Comparison of different rubber stoppers; the effect of sterilization on the number of particles released.
The effect of sterilization on the number of particles released from five different types of rubber stoppers, as well as on their surface roughness and elemental composition before and after sterilization is described. The stoppers were immersed in 200 ml of 0.9% sodium chloride solution in conical flasks. The number of particles released into the sodium chloride solution was measured by Coulter Counter. The surface roughness and the elemental composition of the stoppers were determined by SEM/EDX. All measurements were made both before and after sterilization at 121 degrees C to F0 15 mins. The number of particles released from a stopper during sterilization varies considerably between different stoppers and even between different batches of the same stopper. The only non-siliconized stopper in this study performed well. The absence of surface siliconization may have contributed to this performance. The scanning electron micrographs revealed well the differences in the surface roughness of the stoppers. The sterilization generally increases the surface roughness of the samples. The x-ray microanalysis revealed that the elemental composition of the stoppers may vary not only between different types of stoppers but also between different batches of the same stopper.
Mannermaa
J P
JP
Orion Corporation Farmos, Oulu, Finland.
Muttonen
E
E
Yliruusi
J
J
Juppo
A
A
D004349:Drug Packaging; D008855:Microscopy, Electron, Scanning; D012408:Rubber; D013242:Sterilization
D012408:Rubber