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Description of ASTM-F2227 2013ASTM F2227 - 13Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO 2 Tracer Gas MethodActive Standard ASTM F2227 | Developed by Subcommittee: F02.40 Book of Standards Volume: 15.10 ASTM F2227Significance and Use 5.1 Harmful biological or particulate contaminants may enter the package through imperfections such as pinholes or cracks in trays. 5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation. 5.3 Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means. 5.4 This non-destructive test method may be performed in either laboratory or production environments and may be undertaken on either a 100?% or a statistical sampling basis. This test method, in single instrument use and current implementation, may not be fast enough to work on a production packaging line, but is well suited for statistical testing as well as package developmental design work. 1. Scope 1.1 This non-destructive test method detects pinhole leaks in trays, as small as 50 ?m (0.002 in.) in diameter, or equivalently sized cracks, subject to trace gas concentration in the tray, tray design and manufacturing tolerances. 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.
ASTM Standards D996 Terminology of Packaging and Distribution Environments F1327 Terminology Relating to Barrier Materials for Medical Packaging Keywords carbon dioxide (CO 2 ) leak testing; flexible packaging; infrared CO 2 sensor; medical package integrity test; non-destructive testing; package integrity monitoring; pass/fail criteria; permeable packaging; pinhole leaks; porous packaging; sealing membrane performance; sterile integrity tests; trace gas leak testing; trays pass/fail levels; ICS Code ICS Number Code 11.020 (Medical sciences and health care facilities in general); 19.100 (Non-destructive testing) DOI: 10.1520/F2227 ASTM International is a member of CrossRef. ASTM F2227The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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