Boulder iQ specializes in assembly, light manufacturing and packaging in its ISO Class 7-equivalent, controlled environment. Our precision services provide customizable, cost-effective options while following ISO and FDA guidelines.

In-house packaging, labeling, validation

Our engineers provide packaging design and redesign services for user efficiency and effectiveness, and cost reduction. Customizable packaging capabilities include tray and pouch sealing within a Class 7-equivalent controlled environment. In-house labeling and secondary packaging assure that each product is customer-ready.

• Full-service assembly, including tray and pouch sealing, seal and shipping validation
• ISO 11607 packaging validation, including the development, execution and delivery of protocols and reports
• Packaging (peel pouch, thermoform trays, custom lids/labels)
• Packaging validation (sterile seal, shelf-life, shipping)
• Distribution/shipping validation
• Shelf-life studies
  • Accelerated tests
  • Real-time aging tests
• Packaging testing
  • Peel strength
  • Bubble leak
  • Dye penetration
  • Visual inspection

Terminally sterilized device packaging validation

We also provide ISO 11607 packaging validation work for terminally sterilized devices, including the development, execution and delivery of protocols and reports.

 

ISO 13485 compliance

We take the quality of our packaging just as seriously as the quality of the device itself. By integrating Boulder iQ’s creative design, engineering performance, and ISO 13485 certification, we deliver a simple, yet elegantly packaged product designed to fit each client’s needs – within the compliance requirements of ISO 13485.

 

Complementary services

Sterilization (ethylene oxide and chlorine dioxide options) complement these services. All products are manufactured in compliance with FDA and CE requirements.