ASTM-F2228 2007

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F2228-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO₂ Tracer Gas Method

Published By	Publication Date	Number of Pages
ASTM	2007	5

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Category: ASTM

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Description

1.1 This non-destructive test method detects leaks in non-porous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as small as 100 m (0.004 in.) diameter in the seal as well as 50 m (0.002 in.) diameter pinholes, or equivalently sized cracks in the tray, subject to trace gas concentration in the package, package design and manufacturing tolerances.

Note 1This test method does not claim to challenge the porous (breathable) lidding material. Any defects that may exist in the porous portion of the package will not be detected by this test method.

1.2 The values stated in SI units are to be regarded as standard units. Values in parentheses are for information only.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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PDF Pages	PDF Title
1	Scope Referenced Documents Terminology Summary of Test Method Significance and Use
2	Apparatus Preparation of Apparatus Reagents and Materials Hazards FIG. 1
3	Calibration and Standardization Procedure Report Precision and Bias TABLE 1
4	Keywords A1. LEAK TEST THEORY A1.1 A1.2 A1.3 A1.4 TABLE 2 TABLE 3

Additional information

Standard Title	F2228-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO<sub>2</sub> Tracer Gas Method
Published Code	ASTM
Publication Date	2007
Pages Count	5

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ASTM-F2228 2007

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