Background: A pharmaceutical company producing amoxicillin API faced issues with fiber contamination and coarse particles (>150μm) in raw materials, resulting in 8% dissolution test failure rate and dust pollution from open screening processes.
Issue: Traditional vibrating screens had poor sealing, frequent sieve clogging (requiring shutdowns every 2 hours for cleaning), and only 70% screening efficiency.
Solutions:
Deployed a closed stainless steel vibrating screen (316L material) with explosion-proof motor and nitrogen protection system.
Adjusted sieve aperture to 100μm (compliant with USP standards).
Integrated CIP (Clean-in-Place) system and 40kHz ultrasonic anti-clogging technology.
Results:
Particle size compliance rate increased to 99.3%, dissolution failure rate reduced to 0.5%.
Dust concentration decreased from 15 mg/m³ to 0.8 mg/m³ (below OSHA limits).
Cleaning time reduced by 80%, saving CNY 500,000 annually in labor costs.
Background: A solid dosage facility producing paracetamol tablets experienced uneven granule size distribution (40-80 mesh particles accounted for only 65%), causing frequent tablet press jams and capacity constraints.
Issue: Multi-layer screens showed poor stratification accuracy, with fine powder (<40 mesh) causing sticking and coarse particles (>80 mesh) damaging dies.
Solutions:
Customized three-layer probability screen with independent vibration control per layer (1,200-2,000 cycles/min adjustable frequency).
Installed 60-mesh top sieve and 100-mesh bottom sieve.
Upgraded to food-grade silicone seals and airflow-assisted screening system to reduce static adhesion.
Results:
Target particle fraction (40-80 mesh) increased to 92%, tablet press downtime reduced by 70%.
Production capacity grew from 1.2 million tablets/hour to 1.8 million, adding CNY 30 million annual output value.
Passed FDA inspection with zero 483 observations.
Background: A TCM manufacturer producing Banlangen granules faced severe hygroscopic lumping (moisture ≥12%), with >3% agglomerates (>1mm) remaining after conventional screening.
Issue: Manual crushing introduced metal contamination risks and violated GMP guidelines for TCM preparations.
Solutions:
Implemented cyclonic vibrating screen with humidity control module (≤40% RH) and magnetic iron removal.
Adopted polyurethane-edged sieve mesh (0.8mm aperture) and 3D elliptical vibration motion.
Results:
Lump rate reduced from 3% to 0.2%, with zero metal contaminants detected.
Screening efficiency reached 98%, energy consumption decreased 35%, saving CNY 280,000 annually.
Achieved 100% microbial compliance with CNAS laboratory certification.
Background: A biopharma company building a piperacillin sodium sterile API line required full containment and automation per EU GMP Annex 1.
Issue: Traditional screens lacked SIP capability, and manual sampling caused repeated media fill test failures.
Solutions:
Installed fully isolated vibrating screen with steam sterilization (SIP, 121°C×30min) and laser-drilled sieve (±5μm accuracy).
Integrated real-time particle counters with automated MES data logging.
Results:
Passed aseptic process validation: 0 CFU in settle/airborne microbial tests.
Batch changeover time reduced from 6 hours to 1.5 hours, OEE improved to 92%.
Became China's first FDA CEP-certified sterile API manufacturer.
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