ASTM F testing provides a qualitative (accept / reject) visual inspection method for evaluating the appearance characteristics of unopened, intact seals in . •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 Visual Inspection is a process of methodically and purposefully examining a package for a specific range of defects and recording observations.
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Visual seal defects will often be the initial indication of heat sealing process variation. Need more than one copy? Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. ASTM F is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
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ASTM-F – Medical Package Testing
Please first verify your email before subscribing to alerts. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. We have no amendments or corrections for this standard.
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: Completeness and uniformity of the entire seal area of the package must be inspected.
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ASTM F1886/F1886M – 16
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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. Proceed to Checkout Continue Shopping. This standard is also available to be included in Standards Subscriptions. Record the number and location of channels identified on each package.
Already Subscribed to this document. They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing.
Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. As the voice of the U.
Any part of the seal where channels appear across entire seal width must asmt identified and recorded. Your Alert Profile lists the documents that will be monitored.
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The ability to visually detect channel defects in package seals is highly reliant on: Subscription pricing is determined by: For more information visit www. 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.
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