Industry Focus: 2025 GMP Full Implementation Drives Solid Dosage Equipment Upgrade Wave, Lysino Machinery’s Core Products Empower Pharmaceutical Compliance Transformation

Three Core Requirements of the New GMP Force Comprehensive Upgrade of Solid Dosage Equipment

1. Data Integrity Requirements: All critical process parameters must be collected in real time, automatically recorded and tamper-proof, and must comply with FDA 21 CFR Part 11 electronic record standards. This requires equipment to have a complete PLC+SCADA+MES three-level control architecture, realizing full-process data traceability from raw material incoming to finished product delivery.
2. Process Control Precision Requirements: The control standards for critical quality attributes such as mixing uniformity, granule quality, fill weight variation and tablet weight variation have been significantly raised. For example, the allowable range of capsule fill weight variation has been tightened from ±7.5% to ±5%, and tablet hardness fluctuation range from ±10% to ±5%.
3. Continuous and Intelligent Production Requirements: Enterprises are encouraged to adopt continuous production technology and intelligent manufacturing systems to reduce manual intervention and improve production efficiency and batch consistency. Online quality inspection, predictive maintenance and digital twin technologies have become standard configurations for new production lines.

Lysino Machinery’s Core Products Fully Compliant with 2025 GMP Requirements

1. GLZ Series Dry Granulator: Intelligent Closed-loop Control Ensures Granule Quality Consistency

• Equipped with online granule particle size and moisture detection system to realize closed-loop control, with granule qualification rate increased to over 99.5%
• Fully enclosed dust-free design completely solves dust leakage and cross-contamination problems
• Integrated MES system interface for real-time upload of all process parameters to meet data traceability requirements
• Modular design enables mold replacement within 15 minutes, adapting to multi-variety and small-batch production

2. NJP Series Automatic Capsule Filling Machine: High-precision Servo Control with Fill Weight Variation ≤±3%

• Maximum capacity of 1,200 capsules per minute with stable operation and low failure rate
• Integrated AI visual inspection system automatically rejects unqualified products such as empty capsules, missing pills and poor locking
• Compliant with cGMP and FDA requirements, supporting export to European and American markets
• Quick mold change design enables switching between different capsule specifications within 30 minutes

3. SNZ Series Intelligent Counting & Cartoning Production Line: Full-process Automation with Zero Manual Intervention

• The intelligent counting machine adopts 3D visual recognition technology with 99.99% counting accuracy and unqualified rate lower than 1/100,000
• Integrated online weight detection, metal detection and visual inspection systems to ensure product quality
• All process data is automatically recorded, realizing full traceability of each bottle of product
• Flexible design enables quick switching between different specifications of tablets, capsules and pills

Lysino Machinery’s One-stop Service Helps Pharmaceutical Enterprises Complete Compliance Upgrade Rapidly

• Process Validation Services: Provide complete DQ/IQ/OQ/PQ validation documents to ensure smooth passage of GMP inspections
• Customized Solutions: Tailor production line solutions according to enterprises’ product characteristics and capacity requirements
• Fast-response After-sales Service: Established a nationwide after-sales service network to respond to customer needs within 24 hours
• Lifelong Technical Support: Provide equipment upgrading and technical consulting services to ensure long-term stable operation of equipment