Sterile Medical Device Manufacturing Project
High-Volume Manufacturing: Injection Moulding, Extrusion, Cleanroom Assembly – ETO Sterilization
Manufacturing Capacity
Facility & Quality Infrastructure
Project Overview
The company manufactures sterile disposable medical devices used in infusion therapy, respiratory care, urology, gastroenterology, and general surgery. The facility is equipped with Class 7 and Class 8 cleanrooms, dust-free injection moulding and extrusion facilities, an in-house Ethylene Oxide (ETO) sterilization plant, and fully equipped Chemical, Instrumentation, Microbiology, and Sterility Testing laboratories. The facility operates under ISO 9001, ISO 13485, CE Mark, and Indian manufacturing licences for medical devices.
Product Range
- IV Cannula
- IV Sets
- Three-Way Stop Cock
- Respiratory Products
- Drainage Products
- Urology Disposables
- Gastroenterology Disposables
IV Cannula Manufacturing
Product Overview
IV Cannulas are critical medical devices used for intravenous drug administration, fluid therapy, blood transfusion, and emergency vascular access. They are manufactured through precision injection moulding, needle insertion, assembly, testing, and ETO sterilization.
Manufacturing Process
Raw Material Inspection
Medical-grade polymers (Polypropylene, Polyethylene, Polycarbonate, ABS) and stainless steel cannula needles are inspected with Certificates of Analysis.
Injection Moulding
Plastic hubs and connectors manufactured in dust-free conditions. Critical parameters: melt temperature, injection pressure, cooling time, and mould temperature.
Needle Insertion
Precision needle insertion in Class 7 and Class 8 cleanrooms with automatic and semi-automatic equipment.
Assembly
Hub assembly, tubing connection, air vent installation, and visual inspection in controlled cleanroom conditions.
Leak Testing
Automated leak testing ensures product safety and reliability.
Packaging
Individual medical-grade blister packing with Tyvek® sealing.
ETO Sterilization
Ethylene Oxide sterilization validated to achieve required Sterility Assurance Level (SAL).
Final Inspection & Release
Sterility testing, functional verification, and batch release by Quality Assurance.
Laboratory Testing
| Raw Material Testing | In-Process Testing | Finished Product Testing |
|---|---|---|
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Applications
- Intravenous drug administration
- Fluid therapy
- Blood transfusion
- Emergency vascular access
IV Sets & Three-Way Stop Cock Manufacturing
Product Overview
IV Sets and Three-Way Stop Cocks are essential for intravenous fluid administration and multi-line infusion management. These products combine injection-moulded connectors with precision-extruded PVC tubing.
Manufacturing Process
Injection Moulding
Plastic components including stop cocks, chambers, connectors, and caps manufactured using precision injection moulding machines in dust-free conditions.
Extrusion
PVC tubing manufactured through continuous extrusion lines with vacuum sizing, cooling, diameter inspection, and online cutting.
Cleanroom Assembly
Components transferred into Class 7 and Class 8 cleanrooms for tube connection, stop cock assembly, filter fixing, and leak testing.
Utilities Required
- Steam Boiler
- Cooling Water
- Chilled Water
- Compressed Air
- Vacuum System
- Nitrogen
- Purified Water
Applications
- Intravenous fluid administration
- Blood transfusion
- Nutritional therapy
- Multi-line infusion management
- Pressure monitoring
- Drug administration
Respiratory & Drainage Products
Product Overview
Respiratory and Drainage products including oxygen tubing, suction catheters, and wound drainage tubes are manufactured using medical-grade PVC extrusion combined with precision connectors and safety features.
Manufacturing Process
Material Selection
Medical-grade PVC, silicone, and rubber components selected for biocompatibility and performance.
Extrusion
Continuous extrusion of tubing with vacuum sizing and cooling.
Component Assembly
Connector fitting, air vent installation, and roller clamp assembly in controlled environments.
Testing
Pressure resistance, leakage testing, and functional verification.
Sterilization
ETO sterilization to achieve required SAL.
Packaging & Release
Blister packing, heat sealing, and batch release.
Laboratory Testing
| Chemical Analysis | Mechanical Testing | Sterility & Safety |
|---|---|---|
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Applications
- Oxygen therapy
- Nebulization
- Airway management
- Suction procedures
- Surgical wound drainage
- Thoracic drainage
- Post-operative fluid collection
Manufacturing Equipment
Production Equipment
- Injection Moulding Machines
- PVC Extrusion Lines
- Needle Grinding Machines
- Tube Cutting Machines
- Assembly Stations
- Ultrasonic Welding Machines
- Leak Testing Equipment
- Automatic Printing Machines
- Automatic Packaging Machines
Sterilization & Cleanroom Equipment
- ETO Sterilizer
- Aeration Chambers
- Humidity Control Systems
- Gas Monitoring Systems
- Laminar Air Flow Units
- HEPA Filtration Systems
- Air Showers
- Pass Boxes
- Differential Pressure Monitoring
Laboratory & Testing Equipment
- HPLC
- UV Spectrophotometer
- Tensile Testing Machine
- Universal Testing Machine
- Incubators
- Autoclaves
- Sterility Testing Isolators
- Environmental Monitoring Instruments
- Particle Counters
- Microbial Air Samplers
Quality Assurance & Testing
Laboratory Testing Capabilities
Chemical Laboratory
- Raw material identification
- PVC formulation testing
- Residual ETO analysis
- Material compatibility studies
Instrumentation Laboratory
- Dimensional inspection
- Tensile strength testing
- Flow rate testing
- Pressure resistance testing
- Leakage testing
- Needle penetration force
- Burst pressure testing
Microbiology Laboratory
- Sterility Testing
- Bioburden Testing
- Environmental Monitoring
- Surface Monitoring
- Air Monitoring
- Water Microbiology
- Personnel Monitoring
Regulatory Compliance
- ISO 9001
- ISO 13485
- CE Mark
- Medical Device Rules (India)
- GMP Compliant
Packaging & Sterilization
Packaging Operations
- Individual medical-grade blister packing
- Tyvek® or medical paper sealing
- Heat sealing validation
- Printing of batch number
- Manufacturing date and expiry date
- CE Marking
- Sterilization indicator
- Carton packing
- Shrink wrapping
- Palletization and dispatch
Validation & Testing
- Seal Strength Testing
- Dye Penetration Testing
- Burst Testing
- Transportation Simulation
- Shelf-Life Studies
ETO Sterilization Process
Products are sterilized using validated Ethylene Oxide cycles consisting of pre-conditioning, humidity conditioning, ETO exposure, aeration, and residual gas removal to achieve required Sterility Assurance Level (SAL) for sterile medical devices.
Project Summary
The project demonstrates high-volume manufacturing of sterile disposable medical devices through precision injection moulding, cleanroom extrusion, validated assembly, in-house ETO sterilization, and comprehensive laboratory testing. The combination of advanced manufacturing technology, ISO Class 7 and 8 cleanrooms, validated processes, and robust quality systems enables reliable production of IV Cannulas, IV Sets, Three-Way Stop Cocks, and Respiratory/Drainage products meeting domestic and international regulatory requirements including ISO 13485 and CE Mark compliance.
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