Inhalable Insulin Manufacturing Facility
MannKind Corp – Danbury, CT
A manufacturer of a new inhalable product hired ACC to provide a Process Automation System (PAS) for a new manufacturing facility.
 
The process included prep and hold tanks, formulation, lyophilization, and filtration along with typical process utilities (CIP, WFI, etc). The PAS also monitored critical GMP environmental systems. In addition, ACC was contracted to coordinate the various OEMs providing skids to this facility. Overall I/O count for the PAS was approximately 1,200 and included a combination of Rack I/O, DeviceNet and Fieldbus.


The system was architected around the suite of Rockwell Automation FactoryTalk and Logix family products.  Eight ControlLogix PLCs handled process control and alarm detection.  HMI was provided by redundant FactoryTalk ViewSE servers with ten clients located throughout the facility.  FactoryTalk Historian was the repository for process data; FactoryTalk Asset Centre provided change control and storage for all control and HMI software.

ACC also developed batch reporting applications utilizing Microsoft SQL reporting services.  The SQL database also served as the repository for the Part 11 compliant audit trail.
This manufacturing facility subsequently became the recipient of two ISPE (International Society of Pharmaceutical Engineering) Facility of the Year awards.

ACC’s deliverables spanned the entire project life cycle, including functional specifications, hardware and software design, implementation, FAT, Commissioning, SAT and validation support.