Abstract
A novel reference film was characterized to improve the oxygen gas transmission measurement accuracy of plastic materials for pharmaceutical packaging. The material processing, homogeneity, stability, jointly determined value and uncertainty evaluation were discussed. The film is the first reference film characterized by multiple laboratories using both manometric and coulometric methods. The oxygen transmission rate of the reference film was 20.53 with the expanded uncertainty of 1.36. The newly characterized reference film can be used in the calibration and self-calibration of oxygen transmission measurement equipment and analytical method verification to improve the measurement accuracy and achieve traceable data.
Highlights
Oxygen gas transmission rate is one of the most important parameters for evaluating the barrier properties of food and drug packaging materials [1]
Oxygen gas transmission rate is usually measured by the manometric method [4] described in ISO 15105-1:2007 and the coulometric method [5,6] published in the ISO 15105-2:2003
A reference film for oxygen gas transmission measurements was characterized upon processing, homogeneity, stability, joint determination and uncertainty
Summary
Oxygen gas transmission rate is one of the most important parameters for evaluating the barrier properties of food and drug packaging materials [1]. It is a key factor involved in the quality control of packaging materials [2,3]. Oxygen gas transmission rate is usually measured by the manometric method [4] described in ISO 15105-1:2007 and the coulometric method [5,6] published in the ISO 15105-2:2003. Reducing the inter-laboratory variation in oxygen gas transmission measurements is highly urgent to produce reliable and comparable data
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