High containment by design
As pharmaceutical technology progresses, manufacturing facilities must keep up with increasingly potent active pharmaceutical ingredients (APIs).
Replacing a single piece of equipment is not enough. Handling modern production demands requires looking at the entire manufacturing process through a broader lens.
This holistic approach is performance by design. It focuses on engineering excellence from the ground up to handle pharmacologically potent materials safely, meet strict compliance rules, and hit sustainability targets. Solving these challenges takes specialist expertise, multi-disciplinary teams, and true collaboration.
Five pillars of performance by design
- Data-driven modeling
- Integrated line architecture
- High technical containment for safety
- Clean-in-place ready by design
- Design for validation from the start
Predictability is everything. Surprises during the scale-up phase lead to costly delays. That is why performance by design starts long before physical equipment arrives. Process engineers use simulations and modeling to predict process performance and map out manufacturing flows. Monitoring processes dynamically by systematic use of Process Analytical Technology during commissioning and operation ensures consistent product quality and reduces batch failures, giving you total control over output.
A tableting line is only as strong as its weakest link. This makes integration essential: every stage, from fluid-bed granulation and drying through to tableting, must work together seamlessly. If any step is disconnected, you risk downtime and waste. We design tableting lines as fully integrated processes: Linking material feeding, granulation, fluid-bed drying, and tabletting, to ensure consistent quality at each stage and smooth, reliable production from start to finish. Quality control is incorporated to test and verify product consistency, ensuring that every batch meets the highest standards.
As APIs become more potent, operator safety is the top priority. Rather than relying solely on personal protective equipment (PPE), we focus on high technical containment. By engineering closed transfers and clean-in-place (CIP), highly potent compounds stay strictly contained. This builds safety directly into the equipment, creating safe workspaces and additionally alleviates the burden of PPE.
Thorough decontamination between batches is essential, but manual cleaning wastes valuable production hours. We make sure your processes are CIP-ready from day one. By eliminating dead legs, ensuring segregated drainability, and baking automated cleaning cycles into the facility layout, we remove the variability of manual cleaning. Your equipment meets the exact same standard every time, getting your line back into production much faster.
A facility must be demonstrably compliant. When you use the performance by design methodology, validation is never an afterthought. Quality assurance experts integrate commissioning and qualification right into the engineering phase. We establish testable criteria early, so there is no ambiguity when it is time to turn the equipment on.
Collaboration drives engineering excellence
You cannot design a highly integrated facility in a silo. Achieving true performance by design requires a deep, transparent partnership between engineers, facility leaders, and operations teams.
We sit down together to understand your specific challenges, analyze risk tolerances, and build a strategy that meets your long-term goals.
When projects are complex, as they are in pharma, co-engineering is the way to go
says Henrik Brun Philipsen, senior process engineer at AFRY.
Co-engineering is the most effective way to eliminate friction, anticipate regulatory hurdles, and design flexible solutions that adapt to your future product lines.
Ready to build for performance?
As new therapies emerge, your manufacturing facilities need to adapt without compromising operator safety or operational efficiency.
At AFRY, we have the specialized knowledge, multi-disciplinary teams, and collaborative spirit to help you navigate complex engineering challenges. We provide a strategic pathway to secure, reliable, and sustainable manufacturing.
If you want to upgrade your production capabilities, integrate advanced modeling, or achieve seamless compliance, we are here to help. Reach out to our team today, and let us build the next generation of pharmaceutical manufacturing facilities together.