ASTM F2559 F2559M-2006(2015) Standard Guide for Writing a Specification for Sterilizable Peel Pouches《用于制定消毒皮袋规格的标准指南》.pdf

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1、Designation: F2559/F2559M 06 (Reapproved 2015)Standard Guide forWriting a Specification for Sterilizable Peel Pouches1This standard is issued under the fixed designation F2559/F2559M; the number immediately following the designation indicates the yearof original adoption or, in the case of revision,

2、 the year of last revision. A number in parentheses indicates the year of last reapproval.A superscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide defines the requirements and considerationsfor flexible peel pouches with one open, unsealed e

3、nd that areintended to be sterilized containing medical devices. These arealso known as preformed sterile barrier systems.1.2 Pouch styles are categorized as chevron, header, andcorner peel. These pouches are typically manufactured by heatsealing, or in some cases, by cohesive cold sealing. The seal

4、ingbond is intended to be peeled open to aseptically dispense thecontents.1.3 Pouch materials may be either porous, nonporous, orany combination of the two.1.4 This guide addresses some critical printing requirementson the pouch.1.5 The values stated in either SI units or inch-pound unitsare to be r

5、egarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.1.6 This standard does not purport to address all of thesa

6、fety 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 determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E122 Practice for Calculating

7、Sample Size to Estimate, WithSpecified Precision, the Average for a Characteristic of aLot or ProcessF17 Terminology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible BarrierMaterialsF1140 Test Methods for Internal Pressurization Failure Re-sistance of Unrestrained

8、PackagesF1886 Test Method for Determining Integrity of Seals forMedical Packaging by Visual InspectionF2054 Test Method for Burst Testing of Flexible PackageSeals Using InternalAir Pressurization Within RestrainingPlatesF2097 Guide for Design and Evaluation of Primary FlexiblePackaging for Medical P

9、roductsF2203 Test Method for Linear Measurement Using PrecisionSteel RuleF2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging Materi-alsF2475 Guide for Biocompatibility Evaluation of MedicalDevice Packaging Materials2.2 TAPPI Standards:T437 Dirt in P

10、aper and Paperboard33. Terminology3.1 DefinitionsFor definitions and terms used in thisguide, see Terminology F17.3.2 Definitions of Terms Specific to This Standard:3.2.1 pouch, na flexible package constructed of one ormore materials sealed together to form a preformed sterilebarrier system. When pu

11、rchased, one end or side is open toallow for product loading and final sealing.3.2.2 specification, nan explicit set of requirements to besatisfied by a material, product, system, or service. Examplesof specifications include, but are not limited to, requirementsfor; physical, mechanical, or chemica

12、l properties, and safety,quality, or performance criteria. A specification identifies thetest methods for determining whether each of the requirementsis satisfied.44. Summary4.1 This guide provides guidance for writing a peel pouchmaterial specification. Materials, method of manufacture,1This guide

13、is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved Oct. 1, 2015. Published October 2015. Originallyapproved in 2006. Last previous edition approved in 2010 as F

14、2559/F2559M-06(2010)1. DOI: 10.1520/F2559_F2559M-06R15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Avail

15、able from Technical Association of the Pulp and Paper Industry (TAPPI),15 Technology Parkway South, Norcross, GA 30092, http:/www.tappi.org.4In accordance with ASTM International Form and Style for ASTM Standards.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA

16、 19428-2959. United States1physical properties, performance requirements, dimensioning,appearance, and printing are all issues that need to be ad-dressed in a peel pouch specification.Appropriate requirementsand test methods are suggested for preparing a specification.5. Significance and Use5.1 Medi

17、cal device peel pouches are universally used by theindustry and produced by a myriad of suppliers. They may beconstructed of many different materials including films, foils,paper, nonwovens such as Tyvek, and combinations thereof.However, even with the diversity of materials, there are stillbasic re

18、quirements that all pouches should exhibit. Above all,the pouches must contain and protect the device while main-taining sterility during all physical handling.5.2 Pouch requirements may be divided into two categories,initial pouch and material qualification, and routine productionand receipt requir

19、ements to ensure the purchaser receivesexactly what is ordered. While all requirements should beincluded in the written specification, initial qualification testsmay only be needed prior to the first order. Routine productionand receipt requirements should be adhered to on every order.Initial qualif

20、ication requirements are indicated within eachclause, where applicable.5.3 This guide provides an understanding of the require-ments needed for the manufacture, purchase, and acceptance ofa preformed peelable pouch. Appropriate test methods forcompliance are also cited.NOTE 1All test methods for a p

21、articular requirement may not be citeddue to specific or unique circumstances. For additional guidance onapplicable methods, refer to Guide F2097.5.4 The specification and its requirements should be mutu-ally agreed to by the supplier and purchaser of pouches. Thishelps ensure that pouches will comp

22、ly to specified require-ments.6. Specification6.1 Classification:6.1.1 Style:6.1.1.1 Chevron pouch (see Fig. 1),6.1.1.2 Corner peel pouch (see Fig. 2), and6.1.1.3 Header bag (see Fig. 3).6.2 Materials and Manufacture:6.2.1 Materials used in the construction of medical devicepeel pouches should be sp

23、ecified as non-toxic, providing amicrobial barrier and any other appropriate physical barrier(oxygen, water vapor, light, and so forth), and being compat-ible with the intended sterilization process. These requirementsshould be evaluated during the initial package qualification andare not typically

24、performed on a routine production basis.NOTE 2There are numerous test methods associated with determiningphysical and chemical properties of flexible materials used in thefabrication of pouches. Care should be taken in selecting the mostappropriate test for the users particular application and use.

25、For guidancein determining which methods to use, refer to Guide F2097.6.2.2 The ability of the materials to demonstrate compliancewith predetermined requirements may be addressed by eitherthe certification from raw or component materials supplier orby actual testing performed by the pouch manufactur

26、er incompliance with quality systems. These requirements are oftenevaluated during the initial package qualification and nottypically performed on a routine production basis.6.2.3 Pouches should be manufactured within a formalquality system.6.2.4 The process of converting materials into pouchesshoul

27、d be validated to demonstrate it is capable of consistentlyproducing a product that complies with predetermined require-ments such as dimensions, quality attributes, seal strength andseal integrity.6.3 Physical Properties:6.3.1 The critical physical property for a peel pouch is howwell the seal is f

28、abricated and how well it will stand up to thestresses of sterilization, distribution, storage, and handlingenvironments.6.3.2 A seal strength should be specified. This requirementmay be a minimum or maximum value, or both, the user hasqualified, or it may be an average or range value based on these

29、aling process capability.NOTE 1Dimension “I” or “J” but not both.FIG. 1 Chevron Pouch FIG. 2 Header BagF2559/F2559M 06 (2015)2NOTE 3Minimum seal strength is typically that which maintainspackage integrity through the processing, sterilization, handling, anddistribution systems. Maximum seal strength

30、 is that which, if exceeded,may result in the perception that the pouch is too difficult to open or causesfiber tear or delamination between one or more of the bonded substrates.6.3.2.1 Seal strength is measured using a tensile test methodsuch as Test Method F88 or burst test using Test Method F2054

31、or Test Method F1140.NOTE 4Burst testing is more commonly used for in-process testingrather than acceptance testing. If burst strength is to be used for in-processcontrol, then concurrent tensile and burst testing should be performed atthe time of validation.6.3.2.2 Test Method F88 indicates three d

32、ifferent tail hold-ing methods for the test sample: unsupported, supported 90(by hand) and supported 180. Because the effect of each ofthese on test results is varied, consistent use of one techniqueshould be negotiated with the supplier and indicated in thespecification.6.3.3 The visual seal appear

33、ance either in the intact orpeeled state should be specified as continuous around theperimeter of the seal with no skips, channels, or unsealed areas.The seal pattern, which can be solid, ribbed, or grid, should behomogeneous over the entire seal area with no spotty ormottled appearance, which typic

34、ally indicates an insufficientseal. Refer to Test Method F1886.6.3.4 Pouch seals should be able to withstand the intendedsterilization process(es). This requirement should be evaluatedduring the initial package qualification and not typicallyperformed on a routine production basis.NOTE 5Some sterili

35、zation processes may cause seals to soften andseparate, or increase or decrease seal strength.6.4 Performance Requirements:6.4.1 Peeled pouch seal characteristics and requirementsshould be indicated. When seals are peeled open, there shouldbe no visible film fracturing, delamination, or fiber tear t

36、hat cancreate foreign particulate in the operating room sterile field.The pouch is opened in such a way that allows for asepticpresentation of the product. Longer pouches may not need tobe opened their entire length to facilitate or provide acceptabletransfer technique; therefore, the performance pe

37、el assessmentmay include:6.4.1.1 Full pouch length if less than 15 cm 6 in. long.6.4.1.2 One half (12 ) the pouch length if 15 to 45 cm 6 to18 in. long.6.4.1.3 One third (13 ) pouch length if greater than 45 cm18 in. long.NOTE 6Peeling or opening technique, as well as pouch geometry andmaterials, ma

38、y affect the visual characteristics of the pouch seal. Thepeeling technique should be one continuous motion.6.5 Dimensions and Tolerance:6.5.1 Dimensions critical to product fit and function shouldbe specified. These typically include, but are not limited to,overall length and width, inside length (

39、to the apex of achevron pouch) and width, chevron or peel angle, and sealwidth. Other dimensions should be determined based onindividual applications and requirements. Refer to Fig. 1, Fig.2,orFig. 3.6.5.1.1 Linear dimensions should be measured in accor-dance with Test Method F2203.6.5.1.2 Dimension

40、al tolerances should be in accordancewith Table 1.6.6 Workmanship, Finish, and Appearance:NOTE 7Visual inspection of the pouch and pouch materials should beNOTE 1Dimension “J” or “K” but not both.FIG. 3 Corner PeelF2559/F2559M 06 (2015)3without magnification under normal lighting conditions at a dis

41、tance of approximately 30 to 45 cm 12 to 18 in. and any defects should beTABLE 1 Dimensional TolerancesStyle Dimension Description ToleranceChevron Pouch A Length OD 3 mm up to 0.5 m 18 in.upto20in.6 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.12 mm over 1.0 m 12 in. over 40 in.B Width OD 3

42、 mm up to 0.5 m 18 in.upto20in.6 mm over 0.5 m 14 in. over 20 in.C Length ID 3 mm up to 0.5 m 18 in.upto20in.6 mm over 0.5 m 14 in. over 20 in.D Width ID 1.5 mm up to 0.5 m 116 in.upto20in.3 mm over 0.5 m 18 in. over 20 in.and for highly heat sensitive materialsE Chevron setback 3 mm up to 0.5 m 18

43、in.upto20in.6 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.12 mm over 1.0 m 12 in. over 40 in.F Side seal width 1.5 mm 116 in.3 mm 18 in. for highly heat sensitive materialsG Chevron seal width 1.5 mm 116 in.3 mm 18 in. for highly heat sensitive materialsH Seal flange 1.5 mm 116 in.I Tack se

44、al length(not present on pouches withend gaps/seal gaps)3 mm up to 0.5 m 18 in.upto20in.6 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.12 mm over 1.0 m 12 in. over 40 in.J End gap/Seal gap(not present on pouches withtack seals)3 mm up to 0.5 m 18 8 in. up to 20 in.6 mm between 0.5 and 1.0-m

45、14 in. between 20 and 40 in.12 mm over 1.0 m 12 in. over 40 in.K Chevron seal angle 5L Lip 3 mm 18 in.M Thumb notch width 3 mm 18 in.N Thumb notch depth 3 mm 18 in.O Thumb notch position(to thumb notch c/l)3 mm 18 in.P Hang hole size 1.5 mm 116 in.R Hang hole setback(to hang hole c/l)3 mm up to 0.5

46、m 18 in.upto20in.6 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.12 mm over 1.0 m 12 in. over 40 in.S Hang hole position(to hang hole c/l)3 mm 18 in.Header Bag A Length OD(to end of shorter web)3 mm up to 0.5 m 18 in.upto20in.6 mm over 0.5 m 14 in. over 20 in.B Width OD 3 mm up to 0.5 m 18 in

47、.upto20in.6 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.12 mm over 1.0 m 12 in. over 40 in.C Length ID 3 mm up to 0.5 m 18 in.upto20in.6 mm over 0.5 m 14 in. over 20 in.D Width ID 3 mm up to 0.5 m 18 in.upto20in.6 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.12 mm over 1.0 m 12 in.

48、over 40 in.E Top seal width 3 mm 18 in.F Bottom header seal width 3 mm 18 in.G Side seal width 3 mm 18 in.H Header length 3 mm 18 in.I Bottom header lip/Pull tab 3 mm 18 in.J End gap/Seal gap 3 mm up to 0.5 m 18 in.upto20in.6 mm over 0.5 m 14 in. over 20 in.K FilmLip 3mm18 in.L Film header lip 3 mm

49、18 in.M Wicket hole size 1.5 mm 116 in.N Wicket hole separation 3 mm 18 in.O Wicket hole setback(to wicket hole c/l)3 mm up to 0.5 m 18 in.upto20in.6 mm over 0.5 m 14 in. over 20 in.P Wicket hole position(to wicket hole c/l)3 mm up to 0.25 m 18 in.upto10in.6 mm between 0.5 and 1.0-m 14 in. between 10 and 20 in.12 mm over 1.0 m 1