ASTM F1886-1998(2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection《用目视检验测定医疗包装密封完整性的标准试验方法》.pdf
《ASTM F1886-1998(2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection《用目视检验测定医疗包装密封完整性的标准试验方法》.pdf》由会员分享,可在线阅读,更多相关《ASTM F1886-1998(2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection《用目视检验测定医疗包装密封完整性的标准试验方法》.pdf(4页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F 1886 98 (Reapproved 2004)Standard Test Method forDetermining Integrity of Seals for Medical Packaging byVisual Inspection1This standard is issued under the fixed designation F 1886; the number immediately following the designation indicates the year oforiginal adoption or, in the case
2、 of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers the determination of channels inthe package seal down to a width of
3、 75 m (0.003 in.) with a60100 % probability (see Section 8).1.1.1 The ability to visually detect channel defects inpackage seals is highly dependent on the size of channel, thedegree of contrast from sealed and unsealed areas, the amountand type of adhesive between the two package layers, reflect-in
4、g light angle, types of material used, the use of magnification,and the inspectors level of training and experience.1.2 This test method is applicable to flexible and rigidpackages with at least one transparent side so that the seal areamay be clearly viewed.1.3 The values stated in SI units are to
5、be regarded as thestandard. The values given in parentheses are for informationonly.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and
6、 determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F17 Terminology Relating to Flexible Barrier Materials3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 channel, nany unimpaired pathway across the entirewidth of the
7、intended seal.3.1.2 sterile package integrity, nproperty of the packageseal and material, which ensures that it presents a microbialbarrier. (see also Terminology F17, microbiological packageintegrity).4. Summary of Test Method4.1 This test method provides a qualitative (accept/reject)visual inspect
8、ion method to evaluate the appearance character-istics of unopened, intact seals in order to determine thepresence of defects that may affect the integrity of the package.5. Significance and Use5.1 Seal attributes can be linked directly to a number ofvariables in process parameters, equipment, or ma
9、terial, as wellas environmental (room temperature and relative humidity).Visual seal characteristics and defects can provide evidence ofsterile package integrity and production sealing problems.5.2 Visual seal defects often will be the first indication ofheat sealing process variation. They also wil
10、l indicate a lack of,or potential compromise to, package integrity after physicalpackage performance testing.6. Apparatus6.1 Illuminant, lighting arrangements to give about 540lumens/m2(50 fc) of white light or daylight on the specimens.6.2 Indelible Marking Pen.7. Procedure7.1 Visual acuity shall b
11、e such that the inspection of the sealmay be performed at a distance of 30 to 45 cm (12 to 18 in.)NOTE 1Magnification devices, such as eyeloops, may be used as ananalytical tool to characterize identified seal defects.7.2 Inspect the entire sealed area of the package for com-pleteness and uniformity
12、.NOTE 2Different package sizes and shapes may require differinglengths of time to adequately inspect the entire seal perimeter. Any timerequirement associated with visual inspection should allow for completeseal inspection.1This test method is under the jurisdiction of ASTM Committee F02 on Flexible
13、Barrier Materials and is the direct responsibility of Subcommittee F02.40 onPackage Integrity.Current edition approved June 1, 2004. Published June 2004. Originallyapproved in 1998. Last previous edition approved in 1998 as F 1886 98.2For referenced ASTM standards, visit the ASTM website, www.astm.o
14、rg, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.NOTE 3Some p
15、ackaging materials and adhesives may fluoresce underultraviolet light. Viewing the seal area in a UV light box will enhance thesealed-to-unsealed area contrast, and provide for easier defect identifica-tion.7.3 Identify and record any part of the seal where channelsappear across the entire seal widt
16、h. Mark the location of thechannels.NOTE 4All other assessed defects (refer to Appendix X1) should becategorized according to user defined accept/reject criteria. Define theactions to be taken in the event defects are detected during normalproduction runs.7.4 Record the number and location of channe
17、ls identifiedon each package.NOTE 5If confirmation of channels or incomplete seal areas inpeelable packages is necessary, hand peel such suspected packagecompletely separating the two material components and inspect the sealarea of the transferred adhesive for the same incomplete seal attributes ast
18、he unopened package. Care should be taken to ensure a smoothcontinuous peeling motion so as not to cause any extraneous attributes.Heat seals should be cooled to ambient conditions before peeling open toallow for adhesive bonding to the opposite substrate to occur.In some instances, a channel or uns
19、ealed area may be observed onlyafter the package is peeled open. Adhesive transfer is a qualitativemeasure of a materials ability to release the coating rather than conclusiveevidence that the seal has not been made. It is possible to have continuousseal integrity but fail to give complete transfer.
20、 This is because the coatingmay have a stronger affinity for the substrate on which it is coated ratherthan the one to which it is sealed. In such cases, an additional physical sealintegrity test may be required to confirm if it is an unsealed area.8. Precision and Bias38.1 A round robin study was c
21、onducted in 1997, whichincluded ten laboratories, four package types, and two differentchannel sizes randomly produced with 75 m (0.003 in.) and125 m (0.005 in.) diameter wire. The negative control consistsof the same type packages produced with no channels. The fourdifferent types of medical device
22、 packages are:8.1.1 Open pouch (5 by 7 in.)clear film/coated paper;8.1.2 Open pouch (514 by 712 in.)clear film/uncoatedTYVEK4;8.1.3 Sealed rigid blister (812 by 514 in.)blue tintedblister/coated TYVEK; and,8.1.4 Open end pouch (6 by 812 in.)clear film/clear film(clear seal).8.2 The results of this s
23、tudy are pass or fail; therefore, thedata is binomial with an expected average of np and anexpected variance of npg where n is the number of samples, pis the probability of an incorrect evaluation, and q is theprobability of a correct evaluation. A statistical analysis of thedata by means of a conti
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