Tyvek vs Medical Paper: When Buyers Choose Wrong

Category: Medical Packaging
Insight: Packaging is a Regulatory Decision, not just a Price Decision.

Overview

Choosing packaging is about: 1. Sterilization compatibility 2. Shelf life requirements 3. Audit defensibility

1. When Tyvek Is Mandatory

You must consider Tyvek if: * You use EO (Ethylene Oxide) or Plasma sterilization. * You require a long shelf life (5 years+). * The device is moisture-sensitive. * High MDR scrutiny is expected (Tyvek's microbial barrier is superior).

2. When Medical Paper Is Enough

Medical grade paper is acceptable if: * You use Steam sterilization. * The device is low-risk. * The market is highly cost-sensitive and shelf-life demands are lower.

3. Common Buyer Mistakes

• Using paper for EO: While possible, it often leads to validation issues.
• No seal validation: Auditors check seal strength (tensile/burst) rigorously.
• Ignoring burst strength: Cheap paper tears during transit, rendering the device non-sterile.