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

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)