Meeting 21CFR 11 Standards for Pharma

Bachem Americas, a pharmaceutical company, designed and built a new cleavage unit for its chemical process at its Vista, Calif. facility. Inductive Automation’s Ignition software was used as a uniform HMI for the cleavage unit control system to provide fast and reliable access for monitoring data and sending commands securely.

Problem:
Process equipment for the cleavage unit includes chemical reactors, pumps, a filter dryer, and heating cooling skids. The new cleavage unit control system needed to be in a NFPA Class 1 Dev.2 environment. Bachem has implemented a similar system in Bubendorf, Switzerland, with a Siemens control system and HMI. For this new system in the United States, Bachem was seeking a local solution that can be flexible enough to cover the system’s functional specification and be reliable enough to fulfil the 21CFR 11 compliance features for the Food and Drug Administration.

Solution:
Bachem reached out to Wunderlich-Malec Engineering to provide a control system solution for this project. After reviewing the 21CFR 11 standards and evaluating the requested functions in regard to logging capabilities, domain security, expandability, and ease of installation, Wunderlich-Malec recommended Ignition in a virtualized single gateway. The new Ignition Gateway provided a uniform HMI application across the cleavage system. Touchscreen PC panels used the client of the Ignition Gateway to act as local HMI panels. The main operator terminal for this project was located inside an explosion-proof area. A central database machine located in the heart of the enterprise network tied to the Ignition Gateway to store all the required process history tags and historical alarms securely. This solution left many options for Bachem for future implementation and custom HMI screens that represent the actual process in the cleavage room. Wunderlich-Malec also developed a simulated environment along with a PLC simulator for conducting the software acceptance test prior to actual installation of the system.

Result:
Due to a tight schedule for the validation and commissioning of the control system, the Ignition UDTs and templates were a big help to accomplish the project deadline. Because most of the functions were tested in a simulated HMI environment, the execution of validation documents went smoother than expected with a new standard of quality.

Some key benefits:

• Keep track of all the production activities through the audit trail and guarantee the reliability of the records by putting them into a store-and-forward engine
• Maximizing situational awareness by implementing sequence steps and process overview screens using Ignition’s powerful Vision Module and Python scripts
• Coherence of PLC codes and HMI application in addition to standard naming convention by replicating PLC function blocks into tag UDTs and graphic templates
• Reliable application archival by documenting changes through the Ignition designer versioning
• Secure user access to production with single authentication (same as enterprise credentials) and eliminating confusion on multiple users by using Active Directory users and domain groups for HMI

By implementing the Ignition platform in this project, Wunderlich-Malec met Bachem’s requirements — and also opened a wide variety of ideas for future expansions and improvements.