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What goes wrong

Something grew in it

Updated

On this page5

A dry powder is one of the safer food-adjacent products there is, right up until moisture reaches it. Then it is a growth medium with a large surface area.

Dry powder is safe until it is not

The low-to-zero moisture content of these formulations is what gives them a long shelf life, because microorganisms cannot live without water. That is the whole of the protection.

It is not a preservative, not a process step and not anything you added. It is an absence, and absences can be filled.

How water gets in

Three routes, in order of likelihood.

The customer. A wet scoop returned to the tub, a damp kitchen, a lid left off, a tub stored above a kettle. This is by far the commonest and it is outside your control except through instruction.

The package. A seal that is not a moisture barrier, on a hygroscopic powder, over months.

You. Filling in humid conditions seals room air against the product, and a raw material that arrived damp brings the problem with it.

What it looks like

Clumping first, which people read as caking. Then discoloration, then visible growth, then a musty smell.

The important distinction is that caking from moisture and mold from moisture are the same process at different stages. A tub that has caked is a tub that has taken up water, and treating that as cosmetic is a mistake.

Preventing it

A real moisture barrier: induction seal or foil pouch rather than a friction lid, and a desiccant where the formula justifies it.

Dry filling conditions, sealed bulk storage, and checking incoming material for moisture rather than assuming.

And clear instructions to the customer: keep it sealed, keep it dry, keep the scoop dry, do not store it in a bathroom or above a hob. Those sentences do more for this failure than anything in your process.

References

Formulation Strategies to Improve the Stability and Handling of Oral Solid Dosage Forms of Highly Hygroscopic Pharmaceuticals and Nutraceuticals. ncbi.nlm.nih.gov
Written from published regulation and peer-reviewed work, not from a laboratory of our own. Your own certificates of analysis, your blend uniformity results and your own written specifications override anything general said here. Nothing on this site is a substitute for the records 21 CFR 111 requires you to keep.