Mammalian Cell Culture Fast Track Project
Fast track project comprised of cell culture trains, cell separation, purification, buffer and media mix areas, water systems, kill and pH neutralization systems, CIP systems, environmental monitoring systems, and utilities. Total systems comprised of ~80 processor nodes and ~25 HMI nodes. Security system and utility monitoring segregated from process automation (process and utility alarms repeated to security during off-hours.)
Batch records produced based on acceptance criteria provided.
Responsible for commissioning, loop tuning, validation and initial startup. Our engineers wrote all FAT, and validation protocols, and executed protocols on site. In addition, our engineers provided construction managers support for the duration of the project.
|Type of Project:||Automation|
Systems complete and first three validation production runs underway within 14 months of project inception. No batches lost in 5 years of operation.