NJP Series capsule filling machines engineered for pharmaceutical GMP factories, delivering validated performance, complete regulatory documentation, and cGMP-compliant batch production.
Pharmaceutical GMP factories face stringent regulatory requirements including validated equipment, complete batch documentation, and reproducible production records. The NJP Series hard capsule filling machines are purpose-built to meet these demands, offering full DQ/IQ/OQ/PQ validation protocol packages, 21 CFR Part 11-compliant electronic records, and a complete documentation suite that simplifies regulatory submissions and facility audits.
Verified factory data - not marketing estimates
Complete DQ/IQ/OQ/PQ validation protocol documentation is included with every NJP machine. Protocols align with PDA, ISPE, and WHO guidelines, ready for direct submission to regulatory agencies including FDA, EMA, and NMPA.
Comprehensive DQ documentation includes detailed machine specifications, material certificates, surface finish verification, and design review records confirming the NJP machine meets all user requirement specifications.
IQ documents verify as-delivered equipment against purchase specifications. OQ tests confirm functional performance (speed, accuracy, rejection rates) under simulated production conditions at the customer facility.
PQ protocols validate the NJP machine against your actual production formulation, confirming fill weight uniformity, capsule integrity, and batch yield under real-world production conditions at your facility.
The HMI control system includes user authentication, role-based access control, electronic signatures, and audit trail logging for all production parameters and batch records to comply with FDA 21 CFR Part 11.
All product-contact parts are serialized and traceable with 3.1/3.2 material certificates. This enables full traceability in the event of a batch recall and supports annual product quality reviews (APQRs).
Our team responds within 2 hours with CIF/CFR/FOB pricing and delivery timeline.
YohoAI provides a complete validation document package including URS (User Requirement Specification), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. All documents align with FDA, EMA, and WHO GMP guidelines.
The NJP HMI system implements user access controls, electronic signatures, audit trail logging of all production parameters, and data export capabilities. These features satisfy FDA 21 CFR Part 11 requirements for electronic records in pharmaceutical manufacturing.
Yes. YohoAI engineers support on-site IQ/OQ execution and can coordinate with your QA team for PQ studies. Optional GMP consulting support is available for facilities preparing for FDA, EMA, or NMPA inspections and regulatory submissions.
YohoAI provides CIP (Clean-in-Place) validation protocols and worst-case residue calculation documentation. Contact part surface areas and material compatibility data are included in the validation package for your cleaning validation study.
The NJP HMI stores up to 100 production recipes with all fill parameters locked and logged per batch. Each batch record automatically captures machine speed, fill weights, rejection counts, and operator identification, generating a complete electronic batch record for GMP documentation.
Pricing varies by configuration and accessories. Please send us your specific requirements including production capacity needs, tube/can/capsule format, and required certifications. We typically respond within 2 hours with CIF/CFR/FOB pricing.
Standard delivery ranges from 30-90 working days depending on the model and configuration. Pharmaceutical GMP configurations with validation documentation packages require additional 5-10 working days. Expedited manufacturing is available for urgent orders at a 15-25% premium.
All YohoAI machines carry CE certification and are designed to meet cGMP and ISO9001 standards. Additional certifications including FDA compliance and specific food-grade standards are available depending on the product line and configuration.
GMP capsule filling line installation requires strict adherence to pharmaceutical facility qualification protocols. Begin with a Design Qualification (DQ) review to confirm the selected NJP model meets all User Requirement Specifications including capacity, fill accuracy, and documentation requirements. Installation Qualification (IQ) verifies as-delivered equipment against purchase specifications: confirm all components are present, serial numbers are logged, and utilities (380V/50Hz 3-phase power, compressed air, dust extraction) are within specified parameters. YohoAI provides full DQ/IQ/OQ/PQ protocol documentation aligned with PDA, ISPE, and WHO guidelines ready for regulatory submission to FDA, EMA, or NMPA.
Operational Qualification (OQ) testing at the customer facility confirms functional performance under simulated production conditions. Test fill weight uniformity, rejection system accuracy, and HMI user access controls. Validate the electronic batch record auto-logging system captures all required production parameters including machine speed, fill weights, rejection counts, and operator identification. The 21 CFR Part 11-compliant audit trail must be verified to confirm all data changes are timestamped, attributed, and immutable. Performance Qualification (PQ) validates the NJP machine against your actual production formulation under real-world conditions at your facility.
Ongoing GMP maintenance requires annual revalidation of the complete NJP line. Verify 316L stainless steel contact parts retain Ra < 0.8 um surface finish through periodic surface analysis. Confirm user access control settings are current with no unauthorized role escalation. Export electronic batch records quarterly and verify data integrity against physical production logs. Cleaning validation protocols (CIP) must be reviewed annually using worst-case residue calculations and validated cleaning agent contact time data. YohoAI provides lifetime software updates ensuring the HMI and SCADA systems remain current with evolving regulatory requirements.
Entry-level 8-station GMP capsule filler for R&D and small-scale production
Dual-format GMP-compliant capsule filler for powder and pellet production
Mid-capacity GMP production model with recipe management and full documentation
