Medical Device Link.

PACKAGING

Return to Article: Measuring Porous Microbial Barriers, Part 1

1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0-µm particles and assessing the filtration efficiency of the material using either single or dual particle counters.

1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.

1.3 The intent of this test method is to determine the flow rate through a material at which maximum penetration occurs. The porous nature of some materials used in sterile packaging applications might preclude evaluation by means of this test method. The maximum penetration point of a particular material could occur at a flow rate that exceeds the flow capacity of the test apparatus. As such, this test method may not be useful for evaluating the maximum penetration point of materials with a Bendtsen flow rate above 4000 mL/min as measured by ISO 5636-3.

1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses [in the standard] are for information only.

[The test incorporates] ISO 5636-3 Paper and Board—Determination of Air Permeance (Medium Range)—Part 3: Bendtsen Method.