Bringing blending in-house - Verification or full validation? (Disinfectants)

#1
Hi,

Just joined today and after a bit of advice.

Disinfectant manufacturing

External contractor currently mixes and sends IBC's to us for bottle filling/labelling. They can't keep up with volume demand so we're bringing the blending of a particular product in-house, alongside the other disinfectants that we currently blend using our own mixing vessel/process.

Is it sufficient to verify that our blend is equivalent chemically (using same raw materials/ratios etc) so pH/actives% etc is identical or do we need to send off for full external microbial efficacy testing as well?

Our consultant is saying we should.......I'm not certain that it is required.

Any advice appreciated!
 
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Ninja

Looking for Reality
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#2
I am not in the medical arena, so keep that in mind.

I would suggest that the decision on level or formality of verification through change of manufacturing site may be something your customers have firm opinions about.

What do they require? Do they know? Do you plan to inform them? I would if I were you...then you'll have more input than you want ;)
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
The side of caution would be to validate that your equipment can reproduce the customer's end product exactly. You may have different tanks and mixers than they have so you may need to mix for a different time period or different temperature, etc.

If the customer was to install a new blending line they would need to validate it. This is essentially the same situation.

You also may need to put some work into your cleaning process between batches to ensure there is no cross batch contamination.


As Ninja says - consult with your customer. And see if they can help you with the qualification of your site. They may also have a way to rationalize it and minimize the qualification/validation work.
 

v9991

Trusted Information Resource
#4
External contractor currently mixes and sends IBC's to us for bottle filling/labelling. They can't keep up with volume demand so we're bringing the blending of a particular product in-house, alongside the other disinfectants that we currently blend using our own mixing vessel/process.

Is it sufficient to verify that our blend is equivalent chemically (using same raw materials/ratios etc) so pH/actives% etc is identical or do we need to send off for full external microbial efficacy testing as well?

Any advice appreciated!
clearly, the critical of blending to be kept in mind, viz.,
* are the two components easily miscible ( soluble vs suspension) viz., is it an simple blending vs homogenization, time/speed of mixing etc
* since you mention actives/pH, what are important steps, viz., sequence of addition, is the batch/lot size same,
* similarity or importance of the material of construction or materials contact with the product.
* as the batch/lot size is different, how does it support the storage conditions, hold-time of the batches etc.,


the point is, the assessment has to take into account details specific to product & process before arriving at the decision.

do an risk assessment against the impact of the site/lot-size/process-paramters change wrt critical quality attributes, and then arrive at the decision.

this will atleast ensure the process of arriving at certain decision. ( either way)
 
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