TABLE OF CONTENTS This is a case study of a batch manufacturing operations strategy implemented at a large-scale, multi-product, multi-train biotechnology fermentation and product recovery facility. The batch management automation of this plant consists of recipe and lot number assignment, recipe scheduling and execution, material control and tracking, collection of equipment and process information, operator actions, batch product and equipment reports.
Equipments are organized in units as defined by the process model, and are automated through phases and corresponding control modules. Equipment resources are acquired and released by the recipe with equipment status clean, dirty, in-process, etc. which are set or changed by recipe or phase execution. Manufacturing and product quality assurance is accomplished with help of the batch control system online batch report inspections and the escalation of anomalies for subsequent resolving of incidents.
ABC Biotech is a leading biotechnology company using human genetic information to discover, develop, manufacture and market pharmaceuticals that address significant unmet medical needs. ABC Biotech started work for a new pharmaceutical manufacturing campus in early 1990s with the development of manufacturing requirements and the search for a suitable plant site. The selected site-A is about 100 km from ABC Biotech head office. The manufacturing facility is designed for large-scale, cell culture fermentation and recovery production. It has the capability and flexibility to produce approved products, as well as products which are in the product development pipeline. A product for breast cancer approved by the FDA is manufactured at...
