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Production & Quality

Swiss precision and cutting-edge technology

Keyfacts

  • Quality management systems according to GMP, pharmaceutical, and ISO 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

Sterilization

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.

FAQ - Frequently Asked Questions

In case you missed something

Are your products suitable for sterile production?

Sterilization by gamma irradiation is possible to a certain extent.

Can single-use containments also be used for liquid media?

Yes. If you are interested, please contact us directly via e-mail at anfrage@lugaia.ch.

What documentation is included in the delivery?

Batch-related manufacturer certificate, declaration of conformity, special certificates on request Isolator: Additional technical documentation and operating instructions.

What industry requirements do the products meet?

Our technologies have the necessary certifications for the pharmaceutical, biotechnology, and life science’s industries. All components are manufactured in an ISO8 / 7/5 clean room and remain in this environment until final packaging and delivery.

What is the main application of Lugaia products?

Production of active ingredients in powder form (API’s, HPAPI’s).