ASTM F2228-13 (R2021) pdf free download.Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method.
1.1 This non-destructive test method detects leaks in nonporous 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 pm (0.004 in.) diameter in the seal as well as 50 pm (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 1—This test method does not claim to challenge the O1OUS (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. The values given in parentheses after SI units are provided for information only and are not considered standard.
3. Terminology
3. 1 General Term Definitions—For definitions used in this standard, see Terminologies D996. F17. and F 1327.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 basal flow, n—transverse transport of trace gas across the seal due to gas flow within the plane of the porous barrier material as well as flow between the porous barrier and the temporary gasketing. This is an expected properly of the porous barrier material and does not represent a leak. Experimentally, this flow may be thought of as noise, which will always be present, to some degree, during testing and must he accounted for.
3.2.2 trace gas, n—a compound selected solely for use to identify leakage flow.
4. Summary of Test Method
4.1 This test method utilizes CO2 sensing techniques in the detection of a CO2 trace gas to quantify leaks in medical packaging, which incorporates porous harrier material. This test method provides a qualitative (accept/reject) inspection method to evaluate packages for pinhole, crack and channel leaks. Further information on the "Leak Test Theory" may be found in Annex Al.
5. Significance and Use
5. 1 Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.
5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation. The non-destructive nature of the test may he important when testing high value added products.ASTM F2228 pdf download.