• 459 Qianmo Road, distrito de Binjiang, Hangzhou, China
Presupuesto

Pharmaceutical Manufacturing Solutions

Focused Photonics (Hangzhou) Inc. delivers innovative Pharmaceutical Manufacturing Solutions with precision Gas Analyzers and Process Monitoring Systems. Our technologies ensure purity control, contamination detection, and regulatory compliance in drug production, enhancing product quality and streamlining manufacturing processes for global pharmaceutical leaders.

SOLICITAR PRESUPUESTO

Puntos débiles del sector y situación actual

The pharmaceutical manufacturing industry faces critical challenges amid rising demand and stringent regulations.

Narrative Insight: Unmonitored VOC and residual solvents in production environments lead to 5-10% batch rejections. The 2023 FDA recall of a major antibiotic due to contamination underscores the need for real-time monitoring.

  • FDA 21 CFR Part 11: Electronic data integrity for records.
  • EU GMP Annex 1: Strict sterility standards.
  • Outcome: 20% of firms face audits annually, with non-compliance fines exceeding $100,000.
  • Delay Cause: Manual análisis de gases slows validation by 15-20%.
  • Cost Impact: $500,000+ per month in lost production for large plants. Automation is critical to address these bottlenecks.

Current trends emphasize real-time analytics and Industry 4.0, but reliance on traditional methods limits scalability and innovation.

Metric
Current State
Target

Purity Level

95%

99.9%

Batch Rejection

8%

<2%

Inconsistent process monitoring hampers achieving these goals.

Cómo resuelve FPI estos retos

FPI Pharmaceutical Manufacturing Solutions provide continuous gas analysis and contamination tracking with Laser-Based Analyzers. We ensure purity levels above 99.8% and reduce batch rejections by 75%, integrating with MES for seamless data integrity. Our systems support predictive maintenance, cutting downtime by 18%.

Póngase en contacto con nuestros expertos.

Our Solution Process: From Validation to Long-Term Partnership

We tailor our expertise to your production needs

Validation

Conduct risk assessments and cleanroom audits.

Customization

Design Process Monitoring Systems for specific drug formulations.

Implementation

Deploy with GMP-compliant installation in 5-7 weeks.

Partnership

Provide 24/7 technical support, annual calibrations, and a 3-year warranty.

Our Comprehensive Pharmaceutical Manufacturing Solutions

Nuestras ofertas combinan tecnología innovadora con conocimientos prácticos.

Analizador láser de gases LGA-C300 con valor calorífico

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Analizador de láser de diodo sintonizable (TDL) con derivación LGA-4500

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Analizador de gases con láser de diodo sintonizable (TDL) in situ LGA-4100

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  • Real-time VOC and residual solvent detection.
  • Sterility and particulate matter analysis.
  • Gas composition monitoring in production environments.
  • Water vapor and oxygen control in storage.
  • Ultra-Precision: Detects ppb-level impurities, 30% more accurate.
  • Compliant Design: GMP-certified, ensuring audit readiness.
  • Efficient Workflow: Reduces validation time by 25%
  • Cost Reduction: 20% lower production costs with fewer rejections.
  • Quality Assurance: Supports FDA-approved processes.
  • FDA 21 CFR Part 11: Ensures electronic records compliance.
  • EU GMP Annex 1: Meets sterility and cleanroom standards.
  • ICH Q3D: Controls elemental impurities.
  • WHO GMP: Aligns with global quality standards. Our systems deliver validated compliance documentation.
  • Pfizer Inc.: LGA-5000 improved VOC detection, reducing batch rejections by 70% per FDA 21 CFR.
  • Novartis Pharma AG: PMS-6000 enhanced purity control, cutting downtime by 15% in API production.
  • Dr. Reddy’s Laboratories: CMS-4000 ensured sterility, meeting EU GMP Annex 1 standards.
  • ...

¿Por qué elegir a FPI como su socio para soluciones de fabricación farmacéutica?

With 18+ years in pharma analytics, FPI has installed 250+ systems globally, achieving 98% customer satisfaction. Our laser technology ensures unmatched purity. Partner with us for

  • Proven Track Record: 35+ patents, work with Pfizer y Novartis.
  • Global Assistance: 24/7 support from Hangzhou and pharma hubs.
  • Advanced Technology: AI-enhanced process optimization.
  • Value Delivery: 15% reduction in compliance costs. Choose FPI for reliable pharmaceutical manufacturing excellence.

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