ASTM F2097-14

ASTM F2097-14 - 1.4.2014

Significance and Use

4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance.

4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.

Note 1—Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.

4.4 All categories must be considered for applicability.

4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.

4.6 Test Description and Applicability (see Table 1):

4.6.1 Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases.

4.6.1.1 Package Design: Characterization of the Materials and Evaluation of the Resultant Package—This is referred to as “R&D Evaluation” in Table 1. Testing during this phase is characterized by the generation of quantitative data on the performance of the component materials and the package assembly. These test methods are lengthy, making them inappropriate for the manufacturing environment where rapid response is required for process control. Often, they are expensive and require specialized equipment not readily available at a medical packaging or device manufacturing facility.

4.6.1.2 Package Compliance: Routine Monitoring of Adherence to Specifications—This is referred to as “Compliance Testing” in Table 1. Testing during this phase must be rapid, inexpensive, and readily implemented in a manufacturing environment. The objective is not to develop design data, but to ensure that the design specifications are being met. These test methods do not necessarily make direct measurements of critical values, but detect variations in material, process, or product that are indicative of all critical characteristics.

4.6.2 It is important to note that no individual test method is entirely predictive of final package performance. Filled packages must be evaluated under conditions of use.

4.7 Once the design of the package and/or packaging materials has been determined, it may be appropriate to create a package and/or material specification. Guides F99 or F2559 may provide useful guidance.

1. Scope

1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.

1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.

1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.

1.4 This guide does not assess the product to be packaged or the sterilization method to be used.

1.5 The units cited in the referenced standard should be used.

2. Referenced Documents

D3078-02(2021)e1	Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission (Includes all amendments and changes 2/15/2021).
D3079-94(1999)	Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products
D3335-85a(2020)	Standard Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption Spectroscopy (Includes all amendments and changes 2/6/2020).
D3420-21	Standard Test Method for Pendulum Impact Resistance of Plastic Film
D3776-09	Standard Test Methods for Mass Per Unit Area (Weight) of Fabric
D3985-17	Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
D4169-23	Standard Practice for Performance Testing of Shipping Containers and Systems
D4279-95(2022)	Standard Test Methods for Water Vapor Transmission of Shipping Containers—Constant and Cycle Methods
D4321-15	Standard Test Method for Package Yield of Plastic Film (Withdrawn 2024)
D4332-22	Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
D4754-18	Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
D5264-98(2019)	Standard Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester
D7386-16	Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems
E398-20	Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement
F17-20	Standard Terminology Relating to Primary Barrier Packaging
F88-07	Standard Test Method for Seal Strength of Flexible Barrier Materials
F99-21	Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
F151-86(1997)	Standard Test Method for Residual Solvents in Flexible Barrier Materials (Withdrawn 2004)
F372-99	Standard Test Method for Water Vapor Transmission Rate of Flexible Barrier Materials Using an Infrared Detection Technique
F392-93(1999)	Standard Test Method for Flex Durability of Flexible Barrier Materials
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
D3718-85A(2022)e1	Standard Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy (Includes all amendments and changes 7/7/2022).
F2391-22	Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
F2475-20	Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
F2476-20	Standard Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using an Infrared Detector
F2559-06	Standard Guide for Writing a Specification for Sterilizable Peel Pouches
F2622-20	Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using Various Sensors
F2638-22	Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
F2714-08(2021)	Standard Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay
F2824-10(2020)	Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids
F2825-18	Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
F2981-15(2020)	Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
F3004-13(2020)	Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
F3039-23	Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
D589-97	Standard Test Method for Opacity of Paper (15°Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing)
D638-22	Standard Test Method for Tensile Properties of Plastics
	Bacterial Filtration Efficiency
F1927-20	Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector
F1929-23	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
F1980-21	Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
F2029-16(2021)	Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength
F2054-07	Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
F2095-07(2021)	Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
F2096-11(2019)	Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
F2203-13(2022)	Standard Test Method for Linear Measurement Using Precision Steel Rule
F2217-02	Standard Practice for Coating/Adhesive Weight Determination
F2250-13(2018)	Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
F2251-13(2023)	Standard Test Method for Thickness Measurement of Flexible Packaging Material
F2252-13	Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
F2227-13(2021)	Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
F2228-13(2021)	Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895-11(2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F904-22	Standard Practice for Separation of Plies for Bond Strength of Laminated Flexible Materials
F2338-09(2020)	Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
F1140-07	Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
F1249-20	Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
F1306-21	Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
F1307-20	Standard Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor
F1443-93(1998)	Standard Practice for Using 0.008-in. (0.203-mm) Aperture Reflectometers as Test Instruments for Measuring Visual Image Quality of Business Copy Images
F1608-21	Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
F1884-04(2023)	Standard Test Methods for Determining Residual Solvents in Packaging Materials
F1886-98	Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
F1921-12	Standard Test Methods for Hot Seal Strength (Hot Tack) of Thermoplastic Polymers and Blends Comprising the Sealing Surfaces of Flexible Webs
F3136-22	Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation Method
EN 868/1	Annex C Gurley, Schopper, Dye Penetration
	Plastics--Determination of Gas Transmission Rate of Films and Thin Sheets Under Atmospheric Pressure--Manometric Method
	Paper and Board--Determination of Air Permeance (Medium Range)--Part 5: Gurley Method
ISO 10993	Biological Evaluation of Medical Devices
	Packaging for Terminally Sterilized Medical Devices, Annex C


D645-D645M-97	Standard Test Method for Thickness of Paper and Paperboard
D726-94(1999)	Standard Test Method for Resistance of Nonporous Paper to Passage of Air
D374-99	Standard Test Methods for Thickness of Solid Electrical Insulation
D882-18	Standard Test Method for Tensile Properties of Thin Plastic Sheeting
D1003-21	Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
D1434-23	Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D1709-22	Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
D1777-96(2019)	Standard Test Method for Thickness of Textile Materials
D1894-14	Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting (Withdrawn 2023)
D1922-23	Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
D1938-19	Standard Test Method for Tear-Propagation Resistance (Trouser Tear) of Plastic Film and Thin Sheeting by a Single-Tear Method
D2019-97	Standard Test Method for Dirt in Paper and Paperboard
D2457-21	Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics