•Many Medical Device Manufactures are referencing ASTM F as the visual inspection method they use to verify the sterile barrier integrity of their packaging . ASTM F testing provides a qualitative (accept / reject) visual inspection method for evaluating the appearance characteristics of unopened, intact seals in . Designation: F – 98 (Reapproved ) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual.

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These too can result in a channel through the entire f18866. In some instances, a channel or unsealed area may be observed only after the package is peeled open. NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately inspect the entire seal perimeter.

For more information visit www. Current edition approved June 1, Precision and Bias 3 8. The width of package seals need to be compared to individually de?

A superscript epsilon e indicates an editorial change since the last revision or reapproval. Mark the location of the channels. The results are presented in Tables A number in parentheses indicates the year of last reapproval.

Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. In other situations there may not be adequate strength, and a channel results.

ASTM F1886/F1886M – 16

Seal rupture can occur due to internal or external forces placed on the seal due to sterilization conditions, weight of product, stressful handling of the package, and so forth. The negative control consists of the same type packages produced with no channels. A spotty or mottled appearance may be a function of the adhesive properties, as well. Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems.

Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package. Your comments are invited either for revision of this standard or atsm additional standards and should be addressed to ASTM International Aatm.

ASTM-F – Medical Package Testing

Seal 1f886 can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental room temperature and relative humidity. Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and?


Visual inspection may or may not detect tears or pinholes. Causes to this problem include misalignment of package to seal bar or platen, aastm of the seal bar or platen to the mating seal surface, foreign matter underneath the seal bar or platen preventing a seal, or damage to the seal bar or platen that prevents the seal. Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur.

ASTM F (Reapproved )_百度文库

Causes for channels have been satm above in X1. The f18886 given in parentheses are for information only. Each requirement should be established with appropriate rationale and necessary supporting documentation.

Individual reprints single or multiple copies of this standard may be obtained by contacting ASTM at the above address or at phonefaxor service astm. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing.

If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards, at the address shown below. A statistical analysis of the data by means of a contingency table show signi? Further evaluation may be required if visual inspection is not adequate to determine acceptability. Any time requirement associated with visual inspection should allow for complete seal inspection without taking too much time to intensely focus on any given area.

Last previous edition approved in as F — This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be maintained. Care should be taken to ensure a smooth continuous peeling motion so as not to cause any extraneous attributes. Summary of Test Method 4. Completeness and uniformity of the entire seal area of the package must be inspected. ASTM F is pertinent to flexible and astmm packages with at least one transparent side so that the seal area t1886 be clearly viewed.

This may become evident through an evaluation for pinholes or cracks along the seal. This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? Light box inspection or physical package integrity tests may be appropriate.


Any part of astmm seal where channels appear across entire seal width must be identified and recorded. Insufficient sealing temperature either too much, too little, or unevenly applied pressure; too short a process time; or, excessive material thickness variation are some of the conditions that may cause seals to appear to be spotty or mottled. Visual seal r1886 will often be the initial indication of heat sealing process variation. In such cases, an additional physical seal integrity test may be required to con?

The visual characteristics of a package that has never been sealed versus one that has been sealed, and subsequently opened, are very different, and depend on the material substrates being examined.

Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi? This is because the coating may have a stronger affinity for the substrate on which it is coated rather than the one to which it is sealed. There also can be foreign contamination on the packaging materials that prevents a seal from being made.

Generally, this occurs with? The ability to visually detect channel defects in package seals is highly reliant on: They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing.


Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems. Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility.