Isolation Technology for Research and Development Applications: From Concept to Production

Abstract

A prototype parenteral manufacturing facility based on isolation technology was designed, constructed, and commissioned at Warner-Lambert Co., Morris Plains, NJ, with emphasis on its application to research and development (R&D) settings. The facility contains closed isolators for holding, transferring, and manufacturing sterile products. Vaporized hydrogen peroxide (VHP) was used for sanitization of the isolators. Various factors were evaluated to ensure complete distribution of VHP inside the isolators. VHP sanitization validation of the isolators was performed using chemical and biological indicators, and by swab testing the inside surfaces of the isolators. On the basis of these studies, operating conditions for routine VHP sanitization of the various isolators were established. Performance qualification of the manufacturing facility was conducted via media fills, which demonstrated sterile integrity of the manufacturing process. The media fills revealed certain deficiencies in handling procedures of filled product, which were subsequently corrected. The Warner-Lambert isolation technology-based parenteral facility proved to be a reliable and cost-effective alternative to standard clean room technology. The facility is ideally suited for manufacturing small batches. Closed isolator technology has its limitations when used for production-size batches involving automated processing.

Keywords:

• Isolation technology
• Validation
• VHP sanitization