ASTM F1886 PDF

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. Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. Visual seal defects will often be the initial indication of heat sealing process variation. They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing. The ability to visually detect channel defects in package seals is highly reliant on: Size of channel Degree of contrast from sealed and unsealed areas Amount and type of adhesive between the two package layers Reflecting light angle Use of magnification ASTM F procedure is comprised of the following: ASTM F is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed. Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in.

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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. Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. Visual seal defects will often be the initial indication of heat sealing process variation.

They also will demonstrate a lack of, or potential compromise to, package integrity after physical package performance testing. The ability to visually detect channel defects in package seals is highly reliant on: Size of channel Degree of contrast from sealed and unsealed areas Amount and type of adhesive between the two package layers Reflecting light angle Use of magnification ASTM F procedure is comprised of the following: ASTM F is pertinent to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.

Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. Completeness and uniformity of the entire seal area of the package must be inspected. Any part of the seal where channels appear across entire seal width must be identified and recorded. Record the number and location of channels identified on each package.

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Dakree The r are presented in Tables The ability to visually detect channel defects in package seals is highly reliant on: Last previous edition approved in as F — Seal attributes can be directly linked to a vast amount of variables in process parameters, equipment, or material, as well as environmental room qstm and relative humidity. 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. Individual reprints single or multiple copies of this standard may be obtained by contacting ASTM at the above address or at phonefaxor service astm. A spotty or mottled appearance may be a function of the adhesive properties, as well.

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Insufficient sealing temperature either too much, too little, or unevenly applied pressure; too short a process time; or, excessive material thickness asym are some of the conditions that may cause seals to appear to be spotty or mottled. Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. Impact also may cause the seals to partially rupture. 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. The four different types of medical device packages are: It is possible to have continuous seal integrity but fail to give complete transfer. Individual reprints single or multiple copies of this standard f be obtained by contacting ASTM at the above address or at phonefaxor service astm.

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