Types of Package Testing

Packaging Distribution

Prior to receiving regulatory approvals, the SBS must prove that it's capable of withstanding the expected transit life cycle. Testing intensity is decided to support the precise device and system. Final testing after simulation proves the strength and integrity of the SBS.

Aging Studies

Aging studies must be completed before receiving regulatory approvals to prove the SBS remains intact at the top of the labeled time period. Medical package testing must verify package strength and integrity after the specified time point(s). Accelerated aging is often completed for regulatory submission, but real-time aging samples must run in parallel.

Types of Package Testing

Package Integrity Testing

Package Integrity Testing is vital in determining sterility and therefore the time period of a medical device or product. This is done by documenting that the SBS system has no detectable path through, channels or punctures which will allow the introduction of microbes into the system. A visual inspection should even be wont to confirm package integrity. 

Package Strength Testing

Package Strength Testing shows the force required to separate the 2 components of the sterile barrier system. Packaging strength is vital to point out that the package protecting the merchandise is robust enough to contain the merchandise system after distribution or aging. Seal strength also allows the medical device manufacturer to verify the reproducibility of their sealing process and adherence to style specifications. 

When performed together, integrity and strength testing provide documented evidence both qualitatively and quantitatively that the SBS is strong and appropriate to take care of product integrity.