Medical Device Validation generally follows the guidelines identified
in ISO 11607.
Use the links below to learn more about tests and procedures available
to simulate the effects of the potentially hazardous distribution
environment as well as integrity tests used to evaluate packaging
against your specific acceptance criteria.
Gross Leak Detection - ASTM F2096
Gross Leak Detection testing, also known as Bubble Testing, identifies
gross leaks as well as abnormalities in the pouch material through
the internal pressurization of a pouch or tray while it is submerged
under water. This method helps identify small leaks that are commonly
missed by the naked eye during visual inspections.
Sterile
Barrier
Dye Penetration - ASTM F1929
Dye Penetration allows the test engineer to identify very small
defects in the seals of a pouch or tray. Evidence of defects in
the seals is considered a potential breach of the sterile barrier
of the package system which can compromise the sterile integrity
of the package.
Seal Strength - ASTM F88
Seal Strength testing, also known as Peel Testing, measures the strength of seals within flexible barrier materials. This measurement can then be used to determine consistency within the seal, as well as evaluation of the opening force of the package system.
Seal Strength - ASTM F88
Accelerated Aging - ASTM F1980
Accelerated Aging testing is used to simulate the passage of time utilizing temperature and humidity inputs. Conducting aging studies will help to identify any environmental effects on the sterile integrity of the packages due to extended shelf life.
Accelerated Aging
- ASTM F1980
Use the links below to learn more about the different tests we can conduct to simulate the hazards of a potentially difficult product distribution cycle and the importance of these tests.
PDF Spec
Sheets
