Quality Control

Quality Control

Each batch of products undergoes rigorous testing from raw material intake to finished product shipment, including tests for melt flow index, moisture content, tensile strength, and degradation rate.

99%
Batch Consistency
15+
Certifications
100%
Batch Traceability
Zhejiang Hisun Biomaterials Co., Ltd
Certified
ISO · GMP

Quality Control Workflow

A systematic, multi-stage approach ensuring excellence at every step
01

Raw Material Inspection

Every incoming batch undergoes identity verification and purity analysis before production.

02

In-Process Monitoring

Real-time analytical checkpoints at critical stages ensure reaction completeness.

03

Final Certification

Finished products tested against international standards with full analysis certificates.

04

Retention & Traceability

Sample retention for every batch enables full traceability and audit readiness.

Core Capability

Analytical Instrumentation

HPLC, GC-MS, NMR and ICP-OES systems provide comprehensive molecular, elemental and structural analysis for unmatched precision.

Precision Standards

Calibration traceable to international reference materials.

Documentation

Complete COA, COO and regulatory dossiers for every batch.

Stability Testing

Long-term and accelerated stability studies under ICH guidelines.

Regulatory Compliance

Audited and certified under ISO, GMP and REACH frameworks.

Zhejiang Hisun Biomaterials Co., Ltd

Quality Management System

We are ISO 9001 certified, and our products meet export market requirements such as EN 13432, ASTM D6400, and REACH.

Statistical Process Control

SPC monitoring at every production stage ensures consistent quality and identifies variations in real-time.

Risk Mitigation

FMEA systematically identifies and addresses potential failure points before they impact production.

Knowledge Management

Institutional expertise captured through systematic documentation and continuous improvement protocols.

Continuous Improvement

CAPA-driven feedback loops ensure every deviation becomes an opportunity for systemic enhancement.