’t closed properly. How do you assure there's no uncontrolled airflow without a film?

[kfromNE]

Is it only certain customers. I would look at transportation and have the customer send you info from their end. 

[GMO]

Do some RCA.  Try and think of all the different modes of failure then knock them off.

 

For example:

 

Method:  Have you checked all your inputs?  Pasteurisation temperatures, vat process?  Have you double checked the acidity formation during the vat process?  Are you needing more culture to get the same acidity?  (Just thinking about phages and failed vats which may have gone undetected.)  Does your packaging have tamper evidence on it?  (If no inner seal.)

 

Machinery:  Have you stripped it back and done some Y&M swabs?  Could something be oozing out over a shift?  Have you checked any CIP systems?  Is everything up to date on PPMs?

 

Material:  Is your packaging stored hygienically?  Fully sealed in bags until use?  What happens to part bags of lids or bases?  Have you checked your culture dilution process for hygiene?

 

Manpower:  Is this linked to a specific shift or time?  Indicating some people doing something different?  Have you checked people's personal hygiene?  Mould spores can be carried on people.  Also have you looked at the full supply chain?  Is the chill chain and packaging integrity maintained?

 

Measurement:  Do you measure acidity at potting?  Have you looked at what kinds of moulds are growing (or asked your lab to) as that may indicate where they're from.

Environment:  Do you take your environmental tests at all times of the day or only at start of production?  Is there a risk of different conditions, e.g. after long runs, at night?