PT  - JOURNAL ARTICLE
AU  - Degrazio, Fran L.
AU  - Hlobik, Tibor
AU  - Vaughan, Stacey
TI  - Silicone Absorption of Elastomeric Closures—An Accelerated Study
DP  - 1998 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 19--22
VI  - 52
IP  - 1
4099  - http://journal.pda.org/content/52/1/19.short
4100  - http://journal.pda.org/content/52/1/19.full
SO  - PDA J Pharm Sci Technol1998 Jan 01; 52
AB  - There is a trend in the parenteral industry to move from the use of elastomeric closures which are washed, siliconized, dried and sterilized in-house at the pharmaceutical manufacturers' site to pre-prepared closures purchased from the closure supplier. This preparation can consist of washing to reduce particle-load and bioburden, siliconization, placement in ready-to-sterilize bags and may eventually extend to sterilization by steam autoclave or gamma irradiation. Since silicone oil lubrication is critical to the processability/machinability of closures, research was designed to investigate this phenomenon in closures prepared using the Westart® RS (Ready-to-Sterilize) process. This paper presents the data gathered in a study of the characteristic of silicone absorption into elastomeric closures under accelerated conditions. Variables such as silicone viscosity, rubber formulation, effect of sterilization and others are considered.