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A New Paradigm for Achieving Regulatory Compliance in Life Sciences

April 10, 2014
Technology advances make it easier for pharmaceutical companies and other life sciences firms to migrate to a single platform for building management, process automation and environmental monitoring. This eases validation efforts, improves time to market and more. Brought to you by Rockwell Automation.

To comply with Food and Drug Administration (FDA) regulations, facilities operating in industries such as pharmaceutical and biotechnology must meet specific requirements related to assuring the identity, strength, quality and purity of goods manufactured. Maintaining tight tolerances over environmental conditions such as temperature, pressure and relative humidity is a key part of providing this assurance. In addition, FDA regulations such as 21 CRF Part 11 require this data to be complete, accurate, secure and retrievable.

These requirements give rise to a more robust approach for the management and control of environmental parameters that directly affect product quality.

Traditionally, facilities that operate within regulated environments have relied upon some combination of various disparate automation systems, stand-alone chart recorders, or manual data recording to manage critical environmental data. Typically, the building automation system that monitors building conditions and the manufacturing automation system that controls the facility’s equipment use automation systems manufactured by different vendors. However, life sciences firms increasingly are finding it inefficient and costly to maintain and support multiple systems, especially given cuts to many engineering departments that have resulted from lean initiatives.

Technology advances, including advances in industrial Ethernet, virtualized application servers, and scalable architectures have made it easier to migrate to a single platform for building management, process automation and environmental monitoring. Merging these functions into a unified solution creates a paradigm shift that will ease validation efforts, improve product quality, reduce total cost of ownership and improve time to market. These technologies also help users reduce both the risk of failure and the impact of failures on facility operations and data.

Commercial Doesn’t Always Cut It

A commercial building automation system (BAS), also known as a DDC control system, has historically been a popular option for life sciences firms facing the need for regulatory compliant environmental control. In many cases, these commercial BAS solutions were designed originally for a traditional building environment focused on personnel comfort, which requires only a basic level of control.

These systems typically aren’t capable of controlling to the tight tolerances for environmental factors required by industry. While some organizations might be drawn to the lower up-front costs these commercial BAS systems offer at face value, a number of factors ultimately increase the total cost of ownership:

• System Longevity. A commercial BAS often needs to be replaced or upgraded after seven to eight years, an exercise which adds cost and requires revalidation.

• Unexpected Failure. Commercial systems aren’t designed for validated manufacturing environments, and tend to be less robust than industrial platforms. As a result, they might experience more unexpected failures, which can lead to downtime. A commercial offering, for example, might not offer the same component meantime between failure (MTBF) rates or redundant server, networking and controller topologies to prevent a single point of failure from causing the loss of data.

• Less Reliable System Data. Because traditional systems aren’t based on high-reliability platforms that use virtualization technology to meet requirements, reliability issues might exist. An inability to track these direct impact parameters in adverse conditions can lead to costly waste. In some systems, transactions between disparate information sources can lead to problems with data integrity, such as when a proprietary archiving mechanism fails to provide easy access to the level of event tracking and reporting needed. 

Selecting a Unified System

Historically, it has been common to install and maintain a system to control building environments and a separate system to monitor building environments. The driver behind this strategy is to limit the scope of validation to be only applicable to the building monitoring system. After considering process/equipment control systems, it’s typical for a pharmaceutical facility to have three systems deployed in maintaining their day-to-day operations.

The move toward using standard Ethernet networks on the plant floor and for business systems is making it technologically easier to standardize platforms across the enterprise. One way life sciences organizations are reducing the number of disparate systems they must support is by extending their existing process automation platform to include environmental monitoring requirements.

In addition, some companies are finding that the difference in the amount of effort to commission versus validate the environmental control system isn’t sufficient to justify the cost of the additional infrastructure for a stand-alone system.

A unified plantwide solution offers closed-loop control and monitoring of the entire HVAC system, including temperature, pressure, humidity, door status and particle counts, and control and monitoring of the all process/equipment operations. Using this approach, the same functionality applied to process-control system validation is used to meet validation requirements for building automation.

Issues such as event historization, data security and reporting become much easier — the plant historian, for example can now provide secure, auditable data. Electronic batch reporting (EBR) can include environmental data properly time sequenced with conditions occurring during production for accurate reports.

Another benefit of a unified approach is the reliability provided by the robust hardware architecture that is native to this industrial solution. Redundant server, networking and controller topologies help ensure there is no single point of failure in the system. Higher quality components offer greater MTBFs and tend to result in a longer product life cycle.

Reducing the number of platforms by leveraging existing process automation system investments isn’t only more efficient; it also makes it easier and less expensive to compile necessary compliance documentation when all data is captured in one system A unified plantwide solution takes advantage of a common approach to engineering and standard documentation.

Common validation documentation covers both building automation and process automation equipment, and users receive documentation that has already been developed and published — a robust set of Good Automated Manufacturing Practices (GAMP) documents is provided to support the validation process and speed time to market.

Streamlining systems to use a single platform across both process and building automation systems offers numerous benefits:

• Lower Total Cost of Ownership. Using existing process automation investments and maintaining a single platform across the enterprise requires less training, fewer spares and lower support costs.

• Increased Connectivity. Because the unified plantwide system uses the same platform as the process automation system, it’s easier to tie critical data together to help achieve plantwide optimization goals.

• Reduced Time to Launch Costs. Relying on a single platform allows the manufacturer to execute projects more efficiently, so projects can get to market — and generate revenue — more quickly.

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4 Considerations for Implementing a Unified Plantwide System

When it comes to implementing a unified plantwide BAS, not all vendors are created equal. Consider a few key areas when selecting a vendor that will deliver an effective solution:

• Global Deployment. Organizations operating in multiple geographies need a vendor capable of deploying a standard solution across different facilities around the world.

• Understanding Standards. Vendors should have the ability to implement standard solutions using standard methodologies, or define requirements and implement a system that is custom developed on a per-project basis to specific customer requirements. It’s important the vendor understands global regulations and can implement systems that comply with local regulatory requirements regardless of which path is chosen. 

• Local Support. As the vendor implements a solution in multiple geographies, it’s valuable to have local support from the region where the solution is being deployed. Employing local people to develop the application can help ensure language, customs and local requirements are addressed, and saves on travel costs associated with the use of bringing in people from remote locations.

• Standardized Code. The vendor should use a standard library of pretested code, written specifically for the industry. This practice provides consistency across projects and helps speed deployments, while reducing errors.

Learn more about Rockwell Automation Life Sciences Solutions.

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