In the course of package choice, development, and validation, permeation of packages and packaging materials is a critical property that affects product quality and shelf-life. As such, many suppliers, especially in the flexible film market, provide indications of water vapor / moisture, oxygen, and/or CO2 permeation rates in their technical information according to ASTM test standards using Mocon permeability analyzers.
It should be noted that there are numerous approaches for testing moisture and oxygen transmission that may be more appropriate than these standards in the context of qualifying a pharmaceutical, biotech, or medical device package for its intended purpose.
Often times, end-users seek to perform the same testing either as part of internal package development in the absence of supplier-generated data, in an effort to compare two packages or materials, to confirm materials received meet specifications as indicated by the supplier, or to evaluate transmission at different conditions. CS Analytical maintains the ability to include ASTM Mocon test results as part of a container testing program.
Below are the methods are commonly adapted for this purpose:
ASTM F1249 – Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
“This test method covers a procedure for determining the rate of water vapor transmission through flexible barrier materials. The method is applicable to sheets and films up to 3 mm (0.1 in.) in thickness, consisting of single or multilayer synthetic or natural polymers and foils, including coated materials. It provides for the determination of water vapor transmission rate (WVTR), the permeance of the film to water vapor, and for homogeneous materials, water vapor permeability coefficient.”
This method is routinely applied to whole packages as well, and an ASTM method specifically for whole package systems is pending.
ASTM D3985 – Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
“This test method covers a procedure for determination of the steady-state rate of transmission of oxygen gas through plastics in the form of film, sheeting, laminates, coextrusions, or plastic-coated papers or fabrics. It provides for the determination of oxygen gas transmission rate (OTR), the permeance of the film to oxygen gas (PO2), and oxygen permeability coefficient (P′O2) in the case of homogeneous materials.”
This method is routinely applied to whole packages as well, either directly, or with reference to sister methods listed below. Testing in “wet” conditions is also enabled by reference to ASTM F1927.
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- ASTM F1307 – Standard Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor
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- ASTM F1927 – Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector
ASTM F2476 – Standard Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using an Infrared Detector
“This method covers a procedure for determination of the steady-state rate of transmission of carbon dioxide gas through plastics in the form of film, sheeting, laminates, coextrusions, or plastic-coated papers or fabrics. It provides for the determination of carbon dioxide gas transmission rate (CO2TR), the permeance of the film to carbon dioxide gas (PCO2), and carbon dioxide permeability coefficient (P’CO2) in the case of homogeneous materials.
This method is routinely applied to whole packages as well.