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HUANGHAI

MJ150 ODF & Transdermal Patch Film Making Machine – Precision Pharmaceutical Film Production Equipment

MJ150 ODF & Transdermal Patch Film Making Machine – Precision Pharmaceutical Film Production Equipment

Pharmaceutical Film Manufacturing Solutions

The MJ150 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 in 30+ countries for over 40 years.

MJ150 ODF & Solvent-Based Transdermal Patch Film Making Machine

The MJ150 Film Coating Machine is engineered for high-efficiency production of oral dissolvable films (ODF) and solvent-based transdermal patches. Its customizable design allows seamless adaptation to specific production needs, featuring an innovative modular structure that facilitates easy transitions between applications.

Key features include:

Customizable Applications: Tailored configurations for ODF or transdermal patch production.

Innovative Efficiency: Streamlined design maximizing production capacity.

Compound Coating Capabilities: Advanced technology enabling high-efficiency compound drug coating.

Seamless Scalability: Consistent formulation compatibility across various production scales.

Comprehensive Automation: Fully automated processes from raw material processing to final packaging.

Regulatory Compliance: Meets cGMP and FDA 21 CFR Part 11 standards.

This machine is ideal for pharmaceutical manufacturers aiming for precision, efficiency, and compliance in film-based drug delivery systems.

Description:

 

The MJ150 Film Coating Machine is a high-efficiency production solution designed for large-scale manufacturing. With customizable options tailored for either oral dissolvable films (ODF) or solvent-based transdermal patches, this machine adapts to your specific production needs. Its innovative modular design ensures seamless customization—only the cutting head requires modification to transition between the two applications.

 

Engineered to maintain exceptional performance, MJ150 guarantees consistent results across various production scales, from small-batch trials to full-scale manufacturing. Furthermore, the Huanghai MJ series offers unmatched formulation stability across models, eliminating the need to adjust drug formulations when scaling from laboratory trials to mass production.

 

Key Features:

    

1. Customizable for Specific Applications: Supports precise customization for oral dissolvable films (ODF) or solvent-based transdermal patches, catering to diverse pharmaceutical needs.

2. Innovative Efficiency: Streamlined design maximizes production capacity, ideal for high-throughput manufacturing scenarios.

3. Compound Coating Capabilities: Advanced technology enables high-efficiency compound drug coating, offering significant advantages over single-compound coating machines.

4. Intellectual Property: Backed by proprietary patented technology for innovative multi-compound drug coating systems, enabling efficient and precise application compared to conventional single-compound solutions.

5. Seamless Scalability: Ensures formulation compatibility and performance consistency across Huanghai’s small, medium, and large-scale machines, minimizing R&D and operational adjustments.

6. Comprehensive Automation: Fully automated processes from raw material processing, coating, and cutting to final packaging.

7. Regulatory Compliance: Meets cGMP, FDA 21 CFR Part 11, and other international pharmaceutical manufacturing standards.

8. User-Friendly Design: Intuitive control interface for efficient operation and real-time monitoring of key parameters.

 

Technology Lineage & Patent References

  • Production-scale dryer/coater architecture (legacy reference): Early medical film-coating dryer concepts align with CN201668734U (granted 2010; statu). 
  • Current core innovation (in use): HUANGHAI’s CN117323228A enables simultaneous multi-formula coating and method continuity from pilot to commercial MJ series without reformulation.

Parameter Specification

 

l   Running Speed   0.2–5 m/min

l   Coating Method Scraper Coating

l   Coating Width     130 mm

l   Coating Thickness      0.1–2 mm

l   Intake Air Velocity      1–12 m/s

l   Exhaust Air Velocity    1–12 m/s

l   Drying Temperature   Room Temp –120°C

l   Compressed Air Pressure  0.5–0.8 MPa

l   Drying Tunnel Length 6 m

l   Power Supply       3X220/380V 50 Hz

l   Maximum Power 12 kW

l   Equipment Dimensions      9500 × 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.

Frequently Asked Questions

Q: What is the difference between MJ150 and MJ180?

A: The MJ150 is designed for small-to-medium batch production (up to 20,000 films/hour), while the MJ180 offers a wider coating path for higher-volume commercial ODF manufacturing. Both feature patented hot-air gradient drying (CN201668734U) with independent multi-zone temperature control.

Q: Does the MJ150 comply with FDA 21 CFR Part 11 and GMP requirements?

A: Yes. The MJ150 supports electronic batch records, operator login with access control, and audit trail functionality that meets 21 CFR Part 11 requirements. The equipment design aligns with EU GMP Annex 11 and cGMP standards.

Q: What solvents can the MJ series handle?

A: The MJ series supports both aqueous and solvent-based formulations. The explosion-proof (ATEX-compliant) configuration handles Class I, Division 1 solvents including ethanol, acetone, and ethyl acetate with integrated vapor recovery and exhaust ventilation.

Q: What scale does the MJ150-L support, and how does it bridge to MJ150 commercial scale?

A: The MJ150-L is the pilot-scale predecessor, designed for R&D and small-batch validation runs. Its process parameters (drying temperature profile, coating speed, film tension) are directly transferable to the MJ150 commercial line, enabling smooth scale-up without reformulation.


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.

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