ASTM F2559-2006 Standard Guide for Writing a Specification for Sterilizable Peel Pouches《书写可灭菌可剥离袋规范的标准指南》.pdf

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1、Designation: F 2559 06Standard Guide forWriting a Specification for Sterilizable Peel Pouches1This standard is issued under the fixed designation F 2559; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A

2、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 guide defines the requirements and considerationsfor flexible peel pouches with one open, unsealed end that areintended to be ste

3、rilized 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 sealingbond is intended to be pee

4、led 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 This standard does not purport to address all of thesafety concerns, if any, associated with its

5、 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:2E 122 Practice for Calculating Sample Size to Estimate,With a Specified

6、Tolerable Error, the Average for a Char-acteristic of a Lot or ProcessF17 Terminology Relating to Flexible Barrier MaterialsF88 Test Method for Seal Strength of Flexible BarrierMaterialsF 1140 Test Methods for Internal Pressurization FailureResistance of Unrestrained Packages for Medical Applica-tio

7、nsF 1886 Test Method for Determining Integrity of Seals forMedical Packaging by Visual InspectionF 2054 Test Method for Burst Testing of Flexible PackageSeals Using Internal Air Pressurization Within RestrainingPlatesF 2097 Guide for Design and Evaluation of Primary Pack-aging for Medical ProductsF

8、2203 Test Method for Linear Measurement Using Preci-sion Steel RuleF 2250 Practice for Evaluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging MaterialsF 2475 Guide for Biocompatibility Evaluation of MedicalDevice Packaging Materials2.2 TAPPI Standards:T437 Dirt in Paper

9、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 purchas

10、ed, 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 chemical pro

11、perties, 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,physical properti

12、es, 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 Medical device peel pouches are universally used

13、 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.1This guide is under the jurisdiction of ASTM Committee F02 on FlexibleBarrier Packaging and is the direct respons

14、ibility of Subcommittee F02.50 onPackage Design and Development.Current edition approved Nov. 1, 2006. Published November 2006.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information

15、, refer to the standards Document Summary page onthe ASTM website.3Available 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.1Copyright ASTM

16、 International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.However, even with 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

17、 during all physical handling.5.2 Pouch requirements may be divided into two categories,initial pouch and material qualification, and routine productionand receipt requirements to ensure the purchaser receivesexactly what is ordered. While all requirements should beincluded in the written specificat

18、ion, initial qualification testsmay only be needed prior to the first order. Routine productionand receipt requirements 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-men

19、ts needed for the manufacture, purchase, and acceptance ofa preformed peelable pouch. Appropriate test methods forcompliance 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

20、 to Guide F 2097.5.4 The specification and its requirements should be mutu-ally agreed to by the supplier and purchaser of pouches. Thishelps ensure that pouches will 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 pe

21、el 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 specified as non-toxic, providing amicrobial barrier and any other appropriate physical barrier(oxygen, water vapor, light, and so

22、forth), and being compat-ible with the intended sterilization process. These requirementsshould be evaluated during the initial package qualification andare not typically performed on a routine production basis.NOTE 2There are numerous test methods associated with determiningphysical and chemical pr

23、operties of flexible materials used in thefabrication of pouches. Care should be taken in selecting the mostappropriate test for the users particular application and use. For guidancein determining which methods to use, refer to Guide F 2097.6.2.2 The ability of the materials to demonstrate complian

24、cewith predetermined requirements may be addressed by eitherthe certification from raw or component materials supplier orby actual testing performed by the pouch manufacturer incompliance with quality systems. These requirements are oftenevaluated during the initial package qualification and nottypi

25、cally 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 pouchesshould be validated to demonstrate it is capable of consistentlyproducing a product that complies with predetermined require-ments su

26、ch 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 fabricated and how well it will stand up to thestresses of sterilization, distribution, storage, and handlingenvironments.6.3.2 A

27、 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 thesealing process capability.NOTE 3Minimum seal strength is typically that which maintainspackage integrity through the processing,

28、sterilization, handling, 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 t

29、est methodsuch as Test Method F88 or burst test using Test MethodF 2054 or Test Method F 1140.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 per

30、formed atthe time of validation.NOTEDimension “I” or “J” but not both.FIG. 1 Chevron PouchFIG. 2 Header BagF25590626.3.2.2 Test Method F88indicates 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 t

31、est results is varied, consistent use of one techniqueshould be negotiated with the supplier and indicated 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 a

32、reas.The seal pattern, which can be solid, ribbed, or grid, should behomogeneous over the entire seal area with no spotty ormottled appearance, which typically indicates an insufficientseal. Refer to Test Method F 1886.6.3.4 Pouch seals should be able to withstand the intendedsterilization process(e

33、s). This requirement should be evaluatedduring the initial package qualification and not typicallyperformed 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 se

34、al characteristics and requirementsshould be indicated. When seals are peeled open, there shouldbe no visible 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 t

35、he product. Longer pouches may not need tobe opened their entire length to facilitate or provide acceptabletransfer 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

36、 in.) long.6.4.1.3 One third (13) pouch length if greater than 45 cm (18in.) long.NOTE 6Peeling or opening technique, 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

37、.1 Dimensions critical to product fit and function shouldbe specified. These typically include, but are not limited 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 app

38、lications 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 F 2203.6.5.1.2 Dimensional tolerances should be in accordancewith Table 1.6.6 Workmanship, Finish, and Appearance:NOTE 7Visual inspection of the pouch and pouch ma

39、terials should bewithout magnification under normal lighting conditions at a distance ofapproximately 30 to 45 cm (12 to 18 in.) and any defects should benoticeable without an extended inspection time.6.6.1 Loose foreign matter limits for both inside and outsideof the pouch should be specified and n

40、egotiated with andagreed to by all parties. Requirements may be establishedbased on the Dirt Estimation Chart in TAPPI T437.6.6.2 There should be no wrinkles that could cause chan-neling through the seal or voids in the seal, and no holes ortears in the pouch.6.6.3 There should be no scratches or sc

41、uffing on the film, ifapplicable. The degree of scratches or scuffing, if any, shouldbe determined as appropriate for the material used.NOTEDimension “J” or “K” but not both.FIG. 3 Corner PeelF2559063TABLE 1 Dimensional TolerancesStyle Dimension Description ToleranceChevron Pouch A Length OD 63mmupt

42、o0.5m(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.)B Width OD 63mmupto0.5m(18 in.upto20in.)66 mm over 0.5 m (14 in. over 20 in.)C Length ID 63mmupto0.5m(18 in.upto20in.)66 mm over 0.5 m (14 in. over 20 in.)D Width ID 61.5mmupto0.5m(1

43、16 in.upto20in.)63 mm over 0.5 m (18 in. over 20 in.)and for highly heat sensitive materialsE Chevron setback 63mmupto0.5m(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.)F Side seal width 61.5mm(116 in.)63mm(18 in.) for highly heat sen

44、sitive materialsG Chevron seal width 61.5mm(116 in.)63mm(18 in.) for highly heat sensitive materialsH Seal flange 61.5mm(116 in.)I Tack seal length(not present on pouches withend gaps/seal gaps)63mmupto0.5m(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 (

45、12 in. over 40 in.)J End gap/Seal gap(not present on pouches withtack seals)63mmupto0.5m(18 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 63mm(18 in.)M Thumb notch width 63mm(18 in.)N Thumb notch depth 6

46、3mm(18 in.)O Thumb notch position(to thumb notch c/l)63mm(18 in.)P Hang hole size 61.5mm(116 in.)R Hang hole setback(to hang hole c/l)63mmupto0.5m(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.)S Hang hole position(to hang hole c/l)63m

47、m(18 in.)Header Bag A Length OD(to end of shorter web)63mmupto0.5m(18 in.upto20in.)66 mm over 0.5 m (14 in. over 20 in.)B Width OD 63mmupto0.5m(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.)C Length ID 63mmupto0.5m(18 in.upto20in.)66

48、mm over 0.5 m (14 in. over 20 in.)D Width ID 63mmupto0.5m(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 63mm(18 in.)F Bottom header seal width 63mm(18 in.)G Side seal width 63mm(18 in.)H Header length 63mm(18 in.)I Bo

49、ttom header lip/Pull tab 63mm(18 in.)J End gap/Seal gap 63mmupto0.5m(18 in.upto20in.)66 mm over 0.5 m (14 in. over 20 in.)K Film Lip 63mm(18 in.)L Film header lip 63mm(18 in.)M Wicket hole size 61.5mm(116 in.)N Wicket hole separation 63mm(18 in.)O Wicket hole setback(to wicket hole c/l)63mmupto0.5m(18 in.upto20in.)66 mm over 0.5 m (14 in. over 20 in.)P Wicket hole position(to wicket hole c/l)63mmupto0.25m(18 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 2