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
Over 50% of all newly developed active ingredients today are classified as highly potent substances (HPAPIs) and fall under OEB Level 3 or higher. 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 relies on intelligent, flexible containment solutions that are precisely tailored to the needs of the pharmaceutical industry.
- 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 – It’s a Holistic Strategy
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.