•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? Record the number and location of channels identified on each package. There also can be foreign contamination on the packaging materials that prevents a seal from being made.
In some situations the seal may be of ashm strength to form a complete seal. ASTM-F Standard Test Method for Determining Integrity of Seals for Medical 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 adtm relative humidity. In other situations there may not astmm adequate strength, and a channel results. Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.
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. A number in parentheses indicates the year of last reapproval.
This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? Originally approved in Seal creep may be a result of the sterilization process or stressed seals at temperature extremes. 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.
Any part of the seal where channels appear across entire seal width must be identified and recorded. Generally, this occurs with? Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur. The values given in parentheses are for information only. 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.
These types of characteristics often are hard to judge by visual inspection alone and need to be further evaluated by alternate means such as dye penetration.
ASTM-F – Medical Package Testing
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. ASTM F is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
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. Impact also may cause the seals to partially rupture. Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and?
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. Each requirement should be established with appropriate rationale and necessary supporting documentation.
A superscript epsilon e indicates an editorial change since the last revision or reapproval. 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.
A statistical analysis of the data by means of a contingency table show signi? Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. This may become evident through an evaluation for pinholes or cracks along the seal. Visual seal defects will often be the initial indication of heat sealing process variation.
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. 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. Light box inspection or physical package integrity tests may be appropriate.
Completeness and uniformity of the entire seal area of the package must be inspected. In some instances, a channel or unsealed area may be observed only after the package is peeled open. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. Current edition approved June 1, Visual inspection may or may not detect tears or pinholes.
Often it is easier to see this type of defect under a magnifying light or UV light box.
ASTM F (Reapproved )_百度文库
Visual seal characteristics and defects can provide evidence xstm sterile package integrity and production sealing problems. Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi? NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately inspect the entire seal perimeter.
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: This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile f11886 integrity can be maintained.
It ff1886 possible to have continuous seal integrity but fail to give complete transfer. 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.
Last previous edition approved in as F — Summary of Test Method 4. For more information visit www. They also will indicate a lack of, or potential compromise to, package integrity after physical asrm performance testing.
Precision and Bias 3 8. A spotty or mottled appearance may be a function of the adhesive properties, astn well. Individual reprints single or multiple copies of this standard may be obtained by contacting ASTM at the above address or at phonefaxor service astm.