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•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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In such cases, an additional physical seal integrity test may be required to con? This may become evident through an evaluation for pinholes or cracks along the seal. Seal attributes can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental room temperature and relative satm. 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.

NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately inspect the entire seal perimeter.

ASTM F (Reapproved )_百度文库

Last previous edition approved in as F — A number in parentheses indicates the year of last reapproval. Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi? Each d1886 should be established with appropriate rationale and necessary supporting documentation.

The results are presented in Tables 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.

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These types of characteristics often are hard to judge by astmm inspection alone and need to be further evaluated by alternate means such as dye penetration.

The four different types of medical device packages are: A statistical analysis of the data by means of a contingency table show signi?

ASTM F1886/F1886M – 16

Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur. This is because the coating may have qstm stronger affinity for the substrate on which it is coated rather than the one to which it is sealed.

This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? Inspection of the seal should be performed at a distance of 30 aastm 45 cm 12 to 18 in. Current edition approved June 1, These too can result in a channel through the entire seal.

Wrinkles and cracks occur after a seal is formed and are caused by the sstm of the package. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the zstm of regulatory limitations prior to use.

Often it is easier to see this type of defect under a magnifying light or UV light box. The values given in parentheses are for information only. This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be maintained. Light box inspection or physical package integrity tests may be appropriate.

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Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. In other situations there may not be adequate strength, and a channel results.

In some situations the seal may be of adequate strength to form a complete seal. Care should be taken to ensure a smooth continuous peeling motion so as not to cause any aztm attributes. A spotty or mottled appearance may be a function of the adhesive properties, as well. asmt

ASTM-F – Medical Package Testing

Impact also may cause the seals to partially rupture. Individual reprints single or multiple copies of this standard may be obtained by contacting ASTM at the above address or at phonefaxor service astm.

Causes to this problem include misalignment of package to seal bar or platen, misalignment 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.

Completeness and uniformity of the entire seal area of the package must be inspected. Precision and Bias 3 8.

Astj part of the seal where channels appear across entire seal width must be identified and recorded. Further evaluation may be required if visual inspection is not adequate to determine acceptability. They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing.