Sachet barrier data, carton counts, child-resistant test criteria, and what changes between a 500-box pilot and a 5,000-box run of oral film strips.
Sachet laminates, with numbers
Humidity a capsule ignores will soften a strip or shift its dissolve time, so ask for the water vapor transmission rate. At 38 °C and 90 % RH a 1 mil PET film passes 16–20 g/m²/day and LDPE 16–23; metallized PET roughly 0.5–1.0; a laminate with true aluminum foil about 0.005–0.006, effectively zero. That gap is why our standard sachet is PET/aluminum/PE. Thin foil has pinholes: allowances cited in a TAPPI paper average 423 per square meter at 7 μm, 211 at 9 μm, zero at 25 μm. A foil pinhole under intact polymer layers leaks little; a cracked seal leaks freely, so seal integrity is a release control on every lot. Stability programs use ICH Q1A conditions (40 °C/75 % RH six months accelerated, 25 °C/60 % RH twelve months long-term); our 24-month target stays a target until that data exists.
What goes on the sachet and the carton
One strip per four-side-seal sachet with tear notch and lot code; no desiccant inside by default. Sachet dimensions follow from strip size plus seal width and are set in scoping with the print method. Carton counts follow the category: Listerine PocketPaks sell as 24-strip packs; melatonin strips on Amazon and brand sites are mostly 30-count. Our pilot standard is 20- or 30-count, with 10- to 60-count, wallet, sample and AM/PM cartons at pilot scale. Panels are small, so final art waits until package specification and label copy are locked.
Child-resistant packaging: when it applies and how it is tested
A foil sachet is not child-resistant, and we do not describe it as one. Where law, a retailer or your specification requires it, we source certified child-resistant secondary pouches or cartons through packaging partners. The U.S. test is 16 CFR 1700.20: panels of children aged 42 to 51 months, in groups of 50 up to 200; at least 85 percent must fail to open the package in five minutes and 80 percent after a demonstration and five more; 90 percent of 100 adults aged 50 to 70 must open and re-close it.
Worked example from our benchmarks: an iron strip at up to 27 mg elemental iron in a 20-count carton holds about 540 mg per package. 16 CFR 1700.14(a)(13) requires child-resistant packaging for supplements with 250 mg or more of elemental iron per package, so that product needs a certified child-resistant carton or pouch from the first pilot.
What changes between 500 and 5,000 boxes
Five thousand 30-count boxes is 150,000 strips, ten times the pilot. FDA's SUPAC-IR drug guidance treats a batch-size change up to ten times the pilot batch as a Level 1 change when equipment design, formulation, procedures and controls stay the same: not a supplement rule, but a fair description of a low-risk scale-up. What actually moves: actives bought in supplier pack sizes, each new lot identity-tested under 111.75; film cast as several lots, so lot-to-lot weight and potency uniformity are the thing to watch; sachet stock as full rolls and cartons on offset rather than digital print, with longer lead times; a Lot Release Packet per lot. Model 1,000, 3,000, 5,000 and 10,000 boxes before the pilot sells through.
Common questions
Yes. One strip per high-barrier PET/aluminum/PE heat-seal sachet, lot-coded; dimensions, print and seal are confirmed in scoping.
Yes. 20- or 30-count is the pilot standard; 10- to 60-count, wallet, sample and AM/PM cartons are available.
Often. Converters set minimum runs and lead times independently of 500 boxes, so component quantities and any surplus are stated in the quote.
Purchasing and lot count. Actives are identity-tested per lot, film is cast as several lots, print runs take longer, and each lot has its own release testing. Formula, strip size, sachet and artwork stay fixed.
Primary sources
- Poly Print: Water vapor transmission rate of common films (38 °C, 90 % RH)
- CarePac: PET/AL/PE barrier laminates, WVTR and OTR
- Fujian Super Tech: Aluminized PET film vs. aluminum foil barrier performance
- TAPPI PLACE 2006, Murray: The Impact of Foil Pinholes and Flex Cracks on the Moisture and Oxygen Barrier of Flexible Packaging
- ICH Q1A(R2): Stability Testing of New Drug Substances and Products
- 16 CFR 1700.20, testing procedure for special packaging (Cornell LII)
- 16 CFR 1700.14, substances requiring special packaging, including iron-containing dietary supplements (Cornell LII)
- FDA SUPAC-IR: Immediate Release Solid Oral Dosage Forms, Scale-Up and Postapproval Changes (1995)
- 21 CFR 111.75, testing and examination (Cornell LII)
- Listerine Cool Mint PocketPaks, 24-strip pack (Walmart listing)
- Solves Strips melatonin, 30 strips per box (product page)
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