6 replies to this topic

[jtw121]

Hello everyone,

 

I am wondering if someone can help. 

 

I am working in a supplement manufacturers. Most raw materials are stable with the exception of probiotics, vitamin C and enzymes.

 

How would we go about validating our shelf life? We are not sure where to begin.

 

Thank you!

[kconf]

Shelf life of raw materials or the products you manufacture? 

[jtw121]

The products we manufacture.

[SHQuality]

Do you only blend your raw materials or do you do any processing or add any preservatives that might change the shelf life of these materials?

[jtw121]

We do both. 

[mm.stf]

Similar type of products here. Our shelf life is between 12-15mo and ingredients shelf life is on average 18-24mo.

 

Is it a new company or have you been manufacturing for a while? I would start with a safe time limit, like around 12mo, if this makes sense according to your raw materials average age when you pack it.

I would then send samples for monthly analysis when they hit this mark of 12 months old and keep monitoring the stability until you hit a shelf life time that is suitable for your company. 

You will probably have a case of 'Best Before' and not 'Expire' date.

 

I'm not sure if BRCGS has any specific requirements for how you determine it though.... 

Edited by mm.stf, 27 November 2025 - 11:54 PM.

[Bo16]

As an expert on enzymes manufacturing and shelf life, the shelf life must be conducted in real time on the finished product.  You cannot use accelerated studies since temperature can decrease the shelf life.  Also, mixtures of diluents and multiple enzymes can create shelf life issues as well.  Most enzymes have side activities and when added together can either be synergistic and add to the expected activity level or cause degradation and reduce the expected activity.  Don't get me started on what a strong protease can do to other testing as well (ELISA, micro, etc.)  Please check with your enzyme supplier for help.  

 

Also, just a note there has been a lot of adulterated bromelain on the marked in the last few years.  Please find a reputable laboratory to test multiple assays, not just the GDU to ensure the product has ANY bromelain in it.  We have notified the FDA several time about adulterated bromelain.  We actually ran protein SDS-PAGE and proved there was no bromelain in the products, but nothing has been done by them.  See the article from the American Botanical Council:  https://www.herbalgr...n-adulteration/