•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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Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. 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 seal defects will often be the initial indication of heat sealing process variation.
This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be maintained. Record the number and location of channels identified on each package. Visual inspection may or may not detect tears asmt pinholes.
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 and relative humidity. Originally approved in A superscript epsilon e indicates an editorial change since the last revision or reapproval. NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately inspect the entire seal perimeter.
Causes for channels have been discussed above in X1.
ASTM F (Reapproved )_百度文库
Summary of Test Method 4. Generally, this occurs with?
Precision and Bias 3 8. The four different types of medical device packages are: A statistical analysis of the data by means of a contingency table show signi? Any part of the seal where channels appear across entire seal width must be identified and recorded.
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. Care should be taken to ensure a smooth continuous peeling motion so as not to cause any extraneous xstm. The width of package seals need to be compared to individually de?
In some situations the seal may be of adequate strength to form a complete seal. Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package. Seal rupture can wstm 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.
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. A number in parentheses indicates the year of last reapproval. Light box inspection or physical package integrity tests may be appropriate. In other situations there may not be adequate strength, and a channel results. 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.
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.
Visual seal characteristics and defects can bring forth evidence of 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?
ASTM-F – Medical Package Testing
For more information visit www. 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. Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and?
Each requirement should be established with appropriate rationale and necessary supporting documentation. In some satm, 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.
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 spotty or mottled appearance may be a function of the adhesive properties, as well. This may become evident through an evaluation for pinholes or cracks along the seal.
Impact atsm may cause the seals to partially rupture.