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F1886
F1886
F1886
visual inspection method to evaluate the appearance characteristics of unopened, intact seals in order to determine the
presence of defects that may affect the integrity of the package.
1. Scope
1.1 This test method covers the determination of channels in
the package seal down to a width of 75 m (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,
and the inspectors 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 stated 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.
2. Referenced Documents
2.1 ASTM Standards:
F 17 Terminology Relating to Flexible Barrier Materials2
7.2 Inspect the entire sealed area of the package for completeness and uniformity.
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 channel, nany unimpaired pathway across the entire
width of the intended seal.
3.1.2 sterile package integrity, nproperty of the package
seal and material, which ensures that it presents a microbial
barrier. (see also Terminology F 17, microbiological package
integrity).
7.3 Identify and record any part of the seal where channels
appear across the entire seal width. Mark the location of the
channels.
1
This test method is under the jurisdiction of ASTM Committee F02 on Flexible
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
Medical Packaging.
Current edition approved July 10, 1998. Published November 1998.
2
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.
F 1886
TABLE 1 Percent Incorrect by Laboratory
Lab
Samples
Inspected
Incorrect
Analysis
Percent (%)
Incorrect
1
2
3
4
5
6
7
8
9
10
117
117
117
117
117
117
117
117
117
117
0
24
5
17
5
12
9
18
26
10
0.00
20.51
4.27
14.53
4.27
10.26
7.69
15.38
22.22
8.55
Samples
Inspected
Incorrect
Analysis
Percent (%)
Incorrect
300
300
290
280
14
38
59
15
4.67
12.67
20.34
5.36
Samples
Inspected
Incorrect
Analysis
Percent
(%) Incorrect
370
400
400
20
83
23
5.41
20.75
5.75
Film/TYVEK
PETG/TYVEK
Film/film
Defect Type
none
75 m
125 m
none
75 m
125 m
none
75 m
125 M
none
75 m
125 m
Samples
Inspected
Correct
Analysis
Percent (%)
Correct
100
100
100
100
100
100
90
100
100
80
100
100
97
89
100
97
69
96
88
60
83
68
99
98
97
89
100
97
69
96
98
60
83
85
99
98
9. Keywords
9.1 channels; medical packaging; minimum seal width;
spotty seals; sterile package integrity; visual seal inspection
F 1886
APPENDIX
(Nonmandatory Information)
X1. VISUAL SEAL APPEARANCE CHARACTERISTICS AND PROBABLE CAUSES
F 1886
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