•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? The width of package seals need to be compared to individually de? A statistical analysis of the data by means of a contingency table show signi? This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? Precision and Bias 3 8. The values given in parentheses are for information only.


zstm Record the number and location of channels identified on each package. This may become evident through an evaluation for pinholes or cracks along the seal. In some instances, a channel or unsealed area may be observed only after the package is peeled open. 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.

NOTE 2—Different package sizes and shapes may require differing lengths of time to ashm inspect the entire seal perimeter. Completeness and uniformity of the entire seal area of the package must be inspected.

Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package. Mark the location of the channels.

It is possible to have continuous seal integrity but fail to give complete transfer. This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be maintained. The ability to visually detect channel defects in package seals is highly reliant on: Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.


A spotty or mottled appearance may be a function of the adhesive properties, as well. 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.

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

They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing. Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur. 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.

There also can be foreign contamination on the packaging materials that prevents a seal from being made. 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.

Light box inspection or physical package c1886 tests may be appropriate. The negative control consists of the same type packages produced with no channels.

Summary of Test Method 4. Any 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. Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. 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.

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. Visual seal defects will often be the initial indication of heat sealing process variation. Current edition approved June 1, These too can result in a channel through the entire 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 humidity.

A superscript epsilon e indicates an editorial change since the last revision or reapproval. A number in parentheses indicates the year of last reapproval.


For more information visit www. In other situations there may not be adequate strength, and a channel results. ASTM F is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.

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

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 g1886 cause seals to appear to be spotty or mottled. If you feel that your comments have not received a fair hearing you should make your views r1886 to the ASTM Committee on Standards, at the address shown below.

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. Visual inspection may or may not detect tears or pinholes. The four different types of medical device packages are: Generally, this occurs with?

ASTM-F – Medical Package Testing

Care should be taken to ensure a smooth continuous peeling motion so as not to cause any extraneous attributes. ASTM-F Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection Seal attributes can be directly linked to a asttm amount of variables in process parameters, equipment, or material, as well as environmental room temperature and relative humidity.

Seal rupture ast, 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.