Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

SCOPE
1.1 this test method covers the determination of channels in the package seal down to a width of 75 um (0.003 in.) with a 60-100% probability (see Section 8).  
1.1.1 The ability to visually detect channel defects in package seals is highly dependent on the size of channel, the degree of contrast from sealed and unsealed areas, the amount and type of adhesive between the two package layers, reflecting light angle, types of material used, the use of magnification, an the inspector's level of training and experience.  
1.2 This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
1.3 The values states in SI units are to be regarded as the standard. The values given in parentheses are for information only.  
1.4 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.

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09-Jul-1998
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ASTM F1886-98 - Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 1886 – 98
Standard Test Method for
Determining Integrity of Seals for Medical Packaging by
Visual Inspection
This standard is issued under the fixed designation F 1886; 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 istics of unopened, intact seals in order to determine the
presence of defects that may affect the integrity of the package.
1.1 This test method covers the determination of channels in
the package seal down to a width of 75 μm (0.003 in.) with a
5. Significance and Use
60 – 100 % probability (see Section 8).
5.1 Seal attributes can be linked directly to a number of
1.1.1 The ability to visually detect channel defects in
variables in process parameters, equipment, or material, as well
package seals is highly dependent on the size of channel, the
as environmental (room temperature and relative humidity).
degree of contrast from sealed and unsealed areas, the amount
Visual seal characteristics and defects can provide evidence of
and type of adhesive between the two package layers, reflect-
sterile package integrity and production sealing problems.
ing light angle, types of material used, the use of magnification,
5.2 Visual seal defects often will be the first indication of
and the inspector’s level of training and experience.
heat sealing process variation. They also will indicate a lack of,
1.2 This test method is applicable to flexible and rigid
or potential compromise to, package integrity after physical
packages with at least one transparent side so that the seal area
package performance testing.
may be clearly viewed.
1.3 The values stated in SI units are to be regarded as the
6. Apparatus
standard. The values given in parentheses are for information
6.1 Illuminant, lighting arrangements to give about 540
only.
lumens/m (50 fc) of white light or daylight on the specimens.
1.4 This standard does not purport to address all of the
6.2 Indelible Marking Pen.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
7. Procedure
priate safety and health practices and determine the applica-
7.1 Visual acuity shall be such that the inspection of the seal
bility of regulatory limitations prior to use.
may be performed at a distance of 30 to 45 cm (12 to 18 in.)
2. Referenced Documents
NOTE 1—Magnification devices, such as eyeloops, may be used as an
2.1 ASTM Standards: analytical tool to characterize identified seal defects.
F 17 Terminology Relating to Flexible Barrier Materials
7.2 Inspect the entire sealed area of the package for com-
pleteness and uniformity.
3. Terminology
NOTE 2—Different package sizes and shapes may require differing
3.1 Definitions of Terms Specific to This Standard:
lengths of time to adequately inspect the entire seal perimeter. Any time
3.1.1 channel, n—any unimpaired pathway across the entire
requirement associated with visual inspection should allow for complete
width of the intended seal.
seal inspection without taking too much time to intensely focus on any
3.1.2 sterile package integrity, n—property of the package
given area.
seal and material, which ensures that it presents a microbial
NOTE 3—Some packaging materials and adhesives may fluoresce under
barrier. (see also Terminology F 17, microbiological package ultraviolet light. Viewing the seal area in a UV light box will enhance the
sealed-to-unsealed area contrast, and provide for easier defect identifica-
integrity).
tion.
4. Summary of Test Method
7.3 Identify and record any part of the seal where channels
4.1 This test method provides a qualitative (accept/reject) appear across the entire seal width. Mark the location of the
visual inspection method to evaluate the appearance character-
channels.
NOTE 4—All other assessed defects (refer to Appendix X1) should be
This test method is under the jurisdiction of ASTM Committee F02 on Flexible categorized according to user defined accept/reject criteria. Define the
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
actions to be taken in the event defects are detected during normal
Medical Packaging.
production runs.
Current edition approved July 10, 1998. Published November 1998.
Annual Book of ASTM Standards, Vol 15.09.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1886–98
TABLE 1 Percent Incorrect by Laboratory
7.4 Record the number and location of channels identified
on each package. Lab Samples Incorrect Percent (%)
Inspected Analysis Incorrect
NOTE 5—If confirmation of channels or incomplete seal areas in
1 117 0 0.00
peelable packages is necessary, hand peel such suspected package
2 117 24 20.51
completely separating the two material components and inspect the seal
3 117 5 4.27
area of the transferred adhesive for the same incomplete seal attributes as
4 117 17 14.53
the unopened package. Care should be taken to ensure a smooth 5 117 5 4.27
6 117 12 10.26
continuous peeling motion so as not to cause any extraneous attributes.
7 117 9 7.69
Heat seals should be cooled to ambient conditions before peeling open to
8 117 18 15.38
allow for adhesive bonding to the opposite substrate to occur.
9 117 26 22.22
In some instances, a channel or unsealed area may be observed only
10 117 10 8.55
after the package is peeled open. Adhesive transfer is a qualitative
measure of a material’s ability to release the coating rather than conclusive
evidence that the seal has not bee made. It is possible to have continuous
TABLE 2 Percent Incorrect by Material
seal integrity but fail to give complete transfer. This is because the coating
Samples Incorrect Percent (%)
may have a stronger affinity for the substrate on which it is coated rather
Material Inspected Analysis Incorrect
than the one to which it is sealed. In such cases, an additional physical seal
Film paper 300 14 4.67
integrity test may be required to confirm if it is an unsealed area.
Film TYVEK 300 38 12.67
PETG/TYVEK 290 59 20.34
8. Precision and Bias
Film/film 280 15 5.36
8.1 An round robin study was conducted in 1997, which
included ten laboratories, four package types, and two different
channel sizes randomly produced with 75 μm (0.003 in.) and TABLE 3 Percent Incorrect by Defect Type
125 μm (0.005 in.) diameter wire. The negative control consists
Samples Incorrect Percent
Defect Type Inspected Analysis (%) Incorrect
of the same type packages produced with no channels. The four
different types of medical device packages are: No channels 370 20 5.41
75 μm channel 400 83 20.75
8.1.1 Open pouch (5 by 7 in.)—clear film/coated paper;
125 μm channel 400 23 5.75
1 1
8.1.2 Open pouch (5 ⁄4 by 7 ⁄2 in.)—clear film/uncoated
TYVEK ;
1 1
8.1.3 Sealed rigid blister (8 ⁄2 by 5 ⁄4 in.)—blue tinted
TABLE 4 Percent Correct by Material and Defect Type
blister/coated TYVEK; and,
Samples Correct Pe
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