ASTM F1929-98

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

SCOPE
1.1 This test method defines materials and a procedure that will detect and locate a leak equal or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent film and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.
1.2 This test method is intended for use on packages with edge seals formed between a transparent film and a porous sheet material. This test method is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the entire seal area for a minimum of 20 s. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with this test method.
1.3 This test method requires that the dye penetrant have good contrast to the opaque packaging material.
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.5 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.

General Information

• Status: Historical
• Publication Date: 09-Nov-1998
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging

Relations

• Replaced By: ASTM F1929-98(2004) - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• Effective Date: 01-Jun-2004
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 10-Nov-1998

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 1929 – 98
Standard Test Method for
Detecting Seal Leaks in Porous Medical Packaging by Dye
Penetration
This standard is issued under the fixed designation F 1929; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Terminology
1.1 This test method defines materials and a procedure that 3.1 wicking—The migration of a liquid into the body of a
will detect and locate a leak equal or greater than a channel fibrous material. This is distinct from a leak as defined in
formed by a 50 μm (0.002 in.) wire in package edge seals Terminology F 1327.
formed between a transparent film and a porous sheet material. 3.2 dye penetrant—An aqueous solution of a dye and a
A dye penetrant solution is applied locally to the seal edge to surfactant designed to penetrate and indicate a defect location
be tested for leaks. After contact with the dye penetrant for a in the time prior to the onset of wicking which could mask its
specified time, the package is visually inspected for dye presence.
penetration. 3.3 channel—A small continuous open passage across the
1.2 This test method is intended for use on packages with width of a package seal through which microorganisms could
edge seals formed between a transparent film and a porous pass. It is the objective of this test method to visually observe
sheet material. This test method is limited to porous materials the presence of these defects by the leakage of dye through
which can retain the dye penetrant solution and prevent it from them.
discoloring the entire seal area for a minimum of 20 s.
4. Significance and Use
Uncoated papers are especially susceptible to leakage and must
be evaluated carefully fro use with this test method. 4.1 Harmful biological or particulate contaminants may
enter the device through leaks. These leaks are frequently
1.3 This test method requires that the dye penetrant have
good contrast to the opaque packaging material. found at seals between package components of the same or
dissimilar materials. Leaks may also result from a pinhole in
1.4 The values stated in SI units are to be regarded as the
the packaging material.
standard. The values given in parentheses are for information
only. 4.2 This dye penetrant procedure is applicable only to
individual leaks in a package seal. The presence of a number of
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the small leaks, as found in porous packaging material, which
could be detected by other techniques, will not be indicated.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- 4.3 There is no general agreement concerning the level of
leakage that is likely to be deleterious to a particular package.
bility of regulatory limitations prior to use.
However, since these tests are designed to detect leakage,
2. Referenced Documents
components that exhibit any indication of leakage are normally
2.1 ASTM Standards: rejected.
E 165 Practice for Liquid Penetrant Examination 4.4 Since leaks may change in size with different ambient
2.2 ANSI Standards: conditions, comparisons between test stations are not conclu-
Z1.4 Sampling Procedures and Tables for Inspection by sive. Therefore this method is usually employed as a go, no-go
Attributes test.
4.5 The dye solution will wick through any porous material
over time, but usually not within the maximum time suggested.
If wicking does occur, it may be verified by observing the
This test method is under the jurisdiction of ASTM Committee F–2 on Flexible
porous side of the subject seal area. The dye will have
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
Medical Packaging.
discolored the surface of the material.
Current edition approved Nov. 10, 1998. Published March 1999.
4.6 When puncturing the packaging to allow injection of the
Annual Book of ASTM Standards, Vol 03.03.
dye penetrant solution, care should be taken not to puncture
Available from the American National Standards Institute, 11 West 42nd Street
13th Floor, New York, NY 10036. other package surfaces. Puncturing of the package is facilitated
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1929
if it is done adjacent to a dummy device inside the package. indication that the package has been exposed to any liquid, it
The device will provide a tenting effect that will separate the must be thoroughly dried at its typical storage temperature
two sides of the package, reducing the chance of accidental before testing.
puncture of both sides. 9.2 Test specimens shall be conditioned prior to testing.
When no specific conditioning requirements are given, and
5. Apparatus
packaging materials are moisture sensitive, a standard condi-
5.1 Means of breaching one of the packaging materials such tioning atmosphere of 2362°C (73.4 6 3.6°F) and 5062%
as a small knife. relative humidity is recommended, for a minimum of 24 h prior
5.2 Dye Dispenser, such as an eyedropper or syringe for to testing.
injection of the dye penetrant solution.
5.3 Microscope or optical loop with magnification of 53 to 10. Procedure
203.
10.1 Cleaning of packaging prior to dye penetrant applica-
5.4 Fresh aqueous dye penetrant solution consisting of, by
tion is unnecessary.
weight:
10.2 Inject sufficient dye penetrant into the package to cover
Wetting agent: TRITON X-100 0.5 %
the longest edge to a depth of approximately 5 mm (0.25 in.).
Indicator dye: Toluidine blue 0.05 %
Allow the dye penetrant solution to remain in contact with the
5.5 Other colored or fluorescent dyes may be substituted for
seal edge for a minimum of 5 s and a maximum of 20.
toluidine blue but their precision and bias must be experimen-
Channels will be detected within this time period but b
...