Step Inside NuGene Pharma’s State-of-the-Art Manufacturing Facility – PQQ supplier & manufacturer
PQQ supplier & manufacturer – These facility images showcase our cGMP-certified production plant in Shandong, China, where precision meets scale. Our facility features:
- Advanced Synthesis Labs: Automated reactors for high-purity PQQ and specialty ingredients
- Climate-Controlled Production: ISO Class 8 cleanrooms for sensitive compounds
- Quality Control Centers: HPLC, GC-MS, and ICP-MS testing equipment
- Sustainable Operations: Closed-loop systems reducing environmental impact
Every corner reflects our commitment to:
✓ FDA-compliant manufacturing
✓ Batch-to-batch consistency
✓ Scalability from R&D to commercial volumes
Precision Quality Control at NuGene Pharma’s Manufacturing Facility
Our facility features cutting-edge OC (Operation Control) and QC (Quality Control) systems that ensure pharmaceutical-grade precision for every batch:
In-Process OC Equipment:
- PAT (Process Analytical Technology) systems for real-time reaction monitoring
- Automated process controllers maintaining ±0.5% parameter tolerances
- Environmental monitoring stations tracking particulate/TEMP/Humidity 24/7
QC Laboratory Capabilities:
- HPLC/UPLC for purity analysis (99.5%+ verification)
- GC-MS/LC-MS for residual solvent/heavy metal detection
- FTIR & NMR for structural confirmation
- Microbiological testing suites meeting USP/EP standards
Dual-Layer Verification:
1️⃣ In-process checks every 2 hours during production
2️⃣ Final release testing with 21 CFR Part 11 compliant data systems
Certified by: ISO 9001, HALAL, HACCP, and SGS
This integrated approach guarantees:
✓ Raw material-to-finished product traceability
✓ <0.1% batch failure rate over 5 years
✓ Full documentation for regulatory submissions
NuGene Pharma’s Advanced Workshop: Where Precision Meets Production Excellence
At the heart of our manufacturing operations lies NuGene Pharma’s state-of-the-art workshop, a cGMP-certified production hub designed for efficiency, precision, and scalability.
Key Features of Our Workshop:
✔ Modular Cleanroom Design – ISO Class 7/8 environments with continuous particulate monitoring
✔ Multi-Purpose Reactor Systems – 50L to 5000L stainless steel reactors with automated controls
✔ Containment Technology – Isolators and barrier systems for potent compound handling
✔ Continuous Processing Lines – Integrated PAT (Process Analytical Technology) for real-time quality assurance
Specialized Work Zones:
- Synthesis Area: Dedicated spaces for chemical and enzymatic reactions
- Formulation Suite: Granulation, blending, and encapsulation equipment
- Packaging Lines: Automated labeling and serialization for track-and-trace compliance
Operational Excellence:
• 24/7 production capacity with 98.5% uptime reliability
• Paperless batch record system (electronic MES)
• Energy-efficient HVAC systems with 30% reduced carbon footprint
