Biomanufacturing is entering a new era. Stainless steel systems that were once the backbone of high-volume production are being replaced by single-use equipment that are faster to deploy, easier to scale, and better suited to the realities of modern drug development. But with that shift comes operational friction: more manual steps, more room for error, and more complexity on the shop floor.
At Operations Calling 2025, the team behind Sartorius shared how they built a digital execution layer tailored to the realities of single-use manufacturing. From electronic SOPs to contextualized equipment data, they showed how composable apps can reduce errors, tighten traceability, and scale across cleanrooms all without relying on rigid MES platforms. Their approach offers a blueprint for operational teams facing the complexities of modern biomanufacturing.
This article breaks down the evolution from stainless steel to single-use systems, and offers a practical look at how teams are solving the operational challenges that come with it.
A Four-Layer View of Biomanufacturing’s Evolution
The evolution from stainless steel to single-use systems affects every layer of biomanufacturing operations. Understanding this shift requires looking beyond equipment to execution, documentation, and digital architecture.
1) Physical Equipment : From Stainless Steel to Single-Use
Stainless steel systems were built for durability and precision, but in today’s faster, more fragmented pipelines, they come with heavy tradeoffs:
Operational overhead: Cleaning, sterilization, and validation slow everything down
Resource costs: Water, chemicals, and utilities add up quickly
Inflexibility: Reconfiguring equipment for new products is rarely fast or simple
Many teams are transitioning to single-use systems to support early-phase production and more agile development cycles. These setups rely on disposable bags and modular equipment, offering benefits like:
Shorter changeover times
Fewer cleaning steps and validation requirements
Lower contamination risk and resource use
2) Process Execution: From Automation-Led to Operator-Driven
The move to single-use systems significantly changes how processes are executed on the shop floor. In stainless steel environments, execution was largely driven by automation. Recipes dictated most actions, and operators primarily monitored equipment.
Single-use systems introduce far more manual intervention. Operators are now responsible for installing consumables, performing integrity tests, taking samples, and responding to unexpected events during a batch. As described in the session, the recipe no longer dictates everything that happens once a run is underway.
“With single-use, there’s so much more manual intervention that happens in the process... when a batch is running, the recipe isn't necessarily dictating everything. You may have to take a sample, replace a consumable, or respond to something unexpected.”
As human involvement increases, maintaining consistency becomes harder. Execution quality now depends not just on equipment, but on how well operators are guided through complex, real-time decisions.
3) Documentation: From Paper Records to Digital Execution
Paper-based documentation has long been a weak point in biomanufacturing. Even as equipment modernizes, handwritten batch records, binders of SOPs, and physical signatures slow down production and increase risk.
“I had a customer the other day who needed 50 signatures to approve a single batch record, and that was their dialed-down version.”
That kind of overhead isn’t just inefficient, it creates friction across production, quality, and compliance. A more scalable approach starts with two foundational shifts:
Step 1: Digitize High-Friction SOPs
Begin with the procedures that create the most variability or require close oversight, like bag installation or integrity testing. Digital SOPs should:
Provide clear, step-by-step guidance at the point of use
Include embedded visuals or videos
Capture operator inputs automatically
Enforce version control and generate audit trails
This not only improves execution but accelerates onboarding, especially in greenfield facilities or high-turnover teams.
Step 2: Expand into Electronic Batch Records (eBRs)
Once digital SOPs are working, extend that structure to batch records:
Replace handwritten entries with structured digital data
Automate approval workflows with digital signatures
Validate key steps and calculations in real time
Provide visibility for QA and operations as work happens
One example: instead of logging bag integrity test results on paper, a digital system can capture the outcome, associate it with a lot number, and trigger alerts if failures repeat. That closes the loop on quality faster, and with less manual chasing.
Ultimately, digital records aren’t just about compliance. They shape execution, reduce variability, and help ensure that operators do the right thing at the right time.
4) Digital Systems: From Rigid Platforms to Composable Architecture
As digital systems expand, many teams face a familiar bottleneck: rigid architecture. Integrating new apps or equipment often requires long IT cycles and external integrators, and that slows down innovation on the floor.
That’s why more manufacturers are moving toward composable architecture i.e. a modular, building-block approach to digital operations. Instead of customizing a single system for every use case, teams create smaller apps that can be configured, extended, and scaled over time.
“Every single app we’ve built is fully configurable, composable. It’s designed to be flexible and fit to your process needs.”
Benefits of composable systems include:
Faster deployment: Start small and build iteratively
Cross-vendor support: Connect multiple equipment types
No vendor lock-in: Flexibility without fragmentation
Scalability: Expand without rebuilding your stack
But to keep things usable across teams and sites, governance is key. Best practices include:
Standardizing UX and branding across apps
Using a shared (but extendable) data model
Defining who can build, modify, and deploy apps
Documenting changes to avoid “a zoo of different solutions”
“There’s always a risk of having one app in pink, one in yellow… Governance ensures consistency without killing flexibility.”
By designing systems that evolve with your process, composability unlocks a more resilient foundation for digital operations.
Looking Ahead: Continuous Transformation and AI
The transition to single-use systems is just one phase in a broader transformation. As digital infrastructure matures, two trends are reshaping what’s possible on the shop floor: continuous transformation and applied AI.
Continuous Transformation: Moving Beyond Batches
Instead of producing in discrete runs, continuous transformation connects unit operations into a steady, coordinated flow. The benefits are clear:
Higher throughput with fewer changeovers
Improved product consistency
Lower cost per dose
But it also demands more from operations. Processes must be tightly orchestrated, with real-time visibility across steps, and that’s only possible with robust digital systems.
“The development from batch production into continuous manufacturing is a journey… and automation becomes very important.”
The Role of AI: From Automation to Intelligence
AI is no longer theoretical. Teams are already using it to:
Flag anomalies before they become deviations
Generate validation documentation
Guide operators through complex decision points
Identify root causes using historical data
“It’s not about replacing people, it’s about bringing context to the data that already exists.”
Done right, AI becomes a layer of intelligence on top of digital operations, augmenting human decision-making rather than replacing it.
Sustainability and Efficiency Go Hand-in-Hand
Digital systems also support broader sustainability goals. By reducing manual rework, cleaning cycles, and waste, manufacturers are able to:
Minimize chemical and water use
Reduce energy consumption
Lower the environmental impact of each batch
“It feels counterintuitive, but single-use can actually be more sustainable, because we eliminate the cleaning step and reduce chemical consumption.”
The path forward isn’t just about digitizing what exists, it’s about building a foundation for smarter, faster, and more sustainable manufacturing systems
Biomanufacturing is evolving with faster products, more manual steps, and higher expectations on the shop floor. Success now depends on how well teams guide execution, not just design equipment. Start where variability is highest. Build flexible systems. Connect people, data, and decisions. This shift isn’t just technical, it’s operational. And it’s already underway.
How Tulip Helps
Tulip enables biomanufacturers to build flexible digital systems tailored to single-use environments. Instead of rigid MES or paper processes, teams can create step-by-step digital SOPs, track operator actions in real time, and link them directly to equipment data. This helps capture context and what happened, when, and why all while reducing training time, improving consistency, and accelerating review. Tulip’s composable platform also integrates across mixed equipment setups, making it easier to scale and standardize execution across facilities.