Particle release and surface characteristics of polyvinylchloride perfusional containers after steam sterilization

The loss of the plasticizer di(2-ethylhexyl) phthalate (DEHP) from the inner surface of polyvinylchloride (PVC) bags and the surface characteristics of the PVC containers after steam sterilization of bags filled with sterilized water for injectable preparations were studied. Particulate contamination level was obtained using the Coulter counter method. All the sterilized bags showed an acceptable particle number according to the limits established by several pharmacopoeias. These results were confirmed by gas chromatographic and mass spectroscopic (GC-MS) analyses in which low levels of DEHP ranging from 2.4 to 17.2 μg/l were measured. Surface characteristics were determined by atomic force microscopy. Limited changes in the inner surface of the PVC bags after steam sterilization were determined.