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The First FDA compliant fully automated, self-contained
e-liquid compounding system.
System Operational Description
The production system is integrated with a flexible batch management system that provides a platform for automatic control and electronic record-keeping to comply with FDA regulations 21 CFR 210, 211, and 11. Proven products from Rockwell Automation provides the core of control and information management system. It provides the authorized operator with a secure tool for designing flexible recipes that combine operator-entered and automatic data collection into a single work flow. In-process weights are collected automatically and used to manage the flow of ingredients and finished products between storage and blending vessels. System components, including motors and automatic valves are sequenced according to the recipes’ logic. Data are stored in a relational database management system for long-term storage and reporting. PS&D supports the information technologies associated with the recipe management and data collection processes through secure cloud-based computing and network communications platforms.