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Packaging Testing For Medical Devices

Divya Ganapathy

Technical Consultant (Medical Device Regulatory Affairs),

UL India Pvt. Ltd., Bangalore


Medical Device Packaging is highly regulated and must meet the standard requirement. Historically devices have been tested for degradation by accelerated aging and other various material characteristics. Packaging testing is measuring the characteristics and property of packing material. Most precarious factor is the sterility which should be maintained through the distribution and storage. Packaging must comply with ISO 11607 and EN 868-1, in order to satisfy European regulations and obtain a CE Mark. Testing a new packaging design before full scale manufacturing can save time and money. Many manufacture conduct packaging testing in-house or through third party lab (ISO/IEC 17025 accredited) which is accredited and certified (ISTA certified, ISO 17025). The testing is vital to ensure integrity of the package’s seal.

Medical Device Stability

The general factors that influence the product stability are physical, chemical, microbiological and toxicological. Most of the manufacturer conducts the testing at different phases of product life cycle like product design stage, product launch, and new package design, resolve package damage issue and sometimes based on client requirement.

Regulations And Standards For Packaging Testing

Packaging testing guidelines are listed in ISO 11607 describing the available ASTM packaging tests. The key aspects of packaging validation are material qualification, seal validation process and whole package seal integrity. Physical tests like burst, peal, creep and leak tests are performed as per ASTM standards. ISO 11607 require both accelerated and real time to be performed simultaneously. The key areas to be focused in the packaging are stability, performance, package integrity and strength testing (Figure 1).

Package Integrity Test

Depending on package design, a variety of package integrity testing methods may be employed. This is to ensure the integrity of package seal and system. Visual inspection, peel strength, burst strength, creeps and bubble emission test are some of the package integrity test. During the study conduct deformities break or crack, blister can be observed (Figure 2).

Figure 2: Deformities from visual inspection

Figure 3: Burst test (ASTM F1140)

Seal strength test is conducted through a simple burst and / or creep test where packages are pressurized and evaluated for the rupture pressure points and time of failure. It is conducted to measure the ability of package seal to resist separation. Burst and creep testing entails pressurizing the inside of the package and measuring the pressure required to either cause seals to separate or packaging materials to rupture. Some packages use porous materials, allowing the contents to be gas sterilized through the porous package walls after the package has been sealed; burst testing of these packages can require higher inflow capability in order to achieve sufficient pressure to challenge the package.


Figure 4: Dye penetration

Dye penetration test is conducted to detect the presence of any leakage in the seal, (Figure 4). This test method is limited to porus material which can retain the dye penetrant solution and prevent it from discoloring the seal for 5 seconds. The study can be conducted through different methods like injection, edge dip and eye dropper.


Bubble test as per ASTM F2096 standard is conducted by visually inspecting for bubble streams caused due to affect in the packaging while it is submerged in water. This destructive testing provides a practical way to examine packages for gross leaks, which may render the product non-sterile. This test may apply to very large or long packages, which do not fit into any other package integrity test method apparatus.


Figure 5: Bubble Test

Peel Testing is performed in accordance with ASTM F88 and EN 868-5 Standard Method for Seal Strength of Flexible Barrier Materials. The test results are not only related to package integrity, but also to measuring the packaging processes’ ability to produce consistent seals. Given that seal strength is a necessary requirement for packaging, Peel Tests are ubiquitous for all types of packaging.

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