•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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A number in parentheses indicates the year of last reapproval. A superscript epsilon e indicates an editorial change since the last revision or reapproval.
The values given in parentheses are for information only. It is the responsibility of the user of this standard to adtm appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Summary of Test Method 4. Visual seal characteristics and defects can provide evidence asrm 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.
ASTM F (Reapproved )_百度文库
Current edition approved June 1, Qstm approved in Last previous edition approved in as F — NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately inspect the entire seal perimeter. 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.
Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi? Mark the location of the channels. A statistical analysis of the data by means of a contingency table show signi? The results are presented in Tables Care should be taken to ensure a smooth continuous peeling motion so astmm not to cause any extraneous attributes.
Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite t1886 to occur.
In some instances, a channel or unsealed area may be observed only after the package is peeled open. It is possible to have continuous seal integrity but fail to give complete transfer.
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. In such cases, an additional physical seal integrity test may be required to con? Precision and Bias 3 8. The negative control consists of the same type packages produced with no channels. The four different types of medical device packages are: Each requirement should be established with appropriate rationale and necessary supporting documentation.
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. There also can be foreign contamination on the packaging materials that prevents a seal from being made.
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.
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. 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.
A spotty or mottled appearance may be a function of the adhesive properties, as well. This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be maintained.
Often it is easier to see this type of defect under a magnifying light or UV light box. This may become evident through an evaluation for pinholes or cracks along the seal. Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and? Seal creep may be a result of the sterilization process or stressed seals at temperature extremes. Impact also may cause the seals to partially rupture.
The width of package seals need to be compared to individually de? Causes for channels have been discussed above in X1.
ASTM-F – Medical Package Testing
In f18886 situations the seal may be of adequate strength to form a complete seal. In other situations there may not be adequate strength, and a channel results. Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package. Generally, this occurs with? These too can result in a channel through the entire seal.
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. Visual inspection may or may not detect tears or pinholes.
Further evaluation may be required if visual inspection is not adequate to determine acceptability. Light box inspection or physical package integrity tests may be appropriate.
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