Test method for the microbial barrier properties of packaging for medical devices ; RIVM method
Testmethoden voor microbiele barriere van verpakkingsmateriaal
26 May 2012, PDF |
34 pages |
de Bruijn ACP, van Asten JAAM
RIVM Report 319011012
One of the most important qualities of packaging for medical devices is the ability to keep the contents sterile. The quality of the packaging is determined by the quality of the material and the quality of the seals. The former is usually tested with test methods using micro-organisms. In hospitals many packages are formed by wrapping instrument trays in sheet material. The seals are formed by folding the sheet material several times. There is however no standard test method available to test the quality of these kind of seals. The same problem occurs with container packaging system. The filters or valves can be tested with a microbial challenge, but not the complete unit. In 1990 the RIVM developed a physical test method. In contrast to existing testmethods, wich only test the barrier properties of a sample of the material, the RIVM method is capable of testing all aspects of a pack wich influence the barrier properties of the pack after the pack is formed, sealed and sterilized. The initial method was not very accurate and had a poor reproducibility. The method has now been modified. This study shows that the modified RIVM method is both accurate and reproducible.