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:
- 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)