ASTM F34-13(2023) PDF

Overview

ASTM F34-13(2023): Standard Practice for Construction of Test Cell for Liquid Extraction of Flexible Barrier Materials establishes procedures for constructing test cells used to extract and analyze components from flexible barrier materials, such as those used in food packaging. This internationally recognized standard is vital in evaluating the potential for leachable or extractable substances from packaging surfaces that come into contact with food, ensuring compliance with United States Federal Regulations and food safety requirements.

The standard supports regulatory submissions and quality assurance in the packaging industry by defining a practice for building extraction test cells. It specifically addresses test methods aligned with FDA regulations for determining extractables in flexible packaging materials, particularly when in contact with foods or food-simulating solvents.

Key Topics

• Test Cell Construction Guidance is provided for assembling a test cell using durable, non-contributory materials (commonly stainless steel and fluorocarbon gaskets), ensuring that the test apparatus does not itself release extractables that could affect results.

• Significance of Extractables Knowledge of extractives from flexible materials is critical for safety evaluation, especially in food contact applications. These data help determine the suitability of packaging materials for regulatory compliance and consumer safety.

• Regulatory Compliance This standard is directly cited in several key US FDA regulations, including 21CFR 176.170, 21CFR 177.1330, 21CFR 177.1360, and 21CFR 177.1670. In many situations, ASTM F34-13(2023) is the only approved method for extractable testing, making it essential for industry compliance.

• Test Method and Application The practice details the use of suitable extracting liquids-including foods and food simulating solvents-to obtain reliable data. The test cell allows a defined surface area of the flexible barrier material to be in contact with the extraction medium, facilitating gravimetric or other forms of analysis.

Applications

• Food Packaging Safety Assessment The primary application is in the food packaging industry, where materials such as multilayer films or coated papers must be tested for extractables when in contact with food. Ensuring minimal transfer of substances protects consumers and meets regulatory standards.

• Regulatory Submissions This standard is frequently referenced in premarket submissions to regulatory authorities such as the US FDA for food contact substances. Data generated with F34-compliant test cells is often required to demonstrate material safety.

• Research and Development Material scientists and packaging engineers use this standardized practice during R&D to compare the extractable profiles of various barrier materials under controlled conditions, supporting innovation in sustainable and safe packaging solutions.

• Alternate Test Cells The appendix highlights an alternative test cell design recognized by regulatory bodies, offering flexibility and potentially greater efficiency in some laboratory settings.

Related Standards

• ASTM D1193 Specification for Reagent Water, used in the cleaning and preparation of test cells.

• ASTM D4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell (note: not equivalent to F34 as it targets two-sided extraction for homogenous films).

• AOAC Official Method 964.15 Extraction protocol for flexible barrier materials, providing analytical methodology referenced within F34 procedures.

• FDA Guidance and Regulations Directly referenced regulations include various sections of 21 CFR and FDA guidance on premarket submissions for food contact materials, reflecting the broad regulatory acceptance of this practice.

Keywords: ASTM F34-13, liquid extraction, flexible barrier materials, test cell construction, food packaging safety, extractables, FDA food contact regulations, packaging compliance, gravimetric analysis, food simulating solvents