# Oral Film Packaging & Scale-Up Manufacturing | StripWorks

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Description: 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.

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SACHETS · CARTONS · CONVERTING · SCALE-UP

# Oral film packaging and scale-up, engineered as one system.

A dry film in a leaky sachet is not a product. This page covers laminate barrier numbers, sachet and carton content, child-resistant packaging and its test, and what changes between a 500-box pilot and a 5,000-box order.

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ANSWER IN BRIEF

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.

**500** BOX PILOT PATH

**20 / 30** STRIPS PER BOX

**GLOBAL** MARKET SERVED

## Common questions

**Can StripWorks package oral films in individual sachets?**

Yes. One strip per high-barrier PET/aluminum/PE heat-seal sachet, lot-coded; dimensions, print and seal are confirmed in scoping.

**Can the finished product include branded cartons?**

Yes. 20- or 30-count is the pilot standard; 10- to 60-count, wallet, sample and AM/PM cartons are available.

**Does packaging have a different minimum from film production?**

Often. Converters set minimum runs and lead times independently of 500 boxes, so component quantities and any surplus are stated in the quote.

**What changes when an oral-film project scales?**

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)](https://www.polyprint.com/understanding-film-properties/flexographic-wvtr/)

- [CarePac: PET/AL/PE barrier laminates, WVTR and OTR](https://www.carepac.com/pet-al-pe/)

- [Fujian Super Tech: Aluminized PET film vs. aluminum foil barrier performance](https://www.supertech-vip.com/aluminized-pet-film-vs-aluminum-foil-which-offers-better-barrier-performance.html)

- [TAPPI PLACE 2006, Murray: The Impact of Foil Pinholes and Flex Cracks on the Moisture and Oxygen Barrier of Flexible Packaging](https://www.tappi.org/content/enewsletters/eplace/2006/22-2murray.pdf)

- [ICH Q1A(R2): Stability Testing of New Drug Substances and Products](https://database.ich.org/sites/default/files/Q1A(R2%29%20Guideline.pdf)

- [16 CFR 1700.20, testing procedure for special packaging (Cornell LII)](https://www.law.cornell.edu/cfr/text/16/1700.20)

- [16 CFR 1700.14, substances requiring special packaging, including iron-containing dietary supplements (Cornell LII)](https://www.law.cornell.edu/cfr/text/16/1700.14)

- [FDA SUPAC-IR: Immediate Release Solid Oral Dosage Forms, Scale-Up and Postapproval Changes (1995)](https://www.fda.gov/media/70949/download)

- [21 CFR 111.75, testing and examination (Cornell LII)](https://www.law.cornell.edu/cfr/text/21/111.75)

- [Listerine Cool Mint PocketPaks, 24-strip pack (Walmart listing)](https://www.walmart.com/ip/Listerine-Cool-Mint-Pocketpaks-Breath-Strips-24-count/24983787)

- [Solves Strips melatonin, 30 strips per box (product page)](https://www.solvesstrips.com/products/melatonin-dream-mint-strips)

## Build the next step around facts.

Tell us the active ingredients, target amount, flavor direction, formula status, pack count, first-run quantity, launch market, timing, and anything already decided. StripWorks will use the brief to map the most practical next step.

[Start the project brief](https://stripworks.com/#start)

[How oral dissolving films are made](https://stripworks.com/insights/how-oral-dissolving-films-are-made)[Dose loading and ingredient feasibility](https://stripworks.com/insights/oral-film-dose-loading-feasibility)[Manufacturer buyer checklist](https://stripworks.com/insights/choosing-an-oral-film-manufacturer)