Biopharmaceutical manufacturing is changing. With the rise of biologics and personalized medicine, the industry is appreciating the single-use manufacturing style. Instead of large-scale production processes, manufacturers are finding it pays to be agile — which is why many are increasingly adopting single-use technologies to turn over new products and batches quickly and efficiently. Single-use technologies utilize disposable bioprocessing equipment in place of traditional stainless steel. By eliminating the time-consuming clean-in-place (CIP) and steam-in-place (SIP) processes between batches, single-use technologies cut down on the costs of labor, materials, and utilities — all while shortening time to market.

These new technologies play a crucial role in the changing biomanufacturing landscape. Fluid control and automation systems and solutions can help processors reap the benefits of single-use products, including reducing product development time, enhancing operator safety, and increasing productivity.

The Key to Minimizing Downtime

One of the biggest challenges biomanufacturers face is downtime — something single-use technologies overcome. Generally made from platinum-cured silicone or biopharma-graded plastic, these products are disposed of after each use. As a result, single-use products eliminate the need to clean between batches and have a short changeover period compared to stainless-steel equipment. A line changeover for a stainless-steel bioreactor, for example, can take up to 10 hours for the same product — and up to three weeks for a full product changeover. Compare that to a single-use bioreactor, which only requires a few hours between batches. Because of their quick changeovers, single-use products lead to significantly higher throughput and enable smaller, more efficient batches. They can also decrease a facility’s manufacturing footprint, reducing the costs for ventilation, heating, and other utilities.

The G3 Electronic Fieldbus Platform complements the ASCO Series 501 pneumatic valve manifold for easy commissioning and highly distributable I/O. The graphic display for configuration and diagnostics is compatible with various industry-leading communication protocols like Ethernet IP, ProfiNet, DeviceNet, and others. (Credit: Emerson)

It’s important to work with fluidic system suppliers that offer fluid automation products — released or in development — that benefit biomanufacturers making this leap from large-scale to single-use production processes. These suppliers combine their product offering — which can include valve automation solutions, air preparation equipment, instrumentation, and integrated solutions — with industry expertise to provide reliable service.

Single-Use Pneumatic Pinch Valve Reduces Install Time and Costs

For single-use batch production, the ASCO Series 273 pneumatic pinch valve features an innovative design that enables better tube retention and prevents breakage or damage to the soft tubing over repeated use — virtually eliminating any disturbance from valve motion to process media unlike other products on the market. (Credit: Emerson)

From valve automation solutions to advanced control systems, a variety of solutions can help get a single-use biomanufacturing operation up and running. Single-use pneumatic pinch valves, for example, achieve process control automation in areas like bioreactor and fermentation tanks, chromatography, tangential flow filter (TFF) skids, and other drug-discovery lab applications. Look for valves with innovative designs, in which the pinch mechanism holds the soft tubing in place, minimizing any disturbances to process media and preventing tube damage over repeated use.

Valve suppliers should always keep user safety at the forefront of product designs. Pinch valves, for example, should include a protection guard that allows operators to safely work around the pinching mechanism, as well as a manual override function that lets operators insert or remove tubing without actuating the valve. In addition to keeping operators safer, this enhanced valve design accelerates setup, reduces costs, and makes unscheduled maintenance easy — all of which are critical to maximizing uptime in single-use applications.

In addition, the right pinch valve makes no contact with process media, features a high life cycle, and provides a reliable pinching force without the need for an electrical connection. It should also resist corrosion due to tube breakage or washdown.

A One-Stop Shop for Process Control Automation. Bear in mind, as the single-use market continues to expand globally, it pays to use a single, global supplier that can deliver a comprehensive fluid control solution. To that end, many suppliers offer a wide range of systems and solutions that enhance product quality, improve reliability, and reduce operating costs in the biomanufacturing sector.

In addition to pinch valves, which overcome many of the issues related to downtime and operator safety in single-use applications, many suppliers offer directional valves, communication protocols, air preparation units, and other technologies — all of which work together seamlessly so device OEMs can focus on what really matters: optimizing their biomanufacturing operation. From design and implementation, to start-up and ongoing technical support, the supplier can help a single-use operation stay competitive in a global economy, enabling the OEM to:

  • Control aggressive fluids with durable valves. Angle body valves handle aggressive fluids, such as steam, hot water, solvents, and light slurries, in CIP and SIP applications. Air- or water-pressure-operated with a straight-through design, these valves come with advanced accessories, including a signaling box, compact positioner for proportional control, and stroke limiter for even greater precision.

  • Speed time to market with high-performing valve manifolds. Valve manifolds with modular, flexible designs simplify installation, commissioning, and system integration in single-use applications — reducing engineering costs and speeding time to market. These plug-and-play systems include high flow rates, input/output (I/O) capabilities, compatibility with popular industry protocols, and a pressure shutoff function, which allows individual valves to be replaced without halting the production process — further reducing line downtime and maintenance in single-use applications.

  • Improve valve efficiency with next-generation electronics. Electronic fieldbus platforms provide pneumatic valve manifolds with fieldbus and Ethernet connectivity, as well as a graphics display for configuration, commissioning, and diagnostics. They allow programmable logic controllers in single-use systems to more efficiently turn valves on and off. They also channel I/O data from sensors, lights, relays, valves, and other I/O devices via various industrial networks.

  • Minimize downtime with quality air-preparation equipment. Air-preparation devices treat the air quality and pressure in a plant’s pneumatic system. Modular filter regulator lubricator (FRL) assemblies with body-to-body clamps facilitate assembly during installation and service, while optional end plates allow the manifold assembly to be quickly removed by loosening screws — keeping downtime to a minimum in single-use systems.

  • Optimize plant performance with advanced control systems. Distributed control systems (DCS) can improve manufacturing agility in single use applications by helping meet demands in real time. These easy-to-use automation systems often include a suite of services geared toward simplifying operational complexity and reducing project risk. They also adapt to meet specific biomanufacturing needs — scaling easily without adding complexity.

A Robust, Customized Control Cabinet

ASCO Series 290 angle body valves handle various types of fluids in CIP and SIP applications. (Credit: Emerson)

In cleanrooms or environments subject to washdown, OEMs need a quick, easy, and space-saving way to protect sensitive electrical and pneumatic components. Already assembled, tested, and ready to install, integrated enclosures ensure corrosion and damage resistance in sensitive installations. These turnkey packages also withstand regular exposure to aggressive cleaning fluids. In addition to biomanufacturing applications, these enclosures are ideal for the life sciences, food and beverage, petrochemical, and packaging industries.

This article was written by Mukta Sharma, Product Marketing Manager, Fluid Control and Pneumatics at Emerson Automation Solutions, St. Louis, MO. For more information, visit here .


Medical Design Briefs Magazine

This article first appeared in the November, 2020 issue of Medical Design Briefs Magazine.

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