Medical Grade Plastic Packaging
ISO 13485 certified precision injection molding in GMP Class 100,000 cleanroom. We manufacture medical-grade plastic packaging and consumable components for pharmaceutical, diagnostic, and medical device applications — with full traceability and regulatory compliance built into every step.
Purpose-Built for Medical Manufacturing
Our facility, quality systems, and manufacturing processes are designed from the ground up to meet the stringent requirements of medical and pharmaceutical packaging.
ISO 13485 Certified
Medical device quality management system ensuring consistent product quality and regulatory compliance.
GMP Cleanroom
800m² ISO Class 8 (Class 100,000) cleanroom dedicated to medical and food-grade production.
Full Traceability
From raw material to finished product — complete batch traceability for regulatory submissions and audits.
Material Compliance
Medical-grade PP, PE, and specialty resins with MSDS documentation, SGS testing, and biocompatibility data.
Medical Certifications & Licenses
Our medical manufacturing capability is backed by internationally recognized certifications and Chinese government-issued medical device licenses.
ISO 13485:2016
Medical Device Quality Management System — the international standard for organizations involved in the design and manufacture of medical devices.
Class II Medical Device Registration
Filing certificate for Class II medical device business operations, issued by the Suzhou Municipal Market Supervision Administration.
Class III Medical Device License
Business license for Class III medical devices — the highest risk category requiring the most stringent regulatory oversight.
Medical-Grade Production Environment
Cleanroom photo
GMP Class 100,000 Cleanroom
Our 800m² ISO Class 8 cleanroom is purpose-built for medical and food-grade manufacturing. Temperature, humidity, and particulate levels are continuously monitored and controlled to meet the most demanding production standards.
800m² dedicated cleanroom area
ISO Class 8 (GMP Class 100,000) particle control
HEPA filtration with positive pressure differential
Temperature and humidity real-time monitoring
Gowning rooms and air shower entry protocols
Precision Injection Molding
20 injection molding machines (100T–270T) produce medical packaging components with tight tolerances. Our in-house mold design and CNC machining capabilities enable rapid prototyping and production of complex medical packaging geometries.
20 injection machines, 100T–270T clamping force
In-house mold design with CNC & EDM machining
Medical-grade PP, PE, and specialty resins
3D prototyping for design validation
CMM dimensional inspection (300×300mm)
Injection molding photo
Medical Packaging Applications
Our medical manufacturing platform supports a range of healthcare packaging and consumable component applications.
Diagnostic Device Housings
Precision-molded enclosures for IVD test kits, lateral flow cassettes, and point-of-care diagnostic devices requiring tight dimensional control.
Pharmaceutical Packaging
Child-resistant and tamper-evident containers for tablets, capsules, powders, and oral pharmaceutical products with full material compliance.
Medical Consumable Components
Precision plastic parts for medical device assemblies — caps, adapters, connectors, and functional components produced under ISO 13485.
Specimen & Sample Containers
Leak-proof containers for biological specimens, laboratory samples, and collection devices manufactured in controlled cleanroom conditions.
Child-Resistant Medical Packaging
ISO 8317 and 16 CFR 1700 certified child-resistant mechanisms integrated into medical packaging — critical for prescription and OTC products.
Wellness & Nutraceutical
Premium packaging for health supplements, functional oral products, and CBD wellness items — combining food-grade safety with medical-grade quality.
Medical-Grade Quality Control
Every product passes through a rigorous quality control process designed for medical and pharmaceutical industry requirements.
Raw material verification, COA review, material identity testing, and supplier qualification
SPC monitoring, first-article inspection, real-time dimensional checks, process parameter logging
AQL sampling, visual inspection, functional testing (snap force, vacuum, torque), weight verification
Packaging integrity, labeling verification, batch documentation, shipping condition audit
Coordinate Measuring Machine (300×300mm) for precision dimensional verification of critical features
DR-509 tensile tester for material strength verification and snap-fit performance validation
Byes-02 vacuum tester for container seal integrity — critical for sterile and moisture-sensitive products
Ready to Discuss Your Medical Packaging Project?
Whether you need custom medical packaging, precision consumable components, or compliant pharmaceutical containers — our engineering team is ready to support your project from design through mass production.