December 20, 2001 — SOUTHAMPTON, PA — Environmental Tectonics Corporation Sterilization Division has launched its One-Step sterilization and drying process (U.S. patent pending), which the company hopes will reduce production time, as well as cut product losses and related costs for pharmaceutical manufacturers.
Residual moisture is an ongoing problem for the pharmaceutical industry during the processing of bagged stoppers, caps, and line seals used in the production of parenteral drugs. This moisture problem is further exacerbated by the fact that items coming out of washers used during the cleaning phase are often wet when bagged prior to sterilization.
Moisture still remaining in the bags on completion of the sterilization cycle is unacceptable for release to production and, thus, dictates the use of expensive drying ovens to remove the moisture. Current processing technique requires that bagged items removed from the sterilizer on completion of a cycle be transferred to a dry heat oven for final drying — for an additional 8 to 12 hour period — before they may be used for production. Those processes also carry a significant risk of contamination or damage to product during such handling. Until now, conventional sterilization systems have not been successful in delivering useable product in a single process.
The proprietary approach developed by ETC now permits bagged stoppers, caps, and line seals to be sterilized and dried in one operation, without removal from the sterilizer — and without the use of a drying oven.