ASTM F2095 - Pressure decay leak test for flexible packages

ASTM F2095 and quality control of packaging: Testing methods for flexible packaging integrity

ASTM F2095 describes standardized testing methods for quality control of packaging, specifically designed to detect leaks in flexible packaging. These methods use pressure loss as the primary measure.

Importance and application of integrity tests according to ASTM F2095

Applicable to non-porous film, sheet, or laminate flexible pouches, as well as trays sealed with aluminum foil, these methods are fundamental to ensuring the safety of packaging in various sectors, including the pharmaceutical industry. They are also relevant for packaging containing solid products, provided that seals or surfaces do not come into contact with liquids.

Detecting leaks: Methods and detection thresholds

These protocols allow the detection of leaks at a level greater than 1 × 10−4 sccs, offering a rigorous and reliable approach in packaging integrity testing best practices. Method A pressurizes the packaging without restrictions, while Method B uses rigid retaining plates to limit the packaging volume.

Destructive nature of tests and calibration

It is important to note that these methods are destructive: they require opening the packaging and introducing a pressurized gas, such as air or nitrogen. Calibration and verification of the measuring instrument are crucial to ensuring the accuracy of results.

Compliance with ISO standards for medical device packaging

In the context of using ASTM F2095 in the pharmaceutical industry, it is often necessary for medical packaging compliant with ISO 11607-1 standards to supplement pressure loss tests with other testing methods to ensure the integrity of sterile packaging.