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Home Qualification Packaging Test
Laboratory - Shelf life studies - Microbiological swiss tests PDF Print

The shelf life study of packaging is more and more asked during product validation since the publication of the standard ISO11607, in 2006. The complete analysis of the life cycle of products has to be realized, and every element must be tested to guarantee the properties of the products.
The tests of shelf-life are separated into 2 parts:
- The environmental simulation of the parameters: the aim of this part is to demonstrate accelerated simulation of product lifetime, including environmental conditions (temperature, humidity, vibration, pressure) until the final use.
- The tests of resistances: it is a set of physical test which allows to identify the slightest defects which can appear during the product shelf-life

Simulation of the life of the product
Associations packaging / product are subjected to environmental requirements which simulate the conditions that products can meet during their life time.

Accelerated aging test: This simulation consists in subjecting products to a temperature and a humidity given during a defined time representing a real ageing of the product.

Test of transport: These tests contain a series of simulation which reproduce the constraints that products undergo during the transport manipulations: handling, transport, climate, storage.
Constraint of compression
Constraint of vibration
Constraint due to dropping
Thermal and hygrometric constraint (cold, warm, wet)
Various series can be applied according to the standards: ISTA, ASTM, and ISO..

Test of packaging
Further to the simulations of lifetime made on products, a series of test are made on packaging to conclude good condition of the packaging  protecting the product.

Test of resistance of packaging:
- The Resistance of the seals
This test is realized with a tensile machine. It verifies the good opening of the seal, its resistance in Newton during the opening and the exact dimension on which it reaches the requirements of resistance.
- Test of resistance under pressure (burst , creep)
These tests consist in injecting air under pressure into the packaging through a fine hole. The aim is to verify the pressure before it bursts and the time it can support this pressure.

Test of packaging integrity
- Integrity of the seal (dye penetration test)
This test allows verifying the integrity of the seal by the injection of a colored liquid.
- Integrity of packaging (bubble emission test)
This test is realized with a controlled system of air injected directly in the packaging. Then the packaging is placed under the water. This test allows the revelation of holes which can have been created during the manufacturing or the imperfections of packaging (porous or non-porous).
- Integrity of the sterile barrier (microbiological integrity test)
This test allows verifying the good resistance of the packaging to the penetration of germs.

 

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