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.

Industry Pain Points & Current Status

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 gas analysis 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.

How FPI Solves These Challenges

FPI’s 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%.

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

Our offerings blend innovative technology with actionable insights

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.
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Why Choose FPI as Your Pharmaceutical Manufacturing Solutions Partner?

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 and 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.