Innovations in Pharmaceutical Manufacturing

The complexity of processes and the challenge of regulatory compliance can hinder cost control and operational efficiency. An Enterprise Asset Management (EAM) system helps pharmaceutical companies stay in control, by streamlining processes, improving compliance and enhancing financial resilience.

Addressing Compliance Challenges in the Pharmaceutical Sector

Regulatory compliance is a non-negotiable aspect of pharmaceutical manufacturing, demanding rigorous adherence to safety, hygiene, and accuracy standards. From calibrating instruments to ensuring proper maintenance of production assets, manufacturers must meet evolving regulations to avoid costly shutdowns or contamination incidents. After all, improper maintenance activities can result in product contamination, halting production and triggering substantial financial losses. And while compliance is essential, it has the propensity to complicate and prolong even the simplest of tasks.

Unplanned downtime, often caused by mechanical failures, is another major disruption that pharmaceutical companies face. Facilities lose an average of 27 hours per month to machine failures, costing approximately $532,000 per hour¹.  Therefore, controlling downtime and maximizing uptime is critical. A strong maintenance strategy, supported by an efficient EAM system, helps reduce these disruptions, ensuring that production assets are continuously operational and compliant with regulations.

The Importance of Maintenance and Cost Control

Maintenance strategies are fundamental to ensuring the longevity of production assets while managing costs effectively. Pharmaceutical manufacturers, particularly those handling high-value or patented products, must prioritize uptime and batch loss prevention. Condition-based and predictive maintenance techniques help prevent unnecessary failures and downtime. However, regulatory demands often necessitate regular preventive maintenance, which requires coordination with production schedules and clear communication across teams.

One of the major challenges in pharmaceutical asset management is the lack of a centralized, single-source-of-truth repository of asset information. Information is frequently spread across multiple disconnected systems, making it difficult to gather data, identify problem areas, and benchmark performance. Surveys indicate that only about half of asset managers have access to integrated systems that allow them to pinpoint their ‘bad actors’- poorly performing assets that use up a disproportionate amount of the maintenance budget.

Leveraging Mobile and Cloud Technologies for Better Asset Management

The adoption of mobile technology, cloud solutions, and real-time connectivity presents vast potential for improving operational efficiency in pharmaceutical manufacturing. Many companies still rely on slow, error-prone paper processes, but switching to digital, cloud-based solutions can save time and reduce contamination risks.

Cloud-based EAM systems provide instantaneous access to critical information, enabling remote asset management and faster decision-making. This is particularly beneficial for companies that separate primary and secondary production sites to prevent cross-contamination. By streamlining the complex management of change requests required for maintenance modifications in highly regulated environments, EAM systems can offer exceptional value to organizations in the pharmaceutical industry.

For companies managing production across different regional territories, varying regulatory standards can add further complexity. A centralized, single-source-of-truth EAM platform ensures traceability and documentation of all materials and activities, helping manufacturers meet both local and international compliance requirements.

Innovating Asset Management with EAM Solutions

EAM systems consolidate all asset-related data onto a single platform, offering a “single source of truth” for managing operations. This integration eliminates duplication, improves visibility, and fosters a coordinated approach to maintenance, safety, and financial management. The ability to analyze and utilize data more efficiently enables pharmaceutical manufacturers to make informed decisions that enhance operational performance.

In the pharmaceutical sector, EAM software automates compliance and maintenance processes. It provides a comprehensive audit trail for all activities, ensuring that organizations meet regulatory standards. Moreover, they help answer critical questions about asset longevity, maintenance schedules, and when to refurbish or replace equipment, facilitating both short-term and long-term planning.

These systems are customizable and can integrate with existing technologies, offering flexibility for growing businesses. Mobile functionality further enhances the usability of EAM systems, allowing technicians to review critical information, report issues and register work activities on the go,  reducing errors and improving efficiency.

Advanced Technologies: Digital Twins, AI, and IoT

Emerging technologies such as digital twins, Internet of Things (IoT)-enabled assets, and artificial intelligence (AI) are pushing the boundaries of asset management. Digital twins create a virtual copy of business-critical assets, allowing pharmaceutical manufacturers to simulate scenarios and make informed decisions about the most optimal maintenance strategy. Predictive maintenance powered by IoT sensors helps companies avoid failures before they occur, saving time and money.

AI, too, is unlocking new levels of insight into operational processes, allowing manufacturers to optimize performance, reduce waste, and streamline decision-making.

HAL Allergy Group’s EAM Success

HAL Allergy Group, a European leader in allergen immunotherapy, offers a prime example of how EAM systems can transform asset management in the pharmaceutical industry. In addition to producing its own products, HAL recently began manufacturing a COVID-19 vaccine under contract.

Adopting IFS Ultimo’s best-of-breed EAM platform, HAL improved its job-tracking efficiency and streamlined compliance processes. The self-service module eliminated reliance on call-based communication, allowing users to report incidents directly through the system. This real-time access to asset data enabled quicker problem resolution, cost tracking, and compliance demonstration during audits.

HAL’s EAM system also reduced the risk of production stoppages by ensuring that necessary maintenance parts were always available. The ability to track and manage compliance documentation efficiently has been a significant benefit for the company, demonstrating the tangible value of an integrated EAM solution.

Sustainability Gains from EAM

Pharmaceutical manufacturers, like many asset-intensive companies, face growing pressure to address environmental, social, and governance (ESG) challenges. EAM systems can help reduce energy consumption, minimize waste, and monitor the environmental impact of operations. By optimizing asset performance, companies can enhance their sustainability efforts and meet ESG goals.

In the complex world of pharmaceutical manufacturing, EAM systems offer a critical solution for streamlining processes, maintaining compliance, and controlling costs. By integrating asset management, safety, and maintenance functions into a single platform, pharmaceutical companies can achieve operational efficiency, improve decision-making, and future-proof their business. With the growing adoption of mobile, cloud, and AI technologies, the future of asset management looks brighter than ever.

Read more about this topic in an article I recently wrote for Innovations in Pharmaceutical Technology magazine, or book a free demo to see Ultimo in action.