As pharmaceutical manufacturers face increasing pressure to maintain production continuity, ensure regulatory compliance, and manage ageing equipment, the traditional approach to spare parts management is being challenged. Long OEM lead times, component obsolescence, and supply chain disruptions are exposing critical vulnerabilities across regulated manufacturing facilities. In this exclusive BioPharma Boardroom Q&A, Tom Fripp, Founder and Director of AddParts, explains how digital spare parts, virtual storerooms, and data-driven resilience strategies are transforming maintenance planning, reducing downtime risk, and enabling manufacturers to recover faster from unexpected equipment failures. He also shares real-world examples demonstrating how proactive digital asset management can protect production, safeguard compliance, and improve supply chain resilience.

How are pharmaceutical manufacturers currently quantifying the wider operational and compliance impact of unplanned downtime beyond direct financial losses?

In our experience, pharmaceutical manufacturers are becoming more sophisticated in how they assess downtime because it’s not just a question of the lost production hours or the immediate cost of a line down. Impacts can be significant, and include delayed batch release, knock-on effects across production schedules, idle labour, increased quality workload, investigation time, and in some cases the risk of product loss.

In regulated environments, ensuring continued compliance can be as significant as the disruption itself. If downtime affects controlled processes, validated equipment, or environmental conditions, it can trigger change controls, QA review and potentially revalidation work. That all takes time and eats into resources.

What we are seeing is manufacturers increasingly trying to quantify downtime in terms of risk exposure: how many batches are affected, how long recovery takes, how dependent the site is on a single supplier, and how quickly a compliant replacement part can be obtained. With more than 50% of unplanned downtime caused by internal machine components, and some replacement parts carrying lead times of up to 25 weeks, the real cost is not the component that failed. It is the uncertainty and delay caused by not having full control over its replacement.

What are the biggest vulnerabilities AddParts is seeing around ageing equipment and OEM dependency across regulated manufacturing facilities today?

A major vulnerability is that many pharmaceutical facilities rely on highly specialised (often bespoke for that specific production facility) equipment that may have been in service for decades. That equipment is often still performing well, but the supply chain around it has changed. OEMs may discontinue parts, extend lead times, or prioritise newer platforms.

This creates a difficult situation for manufacturers. The machine may be validated, and embedded into production, but access to replacement components becomes increasingly fragile. Sites then face the choice of holding large physical inventories, waiting weeks or months for parts, or considering expensive equipment upgrades before they may be operationally necessary. In most cases, pharma companies’ engineering and maintenance teams exhaust huge amounts of energy to repair and keep lines operational, simply because of OEM lead times and obsolescence.

OEM dependency also concentrates risk. If a single supplier controls access to a critical part, the manufacturer has limited resilience when disruption occurs. In regulated manufacturing, that risk is amplified because any alternative part needs to be technically suitable, documented, and compliant. AddParts exists to bridge the gap by giving manufacturers a validated, responsive route to components without forcing them to overstock or redesign entire processes.

How are digital spare parts and “virtual storerooms” changing the way pharma companies approach production continuity and maintenance strategies?

Digital strategies help regulated manufacturers protect production continuity and commercial performance by transforming critical spare parts into controlled digital assets that are ready to be engineered, produced and deployed when operational risk arises. Essentially, they give control back to the pharma manufacturer, empowering them to rapidly respond to downtime exposure risk and keep production moving. A virtual storeroom gives the manufacturer a digital inventory of critical parts, supported by the technical data, documentation, and supply pathway needed to reproduce them when they are needed. Instead of tying up capital in shelves of rarely used spares, companies can prioritise which components need to be physically stocked, and which can be held digitally and supplied on demand.

For maintenance and operations teams, this creates a more proactive and controlled approach to production continuity. Instead of relying solely on physical stock or reacting when failures occur, manufacturers can build greater visibility around production-critical spare parts, reduce exposure to uncertain lead times, and improve readiness before disruption impacts output.

What compliance and validation considerations must manufacturers address when implementing digital spare parts solutions in GMP-regulated environments?

It is vital that manufacturers have confidence that continuity improvements in GMP-regulated environments don’t introduce additional operational or quality risk.

To achieve this, it is important to recognise that not all spare parts carry the same level of criticality. Manufacturers need a risk-based approach that considers factors such as product contact, equipment function, material suitability, traceability and the potential impact on validated processes. Tacit knowledge of the engineering, maintenance, procurement, and quality teams who know their production lines better than the OEMs is also crucial and often the starting point.

What is often overlooked is that compliance is about the quality of the supporting data and documentation as much as the part itself. If a manufacturer is going to rely on a digital spare part within its continuity strategy, there needs to be a clear and defensible route covering engineering records, material information, manufacturing controls, inspection data, and change assessment where required.

That is why a controlled digital thread for part data is so important. In pharma, digital spare parts are not simply there to create a faster route to replacement, but to create a more traceable, repeatable, and operationally reliable route to recovery that quality, engineering, and site leadership teams can all be confident in.

Are there particular trends or challenges emerging in pharmaceutical manufacturing resilience that you expect will become major discussion points over the next 12–18 months?

I expect we will see much greater adoption of AI-driven predictive maintenance and condition monitoring across pharmaceutical manufacturing.

Manufacturers are increasingly capable of identifying equipment degradation earlier, predicting failures, and using data to improve maintenance planning and performance. At the same time, we are also seeing a continued trend towards bringing engineering support and maintenance services in-house through larger industrial service providers.

Both trends will continue to help manufacturers improve operational visibility and responsiveness. However, neither fully removes the continuity risk around ageing equipment and production-critical spare parts.

Even when a potential failure is identified early, manufacturers can still face a major challenge if the replacement component has a long OEM lead time or has become obsolete. In many cases, the window between predicting a failure and needing a compliant replacement part is still shorter than the supply chain can support.

That is where we see a growing gap emerging between prediction capability and recovery capability. Service providers and predictive technologies can help identify risk earlier, but they’re often still constrained by the same supply chain dependencies and sourcing limitations when critical parts fail.

As a result, I think the industry focus will increasingly shift towards operational readiness: how manufacturers can build more resilient and digitally enabled routes to recovery before disruption impacts production.

Can you share any real-world examples or case studies demonstrating measurable improvements in operational continuity, lead times, or supply chain resilience through AddParts’ approach?

In one specialty pharma facility, thermal damage to a vial sealing system occurred mid-production, exposing a reliance on OEM lead times and creating the risk of a multi-week interruption to high-value production. AddParts recreated the component in its digital storeroom, manufactured it and supported installation on the line. The site resumed operations in four days, avoiding a £9.5k loss, while the digitised component now provides a permanent contingency against repeat failure.

In another case, a global vaccine manufacturer experienced a component failure during a live production trial. With no stock available and an OEM delay, the programme faced potential batch loss and a complete halt to a time-sensitive campaign. By adding the part to the existing digital storeroom, AddParts enabled a controlled response without compromising the timeline. Production-ready assets were deployed within 12 hours, protecting £75k in value and converting an unplanned inventory blind spot into a secured digital asset.

Both of these examples are companies reacting to production line failure, fixing problems when they occur, leaving them exposed to long lead times, costly workarounds and pressure on output, delivery and site performance. Our recommendation, and the approach that both of these companies have now adopted, is to move from reactive repairs to planned resilience by turning critical spare parts into controlled digital assets that can be engineered, manufactured and deployed quickly when continuity is at risk.