ASTM F1306: Puncture Resistance Testing for Medical Device Packaging and Med. Device Integrity

ASTM F1306 slow-rate penetration fixtures for medical device packaging, showing a compliant puncture resistance fixture, defined probe geometry, and rigid specimen clamping for mounting on a universal testing machine to ensure accurate, repeatable puncture force measurements.

Slow Rate Penetration (Puncture Resistance) Testing of Medical Packaging

Medical device packaging plays a critical role in maintaining sterility, protecting devices during distribution, and ensuring patient safety. To verify both packaging and medical device integrity, industry standards such as ASTM F1306 are widely used to evaluate seal strength, burst resistance, creep behavior, and puncture resistance of sterile barrier systems (SBS). (Plastic films, laminates, wraps etc.)

These standards are commonly referenced during package design validation, process validation, and ongoing quality control, and are often reviewed during regulatory audits. Proper execution of these tests requires not only a compliant testing method, but also well-designed fixtures and a suitable universal testing machine to ensure repeatable, defensible results.

Universal Grip Company (UGC) provides a full solution including universal testing machines, ASTM F1306 standard burst and puncture fixtures, adapters, and application support, allowing medical facilities and or materials testing labs to run these tests confidently and compliantly.

Purpose of ASTM F1306

ASTM F1306 measures the force required to penetrate medical packaging materials using a controlled, slow-moving probe. The test simulates damage that may occur when packaging is exposed to sharp or concentrated loads during:

• Handling and assembly

• Shipping and distribution

• Storage and clinical use

The standard is particularly valuable for comparing relative puncture resistance between different materials, seal constructions, or packaging designs.

Materials Commonly Tested Using ASTM F1306

ASTM F1306 is commonly applied to flexible and semi-flexible packaging materials, including:

• Tyvek® and medical-grade papers

• Flexible polymer films

• Pouches and peelable packages

• Blister lidding materials

• Sterile barrier systems

Because these materials can be highly sensitive to test conditions, strict control of fixture alignment and test speed is essential.

Test Specimen Requirements and Preparation

Sample Quantity

While ASTM F1306 does not mandate a fixed sample count, typical laboratory practice includes:

• Minimum of 10 specimens per material or configuration

• Additional samples for comparative or validation studies

Specimen Conditioning

Specimens are typically conditioned according to laboratory SOPs or industry practices such as ISO 291, with controlled:

• Temperature

• Relative humidity

Environmental conditioning is critical, as flexible packaging materials can exhibit significant changes in puncture resistance based on moisture content and temperature.

Specimen Preparation Best Practices

• Ensure specimens are flat and free of wrinkles

• Avoid pre-damage, creases, or edge defects

• Maintain consistent specimen orientation

• Handle materials carefully to prevent pre-test weakening

Poor specimen preparation is one of the most common sources of test variability.

ASTM F1306 Test Fixture Requirements

Puncture Fixture Components

A compliant ASTM F1306 fixture typically consists of:

• A defined puncture probe (geometry specified in the test protocol)

• A rigid specimen clamping system

• Alignment guides to maintain axial loading

• A stable base to minimize fixture deflection

The fixture must securely restrain the specimen without introducing pre-stress or deformation.

Importance of Probe Geometry

Probe geometry directly influences measured puncture force. Common probe features include:

• Hemispherical or rounded probe tips

• Precisely controlled tip diameter and surface finish

Using worn or non-compliant probes can significantly affect test results and should be avoided.

Alignment and Fixture Stiffness

Accurate ASTM F1306 testing depends on:

• Coaxial alignment between probe and specimen

• High fixture stiffness to minimize compliance

• Uniform clamping pressure around the specimen

Off-axis loading or fixture deflection can artificially increase or decrease puncture force, reducing test repeatability and correlation between labs.

Universal Testing Machine Requirements

Load Capacity and Control

ASTM F1306 testing is typically performed on a universal testing machine equipped with:

• Load capacity commonly ranging from 100 N to 1 kN

• Closed-loop displacement control

• High-resolution force measurement

The machine must be capable of maintaining a constant, controlled crosshead speed throughout the test.

Crosshead Speed

ASTM F1306 specifies slow rate penetration, with common test speeds ranging from:

• 25 to 300 mm/min, depending on material and internal test protocol

Slower speeds improve resolution of the puncture event and reduce dynamic effects.

Data Collection and Test Results

Typical Data Outputs

• Maximum puncture force (N)

• Displacement at puncture

• Force–displacement curve

Some laboratories also calculate energy to puncture by integrating the force–displacement curve.

Failure Observation

Visual observation of the puncture event is critical for:

• Confirming true material penetration

• Identifying atypical failure behavior

• Supporting validation and audit documentation

High-quality fixtures help ensure that failure occurs in the intended test area.

Compliance, Validation, and Audit Considerations

ASTM F1306 is published and maintained by ASTM International and is commonly referenced in medical packaging validation programs.

To support audit readiness, laboratories should ensure:

• Fixture documentation and traceability

• Calibration of force and displacement measurement

• Consistent test procedures and operator training

While machine calibration is critical, fixture compliance and alignment are equally important for defensible results.

Common ASTM F1306 Testing Pitfalls

• Using generic puncture fixtures not designed for medical packaging

• Incorrect or worn probe geometry

• Inconsistent crosshead speed

• Poor specimen conditioning

• Fixture misalignment or insufficient stiffness

These issues can lead to misleading results and reduced confidence in validation data.

Complete ASTM F1306 Testing Solutions from Universal Grip Company

Universal Grip Company offers complete ASTM F1306 testing solutions, including:

• Universal testing machines optimized for medical packaging

• ASTM-compliant puncture resistance fixtures

• Precision puncture probes

• Application guidance and fixture selection support

By supplying both the testing machine and fixtures, Universal Grip ensures system compatibility, repeatability, and confidence in ASTM F1306 test results.

Conclusion

ASTM F1306 provides a reliable method for evaluating the puncture resistance of medical packaging materials under controlled, slow-rate penetration. When performed using a compliant fixture and a properly configured universal testing machine, the test delivers repeatable, defensible data that supports package design, validation, and regulatory compliance.

For laboratories seeking an integrated, audit-ready solution, Universal Grip Company provides everything required to perform ASTM F1306 testing — from the universal testing machine to the puncture fixtures — backed by technical expertise and application support.

Close up of the ASTM F1306 Probe and Film Securing Fixture