•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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Any part of the seal where channels appear across entire seal width must be identified and recorded. 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 handling of the package.

Each requirement should be established with appropriate rationale and necessary supporting documentation. In such cases, an additional physical seal integrity test may be required to con?

A superscript epsilon e indicates an editorial change since the last revision or reapproval. The visual characteristics of a package sstm has never been sealed versus one that has been sealed, and subsequently opened, are very different, and depend on the material substrates being examined.

ASTM F1886/F1886M – 16

Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing.

A statistical analysis of the data by means of a contingency table show signi? Causes to this problem include misalignment of package to seal bar or platen, misalignment of the seal asfm or platen to the mating seal 1f886, foreign matter underneath the seal bar or platen preventing a seal, or damage to the seal bar or platen that prevents the seal.

They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing. A number f11886 parentheses indicates the year of last reapproval. There also can be foreign contamination on the packaging materials that prevents a seal from being made.


The values given in parentheses are for information only. Visual seal characteristics and defects can bring forth evidence of sterile package wstm and production sealing problems. Record the number and location of channels identified on each package. For more information visit www. Originally approved in ASTM-F Standard Test Method for Determining Integrity of Seals for Medical Packaging by Qstm Inspection 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 humidity.

Last previous edition approved sstm as F — Individual reprints single or multiple copies of this standard may be obtained by contacting ASTM at the above address or at phonefaxor service astm. Light box inspection or physical package integrity tests may be appropriate.

In some situations the seal may be of adequate strength to form a complete seal. Summary of Test Method 4. Visual seal defects will often be the initial indication of heat sealing process variation. In some instances, a channel or unsealed area may be observed satm after the package is peeled open.

In other situations there may not be adequate strength, and a channel results. This may become evident through an evaluation for pinholes or cracks along the seal.

Causes for channels have been discussed above in X1. 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. 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.


Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. Seal creep may be a result of the sterilization process or stressed seals at temperature extremes.

Current edition approved June 1, 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. This standard is subject to revision at any time by the responsible technical committee and must be reviewed every?

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. Generally, this occurs with? Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and?

ASTM F (Reapproved )_百度文库

A spotty or mottled appearance may be a function of the adhesive properties, as well. Often it is easier to see this type of defect under a magnifying light or UV light box. Impact also may cause the seals to partially rupture. The negative control consists of the same type packages produced with no channels.

Further evaluation may be required if visual inspection is not adequate to determine acceptability. The width of package seals need to be compared to individually de?

Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.

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 g1886 below.