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〈1207.2〉 Package Integrity Leak Test Technologies

The purpose of this chapter is to provide information guiding the selection and proper use of leak test technologies (also called methodologies, approaches, or methods). The leak test technologies described in this chapter were selected on the basis of relevant research study data published in peer-reviewed journals and/or precision and bias study data generated in support of recognized test method standards. When referencing standard test methods (e.g., ASTM), the reader is advised to refer to the most recent versions. In some cases, the scope of referenced standard test methods does not include the package types of the scope in Package Integrity Evaluation—Sterile Products 〈1207〉. In all cases, methods and literature studies are cited to provide benchmark information useful for pharmaceutical package leak test method development and validation.

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