Sterile Packaging & Kitting

Protecting Your Products. Accelerating Your Market Readiness.

Proper packaging is critical in ensuring sterility, safety, and compliance. Medisurge provides ISO 11607-compliant packaging and custom kitting solutions in our Class 7 cleanroom environment to help medical device OEMs reduce contamination risk, streamline sterilization, and enter the market with confidence.

What We Offer

ISO 11607-Compliant Packaging

  • Tray sealing and pouch sealing for sterile barrier protection
  • Heat-seal validations and dye penetration testing
  • Custom packaging design to fit device dimensions and sterilization method

Class 7 Cleanroom Assembly & Kitting

  • Cleanroom kitting of single-use or multi-component devices
  • Lot tracking, labeling, and documentation
  • Seamless handoff to sterilization workflows

Custom Kit Development

  • Procedure packs and component grouping for end-users
  • Designed to optimize surgical workflows and reduce prep time
Technicians in a cleanroom assembling the Blowmister device, focusing on meticulous quality control for surgical equipment

Packaging Process Highlights

Controlled Environment
All packaging and kitting operations take place in our ISO-certified Class 7 cleanroom. This ensures particulate control and proper environmental handling of sterilized or pre-sterilized goods.

Packaging Flexibility
We support both low-volume and mid-scale production runs, allowing you to iterate designs, adapt to market feedback, and maintain sterile integrity throughout development.

Speed to Sterilization
Medisurge’s sterile packaging is directly integrated with our EO sterilization cycle planning, helping you avoid delays caused by incompatible materials or validation gaps.

Why It Matters

  • Avoid costly re-validation due to packaging failures
  • Ensure compatibility with EO, gamma, or other sterilization methods
  • Streamline end-user experience with well-designed kits
  • Build trust with healthcare buyers through quality presentation and labeling
Medisurge staff assembling and packaging medical devices in a state-of-the-art Class 7 cleanroom, ensuring strict adherence to sterile production protocols

Ready to Seal the Deal?

Let Medisurge protect your device with sterile barrier packaging and cleanroom kitting that meets the highest industry standards.

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Contact

Medisurge

2140 Oak Industrial Dr NE
Grand Rapids, MI 49505

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