Burst Testing
Burst testing serves as a fundamental quality assessment for sterile barrier systems, flexible pouches, and rigid medical device packaging, verifying their ability to maintain integrity under internal pressure. This essential evaluation method replicates critical scenarios where packaging may encounter mechanical stresses during distribution, storage, or clinical handling, enabling manufacturers to identify potential failure points in seal integrity and material robustness. For medical device manufacturers, conducting burst testing is not merely a quality control measure but a regulatory imperative, as it directly supports compliance with ISO 11607, ASTM standards, and FDA 21 CFR Part 820 requirements. By rigorously testing package performance, manufacturers can mitigate the risk of barrier breaches, ensure maintenance of sterility, and prevent product contamination, thereby upholding the highest standards of patient safety and meeting global regulatory expectations for medical device packaging.
Our Service
At Meditronics (a brand of STEMart), we perform precise and reliable burst testing in accordance with ASTM F1140, ASTM F2054, and ISO 11607, ensuring medical device packaging meets industry benchmarks for strength and performance.
1. Sample Preparation
For porous packages, tape is applied to porous surfaces to control air escape and simulate real-world conditions.
2. Testing Setup
The prepared package is placed in the testing machine, and a probe is inserted through a designated port to allow controlled inflation.
3. Pressure Application
The machine gradually increases internal pressure at a specified flow rate until the package bursts.
4. Data Recording and Analysis
The exact burst pressure (in kPa or psi) is measured and documented. The location and mode of failure (e.g., seal rupture, material tear) are recorded to assess weak points in the packaging design.
Why Choose Meditronics?
Meditronics has established itself as a premier testing partner for medical device packaging, bringing unparalleled expertise in burst strength evaluation to the industry. Our comprehensive service offering delivers significant value through:
✔ Tailored Testing Solutions
We develop customized testing protocols that precisely align with your unique packaging configurations, sterilization processes, and compliance needs across global markets including FDA, EU MDR, and ISO regulatory frameworks.
✔ Cutting-Edge Testing Infrastructure
Our laboratory is equipped with the latest generation of high-precision burst testing instrumentation, ensuring measurement accuracy and repeatability that meets the most stringent quality standards.
✔ Streamlined Testing Process
We combine rapid turnaround times with detailed, actionable reporting that includes clear pass/fail determinations and comprehensive data analysis to support your quality decision-making.
Through our partnership approach, medical device manufacturers benefit from:
- Enhanced confidence in packaging system performance
- Guaranteed compliance with international standards
- Reduced time-to-market for new products
- Optimized packaging designs through data-driven insights
To explore how our burst testing services can support your packaging validation needs, we invite you to contact our testing specialists for a personalized consultation.
Online Inquiry
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Need More Information or Request A Quotation?
Related Links
