Complete ODF Film Manufacturing Solution
Complete ODF Film Manufacturing Solution
HUANGHAI delivers a complete, modular solution for Oral Dissolvable Film (ODF) manufacturing — covering everything from precise liquid preparation to high-precision coating, and automated cutting & packaging. Built to meet GMP standards, our systems scale from pilot to commercial production.
1. ODF Liquid Preparation System
Why It Matters
Consistent film quality begins with properly prepared liquids. Inadequate dispersion, poor mixing, or uncontrolled temperature can compromise the entire batch — affecting film uniformity, API distribution, and regulatory compliance.
Application Scenarios
- Pediatric oral films with suspended APIs
- Polymer matrix mixing for transdermal patches
- Ethanol-water solubilization for poorly soluble drugs
- Multi-batch formulation for CRO/CDMO pilot trials
Optional Modules
- Jacketed stainless steel tanks with CIP/SIP capabilities
- Digital PID controllers for temperature and shear rate
- Inline filtration & recirculation loops
- Real-time volume, level, and flow sensors
Technical Overview
- Volume: 30–500L (customizable)
- Control System: PLC + Touchscreen HMI
- Cleaning: Optional CIP/SIP
- Precision: Temp ±0.5°C, Mixing uniformity ±2%
- Material: 316L stainless steel (GMP-compliant)
2. Precision Coating System (ODF & Transdermal Patches)
Why It Matters
Coating thickness and uniformity are critical for dosage accuracy and film functionality. HUANGHAI’s MJ150 and MJ150‑L provide robust control over coating speed, film thickness, and drying curve — suitable for both pharma-grade ODFs and transdermal patches.
Application Scenarios
- Bilayer or dual-API oral films
- Nicotine or lidocaine patch applications
- Zinc, probiotic, or melatonin supplement films
- Flavored pediatric dissolvable film formulations
Optional Modules
- Online thickness measurement scanner
- Dual-component coating heads
- Inert gas drying tunnels
- HEPA-filtered hot air drying zones
- Auto tension control + film shortage alert
Technical Overview
MJ150 – Commercial Coating Line
- Coating Width: 130 mm
- Film Thickness: 0.1–2 mm
- Speed: 0.2–5 m/min
- Drying Tunnel Length: 6 m
- Temperature Range: up to 120°C
- Power: 12 kW
- Machine Size: 9500 × 1400 × 2150 mm
MJ150-L – Pilot Coating Line
- Coating Width: 130 mm
- Film Thickness: 0.1–2 mm
- Speed: 0.2–3 m/min
- Drying Tunnel Length: 2.5 m
- Temperature Range: up to 120°C
- Power: 15 kW
- Machine Size: 2200 × 1400 × 2150 mm
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3. Film Slitting & Packaging Automation
Why It Matters
HUANGHAI’s MJF180 Series allows you to scale from pilot to mass production with flexible sealing technologies.
- Standard Efficiency (Gen 1): Utilizes Rotary Heat Sealing Rollers for reliable, continuous bagging.
- High-Speed Precision (Gen 2): Upgraded with On-Demand Heat Sealing technology. This intelligent system synchronizes sealing action with film cutting, allowing for faster throughput while minimizing thermal stress on sensitive ingredients.
Application Scenarios
- Unit-dose pouch packaging
- Multi-strip format for combo therapies
- Export-quality packaging for global markets
- High-throughput production of large SKU sets
Optional Modules
- Defective film auto-rejection
- Batch number printer + barcode
- Vision inspection + audit trail logging
Technical Overview
- Speed: 0.5–3 m/min
- Cutting Length: 13–35 mm
- Precision: ±0.1 mm
- Sealing Temp: up to 180°C
- Power: 10 kW
- Machine Size: 5200 × 1450 × 2000 mm
- Control System: Touchscreen HMI + Audit Logs
- Compliance: GMP + FDA 21 CFR Part 11
Watch the MJF180 in Action
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Frequently Asked Questions
Q: What is the difference between an ODF film and a transdermal patch?
A: Oral Dissolving Films (ODF) are placed on or under the tongue and dissolve within seconds to minutes, delivering APIs directly through the oral mucosa or via swallowing. Transdermal patches adhere to the skin and deliver APIs through the dermal layers into systemic circulation over hours to days. Despite different delivery routes, both are manufactured using similar solvent-cast film coating processes. Huanghai's MJ150 ODF machine supports both applications on a single platform with approximately 2 working days of changeover time.
Q: What production output can I expect from a Huanghai ODF machine?
A: The MJ150 produces 20,000 films/hour at commercial scale. The MJ150-L targets R&D and pilot production at 8,000–10,000 films/hour. For fully integrated lines, pair either machine with the MJF180 automatic cutting and packaging system (11,900 films/hr) or the more affordable EZ320 (9,000 films/hr). A complete MJ150 + MJF180 line can produce over 150 million finished pouches annually on a single-shift basis. Contact us for pricing and configuration details.
Q: What drying technology does Huanghai use for ODF production?
A: Huanghai uses patented gradient hot-air drying (Patent CN201668734U), which applies a smooth progressive temperature drop rather than stepwise oven zones used by competitors. This results in more uniform film thickness, reduced edge curl, and better API distribution across the film web. An optional far-infrared heating module adds 20–30% drying efficiency for solvent-based formulations. This patented drying system is one of the key technical advantages that justifies Huanghai's position as the preferred ODF equipment supplier to Sinopharm, Shanghai Pharma, and Fosun Pharma.
Q: What are the GMP requirements for ODF production equipment?
A: ODF manufacturing equipment must comply with cGMP (21 CFR Parts 210/211) for US market products, and equivalent standards (EU GMP Annex 1, ChGMP) for other markets. Key requirements: material contact surfaces must be 316L stainless steel or equivalent; CIP/SIP capability or documented cleaning validation; data integrity controls meeting ALCOA+ principles (audit trails, access control). Huanghai ODF machines meet these standards—all product contact surfaces use pharmaceutical-grade materials, and the control system includes operator access logs and parameter change records. Request our GMP compliance documentation.
Q: Can Huanghai machines produce stripe-coated or multi-formula ODF films?
A: Yes. Huanghai holds a patent for multi-formula stripe coating (Patent CN117323228A), enabling two different API formulations to be applied side-by-side in a single coating pass. This eliminates the need for multiple coating/drying cycles when producing combination-drug ODF products. Competitors require manual multi-layer coating with drying intervals between each formula. This capability is particularly valuable for fixed-dose combination products (e.g., dual-API ODFs for cardiovascular or CNS indications) where coating efficiency directly impacts production economics.