Variety of Connections and Unlimited Licensing Aid Cancer Therapy

PROJECT SUMMARY:

This project involved using Ignition in the personalized medicine industry to handle multiple communication protocols in one 21 CFR Part 11-compliant environment. The same regulatory data integrity requirements exist in personalized medicine as in large-scale productions and Ignition has proven to be a valuable tool because of its flexibility, mobility, and above all — device integration.

PROBLEM:

The industry of personalized medicine faces challenges as lab equipment is brought into commercial manufacturing. The equipment consists largely of closed systems that process individual (patient) batches and generate a large amount of GMP data. The equipment is unlike traditional industrial automation equipment, posing a challenge to many different communication capabilities and protocols. The same regulatory requirements, such as 21 CFR Part 11, in large-scale productions persist in personalized medicine, in that data collection and integrity are required for commercialization of the product. Ignition has proven to be a valuable tool with its flexibility, mobility, and above all — device integration — that will serve this industry well.

SOLUTION:

Barry-Wehmiller Design Group chose Ignition because it required a software that could handle multiple communication protocols such as MQTT, OPC UA, and Web Services, all in one environment. Ignition allows users to use portable devices like tablets and laptops, and embedded wall-mounted monitors with web browsers to visualize and interact with the application in clean rooms where traditional HMIs are not ideal because they are difficult to clean and comparatively large. Simple, intuitive screens provide a constant overview of processes, as any minor disruption in an operation can cause a batch to be discarded in cell and gene therapy manufacturing. 

Licensing costs were also a major consideration in choosing Ignition over dedicated software designed to perform a single activity, which often have high licensing prices. This level of flexibility allowed Barry-Wehmiller Design Group to develop custom dashboards for each room, along with floor-plan screens that mirror real-world layouts.

Also, Ignition allows for easy integration of a sitewide Active Directory, which directly helps to ensure secure user access to the Ignition application, by maintaining the policies and requirements (such as password requirements, account lockouts, etc.) defined within the Active Directory. Also, Ignition provides a robust audit trail feature which is very important for 21 CFR Part 11 compliance. In addition, the Ignition application was easily validated during IOQ. All of these items help to ensure Barry-Wehmiller Design Group meets and maintains compliance with 21 CFR Part 11.

RESULTS:

Ignition’s ability to work with a variety of technologies was of utmost importance. This was a key factor, because there are so many different types of equipment. The industry is fairly new, and many companies are still developing their processes, and these processes are established in hospitals and universities across the globe. Depending on where a company begins this journey will determine what process equipment it ultimately ends up using in its commercial manufacturing facilities. Ignition’s “multilingual” capabilities made a significant difference in this regard.

The purpose of 21 CFR Part 11 regulations is to ensure that electronic records (and signatures) can be trusted as much as paper records and ink signatures. Cell and gene therapy processes generate many electronic records that are used for regulated purposes and are therefore subject to the regulations. The equipment used in the process, and in-scope of the Ignition PCS, do not utilize electronic signatures, so we are focused on the electronic records, i.e., information in a digital form that is created or used in some way by a computer system. Our Ignition PCS satisfies a few aspects of the regulations pertaining to rendering records, document storage and record retention, system access, authority checks, and audit trails.

DEPLOY DATE: November 2021