Case Study

Project Transferring product from R&D to HVP

  • Managing process design
  • 3 compounding vessels
  • Beads mill equipment
  • Adapting the existing facility to the product requirements

                 ➢ HVAC changes
                 ➢ Facility (Clean rooms modification for new design)
                 ➢ WFI system (New user points)
                 ➢ CIP system
                 ➢ Cooling and heating system

Project – New technology OSD

  • Managing project design (Layout, facility, utilities, equipment definition)  
  • Dismantling existing equipment (Fluidize bed dryer, mixer, lifter)
  • Purchasing new vacuum dryer ,mixers and lifter
  • Vacuum convey system for working in close containments
  • Adapting the existing facility to the product requirements

            ➢ HVAC changes
            ➢ Facility (Clean rooms modification for new design)
            ➢ Purified Water (New user points) , compressed air , nitrogen , electricity , breathing air, industrial steam.
            ➢ Cooling and heating system

  • Validations
  • Operation and maintenance procedure writing

Project - New bin blender

  • Dismantling old Blender
  • Define and purchase new blender
  • Facility changes (construction ,clean room)
  • Supervision on Installation
  • Validation
  • Operating instructions
  • Maintenance procedures

Project Convey powder in close systems

  • Managing process design
  • Vacuum convey system – Purchasing and installation 
  • Modification on existing equipment
  • Validation
  • Operation and maintenance procedures

Validations - Sample of projects

  • New sterile R&D suite including vials & syringes –
    Responsible for all validation activities:

         ➢ Filling lines (vials + syringes)
         ➢ Autoclaves
         ➢ Compounding vessels (including CIP/SIP systems)
         ➢ Washing machines
         ➢ Temperature mapping (Refrigerators , Freezers , Incubators, more…)
         ➢ Critical systems (HVAC, WFI, Pure steam , Gases )

  • R&D Bio generic

         ➢ Responsible for all validation activities ( Centrifuges , Bioreactors ,Refrigerators , Freezers , Incubators , Autoclaves, Critical systems)

Medical Device - Transferring product from R&D to high volume production

  • Managing project to meet regulation updates 
  • Changes in product including – Mechanical (Injection molding parts , CNC) , Electrical , Software 
  • Modification on existing equipment
  • Validation and Verification (V&V)
  • Updating operation procedures , Manuals & working instructions 

Medical Device - QA Services R&D , Cardio section

  • Managing QA department activities in the company 
  • Establishing, implementing and controlling QMS
  • Risk Management, from planning to RMR
  • Quality Control management
  • Validation and Verification (V&V)

Medical Device - Transferring product from R&D to high volume production

  • Managing project to meet regulation updates 
  • Changes in product including – Mechanical (Injection molding parts , CNC) , Electrical , Software 
  • Modification on existing equipment
  • Validation and Verification (V&V)
  • Updating operation procedures , Manuals & working instructions