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Design and Construction of an Advanced Biotechnology Facility in Compliance with GMP and FDA Standards

Advanced Biotechnology Facility for SIGMA-ALDRICH

Ludan led the design management and construction of an advanced biotechnology manufacturing plant for SIGMA-ALDRICH, ensuring compliance with the strictest GMP and FDA standards.

The project involved the establishment of an advanced biotechnology GMP Biopharm Plant in Jerusalem, Israel, in collaboration with an Italian design firm specializing in biotechnology manufacturing. The plant integrates advanced technologies, smart automation systems, and rigorous quality control processes, ensuring clean, precise, and efficient production in the pharmaceutical industry.

The project was executed in an EPCMV format, including the management, design, procurement, and construction of all critical systems for biotechnology production:

Project Scope:

Full Engineering Design – Including plant layouts, process design, civil engineering, piping design, and electrical and control engineering.
System Design and Control – Advanced monitoring and control systems, automation design, instrumentation, electrical, and infrastructure systems.
Execution and Installations – Including construction, setup, operation, and commissioning of systems.
Validation Tests – In compliance with strict GMP and FDA requirements.

Thanks to Ludan’s professional and innovative management, the project was successfully completed, adhering to high standards, budget, and timeline, incorporating advanced technological solutions in the biotechnology and pharmaceutical industry.

Project Details:

  • Client: SIGMA-ALDRICH
  • Location: Jerusalem, Israel
  • Project Duration: 2005–2007
  • Project Value: $30 million
  • Field of Expertise: EPCMV (Engineering, Procurement, Construction Management, and Validation)

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