ASTM F2559 F2559M-2006(2010)e1 Standard Guide for Writing a Specification for Sterilizable Peel Pouches《消毒包装袋说明书编写的标准指南》.pdf

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1、Designation: F2559/F2559M 06 (Reapproved 2010)1Standard 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.1NOTEUnits information was editorially revised in November 2010.1. Scope1.1 This guide defines the requirements and

3、considerationsfor flexible peel pouches with one open, unsealed end 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

4、heatsealing, or in some cases, by cohesive cold sealing. The sealingbond 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 Th

5、e values stated in either SI units or inch-pound unitsare to be regarded 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 st

6、andard.1.6 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 determine the applica-bility of regulatory limitations prior to use.2. Refer

7、enced Documents2.1 ASTM Standards:2E122 Practice for Calculating Sample Size to Estimate,With Specified Precision, the Average for a Characteristicof a Lot or ProcessF17 Terminology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible BarrierMaterialsF1140 Test Methods

8、 for Internal Pressurization FailureResistance of Unrestrained PackagesF1886 Test Method for Determining Integrity of Seals forMedical Packaging by Visual InspectionF2054 Test Method for Burst Testing of Flexible PackageSeals Using Internal Air Pressurization Within RestrainingPlatesF2097 Guide for

9、Design and Evaluation of Primary FlexiblePackaging for Medical ProductsF2203 Test Method for Linear Measurement Using Preci-sion Steel RuleF2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging MaterialsF2475 Guide for Biocompatibility Evaluation of Me

10、dicalDevice Packaging Materials2.2 TAPPI Standards:T437 Dirt in Paper 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 s

11、ealed together to form a preformed sterilebarrier system. When purchased, 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

12、not limited to, requirementsfor; physical, mechanical, or chemical properties, and safety,quality, or performance criteria. A specification identifies thetest methods for determining whether each of the requirementsis satisfied.41This guide is under the jurisdiction of ASTM Committee F02 on Flexible

13、Barrier Packaging and is the direct responsibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved Oct. 1, 2010. Published November 2010. Originallyapproved in 2006. Last previous edition approved in 2006 as F2559 06. DOI:10.1520/F2559_F2559M-06R10E01.2For referenced

14、 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.3Available from Technical Association of the Pulp and Paper Industry (TAPPI)

15、,15 Technology Parkway South, Norcross, GA 30092, http:/www.tappi.org.4In accordance with ASTM International Form and Style for ASTM Standards.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4. Summary4.1 This guide provides guidance

16、 for writing a peel pouchmaterial specification. Materials, method of manufacture,physical 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 pr

17、eparing a specification.5. Significance and Use5.1 Medical 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 w

18、ith the diversity of materials, there are stillbasic requirements 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

19、qualification, and routine productionand receipt requirements 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 requirem

20、ents should be adhered to on every order.Initial qualification 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 forc

21、ompliance are also cited.NOTE 1All test methods for a particular 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 purcha

22、ser of pouches. Thishelps ensure that pouches will comply 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

23、construction of medical devicepeel pouches should be specified 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

24、the initial package qualification andare not typically 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 mostappropri

25、ate test for the users particular application and use. 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 supplie

26、r orby actual testing performed by the pouch manufacturer 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.

27、4 The process of converting materials into pouchesshould 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 phys

28、ical property for a peel pouch is howwell the seal is fabricated 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 hasNOTEDimen

29、sion “I” or “J” but not both.FIG. 1 Chevron PouchFIG. 2 Header BagF2559/F2559M 06 (2010)12qualified, or it may be an average or range value based on thesealing process capability.NOTE 3Minimum seal strength is typically that which maintainspackage integrity through the processing, sterilization, han

30、dling, anddistribution systems. Maximum seal strength 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

31、Test Method F88 or burst test using Test Method F2054or 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

32、 validation.6.3.2.2 Test Method F88 indicates three different 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 indic

33、ated in thespecification.6.3.3 The visual seal appearance 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

34、area with no spotty ormottled appearance, which typically 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 typicallyperfo

35、rmed on a routine production basis.NOTE 5Some sterilization 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 v

36、isible film fracturing, delamination, or fiber tear that 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 accept

37、abletransfer technique; therefore, the performance peel 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 cm 18in. long.NOTE 6Peeling or opening te

38、chnique, as well as pouch geometry andmaterials, may 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 l

39、imited to,overall length and width, inside length (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 a

40、ccor-dance with Test Method F2203.6.5.1.2 Dimensional tolerances should be in accordancewith Table 1.6.6 Workmanship, Finish, and Appearance:NOTEDimension “J” or “K” but not both.FIG. 3 Corner PeelF2559/F2559M 06 (2010)13TABLE 1 Dimensional TolerancesStyle Dimension Description ToleranceChevron Pouc

41、h A Length OD 63mmupto0.5m18 in.upto20in.66 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.612 mm over 1.0 m 12 in. over 40 in.B Width OD 63mmupto0.5m18 in.upto20in.66 mm over 0.5 m 14 in. over 20 in.C Length ID 63mmupto0.5m18 in.upto20in.66 mm over 0.5 m 14 in. over 20 in.D Width ID 61.5mmupt

42、o0.5m116 in.upto20in.63 mm over 0.5 m 18 in. over 20 in.and for highly heat sensitive materialsE Chevron setback 63mmupto0.5m18 in.upto20in.66 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.612 mm over 1.0 m 12 in. over 40 in.F Side seal width 61.5mm116 in.63mm18 in. for highly heat sensitive

43、materialsG Chevron seal width 61.5mm116 in.63mm18 in. for highly heat sensitive materialsH Seal flange 61.5mm116 in.I Tack seal length(not present on pouches withend gaps/seal gaps)63mmupto0.5m18 in.upto20in.66 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.612 mm over 1.0 m 12 in. over 40 in.

44、J End gap/Seal gap(not present on pouches withtack seals)63mmupto0.5m18 8 in. up to 20 in.66 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.612 mm over 1.0 m 12 in. over 40 in.K Chevron seal angle 65LLip 63mm18 in.M Thumb notch width 63mm18 in.N Thumb notch depth 63mm18 in.O Thumb notch positi

45、on(to thumb notch c/l)63mm18 in.P Hang hole size 61.5mm116 in.R Hang hole setback(to hang hole c/l)63mmupto0.5m18 in.upto20in.66 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.612 mm over 1.0 m 12 in. over 40 in.S Hang hole position(to hang hole c/l)63mm18 in.Header Bag A Length OD(to end of s

46、horter web)63mmupto0.5m18 in.upto20in.66 mm over 0.5 m 14 in. over 20 in.B Width OD 63mmupto0.5m18 in.upto20in.66 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.612 mm over 1.0 m 12 in. over 40 in.C Length ID 63mmupto0.5m18 in.upto20in.66 mm over 0.5 m 14 in. over 20 in.D Width ID 63mmupto0.5m

47、18 in.upto20in.66 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.612 mm over 1.0 m 12 in. over 40 in.E Top seal width 63mm18 in.F Bottom header seal width 63mm18 in.G Side seal width 63mm18 in.H Header length 63mm18 in.I Bottom header lip/Pull tab 63mm18 in.J End gap/Seal gap 63mmupto0.5m18 in

48、.upto20in.66 mm over 0.5 m 14 in. over 20 in.K Film Lip 63mm18 in.L Film header lip 63mm18 in.M Wicket hole size 61.5mm116 in.N Wicket hole separation 63mm18 in.O Wicket hole setback(to wicket hole c/l)63mmupto0.5m18 in.upto20in.66 mm over 0.5 m 14 in. over 20 in.P Wicket hole position(to wicket hol

49、e c/l)63mmupto0.25m18 in.upto10in.66 mm between 0.5 and 1.0-m 14 in. between 10 and 20 in.612 mm over 1.0 m 12 in. over 20 in.Corner Peel A Length OD 63mmupto0.5m18 in.upto20in.66 mm between 0.5 and 1.0-m 14 in. between 20 and 40 in.612 mm over 1.0 m 12 in. over 40 in.B Width OD 63mmupto0.5m18 in.upto20in.66 mm over 0.5 m 14 in. over 20 in.C Length ID 63mmupto0.5m1