Ensure medical packaging integrity with ASTM D3078 testing from the Applied Technical Services Family of Companies (ATS FoC). The medical industry requires that hermetically sealed packaging, which includes pouches, sachets, and containers, protect sensitive products, such as instruments, implants, and drugs. We offer ASTM D3078 testing to ensure client packaging keeps encased products sterile, protected, and preserved.
ASTM D3078 is a pass/fail test for detecting gross leaks in flexible medical packaging. The bubble emission test procedure supports the qualitative analysis of the product’s design. Manufacturers may use the results to evaluate the design’s materials, headspace gas, and appropriateness for the intended contents.
The Importance of Packaging Integrity
The journey from manufacturer to user entails risks to package integrity and sterility. Rough handling, shipping, and storage can compromise package integrity when you need it the most. Three common causes of package leaks include material weakness, external forces, or punctures originating from the package contents themselves.
If medical packaging does not meet standards, external gases, liquids, and microbes may infiltrate the package seal, contaminating the contents. A surgeon unknowingly using a contaminated instrument risks introducing harmful microbes to a patient. Additionally, the package’s contents may spill out, contaminating their surroundings and potentially damaging an entire container of devices.
Leaks in medical packaging can have a far-reaching impact on manufacturers, healthcare providers, and end-users:
- Wasted resources for the manufacturer and clients
- Delayed medical procedures and subsequent loss of income
- Safety hazard to patients and end-users
- Lost reputation and quality
- Legal and regulatory consequences
Our Leak Testing Services
We perform leak testing services in an ISO/IEC 17025-accredited lab. During the procedure, an expert submerges the medical package in fluid and then applies a vacuum level according to your specifications.
Our experts detect leaks in two ways:
- The package emits a stream of bubbles when submerged in the test liquid
- The package retains the test fluid when removed from the chamber
We summarize our analysis and test data in a comprehensive report. Because we can either adhere strictly to the ASTM D3078 standard or tailor the method to your needs, final reporting will note any deviations from the standard procedure.
Related Medical Device and Packaging Services
ASTM D3078 yields a qualitative analysis of package integrity, not a quantitative measure of leak size. You may require additional testing from the wider ATS Family of Companies to complete your understanding of the packaging’s integrity and leak attributes. Our experts perform a wide range of medical device and packaging testing, including:
- ASTM F1929 – Dye Penetration Test for Seal Leaks
- ASTM F88 – Seal Strength Testing of Flexible Barrier Materials
- ASTM D4332 – Environmentally Conditioning Packaging for Testing
- ASTM D642 – Compressive Strength of Shipping Containers
- ISO 11607 – Packaging for Terminally Sterilized Medical Devices
- Extractables and Leachables Testing
About the ATS Family of Companies
ATS delivers premier testing, inspection, and certification (TIC) services for national and international clients. The Family of Companies (FoC) is a collection of TIC firms with a shared goal of safety and reliability. Our staff of professional engineers, chemists, and technicians provides high-quality customer service through quick turnaround rates, accurate findings, and comprehensive reporting.
Our labs are ISO/IEC 17025 accredited in mechanical and chemical testing procedures through accreditation organizations such as A2LA. We employ an ISO 9001:2015-compliant Quality Management System across the organization to ensure consistent service quality and optimized performance.
Contact Us
You can request ASTM D3078 testing through the webform on this page or over the phone.
Call +1 (888) 287-5227 to speak with a representative about any questions you may have. Our experts will gladly explain our capabilities and procedures.
