Ask the expert: How to navigate transfer challenges in aseptic process validation?

Jonathan Bardsley and Christian Dunne from ChargePoint Technology explore aseptic process validation at the transfer point: why it remains one of the industry’s biggest challenges, what manufacturers should look for in a vendor, and how Annex 1 requirements and evolving regulatory expectations are reshaping how manufacturers approach validation.

What are the biggest validation challenges your customers are facing right now?

Jonathan: Transfer. It always comes back to transfer. Every time you move something into or out of an aseptic core, whether that’s an isolator, a vessel or any other piece of process equipment, you’re introducing a point of vulnerability. The revised GMP Annex 1 identifies this making and breaking of connections as one of the greatest sources of contamination risk. So in a way, the thing we’re here to solve is also the thing that creates the biggest validation challenge. Material transfer is an intrinsic part of pharma manufacturing. However you design your process, materials need to be moved between stages and equipment, and this will always be one of the highest-risk moments in the process. Our job is to make sure the solution we provide gives customers the best possible foundation to validate against.

Christian: Transfer might seem like a small, discrete point in the process, but addressing it properly requires looking at the entire picture. How the transfer system interacts with the equipment it connects to, the environment around it and the regulatory requirements at that specific stage. Our equipment spans the full range of those scenarios, so we have to understand the challenges right across the process, not just in isolation. And of course, Annex 1 itself is principles-based rather than prescriptive, so how manufacturers interpret what’s required of their aseptic transfer system can vary significantly.

You mention that interpretations can vary. Can you give an example of how that plays out in practice?

Christian: A good example is aseptic process simulation for powder transfer. The question regularly comes up around whether you should conduct your media fill assessments with powder or with liquid. A microbiologist might argue that liquid is the more searching medium because it reaches every surface. But if you’re simulating a powder process, using liquid isn’t truly representative of the real-world operation. Both perspectives are legitimate, both can be justified, and the choice between them leads to very different validation programmes.

We regularly see these tensions between engineering and quality teams. Engineering needs a practical, workable solution. Quality needs confidence that the approach manages risk adequately. Those two objectives aren’t necessarily conflicting, but the interpretation of what “adequate” means can differ significantly from one person to the next. Navigating those differences takes time, expertise and a willingness to challenge assumptions on all sides.

Where do equipment vendors come into this journey? And, given the complexity, what should manufacturers look for when evaluating how a vendor supports validation?

Jonathan: Transparency. That’s the single most important thing. When you’re assessing how a vendor can support your validation journey, look at what data is being shared and how much of it you can actually see. There are vendors who will provide a snapshot of their test results, enough to make a claim, but not the full picture of how those results were achieved. Our approach has always been to share the full report, cover to cover. We’ve had feedback in the past where customers are surprised by how open we are, because that’s just not the norm. But our view is straightforward: let the data do the talking.

Christian: And beyond the data, look at the level of support offered after the product is delivered. The questions that come up during qualification, the support needed when something unexpected arises during commissioning, the ongoing relationship as the process matures and as regulatory expectations evolve – that matters as much as the data pack you receive at the start.

What might stop manufacturers from upgrading their transfer systems, even when they know a better solution exists?

Jonathan: Often, it’s the fact that what they already have is validated. A manufacturer might know that their current approach isn’t optimal and can see that something better is available, but the system they have has been through validation, it’s been approved, and the prospect of going through that process again feels like a bigger risk than living with the limitations they know. So “approved but not the optimal solution” becomes the default.

It’s easy to see why that mindset persists. Validation involves a significant investment of time, resources and focus. But that rationale warrants re-examination. Regulatory expectations around pharma risk management are tightening, and what was accepted five years ago may come under new scrutiny. Sticking with something because it’s already approved, rather than because it’s genuinely the best approach, is becoming harder to sustain.

That’s an interesting point about regulatory expectations tightening. What’s actually changing?

Christian: One of the most significant shifts in the revised Annex 1 is the embedding of quality risk management principles throughout. The expectation now is that you justify decisions on their merits, based on data and risk assessment, not on the basis of “we’ve always done it this way” or “this vendor has the longest installation list.” That’s a real change in how people are expected to think.

And we’re already seeing the impact. I’ve spoken to customers whose systems had been operating without issue but were now being scrutinised in ways they hadn’t anticipated. Not because the systems had changed, but because the questions being asked of them had.

Jonathan: For manufacturers, that should actually be encouraging. It means the industry is moving toward a place where the best-performing, best-supported solutions win out over the most established ones. If you have confidence in your data and in your approach to risk management, this shift works in your favour. And if you’re working with a partner who can provide robust, transparent validation evidence and support you through the process, you’re well positioned for whatever comes next.

If you’d like support with aseptic process validation at the transfer point, get in touch with our experts at ChargePoint Technology today.