Medical Package Testing: Bubble Emission Testing
Bubble emission testing is an important part of a package validation within Life Science Outsourcing’s medical package testing services.
Reliable Package Integrity Testing
to Protect Your Medical Devices
Bubble emission testing ensures medical device packaging remains sterile and intact until it reaches the end user. At LSO, our FDA-registered, ISO 13485-certified facility provides fast, accurate, and compliant leak detection as part of our comprehensive medical package testing services. Whether you're a startup validating a new design or a large OEM ensuring compliance at scale, our expertise helps you meet ASTM F2096 and ISO 11607 standards, reduce risks, and accelerate time to market.
What is bubble emission testing for medical device packaging?
Medical package testing methods may involve bubble emission testing, which is a non-destructive method used to detect leaks in packaging. It is an important part of the testing process, as it:
- Ensures sterility
- Maintains product integrity
- Examines the whole package for gross leaks such as pin-holes, voids, and channels.
- Meets compliance requirements
Who needs bubble emission testing?
Bubble emission testing is often used by medical device manufacturers to ensure their products are safe and sterile until they reach the end user. Pharmaceutical companies also use it to test packaging integrity for pharmaceutical drugs and medical products.
How does bubble emission testing work?
Bubble emission testing is performed in three steps:
- Preparation
The medical package is submerged in a liquid, which is most often water. - Pressurization
Pressure is applied to the submerged package to simulate conditions that could cause leaks. - Observation
The package is observed for any bubbles that form and rise to the surface. The presence of bubbles indicates a leak.
What standards apply?
Bubble emission testing is often part of the regulatory requirements for medical device packaging.
ASTM F2096 is the standard that is typically used for sterile barrier systems.
ISO 11607 is the international standard with specified requirements for packaging systems for terminally sterilized medical devices, including packaging integrity.
Why LSO?
As an FDA-registered and ISO 13485-certified contract manufacturing organization, Life Science Outsourcing (LSO) offers assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.
Full EtO Validation
Comprehensive packages for regulatory compliance.
Flexible Sterilization Cycles
From fractional to full cycles with EtO residual testing.
Robust Qualification
Secure with 2X qualification.
Choice of PCDs
Tailored to your sterilization needs.
