Package Testing

What it is
Package testing plays a vital role in the delivery of sterile product to the market by ensuring product housing that:

• protects the product
• allows for the attainment of the required Sterility Assurance Level (SAL) for the chosen sterilization method
• holds up to the rigors of the sterilization process
• maintains integrity for the required shelf life of the product

Why you need it
An evaluation of how packaging will hold up over time is critical to assuring continued sterility once the product has been sent to market.

How it is done
Using calibrated instrumentation, in accordance with ISO standards and ASTM test methods, packaging is subjected to physical testing which measures the force necessary to compromise the product.

The tests most commonly performed are:

• Burst testing
• Creep testing
• Tensile strength
• Dye penetration

Testing may be performed on samples at the time of manufacture, post sterilization and/or after a period of accelerated aging.