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Medical Device Assembly Machine Fully Automatic

Categories Medical Device Assembly Line
Brand Name: Quanstar
Certification: ISO
Place of Origin: Shanghai
Payment Terms: L/C,T/T
Packaging Details: wooden box
Name: Medical device assembly machine
Industry: medical
Type: fully automatic
Control system: PLC, HMI
Condition: new
Warranty: one year
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Medical Device Assembly Machine Fully Automatic

Medical device assembly machine


Rotary table machine for medical products assembly and test


CategoryParameterDescription/Value
General SpecificationsLine Length5-30 meters (modular design)
Production Speed50-300 pieces/min (depending on product type)
Workstation Number5-20 stations (flexible configuration)
Power Supply220V/380V AC, 50/60Hz
Cleanroom CompatibilityISO Class 5-8 (optional HEPA filtration)
Assembly ModuleAssembly Accuracy±0.1 mm
Gripper TypeMedical-grade silicone/pneumatic (FDA compliant)
Ultrasonic Welding20-40 kHz (for plastic components)
Component Size Range5-300 mm
Inspection ModuleVision System Resolution5-10 MP (with 10-30 μm/pixel)
Defect DetectionParticulate contamination, surface defects, dimensional accuracy
Leak Test Sensitivity≥1 μm (for syringes, IV bags)
Sterility VerificationOptional ATP bioluminescence detection
Material HandlingConveyor TypeFDA-approved belt/chain (anti-static options)
Positioning Accuracy±0.2 mm
Material CompatibilityPP, PE, PVC, silicone (medical-grade)
Control SystemPLCSiemens (S7-1200/1500), Rockwell Automation
HMI10"-15" touchscreen (21 CFR Part 11 compliant)
Traceability SystemBarcode/RFID (UDI compliance)
Data IntegrityAudit trail, electronic signatures (GMP requirements)
Quality MetricsFalse Rejection Rate≤0.1%
First-Pass Yield≥99.8%
AQL Level0.65 (standard sampling plan)
EnvironmentalOperating Temperature18-26°C (controlled environment)
Humidity Range30-60% RH
Noise Level≤65 dB
Safety & ComplianceRegulatory StandardsISO 13485, FDA 21 CFR Part 820, EU MDR
Safety FeaturesEmergency stop, interlocks, cleanroom-grade materials
Validation PackageIQ/OQ/PQ documentation available

Key Features:

  1. Sterility Assurance: Optional gamma irradiation/EtO compatible materials

  2. Changeover: <10 minutes for different product formats

  3. Materials: All contact parts USP Class VI or ISO 10993 certified

  4. Optional: Vision-guided robots for precise assembly of micro-components

Typical Applications:

  • Syringes and injection pens

  • IV sets and infusion devices

  • Surgical kits and disposable instruments

  • Diagnostic test cartridges

FAQ


1.Q: Are you trading company or manufacturer?
A: We are a manufacturer with over 10 years of production and development experience.


2.Q: What are your major products?
A: We are an assembly automation solution provider specialized in customized automatic machinery for production. For example, we provide customized asembly line, testing and packaging solutions to several electric vehicle (EV) manufacturers, such as component-level lines for battery packs, thermal management systems, steerings and so on.


3. Q: How long is your delivery time?
A: Usually 3 months is a production cycle, the specific delivery date should be arranged according to the product’s complexity and real-time production schedule. Please contact us for the latest delivery date.

4.Q: How about your price?
A: Show us your parts and we will be glad to find solutions and provide a suitable scheme, and offer the most competitive price to you.

5.Q: What is your terms of payment ?
A: 40% deposit and 60% balance payment before delivery.

6.Q: What is the package for you machine?
A: We have standard wooden case package.

7.Q: How long is the warranty?
A: Our aftersale service is one year free warranty, and life-time maintenance guaranteed.


8.Q:What partners do you work with?

A: We can both work with customer’s designated partners and propose other components partners at customer’s request. Some of our technical partners as below:

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