1、Designation: F 2097 08Standard Guide forDesign and Evaluation of Primary Flexible Packaging forMedical Products1This standard is issued under the fixed designation F 2097; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of
2、 last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide provides directions for the design and evalu-ation of primary flexible packages for medical products. Thep
3、ackage materials must be selected appropriately for manufac-turing process, end use, and the product being packaged.1.2 This guide provides a compendium of test methods.Specific individual test methods must be selected based on thepertinent characteristics of the specific product to be packagedand t
4、he purpose for testing, research and development, orcompliance. Not all test methods will be applicable.1.3 This guide does not address acceptability criteria, whichneed to be determined jointly by the package producer and themedical products manufacturer.1.4 This guide does not assess the product t
5、o be packaged;the sterilization method to be used; or package performancethrough sterilization, distribution, and handling.1.5 The values stated in SI units are to be regarded asstandard. The values given in parentheses are mathematicalconversions to inch-pound units that are provided for informa-ti
6、on only and are not considered standard.2. Referenced Documents2.1 ASTM Standards:2D 374 Test Methods for Thickness of Solid Electrical Insu-lationD 589 Test Method for Opacity of Paper (15 DiffuseIlluminant A, 89 % Reflectance Backing and Paper Back-ing)D 638 Test Method for Tensile Properties of P
7、lasticsD 645/D 645M Test Method for Thickness of Paper andPaperboardD 726 Test Method for Resistance of Nonporous Paper toPassage of AirD 882 Test Method for Tensile Properties of Thin PlasticSheetingD 1003 Test Method for Haze and Luminous Transmittanceof Transparent PlasticsD 1434 Test Method for
8、Determining Gas PermeabilityCharacteristics of Plastic Film and SheetingD 1709 Test Methods for Impact Resistance of Plastic Filmby the Free-Falling Dart MethodD 1777 Test Method for Thickness of Textile MaterialsD 1894 Test Method for Static and Kinetic Coefficients ofFriction of Plastic Film and S
9、heetingD 1922 Test Method for Propagation Tear Resistance ofPlastic Film and Thin Sheeting by Pendulum MethodD 1938 Test Method for Tear-Propagation Resistance(Trouser Tear) of Plastic Film and Thin Sheeting by aSingle-Tear MethodD 2019 Test Method for Dirt in Paper and PaperboardD 2457 Test Method
10、for Specular Gloss of Plastic Films andSolid PlasticsD 3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD 3079 Test Method for Water Vapor Transmission ofFlexible Heat-Sealed Packages for Dry ProductsD 3335 Test Method for Low Concentrations of Lead,Cadmium, and Cob
11、alt in Paint by Atomic AbsorptionSpectroscopyD 3420 Test Method for Pendulum Impact Resistance ofPlastic FilmD 3718 Test Method for Low Concentrations of Chromiumin Paint by Atomic Absorption SpectroscopyD 3776 Test Methods for Mass Per Unit Area (Weight) ofFabricD 3985 Test Method for Oxygen Gas Tr
12、ansmission RateThrough Plastic Film and Sheeting Using a CoulometricSensorD 4279 Test Methods for Water Vapor Transmission ofShipping ContainersConstant and Cycle MethodsD 4321 Test Method for Package Yield of Plastic FilmD 4754 Test Method for Two-Sided Liquid Extraction ofPlastic Materials Using F
13、DA Migration CellD 5264 Practice for Abrasion Resistance of Printed Materi-als by the Sutherland Rub Tester1This guide 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
14、 approved May 1, 2008. Published June 2008. Originallyapproved in 2001. Last previous edition approved in 2007as F 2097 07.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, re
15、fer 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.E 398 Test Method for Water Vapor Transmission Rate ofSheet Materials Using Dynamic Relative Humidity Mea-surementF17 Termi
16、nology Relating to Flexible Barrier PackagingF88 Test Method for Seal Strength of Flexible BarrierMaterialsF99 Guide for Writing a Specification for Flexible BarrierRollstock MaterialsF 151 Test Method for Residual Solvents in Flexible BarrierMaterials3F 372 Test Method for Water Vapor Transmission
17、Rate ofFlexible Barrier Materials Using an Infrared DetectionTechniqueF 392 Test Method for Flex Durability of Flexible BarrierMaterialsF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Med
18、ical DevicesF 895 Test Method for Agar Diffusion Cell Culture Screen-ing for CytotoxicityF 904 Test Method for Comparison of Bond Strength or PlyAdhesion of Similar Laminates Made from Flexible Mate-rialsF 1140 Test Methods for Internal Pressurization FailureResistance of Unrestrained PackagesF 1249
19、 Test Method for Water Vapor Transmission RateThrough Plastic Film and Sheeting Using a ModulatedInfrared SensorF 1306 Test Method for Slow Rate Penetration Resistanceof Flexible Barrier Films and LaminatesF 1307 Test Method for Oxygen Transmission RateThrough Dry Packages Using a Coulometric Sensor
20、F 1443 Practice for Using 0.008-in. (0.203-mm) ApertureReflectometers as Test Instruments for Measuring VisualImage Quality of Business Copy ImagesF 1608 Test Method for Microbial Ranking of Porous Pack-aging Materials (Exposure Chamber Method)F 1884 Test Methods for Determining Residual Solvents in
21、Packaging MaterialsF 1886 Test Method for Determining Integrity of Seals forMedical Packaging by Visual InspectionF 1921 Test Methods for Hot Seal Strength (Hot Tack) ofThermoplastic Polymers and Blends Comprising the Seal-ing Surfaces of Flexible WebsF 1927 Test Method for Determination of Oxygen G
22、asTransmission Rate, Permeability and Permeance at Con-trolled Relative Humidity Through Barrier Materials Usinga Coulometric DetectorF 1929 Test Method for Detecting Seal Leaks in PorousMedical Packaging by Dye PenetrationF 1980 Guide for Accelerated Aging of Sterile BarrierSystems for Medical Devi
23、cesF 2029 Practices for Making Heatseals for Determination ofHeatsealability of Flexible Webs as Measured by SealStrengthF 2054 Test Method for Burst Testing of Flexible PackageSeals Using Internal Air Pressurization Within RestrainingPlatesF 2095 Test Methods for Pressure Decay Leak Test forFlexibl
24、e Packages With and Without Restraining PlatesF 2096 Test Method for Detecting Gross Leaks in MedicalPackaging by Internal Pressurization (Bubble Test)F 2203 Test Method for Linear Measurement Using Preci-sion Steel RuleF 2217 Practice for Coating/Adhesive Weight Determina-tionF 2250 Practice for Ev
25、aluation of Chemical Resistance ofPrinted Inks and Coatings on Flexible Packaging MaterialsF 2251 Test Method for Thickness Measurement of FlexiblePackaging MaterialF 2252 Practice for Evaluating Ink or Coating Adhesion toFlexible Packaging Materials Using TapeF 2227 Test Method for Non-Destructive
26、Detection ofLeaks in Non-sealed and Empty Medical Packaging Traysby CO2Tracer Gas MethodF 2228 Test Method for Non-Destructive Detection ofLeaks in Medical Packaging Which Incorporates PorousBarrier Material by CO2Tracer Gas MethodF 2338 Test Method for Nondestructive Detection of Leaksin Packages b
27、y Vacuum Decay MethodF 2391 Test Method for Measuring Package and Seal Integ-rity Using Helium as the Tracer GasF 2475 Guide for Biocompatibility Evaluation of MedicalDevice Packaging MaterialsF 2476 Test Method for the Determination of Carbon Diox-ide Gas Transmission Rate (Co2TR) Through BarrierMa
28、terials Using An Infrared DetectorF 2559 Guide for Writing a Specification for SterilizablePeel PouchesF 2638 Test Method for Using Aerosol Filtration for Mea-suring the Performance of Porous Packaging Materials as aSurrogate Microbial Barrier2.2 EN/ISO Standards:4EN 868/1 Annex C Gurley, Schopper,
29、Dye PenetrationISO 2556 PlasticsDetermination of Gas TransmissionRate of Films and Thin Sheets Under AtmosphericPressureManometric MethodISO 56365 Paper and BoardDetermination of Air Per-meance (Medium Range)Part 5: Gurley MethodISO 116071 Packaging for Terminally Sterilized MedicalDevices, Annex CI
30、SO 151051 PlasticsFilm and SheetingDeterminationof Gas Transmission RatePart 1: Differential-PressureMethodISO 151052 PlasticsFilm and SheetingDeterminationof Gas Transmission RatePart 2: Equal-PressureMethod2.3 Military Specification:53Withdrawn.4Available from International Organization for Standa
31、rdization (ISO), 1 rue deVaremb, Case postale 56, CH-1211, Geneva 20, Switzerland, http:/www.iso.ch.5Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPOPS.F2097082Mil Spec 36954C Bacterial Filtration Efficiency2.4 TAPPI Stan
32、dards:6TAPPI T 404 Tensile Breaking Strength and Elongation ofPaper and PaperboardTAPPI T 437 Dirt in Paper and PaperboardTAPPI T 460 Air Resistance of Paper (Gurley Method)TAPPI T 494 Tensile Breaking Properties of Paper andPaperboard (Using Constant Rate of Elongation Appara-tus)TAPPI T 536 Resist
33、ance of Paper to Passage of Air (HighPressure Gurley Method)TAPPI T 547 Air Permeance of Paper and Paperboard(Sheffield Method)3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 barrier requirements, nthe need to promote orinhibit moisture, gas, or light, or a combination thereof
34、, whilemaintaining necessary levels of sterility.3.1.2 durability requirements, nmaterial properties rel-evant to the ability of the package to protect the product.3.1.3 integrity and seal requirements, nthe ability of thepackage to prevent inadvertent escape of contents or entranceof outside substa
35、nces while preserving intended opening foruse features.3.1.4 printing requirements, nthe printed ink propertiesneeded to ensure physical and chemical resistance to degrada-tion.3.1.5 processing requirements, nthe material characteris-tics needed to ensure the consistent and reliable production ofthe
36、 package.3.1.6 safety requirements, nsafeguard product againstcontamination and deleterious health effects.3.1.7 visibility and appearance requirements, nthe de-sired package aesthetics needed to permit or inhibit viewing ofthe product or to enhance product presentation.3.2 For other terms used in t
37、his guide, see TerminologyF17.4. Significance and Use4.1 This design and evaluation guide describes seven cat-egories for evaluating flexible medical packages and packagingmaterials. These include safety, barrier properties, durability,package and seal integrity, visibility and appearance, process-i
38、ng, and printing ink properties.4.2 The intent of this design and evaluation guide is toevaluate all seven categories and select those that are appli-cable. Once the product has been characterized and thesterilization methodology has been defined, there are numeroussets of requirements for any speci
39、fic package. This design andevaluation guide provides an avenue for assessing theserequirements and choosing test methods for both evaluating thepackage design and monitoring package compliance.4.3 Product characterization shall include mass or weight,geometry (length and width, height, and shape) a
40、nd productcomposition.4.4 All seven categories must be considered for applicabil-ity.4.5 The Summary of Test Methods for Medical PackagingDesign and Evaluation (Fig. 1) provides a compact graphicalpresentation of the test methods referenced in this guide.4.6 Test Description and Applicability (see T
41、able 1):4.6.1 Table 1 lists the test methods commonly used toevaluate flexible medical packaging. The test methods are usedin two phases.4.6.1.1 Package Design: Characterization of the Materialsand Evaluation of the Resultant PackageThis is referred toas “R only that the L929 is an established cell
42、line, well characterized andreadily available, that has demonstrated reproducibleresults in several laboratories.F2097085TABLE 1 ContinuedTest Test Method Description ApplicabilityToxicityUsageR25 %) between laboratories.It is a simplified version of Test Method F 151 providingabout the same level o
43、f accuracy. This method differsfrom Test Method F 151 in that it specifies certainconditions. Test Method F 1884, for example, specifies apre-heat condition of 90C for 20 min. Test Method F 151defines a procedure for determining optimum heatingtime and temperature conditions for the preheat.Because
44、solvents will escape from surface wraps on aroll of film, this test should be performed immediatelyafter manufacturing to provide an indication of solventlevels in the inner wraps of the roll of film.Retained solventsUsageRfurther steps would be needed to correlate these relativenumbers to end-use a
45、pplications.Puncture resistanceUsageR further steps would be needed tocorrelate these relative numbers to end-use applications.This test method could be used to address concerns oversharp edged products packaged in thin flexible materialpenetrating the integrity. This test method will create arelative number for penetration resistance but does notaddress abrasion.Puncture resistanceUsageR or through the ASTM website(www.astm.org).F20970815
