(452f) Cyber-Physical Security of Advanced Automated Continuous Pharmaceutical Manufacturing Pilot-Plant

Currently, Industry 4.0 concepts are being applied to pharma industry to achieve Pharma 4.0 paradigm. It introduces cyber-physical systems that enable the computerization of pharmaceutical manufacturing. Advanced control, automation, advanced analytics, big data, cloud computing, and internet of things (IoT) are some of the terms commonly referred within Pharma 4.0. It has many advantages but also have bigger challenges on the cyber-physical security side. Over the years, there have been many expensive and notorious incidents in other industry that have prompted the necessity of improved cyber security system. Stuxnet, Duqu, Flame and Shamoon were malware specifically designed to target Industrial Control Systems (ICS) and cause physical damage to the equipment, and inhibit processes from executing normally. Today, process manufacturing in general and the pharmaceutical industry in particular are seeing increasing numbers of cyber security threats. To protect themselves, companies have to change the way they operate by addressing cyber security threats and designing appropriate defenses. Pharmaceutical companies have to recognize their high visibility and attractiveness as targets. They must work to understand cyber security concepts, identify weak points and implement appropriate security measures [1]. Therefore, the cyber security of pharmaceutical manufacturing is highly desired not only economical point of view but also for patient safety perspectives.

The continuous pharmaceutical manufacturing (CM) is one of the most suitable platforms to implement Pharma 4.0 concepts. There are several advantages but also different scientific challenges in implementation and protection of CM [2]. One of the current major challenges for the continuous manufacturing is to protect it from any cyber-physical attack since it has more exposure to system and outside word.

In this work, the cyber security aspects of continuous pharmaceutical manufacturing process have been systematically investigated. The CM pilot-plant is controlled via industry standard control platform. A systematic framework including the methods and tools have been developed for proactive identification and mitigation of potential cyber-physical attacks on CM. A Scalence X208 industrial Ethernet switch (Siemens) has been integrated with the plant so that the network traffic data can be collected. The cyber security relevant software tools such as Snap 7, Wireshark, and Tripwire have been integrated with the CM. The Snap 7 is used to monitor the data blocks to and from the PLC. Wireshark is used for packet sniffing purposes, and the Tripwire is used for the file integrity monitoring. The security data collected from these tools together with the process data collected through HMI (human machine interface) have been utilized to show the behaviors of the system both during normal operation as well as during a simulated attack. Additionally, this work was also focused on distinguishing the malicious attempts from common machine and physical failure.

The objective of this presentation is two folds. First to highlight the developed systematic cyber-security framework and second to demonstrate its application for the cyber-physical security of continuous pharmaceutical manufacturing pilot-plant.

References

1. Lee, C. H. (2018). Boosting Cybersecurity in Pharma. Pharma manufacturing magazine. https://www.pharmamanufacturing.com/articles/2018/boosting-cybersecurity-in-pharma/
2. Bhaskar, A., Barros, F. N., Singh, R. (2017). Development and implementation of an advanced model predictive control system into continuous pharmaceutical tablet compaction process. International Journal of Pharmaceutics, 534 (1-2), 159-178. https://doi.org/10.1016/j.ijpharm.2017.10.003.