Life-science companies struggle to reduce their products’ total cost of quality (TCQ) and maintain high levels of regulatory compliance, product quality, and customer service. Several aspects of pharmaceutical operations such as regulatory compliance and validating manufacturing processes are often costly. Manufacturing products according to the process definition and within critical-to-quality (CTQ) values while documenting compliance also entails much expense. Manufacturers in the life sciences are increasingly implementing wireless technologies to reduce the overall cost of compliance.
Wireless technologies are not the same radio-frequency devices that were implemented in the 1980s for inventory management. Today, various wireless products are available. Companies are applying these products in innovative ways and, in some cases, achieving large cost savings. Most recently, manufacturers have successfully applied wireless process transmitters and wireless instrumentation to controls and distributed control systems (DCS) solutions that address validation and safety concerns.
For example, one company had to validate and continuously monitor critical quality parameters in an alcohol tank farm. Because of the concentration of the liquid, the environment was harmful to standard, hard-wired instrumentation. The environment also presented safety and health hazards to the personnel performing the validation and monitoring.
The company deployed wireless-based process instrumentation to continuously monitor the temperature, pressure, volume, and specific gravity of the fluid in the tank. Connecting wireless instrumentation to the tank farm’s DCS reduced the cost of validation by 50% and the overall cost of continuous monitoring by 30%. This arrangement also shielded plant personnel from the safety hazards.
Together with web-based manufacturing controls and systems, wireless technology helps manufacturing and quality personnel operate equipment remotely. This flexibility is achieved using various mobile wireless terminals (e.g., palm devices), pentablets (i.e., handheld computers such as Motion Computing’s “F5” tablet), and convertibles (i.e., laptops such as Panasonic’s rugged “Toughbook” device).
Often, paper-based validation protocols may be adulterated with chemicals and process materials when initiated and completed near process equipment. In some cases, portions of the paper protocol are lost or destroyed, and the protocol must be executed again. But paperless engineering protocols can be initiated at the point of validation. In a paperless approach, the protocols are initiated electronically to capture the execution data and signatures at the point of validation. Rugged wireless terminals manage the electronic protocol. For life-science companies that adopt this approach, the cost savings associated with validation are significant.
A major factor that increases TCQ is the cost to document evidence of manufacturing compliance. Many life-science companies are moving to a paperless batch record that enforces execution decisions and workflow during manufacturing. Using rugged wireless terminals in manufacturing to capture documented evidence where events occur is an easy way to establish a paperless EBR (electronic batch record). The EBR becomes the foundation for a release-by-exception strategy and results in significant savings in overall TCQ.
Data security is critically important to life-science companies. It must be investigated by manufacturers who are considering wireless technology. Wireless transmission makes it easier for unauthorized people to intercept sensitive data. Encryption is the only way to protect data. Because security is such a significant concern to life-science companies, companies such as Cisco Systems (San Jose, CA) are aggressively seeking to embed encryption directly into their wireless technology.
In conclusion, adopting wireless process instrumentation and wireless terminal technology for pharmaceutical manufacturing directly leads to efficient process and equipment validation, consistent manufacturing compliance, improved safety for plant personnel, and an overall reduction in TCQ.
Mike Power is a life-science supply-chain manager at BearingPoint (Mclean, VA)