Packaging Material Testing: Because What’s Outside Matters Too

Published: June 1, 2025

When we think of product quality, we often focus on what's inside the package — the drug, food, or device itself. But in many ways, the packaging is the first line of defense. It protects, preserves, and delivers the product safely to the user.

That’s why Packaging Material Testing is a critical — and regulatory — requirement in industries where product integrity, safety, and shelf life matter.

What is Packaging Material Testing?

Packaging Material Testing is the scientific evaluation of the physical, mechanical, chemical, and biological properties of packaging components — whether they are bottles, blisters, pouches, vials, or cartons.

The goal? To ensure that packaging materials:

• Maintain product stability and safety
• Are compatible with the product
• Can withstand distribution stress
• Comply with regulatory standards

Why It’s Crucial

1. Product Protection
   Prevents contamination, degradation, and mechanical damage during storage and transport.
2. Regulatory Compliance
   Required by agencies like FDA, EMA, and guidelines like USP <661>, ICH Q1A, ISO 11607, and 21 CFR Part 211.94.
3. Shelf Life Assurance
   Ensures that packaging doesn’t negatively affect drug or food stability over time.
4. User Safety and Experience
   Prevents leaching, ensures tamper evidence, and enables safe and convenient use.

Common Packaging Materials Tested

• Primary Packaging: Direct contact with the product
  e.g., blister foils, bottles, ampoules, tubes, pouches
• Secondary Packaging: Outer protection or branding
  e.g., cartons, boxes, shrink wraps
• Tertiary Packaging: Bulk handling/shipping
  e.g., pallets, drums, corrugated cases

Key Tests Performed

Test Type Purpose
| Chemical Compatibility (USP <661>, <661.1>, <661.2>)  | Detects leachables, extractables, and interactions
| Moisture Vapor Transmission Rate (MVTR)  | Assesses barrier against humidity
| Oxygen Transmission Rate (OTR)  | Measures oxygen permeability
| Tensile Strength & Burst Strength  | Tests durability under mechanical stress
| Container Closure Integrity (CCI)  | Verifies airtight and leak-proof seal
| Drop/Compression/Vibration Tests  | Simulates shipping and handling stress
| Light Transmission (USP <671>)  | Assesses protection from UV/light exposure
| Sterilization Compatibility  | Confirms packaging remains intact post-sterilization

Real-World Example: Blister Packaging for Tablets

Blister packs protect tablets from moisture, light, and air. MVTR and OTR testing ensure the packaging can maintain drug potency. CCI testing ensures each cavity is sealed, and peel strength tests confirm the pack can be opened safely.

Challenges in Packaging Material Testing

• Complex formulations (e.g., biologics or inhalables) may react with certain materials
• Sustainability requirements push for eco-friendly but equally protective materials
• Global supply chains require packaging to meet multiple regulatory standards

Collaborating with packaging engineers, QA teams, and regulatory experts is essential to strike the right balance between protection, compliance, and user experience.

Final Thoughts

Your product is only as strong as its packaging. Packaging Material Testing ensures that your product arrives safe, stable, and intact — from production line to end user.

It’s not just about what the packaging looks like — it’s about what it can withstand, prevent, and preserve.