MJ150-L ODF Film Coating Machine – Pilot-Scale Precision Coating System for Oral Films

Pharmaceutical Film Manufacturing Solutions

The MJ150-L ODF Film Coating Machine is developed by Huanghai Machinery — founded by the core team of China's National Pharmaceutical Engineering Research Center (NPERC) and backed by 97+ registered patents including patented hot-air gradient drying technology (CN201668734U). Trusted by pharmaceutical manufacturers, CROs, and CDMOs in 30+ countries for maintaining seamless scalability from pilot to commercial production.

MJ150-L ODF Film Coating Machine

The MJ150-L ODF Film Coating Machine is specifically designed for pilot-scale operations and medium-scale production of oral dissolving films (ODF). It ensures a smooth transition from pilot trials to full-scale manufacturing without the need for formulation adjustments.

Key features include:

Pilot-to-Scale Transition: Replicates industrial-scale production processes for seamless scaling.

Customizable Coating Functions: Configurable for ODF production.

Multi-Compound Coating Technology: Patented technology for efficient multi-compound drug coating.

Compact Design, High Performance: Optimized footprint with high energy efficiency.

Advanced Control Systems: Intelligent parameter settings for precision and consistency.

Regulatory Compliance: Meets cGMP and supports FDA 21 CFR Part 11 standards for audit trails.

This machine is ideal for pharmaceutical companies, CROs, and CDMOs looking to scale up their ODF production processes with precision and efficiency.

Pilot-Scale Film Coating System for Medium-Scale Production

The MJ150-L is specifically designed for pilot-scale operations and medium-scale production of Oral Dissolving Films (ODF) or solvent-based transdermal patches. This model is ideal for pharmaceutical companies, CROs, and CDMOs looking to scale up their production processes. With consistent alignment to industrial-scale systems, the MJ150-L ensures seamless transition from pilot to large-scale production without the need to adjust drug formulations. Equipped with advanced multi-compound coating technology, it provides superior flexibility, high efficiency, and precise control, catering to complex drug delivery systems.

Key Features

• Pilot-to-Scale Transition: Engineered to replicate industrial-scale production processes, enabling a smooth transition from pilot trials to full-scale manufacturing without reconfiguring formulations.
• Customizable Coating Functions: Configurable for either Oral Dissolving Films (ODF) or solvent-based transdermal patches, adapting to the unique needs of pharmaceutical formulations.
• Multi-Compound Coating Technology: Patented technology for efficient and accurate multi-compound drug coating, outpacing traditional single-compound systems and enhancing flexibility.
• Compact Design, High Performance: The optimized footprint and high energy efficiency make the MJ150-L a cost-effective solution for medium-scale operations.
• Advanced Control Systems: Features intelligent parameter settings for drying, coating speed, and airflows to guarantee precision and consistency in production.
• Compliance & Quality Standards: Designed to meet cGMP, EU GMP Annex 11, and support 21 CFR Part 11 standards, ensuring traceability and data integrity.
• Flexible Coating & Drying Options: Adjustable slot-die coating and drying temperatures up to 120°C to accommodate a wide range of drug formulations and substrate materials.
• Enhanced Efficiency: Integrated with state-of-the-art systems for coating, drying, and cutting, achieving superior productivity and minimizing waste.
• User-Friendly Interface: Equipped with an intuitive HMI touchscreen control for seamless operation and real-time monitoring.
• Durable Build: Robust components for reliable performance, capable of operating continuously under demanding production environments.
• Compact Size: Designed for medium-scale production, the machine fits easily into existing production lines while maintaining high output efficiency.

Technology Lineage & Patent References

• Current core innovation (in use): HUANGHAI’s multi-formula strip-based coating is supported by CN117323228A, enabling simultaneous multi-zone coating on a single web for ODFs/patches, improving throughput and dosage-ratio control.
• Advanced Drying Control: Integrated with our exclusive hot-air gradient drying structure (lineage via CN201668734U), securing optimal bottom-up temperature transitions without the risks of static heated plates.

Note: MJ150-L integrates our proprietary commercial-grade upgrades optimized for pilot-scale flexibility.

Parameter Specification

• Coating Width: 130 mm
• Coating Thickness: 0.1–2 mm
• Coating Speed: 0.2–3 m/min
• Drying Path: 2.5 m
• Drying Temperature: Room Temp–120°C
• Compressed Air: 0.5–0.8 MPa
• Airflow Speed: 1–12 m/s
• Power Supply: 3x220/380V, 50Hz
• Maximum Power: 15 kW
• Dimensions: 2200 × 1400 × 2150 mm (L×W×H)

🛡️ Safety Standard: Engineered to meet Class I Div 1 / ATEX explosion-proof standards, ensuring safe handling of volatile transdermal solvents.

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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.