Case Study | Vitamin D Oral Dissolving Film (ODF)

An integrated, production-ready route from precision coating and drying to cutting/die-cutting and single-sachet packaging—delivered by HUANGHAI. All configurations are optional/customizable and do not constitute a formulation or medical claim. Liquid preparation is excluded and will interface with your existing system or a third-party pre-treatment partner.

Who This Is For & Business Value

Serves: Nutrition/health-supplement brands, ODM/OEM factories, and functional-food R&D teams.

Goal: Without changing your existing liquid-prep/pre-treatment system, we provide an integrated equipment + process window starting from the coating section—accelerating pilots to mass production with stable yield and traceability.

Commercial Value: Unit-dose accuracy and water-free convenience; customizable shape/size/flavor for rapid SKU iteration and differentiated marketing; highly compatible with automated single-sachet packaging for e-commerce and retail.

Note: This solution excludes liquid preparation and connects to your in-house or third-party pre-treatment.

Production & QC Pain Points We Solve

  • Micro-dose consistency: Closed-loop control of coat weight → dry film thickness → web tension/speed to reduce intra- and inter-lot variability.
  • Yield & appearance: Minimize pinholes, wrinkles, brittleness, and edge lift; flat film surface and clean die-cuts.
  • Moisture & logistics: Coordinated control between drying and packaging to target residual moisture and seal integrity, reducing caking/stickiness.
  • Rapid changeover: Standardized changeover/cleaning SOPs, fast die/tool swaps, and parameter recall to shorten downtime.
  • Traceability & audit: Inline inspection, batch/barcode printing, and e-records interfaces to support cross-region compliance documentation.

Process Route & Key Control Points (starting from coating)

A. Precision Coating & Film Formation

Broad compatibility with aqueous/dispersion film systems (e.g., Pullulan/HPMC or customer-specified). Coating paths offered per rheology: comma bar, micro-gravure, or slot-die.

KCPs: Coating weight vs. target dry thickness (first-article + in-process checks); web tension, web guiding and edge “dog-bone” control; online/offline thickness checks (optional) to map solids-viscosity-coat weight-dry thickness.

B. Drying & Curing

HUANGHAI approach: Natural hot-air gradient delivers temperature variation without multi-zone segmented control—balancing energy efficiency and film quality, while simplifying maintenance.

KCPs: Coupled inlet/outlet temp-humidity, exhaust/fresh-air ratio, residual moisture/volatiles targets—avoiding case-hardening (surface dry, wet core) and over-drying brittleness.

Optional modules: Inert-gas drying, HEPA-filtered hot-air region, off-gas/residual-solvent sampling ports (configure to internal QA & certification needs).

C. Inline/Offline Slitting & Die-Cutting

Targets dimensional accuracy and clean edges without stringing or edge tearing.

KCPs: Die material and finish, pressure/speed matching, anvil flatness; supports custom shapes/logo die-cuts for brand recognition.

D. Single-Sachet/Strip Packaging & Traceability

Formats: Single aluminum sachets (optional nitrogen), multi-piece strips/linked packs, and card displays.

KCPs: Seal integrity (peel strength/dye penetration/vacuum decay), WVTR/OTR linkage with stability, batch/lot printing, retention sampling, and reject removal.

Compliance integration: E-record/audit-trail interfaces to align with the principles of 21 CFR Part 11 / EU Annex 11 (per your IT system).

Customization & Scale-Up

  • Custom web width: Sized to capacity targets, floor space, and budget.
  • Dual-lane / dual-layer: For high-throughput scenarios, add width + dual lanes or dual-layer to boost output.
  • Speed & drying capacity: Matched to formulation window and drying load assessment.
  • Inspection & vision: Thickness scanning, surface-defect inspection, print verification, and weight/dimension sampling (optional).
  • Packaging formats: Single sachet, strip, carded bundles.
  • Pricing note: Final equipment price depends on width, lane/layer count, speed, drying capacity, and inspection/traceability options—formalized in a URS-based configuration & quotation list.

Quality & Stability

CQAs: Visual integrity; piece weight/thickness uniformity; disintegration/dispersion (per your market method); micro limits/(if applicable) preservative system; seal integrity & packaging compatibility; stability (accelerated/long-term/transport/in-use).

Process control:

  • Coating: First-article approval + periodic in-process checks; key data logging.
  • Drying: Outlet moisture/residuals sampling and parameter curve records.
  • Packaging: Sealing parameter batch records, retention tests, rejects removal & traceability.

Documents delivered (as needed): CQA-CPP matrix; BMR/BPR templates; SOPs (changeover/cleaning/checks/exceptions); seal-integrity & retention management notes; FAT/SAT support and IQ/OQ templates.

FAQs (Engineering & Capacity Oriented)

Do we have to replace our existing liquid-preparation system?

No. This solution starts from the coating section and interfaces directly with your in-house or third-party pre-treatment.

What if our throughput is not enough?

Scale via wider web, dual lanes/layers, or parallel stations. Also align drying and packaging takt for balanced output.

Will multiple flavors/colors slow changeovers?

We use fast-swap coating/die components plus standardized cleaning SOPs and checklists to keep changeovers within the agreed window (line-size dependent).

How do you ensure consistency?

We build a solids-viscosity-coat weight-dry thickness map, combine first-article approval with in-process checks and optional e-records for traceability and CPV.

How do you ensure moisture barrier & seal?

By linking seal-integrity testing (peel/dye/vacuum decay) with WVTR/OTR targets; nitrogen flush/light-barrier materials can be applied when needed.

Project Timeline (Example)

  • W1–W2: URS review & solution confirmation (formulation window, capacity target, space/budget)
  • W3–W5: Pilot runs & window locking; draft SOPs
  • W6–W8: Scale-up/line tuning; stability & seal-integrity verification
  • W9–W12: Production launch, PV batches, training & handover

Note: Actual timing depends on formulation complexity, materials/packaging readiness, and validation scope.

Compliance & Statements

  • Content illustrates HUANGHAI’s capabilities in ODF manufacturing equipment & process only—no efficacy or formulation claims.
  • All configurations/parameters are customizable; final details follow the mutually agreed URS and technical agreement.
  • Customer data/assets are handled under NDA; any public-facing material must be authorized.

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