HF Technology in the Medical Industry
FIAB high-frequency welding machines are an advanced solution for manufacturers of medical devices. HF technology ensures sterile, hermetic welds of the highest strength, meeting the rigorous requirements of the pharmaceutical and medical industry.
Applications in the Medical Industry
- Blood and infusion fluid bags – hermetic containers for blood, plasma, intravenous fluids
- Medical waste bags – sealed containers for biological materials
- Blood pressure cuffs – elastic pneumatic bands
- Medical mattresses – anti-decubitus, rehabilitation, pneumatic mattresses
- Disposable clothing – surgical gowns, surgical covers, protective shields
- Surgical drapes – sterile covers for operating rooms
- Catheter and ostomy bags – sealed containers for body fluids
- Oxygen masks and respirators – medical equipment elements
- Ice bags – therapeutic compresses
- Operating mats – waterproof underlays for procedures
- Sterile packaging – bags and covers for surgical instruments
FIAB Models for the Medical Industry
FIAB 360 (3 kW) – compact machine for small medical products, maximum electrode length 200 mm, welding area 54 cm². Ideal for catheter bags, cuffs, mask elements.
FIAB 500 (5 kW) – welding machine for medium products, electrode up to 700 mm, area 140 cm². Production of blood bags, rehabilitation mattresses, covers.
FIAB SHUTTLE TABLE – shuttle machine designed specifically for the medical industry. Automated positioning and welding with the highest precision and repeatability.
FIAB 960, 1400 – industrial machines for serial production of large medical devices (hospital mattresses, waste bags, large-format covers).
Requirements for Medical Production
Sterility and Cleanliness
- Ability to work in cleanroom environments (class 8)
- Construction materials resistant to disinfectants
- Easy cleaning and disinfection of machine surfaces
Process Validation
- Documentation compliant with ISO 11607-2 (packaging of medical devices)
- Monitoring and recording parameters of each weld
- Process repeatability compliant with GMP (Good Manufacturing Practice)
- CE certification for medical devices
Quality Control
- Precise adjustment of welding power, time, and pressure
- Weld tightness control system
- Saving production data in internal memory
- Compliance with FDA standards (for US market)
Advantages of HF Technology in Medicine
- Sterility – contactless process without contamination
- Tightness – hermetic connections securing contents
- Biocompatibility – no chemical adhesives and solvents
- Strength – welds resistant to stretching and perforation
- Repeatability – identical parameters of each weld
- Speed – short production cycles (2-5 seconds)
- Aesthetics – clean, even welds without processing marks
Medical Materials Welded with HF
- Medical PVC – blood bags, infusion fluids, cuffs
- Polyurethane – anti-decubitus mattresses, elastic covers
- Multi-layer films – sterile packaging for instruments
- Medical laminates – PVC/fabric/foam combinations
Specialist Electrodes
- Shaped electrodes – adapted to product geometry
- Segment electrodes – for welding taps, valves
- Electrodes with controlled heating – for delicate materials
- Engraved electrodes – embossing numbering, markings
Automation and Industry 4.0
FIAB machines offer integration with systems:
- Industrial robots for product feeding and receiving
- Vision systems for weld quality control
- MES/SCADA – production and documentation management
- Traceability – tracking each product with serial number
Standards and Certificates
- ISO 13485 – quality management systems for medical devices
- ISO 11607-2 – packaging of medical devices intended for sterilization
- EN 868-5 – materials and sterilization packaging systems
- FDA 21 CFR Part 820 – quality systems for US market
- GMP – good manufacturing practice
Medical Device Production Process
- Material preparation in cleanroom conditions
- Component cutting according to specifications
- Welding with parameter monitoring
- Tightness and strength control
- Sterilization of finished products
- Final packaging and labeling
- Documentation compliant with regulatory requirements
Efficiency and Economics
- Production of hundreds to thousands of units daily (depending on product)
- Reduction of production costs vs adhesive bonding methods
- Minimization of waste and defects
- Long machine life (15-20 years)
Technical Support
- Training for medical and production personnel
- Validation documentation for regulatory authorities
- Service and calibration compliant with GMP requirements
- Support during FDA, ISO audits
FIAB welding machines are a professional solution for the medical industry, ensuring sterility, tightness, and process repeatability in accordance with the highest quality and safety standards.
