BONNER has supported AbbVie for over 20 years, delivering high-quality calibration services across a wide range of critical process instruments. In a highly regulated pharmaceutical environment, maintaining calibration accuracy is essential for ensuring product quality, compliance, and patient safety.
AbbVie required a more effective way to manage calibration performance across its instrument base. A growing number of out-of-tolerance events was creating operational pressure, increasing downtime, and placing a heavy burden on quality teams responsible for investigations and documentation.
At the same time, any changes to calibration practices had to remain fully aligned with strict regulatory requirements. The challenge was not only to reduce failures, but to do so in a way that preserved data integrity, supported audit readiness, and maintained robust quality control processes.
BONNER introduced a risk-based, preventive calibration approach designed to intervene before instruments reached failure conditions. During calibration activities, instruments approaching the upper limit of their allowable tolerance were carefully assessed and adjusted where appropriate. This early intervention prevented drift from developing into full out-of-tolerance failures.
For instruments that were already outside tolerance, BONNER maintained a rigorous and structured process aligned with AbbVie’s quality procedures. Each failure was clearly identified, escalated through quality triage, and assessed for potential impact on product or process. This ensured that while preventive actions reduced avoidable failures, compliance and oversight were never compromised.
In parallel, BONNER enhanced trend monitoring across the instrument population. By analysing recurring drift patterns and identifying higher-risk assets, the team was able to support continuous improvement through better calibration planning, interval optimisation, and long-term asset management.
The updated calibration methodology was introduced as part of BONNER’s ongoing support programme at AbbVie. Because of the long-standing partnership and deep understanding of site operations, the transition was smooth and efficient.
The new approach was integrated into routine calibration schedules, ensuring minimal disruption to production. BONNER’s Calibration and Preventive Maintenance Team worked closely with site quality and maintenance personnel to ensure alignment with existing procedures and regulatory expectations.
The impact of this proactive calibration strategy was significant. By addressing instrument drift earlier, BONNER reduced the number of out-of-tolerance events and improved overall measurement reliability. This led to fewer disruptions in production and a noticeable reduction in the volume of quality investigations.
Operational efficiency improved as maintenance and quality teams were able to focus less on reactive issues and more on planned activities. At the same time, compliance was strengthened, as all true failures continued to follow a formal triage and documentation process.
Overall, AbbVie achieved greater control over its instrumentation, improved data confidence, and enhanced support for consistent product quality.
In addition to operational improvements, the approach delivered clear sustainability benefits. By reducing repeat failures and avoiding unnecessary equipment replacement, BONNER helped extend the lifecycle of critical assets. Fewer failures also meant less rework, reduced resource consumption, and more efficient use of labour and materials.
This project highlights the value of moving from reactive to proactive calibration practices in pharmaceutical manufacturing. BONNER’s approach enabled AbbVie to reduce risk, improve reliability, and maintain strong compliance in a demanding regulatory environment.
With over two decades of experience and a deep understanding of GMP requirements, BONNER continues to support clients with calibration solutions that deliver measurable, long-term results.