A Decade of Multi-Facility STARLIMS Experience at Baxter Healthcare
Baxter Healthcare is a global leader in medical products and services with core focuses on medical devices, pharmaceuticals and biotechnology. For more than ten years, five of Baxter’s plants specializing in IV bags and solutions have relied upon STARLIMS for integrating a wide range of multi-facility, system-wide, LIMS functionalities to escalate the company’s adherence to FDA regulatory compliant business rules, as well as the design and maintenance of a diverse spectrum of laboratory systems and applications ensuring “mistake-proof” laboratory environments at the company’s facilities.
Overview
Located in North Carolina, Baxter Healthcare’s North Cove Plant manufactures a diverse range of IV bags and solutions. The thirty-two acre plant produces 1.5 million units a day and employs 2,500 employees. With North Cove serving as a primary facility, an additional four other plants located from Cleveland Mississippi to Jayuya, Puerto Rico share similar product/solution ranges and laboratory topologies resulting in a close information flow between them at all levels. A divisional team of three engineers controls the two functional areas – batch quality and bioburden in use by the five facilities involved in producing the various IV lines and solutions. A Batch Laboratory Information Management System controls all batch-related product information and is used for managing solution chemistry, bioburden, particulate matter and chemical raw materials samples. A Biocontrol Lab Automation System is used in the environmental monitoring laboratories for air, water and surface testing. Regulatory laws dictate that products must be certifiably produced in a bacteria clean environment.
Implementation Challenges
Baxter Healthcare’s business is FDA-regulated, therefore adherence to business rules and particularly the systems utilized in product development and implementation is critical for success. Additionally, user requirements even among similar manufacturing facilities can differ – so the design of a standard system is a major challenge in itself. STARLIMS is able to meet a variety of challenges, such as allowing system configuration which meets the needs as described above, as well as the development of new enterprise versions, the standardization of user requirements, the performance of hardware and software upgrades and the ability to help address other organizational challenges such as personnel availability and communication barriers.
Ten Year Historical Relationship
From 1984 to 1993 computer use for managing laboratory data was limited. Although the North Cove facility was using a mainframe-base system with a proprietary designed application, it had limitations and by 1993 was nearing its end. There was a pressing need to acquire and implement an up-to-date, state-of-the-art solution which could address the facility’s demanding needs. North Cove’s Divisional management became aware that a sister facility (Cleveland, Illinois) was using LIMS, and concluded that since the laboratory types were very similar, a joint venture to implement a STARLIMS-based laboratory system at both laboratories would be an excellent solution for the demands of both plants.
In 1994 the plants began to use STARLIMS v4 and in 1995 upgraded to STARLIMS v6. In 2000 the facilities upgraded to StarLIMS v8 and use was expanded to Jayuya and Maricao Puerto Rico, and Round Lake, Illinois. This brought the number of Baxter facilities using a STARLIMS based system to five. In 2002 the bioburden solution module was developed and this allowed bioburden monitoring and its data trending to be captured within STARLIMS. Later a raw materials module was added. 2003 saw the facilities platforms upgraded to STARLIMS v9 with the addition of two more modules addressing particulate matter solutions and automated login of samples. By 2004, Baxter began to develop interconnectivity between its LIMS and the POMS system which further moved the company towards a “paperless” laboratory environment.
Conclusion
STARLIMS’ flexible, upgradeable, user-friendly and robust system has enabled Baxter Healthcare to quickly adapt to new mandatory regulatory environments, while at the same time deploy systems modeled to the exact needs of the company’s facilities and LIMS requirements. Ten years of STARLIMS integration has helped speed the company’s products and solutions to market while allowing for the flexibility to accommodate local differences in plant systems foregoing the need to design separate systems for each plant.
STARLIMS Corporation delivers cost effective, easy-to-use collaborative Laboratory Information Management Systems to organizations in the public health, pharmaceutical, petrochemical, forensics, food & beverage, environmental and chemical industries. The STARLIMS full featured, flexible, multilingual LIMS software solution provides complete traceability leading to regulatory compliance.
A 15 year track record has earned us recognition for “future proofing” our customers’ investments and serving as a platform for new implementations and straightforward conversions of legacy systems.
