ASTM F1886/F1886M-09

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

SIGNIFICANCE AND USE
Seal attributes can be linked directly to a number of variables in process parameters, equipment, or material, as well as environmental (room temperature and relative humidity). Visual seal characteristics and defects can provide evidence of package integrity and production sealing problems.
Visual seal defects often will be the first indication of heat sealing process variation. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing.
SCOPE
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 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 inspector's level of training and experience.  
1.2 This test method is applicable to packages with at least one transparent side so that the seal area may be clearly viewed.
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2009
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.40 - Package Integrity

Relations

• Replaces: ASTM F1886-98(2004) - Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
• Effective Date: 01-Oct-2009
• Replaced By: ASTM F1886/F1886M-09(2013) - Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
• Effective Date: 01-Aug-2013

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: F1886/F1886M − 09
StandardTest Method for
Determining Integrity of Seals for Flexible Packaging by
1
Visual Inspection
ThisstandardisissuedunderthefixeddesignationF1886/F1886M;thenumberimmediatelyfollowingthedesignationindicatestheyear
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 4. Summary of Test Method
1.1 Thistestmethodcoversthedeterminationofchannelsin
4.1 This test method provides a qualitative (accept/reject)
the package seal down to a width of 75 µm [0.003 in.] with a
visual inspection method to evaluate the appearance character-
60–100 % probability (see Section 8).
istics of unopened, intact seals in order to determine the
1.1.1 The ability to visually detect channel defects in
presence of defects that may affect the integrity of the package.
package seals is highly dependent on the size of channel, the
degree of contrast from sealed and unsealed areas, the amount
5. Significance and Use
and type of adhesive between the two package layers, reflect-
5.1 Seal attributes can be linked directly to a number of
inglightangle,typesofmaterialused,theuseofmagnification,
variablesinprocessparameters,equipment,ormaterial,aswell
and the inspector’s level of training and experience.
as environmental (room temperature and relative humidity).
1.2 This test method is applicable to packages with at least
Visual seal characteristics and defects can provide evidence of
one transparent side so that the seal area may be clearly
package integrity and production sealing problems.
viewed.
5.2 Visual seal defects often will be the first indication of
1.3 The values stated in either SI units or inch-pound units
heatsealingprocessvariation.Theyalsowillindicatealackof,
are to be regarded separately as standard. The values stated in
or potential compromise to, package integrity after physical
each system may not be exact equivalents; therefore, each
package performance testing.
system shall be used independently of the other. Combining
values from the two systems may result in non-conformance
6. Apparatus
with the standard.
6.1 Illuminant, lighting arrangements to give about 540
1.4 This standard does not purport to address all of the
2
lumens/m [50 fc] of white light or daylight on the specimens.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
6.2 Indelible Marking Pen.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
7. Procedure
2. Referenced Documents
7.1 Visualacuityshallbesuchthattheinspectionoftheseal
2
may be performed at a distance of 30 to 45 cm [12 to 18 in.]
2.1 ASTM Standards:
F17 Terminology Relating to Flexible Barrier Packaging
NOTE 1—Magnification devices, such as eyeloops, may be used as an
analytical tool to characterize identified seal defects.
3. Terminology
7.2 Inspect the entire sealed area of the package for com-
3.1 For terminology related to flexible barrier packaging,
pleteness and uniformity.
see Terminology F17.
NOTE 2—Different package sizes and shapes may require differing
lengths of time to adequately inspect the entire seal perimeter. Any time
1
This test method is under the jurisdiction ofASTM Committee F02 on Flexible
requirement associated with visual inspection should allow for complete
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
seal inspection.
Package Integrity.
NOTE 3—Some packaging materials and adhesives may fluoresce under
Current edition approved Oct. 1, 2009. Published October 2009. Originally
ultraviolet light. Viewing the seal area in a UV light box will enhance the
approved in 1998. Last previous edition approved in 2004 as F1886 – 98(2004).
sealed-to-unsealed area contrast, and provide for easier defect identifica-
DOI: 10.1520/F1886_F1886M-09.
2
tion.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
7.3 Identify and record any part of the seal where channels
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. appear. Mark the location of the channels.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1886/F1886M − 09
NOTE 4—All other assessed defects (refer to Appendix X1) should be TABLE 1 Percent Incorrect by Laboratory
categorized according to user defined accept/reject criteria. Define the
Lab Samples Incorrect Percent (%)
actions to be taken in the event defects are detected during no
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F1886–98 (Reapproved 2004) Designation:F1886/F1886M–09
Standard Test Method for
Determining Integrity of Seals for MedicalFlexible Packaging
1
by Visual Inspection
ThisstandardisissuedunderthefixeddesignationF1886/F1886M;thenumberimmediatelyfollowingthedesignationindicatestheyear
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This test method covers the determination of channels in the package seal down to a width of 75 µm (0.003 in.)[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 inspector’s level of training and experience.
1.2This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be
clearly viewed.
1.3The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.2 This test method is applicable to packages with at least one transparent side so that the seal area may be clearly viewed.
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
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
2.1 ASTM Standards:
F17 Terminology Relating to Flexible Barrier Packaging
3. Terminology
3.1Definitions of Terms Specific to This Standard:
3.1.1channel, n—any unimpaired pathway across the entire width of the intended seal.
3.1.2sterile package integrity, n—property of the package seal and material, which ensures that it presents a microbial barrier.
(see also Terminology
3.1 For terminology related to flexible barrier packaging, see Terminology F17, microbiological package integrity). .
4. Summary of Test Method
4.1 This test method provides a qualitative (accept/reject) 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.
5. Significance and Use
5.1 Seal attributes can be linked directly to a number of variables in process parameters, equipment, or material, as well as
environmental (room temperature and relative humidity). Visual seal characteristics and defects can provide evidence of sterile
package integrity and production sealing problems.
5.2 Visual seal defects often will be the first indication of heat sealing process variation. They also will indicate a lack of, or
potential compromise to, package integrity after physical package performance testing.
1
This test method is under the jurisdiction of ASTM Committee F02 on Flexible Barrier MaterialsPackaging and is the direct responsibility of Subcommittee F02.40 on
Package Integrity.
Current edition approved JuneOct. 1, 2004.2009. Published June 2004.October 2009. Originally approved in 1998. Last previous edition approved in 19982004 as
F1886 – 98(2004). DOI: 10.1520/F1886-98R04.10.1520/F1886_F1886M-09.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F1886/F1886M–09
6. Apparatus
2
6.1 Illuminant, lighting arrangements to give about 540 lumens/m (50 fc) [50 fc] of white light or daylight on the specimens.
6.2 Indelible Marking Pen.
7. Procedure
7.1 Visual acuity shall be such that the inspection of the seal may be performed at a distance of 30 to 45 cm (12[12 to 18 in.)
i
...