Automatic Pharmaceutical Capsule Filling Machine for GMP-Compliant Production

The HIJ-NJP Series achieves an industry-leading filling accuracy of ±3% or better. This exceptional precision is made possible by our proprietary dosing disc mechanism combined with a 5-stage tamping system.

For example, if your target fill weight is 500mg, the actual fill will consistently be between 485mg and 515mg across thousands of capsules. This level of accuracy ensures:

• Regulatory compliance: Meets USP, EP, and cGMP weight variation requirements.
• Cost savings: Minimizes overfilling and product waste.
• Patient safety: Ensures consistent dosing for critical pharmaceutical formulations.

During Factory Acceptance Testing (FAT), we validate the accuracy with your actual powder or pellet formulation to guarantee performance before shipment.

Yes, the HIJ-NJP Series is specifically engineered to handle challenging powder characteristics, including:

• Fine powders (down to 50 microns): The fully enclosed dosing station prevents powder escape and ensures consistent flow.
• Sticky or hygroscopic powders: Anti-adhesive coating on contact parts and adjustable tamping pressure prevent powder buildup.
• Low-density or fluffy powders: The 5-stage tamping system compresses powder into uniform slugs before filling.
• Granules and pellets (up to 3mm): The dosing disc design accommodates a wide range of particle sizes.

For unique formulations, our engineering team can customize the dosing disc configuration and tamping parameters during the URS phase to optimize performance for your specific material properties.

For the TCF-1200 (72,000 capsules/hour capacity), our standard lead time is:

• Standard configuration: 6-8 weeks from order confirmation and deposit payment.
• Custom configuration: 10-12 weeks (e.g., special voltage requirements, explosion-proof version, or integration with existing line equipment).

Our lead time includes:

• Manufacturing and quality control testing.
• Factory Acceptance Test (FAT) with your team (in-person or remote).
• Complete documentation package (IQ/OQ protocols, user manuals, spare parts list).
• Professional packaging for international shipping.

We provide weekly production updates and can expedite delivery for urgent projects. Contact our team for a detailed project timeline.

Absolutely. Comprehensive validation support is a cornerstone of our turnkey service. We provide:

• IQ (Installation Qualification) Protocol: Step-by-step installation verification checklist, including equipment specifications, component lists, and utility requirements.
• OQ (Operational Qualification) Protocol: Test procedures to verify that the machine operates according to design specifications across all operating ranges.
• FAT (Factory Acceptance Test) Report: Documented proof that the machine passed all performance tests at our facility before shipment.
• SAT (Site Acceptance Test) Support: On-site commissioning assistance to execute IQ/OQ at your facility.
• cGMP Compliance Documentation: Material certificates (SS304/316L), electrical safety certificates (CE), and software validation documents (21 CFR Part 11 ready).

All documents are provided in English and can be customized to align with your company's validation templates and regulatory requirements (FDA, EMA, WHO GMP, etc.).

The HIJ-NJP Series is designed from the ground up for cGMP compliance. Every design decision reflects international pharmaceutical manufacturing standards:

• All product-contact parts in SS316L: Corrosion-resistant, non-reactive, and easy to clean/sanitize.
• Fully enclosed dosing & rotating table: Prevents cross-contamination and protects operators from powder exposure.
• Tool-free disassembly: Critical parts (dosing disc, powder hopper, tamping pins) can be removed and cleaned in under 15 minutes without tools, facilitating validation cleaning studies.
• No dead spaces: Smooth internal surfaces with minimal crevices reduce bacterial harbourage risk.
• Siemens PLC with HMI touchscreen: Provides audit trail capabilities (user login, batch records, alarm logs) to support 21 CFR Part 11 compliance.
• Electrical safety to CE/UL standards: All electrical components are rated for pharmaceutical cleanroom environments.

We also provide a Design Qualification (DQ) document upon request, which outlines how each design feature supports cGMP principles (e.g., quality, safety, traceability, and data integrity).