•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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Causes to this problem include misalignment of package to seal bar or platen, misalignment of the seal bar or asstm 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.
If you feel that your comments have not received a fair hearing you should make your views known to the F186 Committee on Standards, at the address shown below.
A superscript epsilon e indicates an editorial change since the last revision or reapproval. Each requirement should be established with appropriate rationale and necessary supporting documentation.
Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur. Originally approved in This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be aztm.
In some instances, a channel or unsealed area may be observed only after the package is peeled open. Completeness and uniformity of the entire seal area of the package must be inspected. They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing. Often it is easier to see this type of defect under a magnifying light or UV light box.
Any time requirement associated with visual inspection should allow for complete seal inspection without taking too much time astj intensely focus on any given area. Any part f886 the seal where channels appear across entire seal width must be identified and aatm. Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi?
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. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing.
Current edition approved June 1, A spotty or mottled appearance may be a function of the adhesive properties, as well. Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and? There also can be foreign contamination on the packaging materials that prevents a seal from being made.
This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? Seal creep may be a result of the sterilization process or stressed seals at temperature extremes. In other situations there may not be adequate strength, and a channel results.
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. Precision and Bias 3 8. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend.
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.
ASTM-F – Medical Package Testing
Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package. Mark the location of the channels. The values given in parentheses are for information only. The negative control consists of the same type packages produced with no channels. 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 d1886 appear to be spotty or mottled.
Generally, this occurs with? The width of package seals need to be compared to individually de? Visual seal defects will often be the initial indication of heat sealing process variation. These too can result in a channel through the entire seal. 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 satm used Use of magnification ASTM F procedure is comprised of the following: Summary of Test Method 4.
Light box inspection or physical package integrity tests may be appropriate. The results are presented in Tables Causes for channels have been discussed above in X1.