Swiss Quality
Production & QMS – Certified Manufacturing for Containment Systems
Cleanroom production, GMP compliance and Swiss quality in every detail
At Lugaia, our production is guided by a structured and continuously improved Quality Management System (QMS) that ensures full GMP compliance, process reliability, and consistently high product quality.
We manufacture our film-based single-use containment systems in certified ISO 5, ISO 7, and ISO 8 cleanrooms using specially developed converting lines. Each product is documented, traceable and produced under controlled conditions to meet the highest standards in the pharmaceutical, biotech, and chemical industries.
Lugaia manufacturing facility at the headquarters in Raron, Switzerland
Processing of film material of the highest quality in our clean rooms
Qualified machines and validated processes
Isolator leak test in clean room
Precise operation for the highest quality standards
Guarantee Mark ISO 9001
Guarantee Mark ISO 15378
Keyfacts
- Quality management systems according to ISO, GMP and pharmaceutical standards
- Clean room infrastructure ISO 5, ISO 7 and ISO 8
- Certified according to:
- ISO 9001:2015
- ISO 15378:2017
Production
We offer our products in three different quality classes, with each design aimed at a specific area of application. In addition, all production processes, quality controls, and documentation are tailored to their respective applications.
Our infrastructure is designed and set up to manufacture customer-specific products of the highest quality.
|
Extrusion |
Confectioning |
Irradiation |
|
|
Clean room class |
Controlled extrusion air |
ISO 14644-1 class 8 | Optional |
|
Clean room class |
ISO 14644-1 class 8 | ISO 14644-1 class 7 | Optional |
|
Clean room class |
ISO 14644-1 class 5 | ISO 14644-1 class 5 | Optional |
Quality management
As a trusted key supplier to the pharmaceutical industry, Lugaia guarantees that all manufacturing processes strictly follow integrated quality management standards. Our Quality Management System (QMS) complies with Good Manufacturing Practice (GMP) guidelines, ensuring the safety, efficacy and reliability of every product we deliver.
Certified quality standards – ISO 9001:2015 and ISO 15378:2017
Lugaia’s QMS is based on ISO 9001:2015 and enhanced with the ISO 15378:2017 requirements for primary packaging material manufacturers. This ensures full batch traceability, effective risk management, and validated processes – essential factors for delivering high-quality, compliant products.
Controlled manufacturing environment
Our production processes are carried out under strictly controlled environmental conditions, meeting and often exceeding customer-specific and regulatory requirements for GMP-compliant pharmaceutical packaging components.
Highly trained and GMP-certified workforce
Every Lugaia employee receives specialized GMP training to make science- and technology-based decisions, ensuring efficient, safe, and fully compliant production workflows throughout the organization.
Your benefit: Reliable quality without compromise
Thanks to our risk-based QMS approach and strict adherence to international pharmaceutical standards, Lugaia consistently meets or exceeds customer, regulatory, and global requirements for primary packaging materials in the pharmaceutical sector.
