Swiss Quality
Production & Quality
Swiss precision and cutting-edge technology
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 |
Packaging |
Radiation |
|
|
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 key supplier to the pharmaceutical industry, Lugaia continually meets the expectations of pharmaceutical manufacturers. We document that our processes are subject to an integrated quality management system (QMS) and the rules of good manufacturing practice (GMP).
A well-structured QMS is based on ISO 9001: 2015 and expanded with the GMP requirements for manufacturers of primary packaging (ISO 15378: 2017) guarantees the safety, effectiveness, and reliability of our products.
In addition to the requirements of ISO 9001, we comply with GMP-specific criteria such as batch traceability, risk management, and process validation. Production is also based on the higher demands of our customers by manufacturing the products under controlled environmental conditions.
Our QMS is risk-based so that our actions are optimally controlled and the probability of risk is minimized.
Tasks, competencies, and responsibilities apply to all employees not just managers. Every Lugaia employee is familiar with the basics of GMP and has enough training to make GMP-compliant decisions. Corporate decisions take into account the current state of science and technology, especially in the pharmaceutical sector. By adhering to the GMP principles, we also ensure more efficiency in production processes.
The result of our QMS demonstrates that the requirements of our customers, as well as the legal and international requirements for primary packaging for medical products, are fully met.
