•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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Generally, this occurs with? Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems.
ASTM F (Reapproved )_百度文库
They also will demonstrate a lack of, or potential compromise to, package integrity after physical package asm testing. Any part of the seal where channels appear across entire seal width must be identified and recorded. ASTM F is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed. Completeness asmt uniformity of the entire seal area of the package must be inspected. Record the number and location of channels identified on each package.
The ability to visually detect channel defects in package seals ashm highly reliant on: The visual characteristics of a package that has never been sealed versus one that has been sealed, and asym opened, are very different, and depend on the material substrates being examined.
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: It is possible to have continuous seal integrity but fail to give complete transfer.
ASTM F1886/F1886M – 16
In such cases, an additional physical seal integrity test may be required to con? 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. Individual reprints asfm or multiple copies of this standard may be obtained by contacting ASTM at the above address or at phonefaxor service astm.
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.
For more information visit www. 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 results are presented in Asmt The values given in parentheses are for information only.
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 inspection may or may astk detect tears or pinholes.
Care should be taken to ensure a smooth continuous peeling motion so as not to cause any extraneous attributes. Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in.
Light box inspection or physical package integrity tests may be appropriate. In some situations the seal may be of adequate strength to form a g1886 seal. In other situations there may not be adequate strength, and a channel results. 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 spotty or mottled appearance may be a function of the adhesive properties, as well.
Insufficient astk 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. 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 statistical analysis of the data by means of a contingency table show signi? Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur. Summary of Test Method 4. The four different types of medical device packages are: Each requirement should be established with appropriate rationale and necessary supporting documentation.
Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems. 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?
Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. These too can result in a channel through the entire seal. Visual seal astn will often be the initial indication of heat sealing process variation. Precision and Bias 3 8. There also can be foreign contamination on the packaging materials that prevents a seal from being made.