Complete ZP Series range - from 5 to 55 stations - engineered and validated for cGMP, FDA 21 CFR Part 11, and international pharmaceutical regulatory compliance.
YohoAI ZP Series rotary tablet presses are purpose-built for cGMP pharmaceutical manufacturing, spanning five models from the entry-level ZP-5 (5 stations) to the ultra-high-speed ZP-55 (55 stations, 400,000 tablets/hour). Every machine features 316L stainless steel punch tips, Ra <= 0.4 um polished die tables, and full data integrity controls compliant with FDA 21 CFR Part 11. Each unit ships with FAT protocols, IQ/OQ/PQ validation documentation, and EN 10204 material certificates - everything needed for regulatory submission.
Verified factory data - not marketing estimates
316L SS product contact surfaces, Ra <= 0.4 um polished die table, CIP/WIP compatible with zero dead legs in product zones. Designed for cleanroom installation in pharmaceutical manufacturing facilities.
Every machine ships with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation templates aligned with ICH Q10, plus FAT protocols and EN 10204 3.1/3.2 material certificates.
Audit trail, electronic signatures, user access controls, and data logging on the 10-inch HMI. Compliant with FDA 21 CFR Part 11 for electronic records in pharmaceutical manufacturing.
From R&D (ZP-5, 50,000/hr) to pilot (ZP-19, 150,000/hr), commercial (ZP-35, 280,000/hr), and high-volume (ZP-55, 400,000/hr) - one validated platform across all production scales.
Closed-loop servo feedback maintains +/-1% compression force accuracy on both pre-compression and main compression rolls, ensuring consistent tablet hardness per USP <1237> across all stations.
Tool-free punch removal with 200+ pre-stored compression recipes on the HMI. Change between tablet sizes and products rapidly without lengthy revalidation, supporting multi-product GMP facilities.
Our team responds within 2 hours with CIF/CFR/FOB pricing and delivery timeline.
Every ZP Series machine ships with Factory Acceptance Test (FAT) protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation templates aligned with ICH Q10. EN 10204 3.1/3.2 material certificates for all 316L SS product contact parts are included along with a complete operation and maintenance manual.
Yes. ZP Series presses are CE certified, cGMP compliant, FDA 21 CFR Part 11 compliant, and ISO 9001:2015 certified. They meet US FDA, EU EMA, and WHO-Prequalification requirements. YohoAI's engineering team provides on-site IQ/OQ/PQ execution support for regulatory submissions at no additional cost.
Pricing for the complete ZP Series range typically spans USD 15,000 (ZP-5) to USD 95,000 (ZP-55), depending on model and configuration. All models include IQ/OQ/PQ documentation in the standard package. YohoAI equipment is priced 30-40% below comparable European brands such as Fette, Korsch, and IMA.
Standard GMP configurations typically ship within 30-60 days from confirmed purchase order. This includes FAT protocols, IQ/OQ/PQ documentation, material certificates, and quality inspection reports. Custom configurations with non-standard station counts or additional validation upgrades may require 60-90 days.
Yes. YohoAI's Shanghai demo facility can process your actual product or a representative formulation. We can send you filled samples for quality assessment. Demo sessions are typically arranged within 5 working days of inquiry. Video recording of the demo run is provided for internal evaluation.
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.
All ZP Series GMP machines are shipped with complete validation documentation including IQ/OQ/PQ templates aligned with ICH Q10 quality management guidelines. Installation qualification covers equipment placement verification, utility connection confirmation (380V/50Hz 3-phase, 0.6 MPa compressed air), and instrument calibration records. Operational qualification includes compression force verification, weight uniformity testing, and HMI functionality checks. Performance qualification confirms tablet hardness, weight variation, and dissolution results against pre-defined acceptance criteria. YohoAI engineering team provides on-site IQ/OQ/PQ execution support at no additional cost, guiding customers through regulatory submission documentation.
GMP compliance requires documented changeover procedures between different products to prevent cross-contamination. The tool-free punch removal system enables rapid product changeover, but each changeover must include die table cleaning verification, punch tip inspection, and feeder flushing with placebo. Cleaning validation protocols should be established for each formulation type processed on the equipment. All cleaning records, batch production records, and maintenance logs must be retained in the equipment history file for regulatory inspection. The HMI audit trail automatically records all parameter changes, providing an electronic record that meets FDA 21 CFR Part 11 requirements for data integrity.
A robust preventive maintenance program is a GMP requirement, not an option. Maintenance activities must be scheduled, documented, and reviewed as part of the annual product quality review. Spare parts used for repairs must be qualified and traced back to approved suppliers. Calibration of critical instrument parameters including compression force sensors, fill depth encoders, and tablet hardness testers must be performed at defined intervals with certified reference standards. Any deviations from the validated operating range must be investigated and documented before production resumes. YohoAI provides calibration support, spare parts management, and annual GMP audit preparation services for all ZP Series machines.
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