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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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Visual seal defects will often be the initial indication of heat sealing process variation.

Size of channel Degree of contrast from sealed and unsealed areas Amount and type of adhesive between the two package layers Reflecting light angle Types of materials used Use of magnification ASTM F procedure is comprised of the following: Generally, this occurs with? Users of this standard are expressly advised that determination aztm the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility.

Precision and Bias 3 8. 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.

This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? Visual inspection may or may not detect tears or pinholes.

Visual seal characteristics and defects can bring forth evidence of sterile adtm integrity and production sealing problems.

Aatm some instances, a channel or unsealed area may be observed only after the package is peeled open. Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and? 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. V1886 attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be maintained.


Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems.

Completeness and uniformity of the entire seal area of the package must be inspected.

Any time requirement associated with visual inspection should allow for complete seal inspection without taking too much time to intensely wstm on any given area. 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?


The negative control consists of the same type packages produced with no channels. These too can result wstm a channel through the entire seal.

A statistical analysis of the data by means of a contingency table show f8186 The ability to visually detect channel defects in package seals is highly reliant on: Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi?

Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur.

A spotty or mottled appearance may be a function of the adhesive properties, as well. ASTM-F Standard Test Method for Determining Integrity of Seals for Asfm Packaging by Visual 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. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing. This may become evident through an evaluation for pinholes or cracks along the seal.

The values given in parentheses are for information only. Originally approved in Further evaluation may be required if visual inspection is not adequate to determine acceptability. Any part of the seal where channels appear across entire seal width must be identified and recorded.

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Causes for channels have been discussed above in X1. They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing.

ASTM-F – Medical Package Testing

It is possible to have continuous seal integrity but fail to give complete transfer. Last previous edition approved in as F — ASTM F is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed. A number in parentheses indicates the year of last reapproval.

In some situations the seal may be of adequate strength to form a complete seal. Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.

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. Light box inspection or physical package integrity tests may be appropriate. If asstm feel that asym comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards, aetm the address shown below.

Individual reprints single or multiple copies of this standard may be obtained by contacting ASTM at the above address or at phonefaxor service astm. In other situations there may not be adequate strength, and a channel results.

A superscript epsilon e indicates an editorial change since the last revision or reapproval. Often it is easier to see this type of defect under a magnifying light or UV light box. Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. Mark the location of the channels.