our-projects

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

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 - 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 )

Validations - Transferring one site to new site 

Validating entire biosimilar facility that includes critical systems, equipment and providing all quality services for the project

New R&D site – RS Ness were responsible for all validation activities including:

 ➢ Bioreactors
 ➢ Centrifuge 
 ➢ Autoclaves
 ➢ Incubators, Freezers , Refrigerators , Cold rooms.
 ➢ Washing machine
 ➢ Biological Hoods
 ➢ Critical systems
  • Facility & HVAC
  • Purified Water (PW) & SW
  • Pure steam 
  • Gases (CAS,N2,O2,CO2)

Total units – 126 units of Equipment

Upgrading Coating Room

Upgrading coating room and installation of new coating machine (Thomas Engineering – Flex 500) including 2 sizes of drums (150 & 350 liter)

  • Design Management
  • Construction Management in an operating facility
  • Equipment Characterization and Procurement Management
  • Implementing all EHS requirement of working in ATEX area and high potency
  • Facility Upgrades and Utility systems

üHVAC changes

üFacility (Clean rooms modification for new design)

üPurified Water (New user points) , compressed air , nitrogen , electricity , breathing air, industrial steam.

üCooling and heating system

  • Validation Execution– VMP , Protocols , testing and reports

Validating new R&D sterile facility, Equipment’s & Systems

New sterile R&D suite including vials & syringes responsible for all validation activities including:

Two 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  

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

  • 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)