Swiss Quality
Containment in the Pharmaceutical Industry
How to align safety, efficiency and GMP compliance – without compromise
The demands on pharmaceutical production are constantly increasing: modern active ingredients are often highly potent, regulatory requirements are becoming stricter, and competitive pressure calls for efficient, flexible processes. Today, containment is much more than a hygiene factor – it is a strategic success factor for pharmaceutical companies.
Increasing Demands: The Shift in Active Ingredient Development
This means that even the smallest quantities can be toxic – posing risks to personnel, products, and the environment. At the same time, authorities require full GMP compliance and proof that cross-contamination is effectively prevented.
The trend toward smaller batch sizes, flexible multi-product facilities, and increasingly complex molecules requires a fundamental shift in containment strategies. Only those who continuously adapt their protection concepts will remain competitive in the long term.
Balancing Maximum Protection and Economic Productivity
- Contamination remains one of the greatest challenges to occupational safety and product purity.
- Cross-contamination is a major risk, especially in flexible facilities with frequent product changes.
- Interface management continues to be a weak point - every connection between system components carries residual risk.
- Cleaning efforts: Reusable systems result in high costs and time loss due to cleaning and validation.
They key lies in balancing safety, efficiency and flexibility - and that's exactly where modern containment comes in.
A Strategic Crossroad: Traditional Stainless Steel vs. Modern Single-Use Technology
| Criteria | Stainless Steel | Single-Use |
|---|---|---|
| Robustness | Very high | High |
| Cleaning Effort | Very high (time- and cost-intensive) | Minimal to none |
| Flexibility | Low | Very high |
| Cross-contamination | Risk present | Practically eliminated |
| Validation Effort | High | Low |
| Sustainability | Durable, but resource-intensive | Less water/chemicals, more waste (but recyclable) |
Conclusion: Stainless steel is well-established but inflexible and comes with high ongoing costs.
Single-use technology eliminates cleaning and validation efforts, prevents cross-contamination and enables fast and flexible product changeovers. The higher volume of waste is offset by reduced water and chemical consumption and modern recycling solutions.
Our Approach: Smart Containment Through Flexible Single-Use Systems
Lugaia develops modular and flexible containment solutions designed specifically for the challenges of biotechnological production — particularly for use in upstream processes. Whether inoculating with seed crystals or adding media and buffer components such as salts and sugars for the first reaction steps, our systems ensure safe, clean and efficient handling throughout the process.
- Maximum flexibility for changing products and processes.
- Guaranteed prevention of cross-contamination
- Major efficiency gains through the elimination of cleaning and faster batch changeovers
- Full compliance with all regulatory requirements (GMP, OEL, FDA, EMA)
Our Solutions at a Glance
- For handling highly potent substances: Our isolator systems
- For dust-free powder transfer: Our TransferBag systems
- For meeting the strictest exposure limits: Our OEL expertise
Every solution is modular, scalable and tailored to your specific processes.
Containment is more than a product
The best solution starts with dialogue: our experts work closely with you to analyze your processes, risks and goals. Together, we develop a containment concept that not only protects but also enhances your productivity and ensures regulatory compliance.
