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
- 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)