our-projects

Construction of clean rooms and laboratories

Project Scope

  • 1200 M2 of ISO5-ISO8 class
      • QC Lab
      • R&D Lab
      • Production area
      • Offices
    • Vial Filling machine
  • Process

    • Analysis of Company needs
    • Site Selection process -detailed comparison between options.
    • Program definition
    • Presentation to board of directors with recommendation on preferred option
    • Conceptual design
    • Detailed design
    • Full Turn key Project Execution
    • FAT, IQ,OQ, PQ
    • Site hand over

Medical Cannabis

Construction of the largest Indoor cannabis facility in the Middle East

 

Project Scope – Plant breeding Farm 

  • 4000 M2 of ISO8 class
    • Indoor plant breeding farm – AKA “Growing area “
    • Post harvest area
    • Safe rooms
    • QC Lab
    • Offices

Process

  • Managing project design (Layout, facility, utilities)

            ➢ HVAC design and installation
          ➢ Facility (Clean rooms modification for new design)

  • Validations
  • Operation and maintenance procedure writing

The Facility is  designed to meet all aspects of IMC-GMP, EU-GMP, IMC-GAP and GACP and safety requirements.

pharmaceutical

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

medical device

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 

Mapping all infusion pumps components for RoHS 3

Mapping all infusion pumps components for RoHS 3
(RoHS directive 2011/65/EU including Commission Delegated Directive 2015/863) compliance,
replacing non-RoHS compliance components,
certifying all components suppliers as RoHS-3 compliant suppliers

  • Engineering

   Research for RoHS-3 compliant replacement (glue)

   Update BoM

   Test components in TUV laboratory

  • QA

    Certifying all components of pumps

    Certifying process of assembling

    Certifying suppliers as RoHS-3 compliant supplier

  • Regulatory Affair

    Update/ create technical file

Medical Device - QA Services R&D , Cardio section

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)