Swiss Quality
Maximum Safety for Highly Potent Active Pharmaceutical Ingredients (HPAPI)
How our single-use Containment Systems take personnel and product protection to the next level
Safe handling of highly potent active pharmaceutical ingredients (HPAPI) is one of the key challenges in modern pharmaceutical and chemical production. Even the smallest amounts of these substances demand the highest level of precision to protect personnel, products, and the environment. With well-designed containment solutions, regulatory requirements can be reliably met while ensuring efficient production processes.
Safe Handling of Highly Potent Active Pharmaceutical Ingredients (HPAPI)
Challenge: Handling Highly Potent Pharmaceutical Substances
The development and production of highly potent active pharmaceutical ingredients (HPAPI) is steadily increasing in the modern pharmaceutical industry. These substances offer significant therapeutic benefits but also present major challenges in terms of occupational and product safety. Even the smallest amounts can be toxic – resulting in strict occupational exposure limits (OEL) and extensive regulatory requirements. Companies must reliably protect personnel, products, and the environment while ensuring efficient and cost-effective processes.
Our Solution: Flexible Containment Systems for Maximum Safety
Lugaia offers innovative single-use containment systems specifically designed for working with HPAPIs. Our solutions reliably protect employees and products from contamination, reduce cleaning and validation efforts, and enable quick product changeovers. With customizable isolators, TransferBags, and continuous liner systems, we meet the highest safety and quality standards – “Made in Switzerland.”
The Challenge: Risks in the HPAPI environment
Highly potent active pharmaceutical ingredients (HPAPIs) present unique challenges:
- High toxicity demands maximum safety for personnel.
- Very low OEL values make precise containment essential.
- Cross-contamination must be prevented through closed processes.
- GMP requirements call for validated, risk-based solutions.
We understand the risks associated with handling HPAPIs – and provide targeted containment solutions that ensure protection, compliance, and product integrity.
OEB
1,ungefährlich
Containment-Massnahme: Beutelsysteme mit lokaler Absaugung
2,fast ungefährlich
Containment-Massnahme: Beutelsysteme mit lokaler Absaugung, Transfer- und Schutzfoliensysteme
3,wenig gefährlich
Containment-Massnahme: Transfer- und Schutzfoliensysteme
4,gefährlich
Containtment-Massnahme: Isolatorsysteme, Transfer- und Schutzfoliensysteme
5,sehr gefährlich
Containment-Massnahme: Isolatorsysteme, Transfer- und Schutzfoliensysteme
6,extrem gefährlich
Containment-Massnahme: Isolatorsysteme
OEL
>1000 µg/m³
#00688F
100-1000 µg/m³
#007659
10-100 µg/m³
#8DC126
1-10 µg/m³
#FEC900
<1 µg/m³
#F17F26
< 200 ng/m³
#E50B14
Closed systems for absolute integrity
Single-use isolators and transfer systems are ideal for handling highly potent active pharmaceutical ingredients (HPAPI). They offer key advantages:
- No cleaning validation – reduces effort and risk
- Fast product changeovers – increases production flexibility
- Guaranteed containment – ensures reliable personnel protection and prevents contamination
The well-designed single-use approach minimizes downtime and supports GMP-compliant, safe processes – especially in demanding pharmaceutical applications.
SafeSeal Crimp
The Lugaia SafeFlex Isolator
Swiss engineering for your safety
Our advanced infrastructure enables us to develop both standardized containment products in various cleanroom classes and customized single-use solutions – all manufactured to the highest Swiss quality standards and precisely adapted to your on-site process conditions.
swiss
Swiss Quality
As a Swiss company, we stand for exceptional precision, tested quality and maximum reliability.
key
Customized Solutions
We develop tailored, customer-specific containment solutions, aligned with your processes and requirements.
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Design Excellence & Innovation
Our in-house products are continuously developed to meet increasing safety, efficiency and regulatory requirements – ensuring you a sustainable competitive advantage.