This is a new concept where disposable vessels and tank liners are used to reduce the cost of cleaning and verification of process equipment. The site also will include cell-culture production, a clinical suite, and just-in-time warehousing.
"Technology that simplifies scale-up from R&D to commercialised production is critical for biotech facilities to produce as efficiently and reliably as possible," explained Don Wuchterl, director of manufacturing with Shire HGT.
In order to control manufacturing processes at the new facility, Shire HGT has selected a number of Honeywell solutions, including Experion Process Knowledge System (PKS), Experion Batch Manager, the OneWireless industrial wireless network and Uniformance Process Historian Database (PHD).
"Experion and OneWireless are proven to streamline operations and will provide the flexibility required for a multi-purpose facility such as ours," added Wuchterl.
Shire will use Experion as the primary control platform for the new facility. The system helps operators run production by integrating critical subsystems throughout the plant, providing a single view into the manufacturing process via Experion client operator stations. The processing capacity of the C300 controller will reduce the amount of hardware needed to automate Shire's manufacturing process, as well as reduce operating costs.
Shire will also use one of the newest additions to the Experion product line, Experion Batch Manager. Introduced in 2008, Experion Batch Manager further simplifies operations by allowing manufacturers to quickly execute complex batch recipes reliably in a regulated environment.
Additionally, the OneWireless mesh network technology will allow Shire to mount controllers on moveable equipment without having to worry about cabling issues, which can help increase their production flexibility, safety and efficiency. Also, wireless remote operator stations will be used to help reduce the overall number of stations required and eliminate the need for expensive hardened enclosures in environmentally sensitive areas.
For its part, PHD will pull information from Experion and help improve operations by allowing Shire operators to quickly store, retrieve and analyse process control data.
"Our technology enables lower production costs so biopharmaceutical producers like Shire can reinvest in research and development and deliver products to market faster," said Don Maness, regional general manager for Honeywell Process Solutions. "Additional benefits include lower validation costs, faster project implementation and reduced training requirements, all of which help manufacturers achieve operational readiness from day one and drive improved business performance."
Meanwhile, Bristol-Myers Squibb (BMS) is turning to Emerson's Syncade operations management software for its new US$750m large-scale cell culture (LSCC) biopharmaceutical facility at Devens in Massachusetts (Fig.1).
The LSCC facility will produce commercial biopharmaceuticals and have 120 000 litres of bioreactor capacity designed for campaigned, multi-product production. Commercial operations are due to start in 2011.
The facility has been designed to optimise overall operational effectiveness and ensure competitiveness in the global market. Emerson's Syncade Smart Operations Management suite is expected to help achieve these objectives. The operational plan is based on electronic workflow to reduce deviations, expedite batch review and release, improve real-time inventory management, and utilise industry and corporate standards. The use of standards will enable quick response to product demand changes, as well as faster and more efficient technology transfer from research to product launch.
Integration of the real-time plant floor information with business enterprise processes is a key component of the facility's competitive advantage.
Operations management will use modular Syncade software for workflow processes, including: fully automated equipment; electronic work instructions; equipment status tracking; recipe driven operations; material tracking; automated weigh and dispense operations; electronic data capture; exception reporting; and integration of operations workflow with enterprise resource planning.
By using standards-based Syncade suite to optimise operations management, BMS is taking advantage of the latest technology advancements to directly improve operational efficiency and reduce engineering effort.
Specifically, BMS is taking advantage of an integrated recipe design and execution environment that spans both manual and automated processes. This approach will automatically generate a comprehensive electronic batch record to meet regulatory compliance requirements, including electronic signatures.
Overall, Syncade smart operations management suite extends the value of Emerson's PlantWeb digital plant architecture to provide what the company describes as a new class of real-time operations management software to increase productivity and maximise asset utilisation.
