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Home > Biopharmaceutical processing > Projects management
   
  Projects management
   
 
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Our goal: :
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Giving you advice for the definition and the fruition of your project
Development of global solutions in order to master the handling of the project and guarantee we will meet our commitments (performances, schedule)
Ensuring a perfect traceability
 
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Biopharmaceutical processing : Before-project  

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Biopharmaceutical processing: Design  

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Biopharmaceutical processing : Manifacturing and FAT  

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Biopharmaceutical processing : Installation, Tests and Validation on Site  

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Biopharmaceutical processing: Maintenance  
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Preliminary scheme

  • Study of the specifications
  • Technical recommendations and commercial offer

Design

  • Preliminary study: delivery of the simplified functional analysis, equipment dimensioning, preliminary layout, structure of the automation for validation.
  • Detailed study: delivery of the manufacturing drawings, nomenclature, materials data sheet, and detailed functional analysis for validation.
  • Design in accordance with the cGMP and CFR guidelines

Manufacturing and FAT

  • Scheduling and production scheme in compliance with the "Quality Plan Project"
  • Manufacturing & Assembling
  • Finalization of the documentary file
  • Delivery of the FAT protocols
  • Complete FAT in our technical plant before shipment

Commissioning, tests and validation on site

  • Installation on site
  • Preliminary tests
  • SAT
  • Assistance to the IQ and OQ qualifications
  • Training

Maintenance

  • Data processing telemaintenance trough modem
  • Preventive maintenance contract on site
Curative maintenance intervention (in France and abroad upon request)
 
 
       
ACTINI GROUP • Designing & manufacturing of heat treatement plants Actini Actini Actini processing
Parc de Montigny • Maxilly • 74500 EVIAN • France
Phone: 33 (0)4 50 83 12 12 • Fax: 33 (0)4 50 83 12 10 • e-mail