Contract manufacturing for oral thin films and dissolving strips: feasibility, custom formulation, 500-box pilots, sachets, cartons, lot testing and scale-up.
What a contract manufacturing agreement should cover
FDA's 2016 guidance on quality agreements was written for drugs, but it is the clearest public description of how an owner and a contract facility divide the work. It recommends sections for purpose and scope, definitions, dispute resolution, manufacturing activities (quality-unit duties, facilities and equipment, materials, product-specific terms, laboratory controls, documentation), change control and life cycle. Business terms such as pricing, delivery and liability stay out; the contract facility approves its own output and the owner keeps final release.
For supplements the rule is 21 CFR Part 111, and the scope should assign its sections by name: 111.13, qualified supervisors; 111.35, equipment and calibration records; 111.70, specifications; 111.75, identity testing of dietary ingredients and finished-batch verification; 111.210 and 111.255, master manufacturing record and batch record; Subpart O, complaints, usually with the brand.
We take on production to the approved specification, standard release controls on every lot, third-party testing through ILS Lab, a Lot Release Packet per released lot, and retention of the batch record. The brand keeps label and claims review, the complaint file, and the release decision. We hold no cGMP, FDA registration, ISO or NSF certification today, and a scope document from us will not say otherwise.
From brief to specification
A usable brief names the customer, each active and target amount per strip, serving plan, flavor direction, strips per carton, market, timing and quantities, with requirements marked apart from preferences. The specification turns that into numbers: a 22 × 32 mm strip at roughly 50–150 μm dry-film thickness and 100–300 mg finished weight, a 30–60 second dissolve target, single-active loads up to about 250 mg.
Worked example: an 80 mg caffeine strip, the top of our caffeine benchmark. In a 250 mg strip the caffeine is about a third of the dry mass, leaving two thirds for the film former, the plasticizer that keeps it flexible, and the sweetener and flavor that must cover caffeine's bitterness. Feasibility decides whether that holds at 22 × 32 mm or needs a larger format or a two-strip serving. Formula development takes 2–4 weeks, sample iteration 1–3 weeks, against sensory criteria written before the first sample is tasted.
Converting, packaging and the pilot
After casting and drying, film is slit, cut, sealed one strip per sachet, cartoned, lot-coded and case-packed. Barrier is not optional: at 38 °C and 90 % RH a 1 mil PET film passes 16–20 g of water vapor per square meter per day, LDPE 16–23, and converters quote a PET/aluminum/PE foil laminate at about 0.005–0.006. Every StripWorks strip goes into a foil laminate sachet.
The 500-box pilot runs the whole line, about 10,000 strips in 20-count or 15,000 in 30-count cartons. Most new custom programs reach released pilot product in 6–10 weeks: feasibility 3–5 business days, formula 2–4 weeks, samples 1–3 weeks, pilot manufacturing 2–4 weeks after approvals, testing and release about a week. The output is a locked specification and a list of what passed, what must change, and what stays controlled. When comparing manufacturers, ask where the facility is, what the written scope excludes, who tests against the specification and where, whether the batch record is retained, and, for any certification claimed, where the certificate is.
Common questions
None in the product. Placement, active, dose, dissolve target and market still have to be defined per project.
Yes. Feasibility review (3–5 business days), then 2–4 weeks of formula development and 1–3 weeks of sample iteration.
Yes. One strip per lot-coded PET/aluminum/PE sachet, then 10- to 60-count cartons; 20- and 30-count are the pilot standard.
Actives and target amount per strip, flavor direction, whether a formula exists, strips per box and box count, market, timing, and anything already decided.
Primary sources
- FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements (2016)
- 21 CFR Part 111, cGMP for dietary supplements (Cornell LII)
- 21 CFR 111.13, supervisor requirements (Cornell LII)
- 21 CFR 111.35, equipment and utensil records (Cornell LII)
- 21 CFR 111.70, specifications (Cornell LII)
- 21 CFR 111.75, testing and examination (Cornell LII)
- 21 CFR 111.210, master manufacturing record (Cornell LII)
- 21 CFR 111.255, batch production record (Cornell LII)
- FDA Small Entity Compliance Guide: cGMP for dietary supplements
- Poly Print: Water vapor transmission rate of common films (38 °C, 90 % RH)
- CarePac: PET/AL/PE barrier laminates, WVTR and OTR
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