Why We Charge an Allergen Clean-Down Fee (and What 3.5 Hours of Cleaning Buys You)

If your product contains wheat, milk, soy or any other major allergen, your North Lakes quote has a line most brands haven't seen before: Allergen clean-down, $649 per run. Some co-packers bury this cost in their per-unit price. Others skip the clean-down and hope. We'd rather show you exactly what it pays for.

Short version: after an allergen run, we take the line apart from the auger motor down to the deck, clean every surface the powder touched, and verify it before the next brand's product goes through. It takes about three and a half hours. Here's why it matters, what we actually do, and how to pay it as rarely as possible.

Why allergens get their own clean-down

Most changeovers are about flavor. If a little Lemon Lime ends up in the first few Berry sachets, it's a quality issue, and we handle it with a $149 same-size changeover.

Allergens are a safety issue. A trace of wheat or peanut in a product that says nothing about it can put someone in the hospital. Undeclared allergens are one of the leading causes of FDA food recalls every year, and a recall can end a small brand. The FDA's preventive controls rule for food (21 CFR 117) requires facilities to control allergen cross-contact, and supplements fall under their own cGMP rule (21 CFR 111). In practice, that means the line has to be provably clean between an allergen product and one that doesn't declare it.

Powder makes this harder. It's fine, it drifts, and it settles into the auger flights, the fill tube, seams, gaskets and the corners of the deck. You can't rinse a finished sachet. Cross-contact has to be prevented on the line, before the next product runs.

The Major 9

The fee applies when your product contains one or more of the nine major food allergens recognized by the FDA:

• Milk
• Eggs
• Fish
• Crustacean shellfish
• Tree nuts
• Peanuts
• Wheat
• Soybeans
• Sesame (added to the list in 2023)

You declare these in your specification in our client portal. The portal checks your formula as you build it and flags ingredients that commonly carry an allergen, so nothing slips through, and your quote picks up the clean-down automatically.

What three and a half hours actually looks like

After your last allergen pouch comes off the line, the line operator works from the top of the line down, so loosened powder always falls onto surfaces that haven't been cleaned yet:

1. Empty and capture. Remaining powder comes out of the hopper and is lidded and labeled with its lot and allergen profile, set aside for your next run or returned to you. Loose dust is collected with a HEPA vacuum. We don't blow lines down with compressed air, because that just moves allergen dust somewhere else.
2. Infeed and hopper. The conveyor that feeds the hopper and the hopper itself are opened up and cleaned inside.
3. Auger and motor housing. The auger comes out. The flights, the housing and the area around the auger motor are where fine powder hides, so they get the most time.
4. Fill tube and forming area. The fill tube, the forming area and the sealing area are cleaned and wiped down.
5. Down to the deck. Guards, enclosure panels, the deck, and everything around the line where dust settles.
6. Inspect and reassemble. Every part is inspected before it goes back on. Anything that doesn't look clean gets cleaned again.

How we prove it's clean

"Looks clean" isn't the standard for allergens. Two different tests do two different jobs:

• ATP swabs detect organic residue in general. We run them before every production run as part of our pre-op checks.
• Allergen-specific swabs test product-contact surfaces for the allergen itself. ATP can pass on a surface that still carries allergen protein, so after an allergen clean-down we swab the auger, hopper, fill tube and other contact surfaces specifically for it.

Results go on our allergen changeover log with who cleaned, who verified and when. The line doesn't run an allergen-free product until that record is complete. If a brand or auditor asks, we can show it.

Why the allergen brand pays

We could spread the cost across every customer's per-unit price. That would mean brands with allergen-free products paying to clean up after allergens they never put on the line, which isn't fair to them, and it would hide a real cost from you.

So it's a flat line item, priced at roughly what the time costs us, charged to the brand whose product creates the need. The upside works for you too: the same clean-down that protects the next brand is why you can trust that your allergen-free products run on a clean line.

How to pay it once instead of every run

• Book runs back to back. Several runs or flavors with the same allergen profile, scheduled together, pay a single clean-down at the end.
• Run allergen products last. We schedule allergen-free products first and allergen products later in the day, which keeps full clean-downs to a minimum for everyone.
• Tell us early. Declare allergens in your spec before you're quoted, so the price you see is the price you pay.

The fee, in one place

Every fee we charge is published on our pricing page before you sign. No surprises on the invoice.