Standard Historical Last Updated: Dec 31, 2010
ASTM F1886-98(2004)

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

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


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 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.

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Book of Standards Volume: 15.10
Developed by Subcommittee: F02.40
Pages: 4
DOI: 10.1520/F1886-98R04
ICS Code: 55.040