PP
Barrel · plunger · optional hub
Injection molded in-houseDISPOSABLE SYRINGE MANUFACTURING
From medical polymer to a sterile, released syringe.
A fully integrated factory concept covering component production, 100% in-line control, sterile-barrier packaging, validated ETO sterilization and traceable distribution.
Configure your production line ↗Fully integratedMolding to warehouse
AutomatedHigh-speed in-line systems
TraceableLot, expiry and process data
Standards-ledISO 13485 · 7886 · 11135
One continuous quality system.
The line is designed as a connected sequence: every critical component is inspected before it advances, every assembled syringe is leak tested, and every sterile batch remains traceable through aeration, cartoning, palletizing and warehouse release.
MATERIAL STRATEGY
Five critical inputs.
One controlled product.
TPE gasket
Plunger seal
Qualified, ready-made supply304 / 316 steel
Needle tube
Cut · grind · bevel · polishSilicone oil
Internal lubrication
Precisely dosed in-houseMedical UV ink
Graduation scale
Printed and UV-cured in-lineTPE gaskets are specified as qualified, ready-made components; the final make-or-buy scope is confirmed during project engineering.
END-TO-END PRODUCTION FLOW
Sixteen controlled stages.
No blind spots.
Raw material control
Qualified medical-grade PP, ready-made TPE gaskets, stainless steel needle tube, silicone oil and UV ink.
Material drying
Dehumidifying drying removes moisture before molding; a representative PP cycle is 70–90°C for 2–4 hours.
Injection molding
High-precision molds form barrels, plungers and optional needle hubs with controlled temperature, pressure and cooling.
Part inspection
100% camera inspection checks flash, short shots, black spots, contamination and critical dimensions.
Graduation printing
High-resolution UV inkjet printing, LED curing and vision verification create permanent, readable scale marks.
Needle assembly
Automated feeding, positioning, insertion and hub fixing deliver concentric, secure needle assemblies.
Siliconization
Precisely dosed medical-grade silicone supports smooth plunger travel and controlled gliding force.
Automatic assembly
Barrel, plunger and gasket are oriented, inserted and locked with in-line position control.
Leak testing
Every assembled syringe is tested by negative-pressure decay to detect micro-leakage.
Final inspection
360° vision control verifies appearance, print, gasket position, tip, needle and plunger movement.
Individual packaging
Medical-grade pouch or blister packaging protects the sterile barrier and carries lot and expiry data.
ETO sterilization
A validated ISO 11135 cycle targets SAL 10⁻⁶ while preserving product and packaging integrity.
Aeration
HEPA-filtered, monitored aeration reduces residual ETO to the validated release limit.
Final cartoning
Automatic counting, IFU insertion, coding, verification and carton closure provide distribution-ready packs.
Palletizing
Stable layer patterns, stretch wrapping and pallet identification protect each shipment.
Controlled warehouse
WMS traceability, environmental monitoring and FEFO rotation preserve released product quality.
REPRESENTATIVE PROCESS WINDOW
Designed around measurable parameters.
These values summarize the supplied manufacturing workflow. Final settings, speeds and acceptance limits are established for the selected product, equipment, tooling and validated process.
Molding
200–230°C PP melt18–20 s representative cycleUV printing
600–1200 dpi120–160 pcs/min representative speedAssembly
120–180 pcs/min/line≥99.5% inspection accuracyLeak test
Negative-pressure decay100% product coverageETO cycle
47–58°C · 40–80% RH450–1,200 mg/L · 2–6 h exposureAeration
18–28°C8–24 h minimum, as validatedIN-LINE QUALITY GATES
Quality is verified before value is added.
Molded-part vision
Flash, short shot, black spot, contamination and dimensional conformity.
Print verification
Graduation accuracy, contrast, readability, adhesion and UV cure.
Needle & assembly control
Insertion depth, alignment, hub security, gasket position and plunger movement.
100% leak test
Negative-pressure decay identifies micro-leakage before packaging.
Package integrity
Seal temperature, pressure and time; print, code and sterile-barrier inspection.
Sterile release
Validated cycle records, biological indicators and residual ETO verification.
COMPLIANCE FRAMEWORK
Built for documented, repeatable production.
ISO 13485 quality managementISO 7886 syringe performance pathwayISO 11135 ETO sterilizationISO 10993-7 residual ETOISO 11607 sterile barrier packagingISO 14971 risk managementIQ / OQ / PQ qualificationElectronic batch traceability
Applicable standards, claims and regulatory evidence are finalized according to syringe configuration, intended use and destination market.
TURNKEY DELIVERY
A factory engineered as one operating system.
01Capacity and SKU modeling02Facility zoning and material flow03Injection molding and precision tooling04Printing, assembly and inspection integration05Packaging, ETO and aeration engineering06QC laboratory and warehouse systems07Qualification, SOPs and batch records08Training, pilot production and ramp-up
Build a syringe line ready for validated production.
Share the target syringe sizes, annual volume, packaging format and localization scope. We will configure the equipment, facility and qualification pathway.
Start the project discussion ↗