Seal strength Testing is commonly utilized in the medical device industry to ensure that the seals on pouches and trays meet their minimum and maximum strength requirements.
Why Would You Use ASTM F88?
You would use ASTM F88 test results to demonstrate conformance with ISO 11607-1 Sections 5.1.8 Subsection c and 5.1.9 Subsection c.
Seal Strength Test Purposes
Package Integrity: A seal strength test aims to quantitatively evaluate the product package seal. Product packaging systems must ensure a minimum and sometimes a maximum seal strength to allow a proper aseptic transfer into the sterile field.
Manufacturing Process Control: Manufacturers use the test to confirm the consistent production of high-quality seals, which is essential for process validation and control.
Quality Assurance: ASTM F88 testing provides data for quality control and process monitoring to ensure seals maintain their integrity throughout the product’s lifecycle, including sterilization, transport, storage, and usage.
Why Seal Strength Matters
Demonstrate Conformity to ISO 11607-1: Ensures the safety, effectiveness, and marketability of medical devices.
Process Validation: The Seal Peel Test provides a quantitative measure essential for process validation, capability, and control.
Seal Strength & Package Integrity: It evaluates both the seal opening force and package integrity, which are critical for maintaining sterility.
Balanced Seal Strength: Achieving a minimum seal strength is crucial for the package to perform its function, and in some cases, an upper limit ensures ease of opening.
What Does ASTM F88 Measure?
The ASTM F88 standard provides two measurements:
1. Average Seal Strength is the average force required to separate a flexible material from a rigid one or two flexible materials from each other.
2. Maximum Seal Strength is the maximum force required to separate a flexible material from a rigid one or two flexible materials from each other.
Three Techniques for Seal Strength Testing per ASTM F88/F88M
1. Technique A: Tails are clamped in opposing grips; the seal remains unsupported.
2. Technique B: Tails are supported in opposing grips; seal hand-supported at a 90-degree angle.
3. Technique C: The least flexible tail is held flat with an alignment plate; the more flexible tail is brought 180 degrees over the seal and secured in an opposing grip. In 2023, Technique C was updated to include an Alternate Approach without an Alignment Plate. This is typically used for flexible to intact rigid or semi-rigid structures such as trays.
What is ASTM F88/F88M?
The “M in ASTM F88M designates the metric version, meaning that the standard includes both the Imperial (inch-pound) and Metric (SI) units. The values stated in SI or inch-pound units should be regarded separately.
Why Choose WESTPAK for Seal Strength Testing?
Accredited Testing: The A2LA accredited our testing to ISO 17025, and our laboratories are certified by the ISTA.
Commitment to Quality: By choosing WESTPAK for your Seal Strength testing, you ensure that your medical packages meet the highest standards of package integrity.
Trust WESTPAK to help maintain the conformity, safety, and efficacy of your products.