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Optimizing Pharma Packaging Lines with PLC-Based Automation

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TL;DR:

Most pharma packaging lines in Europe run far below their efficiency potential, with outdated control logic limiting speed, traceability, and compliance. PLC-based automation, when treated as embedded software, can push OEE beyond 70%, streamline GAMP 5 validation, and enable real-time quality, data logging, and predictive insights. This blog breaks down how embedded PLC systems transform packaging lines into smarter, scalable, audit-ready ecosystems that keep up with regulatory pressure, multi-SKU demands, and the pace of modern PharmaTech operations.

Common Challenges in Today’s Pharma Packaging Lines

According to pharmaceutical industry OEE benchmarks, a typical manufacturer has an OEE of approximately 37%, with planned and unscheduled downtime accounting for nearly 50% of losses. An additional 20% of losses are linked to performance concerns, such as micro-stops, and 6% to quality losses (see image below on the left).

On the other hand, analysis reveals that top-tier pharmaceutical manufacturers achieve an OEE of around 70%. These high performers have enhanced and automated their operations using Pharma 4.0 technologies. In such setups, availability typically reaches 75%, while performance and quality losses are nearly negligible (see image on the right).

Apart from this:

● Manual inspection and validation failures due to fatigue or oversight lead to rework and recalls.

● Without integrated data logging, organizations miss out on analytics that can prevent errors and drive continuous improvement.

● GAMP 5 and 21 CFR Part 11 compliance demands extensive documentation.

It’s not a hardware problem. It’s how the logic is built, and where the intelligence actually sits.

Where PLC Automation in Pharmaceutical Makes the Most Impact?

Good PLC logic brings control, consistency, and clarity to the packaging floor.

Batch-aware logic loads the right parameters for each run (label type, leaflet, carton dimensions) without operator adjustments.

Real-time sync keeps sealing, printing, and rejection tightly timed, even at high speeds.

Inline QA connects vision systems to the PLC so that deviations trigger actions and logs instantly.

Embedded diagnostics detect early signs of wear, drift, or rejection patterns.

Audit-ready logs track every adjustment with timestamps and user IDs, fully GAMP 5 aligned.

These upgrades can push OEE from the 30s into the 65–75% range, some even crossing 85% when the rest of the packaging line is tuned.

Designing a GAMP 5 Compliant PLC Architecture for Pharma Packaging Lines

In regulated environments, GAMP 5 and 21 CFR Part 11 create a stack of documentation requirements, sometimes consuming half the total project time.

With the right architecture, you make validation part of the process rather than a separate burden.

Modular Code Blocks

Each control function (label check, temperature control, and serialization) is isolated, documented, and tested. Makes mapping to URS and FS clean.

Test-Ready Design

FAT, SAT, IQ, and OQ scripts get tied to the logic itself. No need to retrofit test coverage later.

Role-Based Access

Whether it’s an HMI input or parameter change, your PLC logs who did what. Timestamps included. That’s your audit trail, built in.

Built for EU Inspection

Need to show that the sealing temperature wasn’t altered mid-batch? Or that label rejections followed SOP? The logs sit right there in the controller, formatted and searchable.

So instead of building compliance around automation, you design it into the system from the very start.

What a Good PLC Automation Partner Actually Brings?

Here’s where the difference between a control engineer and a true PharmaTech automation partner like Azilen becomes obvious.

Domain Fluency

They won’t just understand PLCs, they’ll know GAMP 5, cleanroom constraints, serialization mandates, and how MES talks to packaging.

Reusable Logic Libraries

No need to rebuild a print-inspection routine from scratch. The right partner brings tested blocks ready to validate again.

Vendor Agility

Your Line 1 runs on Siemens, Line 2 on Rockwell, and you’re testing Beckhoff next year? Great. They should be fluent in all three.

Ready-for-Scale Design

You want to integrate sensors, push data to the cloud, or plug into an MES? The partner builds your PLC system ready for those connections, without needing a full rip-and-replace later.

That’s the role we play at Azilen, coming in as that embedded software partner who knows your industry inside out, and builds PLC automation solutions for pharma packaging that scale, pass audits, and keep lines running smart.

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Thinking Ahead: Data, Analytics, and the Next Layer of Intelligence

Once you’ve embedded logic into your packaging line, you’ve opened the door to next-level optimization.

MES and ERP Sync

PLC-based automation feeds traceable batch, performance, and quality data upstream.

Predictive Maintenance

You can pull actuator data, monitor air pressure trends, and alert maintenance before a failure ever hits the line.

AI-Assisted QC

Pair your PLC system with an embedded machine learning layer to train it on defect detection patterns. Some setups reduce visual QA misses by up to 40%.

Scalable Intelligence

With foundational PLC logic in place, future layers (IoT, machine learning, digital twins) can be added incrementally.

Time to Rethink the Packaging Line’s Brain

Most pharma lines are underperforming at 30–37% OEE, while the top-tier systems with smart PLC setups are reaching 70–85%.

The difference isn’t always the machine; it’s the way that machine is controlled, monitored, and validated.

At Azilen, we help pharma teams rebuild that control layer with embedded software and PLC architectures that fit how real plants run.

We design modular, validated logic that connects to your hardware, fits into your compliance workflows, and scales when you need it to.

If you’re planning to upgrade packaging performance, this is the right place to start. Let’s connect.

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Top FAQs

1. How does PLC automation improve OEE in pharma packaging lines?

By embedding logic that responds in real time (adjusting speeds, correcting faults, and managing changeovers), PLC automation helps reduce downtime, increase throughput, and maintain quality.

That directly lifts OEE from sub-40% to the 65–85% range when done right.

2. What is the role of embedded software in pharmaceutical packaging control?

It’s the layer that connects physical control (PLCs, actuators, sensors) to business rules and compliance.

Think of it as the smart brain that ensures your line not only runs but runs right – batch-aware, GAMP-compliant, and fully traceable.

3. Can existing packaging equipment be upgraded with smart PLC systems?

Yes. Most upgrades are logical, not mechanical. We retrofit embedded PLC software into your current setup, giving you modern control, data visibility, and compliance without replacing the line hardware.

4. How does PLC-based automation support GAMP 5 and EU MDR compliance?

It simplifies it. Modular logic tied to functional specs, automated logging, role-based access, and test-ready designs reduces manual documentation while aligning perfectly with GAMP 5 expectations.

5. What’s the difference between traditional automation and embedded PLC logic in pharma?

Traditional automation runs the line. Embedded logic makes the line smart. It manages context (batch size, packaging type, operator actions, etc.) and acts accordingly, with full traceability and QA integration.

Glossary

1️⃣ PLC (Programmable Logic Controller): An industrial digital computer used to control manufacturing processes, including real-time packaging line equipment like feeders, sealers, and rejection systems.

2️⃣ Embedded Software: Code that runs on dedicated hardware like PLCs or microcontrollers to control specific functions of a device or machine.

3️⃣ OEE (Overall Equipment Effectiveness): A measure of production line performance that combines availability, performance, and quality.

4️⃣ GAMP 5: A risk-based approach to compliant GxP computerized systems, widely used in pharma automation to ensure system quality and documentation standards.

5️⃣ 21 CFR Part 11: A U.S. FDA regulation that establishes criteria for electronic records and electronic signatures to ensure data integrity in regulated environments.

Siddharaj Sarvaiya
Siddharaj Sarvaiya
Program Manager - Azilen Technologies

Siddharaj is a technology-driven product strategist and Program Manager at Azilen Technologies, specializing in ESG, sustainability, life sciences, and health-tech solutions. With deep expertise in AI/ML, Generative AI, and data analytics, he develops cutting-edge products that drive decarbonization, optimize energy efficiency, and enable net-zero goals. His work spans AI-powered health diagnostics, predictive healthcare models, digital twin solutions, and smart city innovations. With a strong grasp of EU regulatory frameworks and ESG compliance, Siddharaj ensures technology-driven solutions align with industry standards.

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