Paperless Manufacturing

Baxter Healthcare, Ireland

Elan Software, recently acquired by Siemens to strengthen its MES portfolio, implemented an MES solution for paperless manufacturing for Baxter Healthcare in Ireland.

With the acquisition of Elan Software Systems SA, based in Toulouse, France, Siemens reinforces its manufacturing execution system (MES) portfolio with process industry software. Elan Software Systems, an international software supplier for MES in the pharmaceutical and biotech industries, has excellent manufacturing process know-how in these industries, where it has been a recognized partner and preferred software supplier to many well-known companies for 20 years.

Elan Software’s business activities ideally complement the Siemens process industry portfolio, such as the Simatic IT MES portfolio, the Simatic PCS 7 process control system, and the Comos lifecycle management systems added in 2008 through the acquisition of Innotec. Particularly for the pharmaceutical and biotech industries, the XFP software suite supplements the Simatic IT MES portfolio.

Going paperless in the pharmaceutical industry

One company that is already reaping the benefits of working with a solution developed and implemented by Elan is Baxter Healthcare in Ireland. With approximately 46,500 employees worldwide, Baxter Healthcare applies its expertise in medical devices, pharmaceuticals, and biotechnology. Baxter Healthcare operates in three main businesses: bioscience, medication delivery (MD), and renal. This case study focuses solely on the MD and renal divisions that manufacture intravenous (IV) solutions and administration sets, premixed drugs and drug reconstitution systems, prefilled vials and syringes for injectable drugs, and electronic infusion pumps, in addition to other products used to deliver fluids and drugs to patients. The type of products that the MD and renal divisions manufacture cannot be reinspected or reworked, which poses a serious challenge for Baxter: products need to be manufactured right the first time.

Baxter has eliminated more than 90 percent of the paperwork from the process. The e-batch system is the front line of the Baxter production process (Photo: Baxter Healthcare)

In 2003, Baxter’s European MD and renal divisions were eager to implement an electronic batch system, with the principal objectives of cost reduction, increased quality compliance, enhanced flexibility, and acceleration of batch release. They implemented Elan’s XFP software suite to manage all production operations, from the entry of raw materials into the workshop to the transfer of finished goods to the warehouse. The XFP implementation included material flow and inventory management, weighing, counting and dispensing, directed manufacturing, daily equipment checks, mixing, printing, filling, sterilizing, electronic batch records, batch testing and reviews, packaging and labeling operations, and data warehousing. All data are stored in a central repository available for use and review, enabling Baxter to perform trend analysis, such as laboratory trends, and scrap analysis and to measure manufacturing output and scrap.

Electronic batch recording offers multiple benefits

The e-batch system, as it is known internally, guides operators through the complete process, acting as an electronic router with controlled task execution and automatic calculations while also recording all actions. With this system, human error risks have been significantly minimized, and quality has increased. It is now possible to manage more volume with fewer resources and better quality. In addition, less storage space is required.

Thanks to the traceability, electronic signature, and security features, the system helps ensure total quality compliance with any industry regulations, including those of the US Food and Drug Administration. Finally, the new system has led to the reduction of batch release time and, of course, cost. All data are gathered in one batch report, which is accessible at any time. Reviews are performed only on exceptions, which translates into significant time and cost savings.