ASTM F2227-13 (R2021) pdf free download.Standard Test Method for Non-Destructive Detection of L eaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method.
1.1 This non-destructive test method detects pinhole leaks in trays. as small as 50 urn (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. The values given in parentheses after Si units are provided for information only and are not considered standard.
4. Summary of Test Method
4.1 This test method utilizes CO2 sensing techniques in the detection of a CO, trace gas to quantify leaks in medical packaging trays. The test method provides a qualitative (acceptlrcjcct) inspection method to evaluate trays for pinholes and cracks. Further infoniation on the “Leak Test Theory” may he found in Annex Al.
5. Significance 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 he 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.
6. Apparatus
6.1 Non-destructive Trace Gas Leak Detection Apparatus— The apparatus’ test fixture consists of three major elements and is shown in Fig. 1.
6.2 Sealing Membrane—The purpose of the membrane is to seal off the tracer gas transmission out of the top of the open tray.
6.3 Control Trays—Calibrated pinholes, or leaks, constructed in control trays for instrument calibration as well as for test procedure verification.ASTM F2227 pdf download.