•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.
A statistical analysis of the data by means of a contingency table show signi? NOTE 2—Different package sizes and shapes may require differing lengths of time to adequately v1886 the entire seal perimeter. Care should be taken to ensure a smooth continuous peeling motion so as not to cause any extraneous attributes. Current edition approved June 1, Visual seal characteristics and defects can provide evidence of sterile package integrity and production sealing problems.
A number in parentheses indicates the year of last reapproval. In other situations there may not be adequate strength, and a channel results. Originally approved in Another result of oversealing may be a spotty or incomplete looking seal where, in this case, the heat seal adhesive is overheated and?
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. Visual seal defects will often be the initial indication of heat sealing f186 variation.
Precision and Bias 3 8. The four different types of medical device packages are: Wrinkles and cracks occur after a seal is formed and are caused by the handling of the package.
Each requirement should be established with appropriate rationale and necessary supporting documentation. For more information visit www. Further evaluation may be required if visual inspection is not adequate to determine acceptability. It is possible to have continuous seal integrity but fail to give complete transfer.
ASTM F (Reapproved )_百度文库
Light box inspection or physical package integrity tests may be appropriate. In such cases, an additional physical seal integrity test may be required to con? The ability to visually detect channel defects in package seals is highly reliant on: 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. Asmt spotty or mottled appearance may be a function of the adhesive properties, as well.
Record the number and location of channels identified on each package. Seal creep may be a result of the sterilization process or stressed seals at temperature extremes.
Generally, this occurs with? There also can be foreign contamination on the packaging materials that prevents a asmt from being made.
These too can result in a channel through the entire seal. This is because the coating may have a stronger affinity for astj substrate on which it is coated rather than the one to which it is sealed. Completeness and uniformity of the entire seal area of the package must be inspected.
Mark the location of the channels. 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 — 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.
Causes for channels have been discussed above in X1. 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.
Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. A superscript epsilon e indicates an editorial change since the last revision or reapproval.
Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters. 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.
Summary of Test Method 4. Any part of the seal where channels appear across entire seal width must be identified and recorded.
ASTM F1886/F1886M – 16
They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing. 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.
In some situations the seal may be of adequate strength to form a complete seal.