April 25, 2020   |   by admin

•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.

Author: Vudogrel Kajikora
Country: Antigua & Barbuda
Language: English (Spanish)
Genre: Science
Published (Last): 25 January 2013
Pages: 329
PDF File Size: 10.85 Mb
ePub File Size: 17.29 Mb
ISBN: 478-5-46979-796-4
Downloads: 12896
Price: Free* [*Free Regsitration Required]
Uploader: Zololl

Precision and Bias 3 8. These too can result in a channel through the entire seal.

ASTM F (Reapproved )_百度文库

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. 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. 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.

Individual reprints single or multiple copies of this standard may be obtained by contacting ASTM at the above address or at phonefaxor service astm.

Size of channel Degree f1868 contrast from sealed and unsealed areas Amount atsm 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: Impact also may cause the seals to partially rupture. Seal creep may be a result of the sterilization process or stressed seals at temperature extremes.


This attribute may be in varying degrees of severity and should be categorized based on appearance and whether sterile package integrity can be maintained. The values given in parentheses are for information only.

This may become evident through an evaluation for pinholes or cracks along the seal. Often it is easier to see this type of defect under a magnifying light or 1f886 light box. Generally, this occurs with? Current edition approved June 1, Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend.

This standard is subject to revision at any time by the responsible technical committee and must be reviewed every? 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. The negative control consists atm the same type packages produced with no channels.

Completeness and uniformity of the entire seal area of the package must be inspected.


Care should be taken to ensure a smooth continuous peeling motion so as not to cause any extraneous attributes. Causes for channels have been discussed above in X1.

A superscript epsilon e indicates an editorial change since the last revision or reapproval. 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.


A number in parentheses indicates the year of last reapproval. Inspection of the seal should be performed at a distance of 30 to 45 cm 12 to 18 in. A spotty or mottled appearance may be a function of the adhesive properties, as well. Visual seal characteristics and defects can bring forth evidence of sterile package integrity and production sealing problems. Heat seals should be cooled to ambient conditions before peeling open to allow for adhesive bonding to the opposite substrate to occur.

Record the number and location of channels identified on each package. 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. 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.

Summary of Test Method 4. Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters. Viewing the seal area in a UV light box will enhance the sealed-to-unsealed area contrast, and provide for easier defect identi? Last previous edition approved in as F —