Lyophilization Division

Lyophilization Division

Lampugnani Farmaceutici S.p.A. has been operating since 1973 as a specialized contract manufacturing organization (CMO) in the field of bulk lyophilization of sterile and non-sterile Active Pharmaceutical Ingredients (APIs).

With decades of experience, the company combines advanced expertise, state-of-the-art technologies, and a highly skilled workforce to deliver reliable and high-quality lyophilization services. Continuous investment in both technology and personnel enables Lampugnani Farmaceutici S.p.A. to consistently meet the most stringent international quality standards.

Thanks to its proven reliability, operational excellence, and strong commitment to quality, the company has earned the trust of leading pharmaceutical and chemical manufacturers worldwide.

Lampugnani Farmaceutici S.p.A. is the ideal partner for companies seeking to outsource bulk lyophilization to an experienced and dependable organization capable of ensuring the highest standards of quality, regulatory compliance, and process performance.

Production

The lyophilization facilities of Lampugnani Farmaceutici S.p.A. have been specifically designed for contract manufacturing, providing the flexibility required to accommodate a wide range of products and customer-specific process requirements.

The manufacturing process is highly automated, ensuring that the most critical operations are carried out within closed and protected systems. This approach enhances process reliability, and supports full compliance with current Good Manufacturing Practices (cGMP).

In addition, a dedicated Research & Development (R&D) department supports customers in the optimization of existing lyophilization cycles and the development of new processes, facilitating efficient technology transfer and process scale-up while ensuring robust and reproducible manufacturing performance.

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Quality Control

Lampugnani Farmaceutici S.p.A consider quality as a stronghold in its strategy. The whole structure of Lampugnani Farmaceutici S.p.A.is focused on a rigorous Quality System that ensures the compliance of GMP and GLP.

In two laboratories, chemical and microbiologic laboratory, the high skilled staff performs every analysis required.

Technical Area

All the industrial machinery and equipments involved in the manufacturing process have been selected to ensure the maximum possible standard of quality and dependability.

Sterilisable freeze-driers with pressurised steam, distilled water, purified water, pure steam production plants, filtration lines, fluid distribution loops, HVAC plants, dry sterilizers, Autoclaves and all the machines used are guaranteed in their efficiency through rigorous validation and maintenance programs.

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