Use of Design Guide F 2097 & U.S. FDA Recognition Hal Miller - - PowerPoint PPT Presentation

Committee F02 on Flexible Barrier Packaging

Use of Design Guide F 2097 & U.S. FDA Recognition

Hal Miller PACE Solutions, LLC

Note: This guide was originally developed for medical device packaging; however, it applies to the design and evaluation of any flexible package.

Objectives

 How to effectively use the Design Guide  Which standards are Recognized

Consensus Standards by the U.S. FDA/CDRH

 What are Recognized Consensus

Standards

 How to access and use the FDA

Recognized Consensus Standards database

• 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. Scope (continued)

 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. Scope (continued)

 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.

F2097 Overview

 Compendium of commonly used test

methods, practices and guides

 Applicable standards also from TAPPI, ISO,

ISTA, and U.S. Military

 Focus on flexible packaging  Usefulness extends into other industries

F2097 – How to use it

 Organized into eight categories:

 Safety (properties)  Barrier (properties)  Durability (physical properties)  Package Integrity and Seal Strength  Visibility and Appearance  Processing  Printed Ink  Package Performance (in last revision)

• Fig. 1 – Summary of Test
• Methods. . .

 Quick reference guide  Grouped by property

category and subcategories

 (Add new pages (2))

• Fig. 1 – Summary of Test
• Methods. . .

 Package performance was added in the last

revision

F2097 – How to use it

 Assess package requirements in each

• f the categories

 Select the appropriate test methods for:

– Package Design: characterization of

materials and evaluation of resultant package

– Package Compliance: routine monitoring of

adherence to specifications

Selecting a Test Method

For Example, Barrier Testing

Identifies all standards associated with this property

Selecting a Test Method

 Table 1 Test Description and Applicability

 Description

Applicability How Used “R&D evaluation”: characterization of

materials and evaluation of resultant package

“Compliance testing” : routine monitoring

• f adherence to specifications

Selecting a Test Method

Use of Design Guide F2097

 An extremely useful tool for:

 Ensuring the appropriate design and evaluation

considerations have been made

 Selecting the appropriate test methods

 Design and characterization  Ongoing compliance assurance

Reference to FDA Recognized Consensus Standards

 4. Significance and Use/4.2 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.

FDA Recognized Consensus Standards in F2097

Additional standards currently not in F2097 D903 Peel Strength of Adhesive Bonds D4332 Standard Practice for Conditioning F17 Terminology F2825 Standard Practice for Climatic Stress

Recognized FDA Standards

 Totally voluntary  What will this do for you?

 Minimize submissions data and documentation

(declaration of conformity to standards for premarket submissions)

 Tells the FDA reviewer or inspector that this

standard is acceptable to use

 Typically, eliminates test data submission

Must I use only recognized FDA standards?

 No…

If the standard is technically sound and is

better for your package or process, it is completely acceptable to use.

ISO 11607-1 Annex B (informative) lists

numerous standards that may be used for compliance, and many not recognized by the FDA.

EN / ISO 11607-1 Annex B

Table B.1 Test methods and their status*

* Note: ISO 11607-1

Admendment 1, which includes the new Table B.1, is currently at DIS status

http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfStandards/search.cfm

Click

ASTM F2097 in Summary:

 A compendium of test methods and

standards for flexible barrier packaging materials and packages

 A U.S. FDA Recognized Consensus

Standard

 A reliable guide for selecting which

standards to use based on applicability

Appendix

Helpful Links:

 ASTM International http://www.astm.org  FDA Medical Device Standards Program

www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/Standards/default.htm

 FDA Medical Device Standards Database

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfStandards/search.cfm

 ISO http://www.iso.org