ASTM F2338-2009 用真空衰变法的包装紧密性无损检验的标准试验

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【英文标准名称】:     Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method            【原文标准名称】:     用真空衰变法的包装紧密性无损检验的标准试验方法            
【标准号】:     ASTM F2338-2009           
【发布单位】: 美国材料与试验协会(US-ASTM)【起草单位】: F02.40【标准类型】: (Test Method)【标准水平】: ()
【中文主题词】: 衰变;检漏;非破坏性的;包装件;运输;真空的
【英文主题词】: absolute pressure transducer;  barrier performance;  block;  criteria parameters;  differential pressure transducer;  flexible packaging;  food packages;  hole leaks;  holes;  leaks;  mask;  medical packages;  non-destructive testing;  package integrity monitoring;  package integrity test;  permeable packaging;  pharmaceutical packages;  porous barrier;  porous barrier material;  porous packaging;  pressure change leak testing;  pressure transducer;  seal integrity monitoring;  seal integrity test;  seal leaks;  semi-rigid thermoformed trays;  sterile integrity test;  vacuum decay leak testing;  vacuum leak testing;  volumetric airflow meter
【摘要】: Leaks in medical device, pharmaceutical and food packages may result in the ingress of unwanted gases (most commonly oxygen), harmful microbiological or particulate contaminants. Package leaks may appear as imperfections in the package components themselves or at the seal juncture between mated components. The ability to detect leaks is necessary to ensure consistency and integrity of packages. After initial set-up and calibration, the operations of individual tests may be semi-automatic, automatic or manual. The test method permits the non-destructive detection of leaks not visibly detectable. The test method does not require the introduction of any extraneous materials or substances, such as dyes or gases. However, it is important to physically mask or block off any porous barrier surface of the package during the test to prevent a rapid loss of chamber vacuum resulting primarily from gas migration through the porous surface. Leak detection is based solely on the ability to detect the change in pressure inside the test chamber as a result of air egress from the properly masked package when challenged with vacuum conditions. This test is a useful research tool for optimization of package sealing parameters and for comparative evaluation of various packages and materials. This test method is also applicable to production settings as it is rapid, non-invasive and non-destructive, making it useful for either 100 % on-line testing or to perform tests on a statistical sampling from the production operation. Leak test results that exceed the permissible limits for the vacuum decay test are indicated by audible or visual signal responses, or both.1.1 Test PackagesPackages that can be nondestructively evaluated by this test method include:1.1.1 Rigid and semi-rigid non-lidded trays.1.1.2 Trays or cups sealed with porous barrier lidding material.1.1.3 Rigid, nonporous packages.1.1.4 Flexible, nonporous packages (see 1.2.4).1.2 Leaks Detected - This test method is capable of detecting package leaks using an absolute or differential pressure transducer leak detector. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the design of the package test fixture, and critical test parameters of time and pressure. Types and sizes of leaks that may be detected for various package systems, as well as test sensitivities are described below. These data are based on precision and bias confirmation studies.1.2.1 Trays or Cups (Non-lidded) - Hole or crack defects in the wall of the tray/cup of at least 50 m in diameter can be detected at a Target Vacuum of 4104 Pa (400 mbar) using an absolute pressure transducer test instrument.1.2.2 Trays Sealed with Porous Barrier Lidding Material - Hole or crack defects in the wall of the tray/cup of at least 100 m in diameter can be detected. Channel defects in the seal area (made using wires of 125 m in diameter) can be detected. Severe seal bonding defects in both continuous adhesive and dot matrix adhesive package systems can be detected. Slightly incomplete dot matrix adhesive bonding defects can also be detected. All porous barrier lidding material packages were tested at a Target Vacuum of 4104 Pa (400 mbar) using an absolute pressure transducer test instrument. Using a calibrated volumetric airflow meter, the sensitivity of the test for porous lidded packages is shown to be approximately 10-2 Pam3s-1.1.2.3 Rigid, Nonporous Packages - Hole defects of at least 5 m in diameter can be detected. All rigid, nonporous packages were tested at a target vacuum of 5104 Pa (500 mbar) using a differential pressure transducer test instrument. Using a calibrated volumetric airflow meter, the sensitivity of the test for rigid, nonporous packages is shown to be approxima......【中国标准分类号】: A82【国际标准分类号】: 55_180_40;55_180_40【页数】: 9P.;A4【正文语种】:           
         

huo863

楼主有ASTM F2338-09电子版么？