Reliable Sterilization Solutions for a Safer Tomorrow

Real-World Solutions. Real Impact.

Medical Device Manufacturer OEM Support

Customised roll-stock paper and film, EO dialysis pouches and EO indicators for a global manufacturer packaging single-use devices on automatic lines.

  • Suzhou, ChinaLocation
  • Global medical device manufacturerCustomer
  • Medical Device ManufacturersApplication
  • 2021 – presentProject Period
Medical Device Manufacturer OEM Support

1. Customer Background

A multinational manufacturer producing catheters and infusion sets on automatic thermoform-fill-seal lines, sterilized by ethylene oxide.

  • 8Packaging lines
  • EOSterilization
  • Coated paper, PET/PE film, PA/PE forming filmMaterials

2. Challenges

  • Machine compatibilityMaterials had to run on existing lines without adjustment of sealing parameters.
  • DocumentationFull ISO 11607-1 test data was required for the design history file.

3. Solutions Provided

  • Material matchingSamples matched to the incumbent specification and validated in machine trials.
  • Custom printLidding paper printed with the customer's artwork, symbols and lot fields.
  • Supply agreementRolling forecast with safety stock held in Hefei.

4. Product Mix Used

Monitoring

EO Indicator Tape

Type 1 process indicator tape for ethylene oxide (EO) sterilization. Indicator lines change…

  • EO
  • ISO 11140
  • OEM/ODM
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5. Implementation Process

  1. 01Specification review
  2. 02Sampling
  3. 03Machine trials
  4. 04Validation support
  5. 05Serial supply

6. Results & Impact

  • 8Lines running Kangde Med materials
  • ZeroLine changes required

7. Project Gallery

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