Plant Contstruction Equipment and Layouts

Civil Work:

The Company has signed a letter of intent with the Saudi Binladen Group, a leading local contractor for the civil works on the outer shell of the Plant. The outer shell of the Plant will consist of the outdoor area, the outer building structure and their layouts, designing ventilation scheme, ornaments and top roof plan. The Company believes that securing a final contract (with either Saudi Binladen Group or any other party) should be straightforward, given the wide choice of contractors available locally.

Design and Construction (Inner Shell of the Plant):

The Company has signed a turnkey agreement with Biopharamax B.V. (a company incorporated in Netherlands) for the construction of the inner shell of the Plant on a turnkey basis. Biopharmax is a leading international design and construction company of Pharmaceutical, Biotechnological and Chemical plants including critical, sterile systems and clean rooms.

Biopharmax specializes in execution of projects for the pharmaceutical and biotechnological industries on a turnkey basis. Based on its multi-disciplinary experience and unmatched in-house flexibility, Biopharmax undertakes all project management, design, construction, commissioning and validation until the hand-over of a complete plant.

The inner shell of the Plant will consist of the technical equipment, the process equipment, the production and cleaning utilities, clean room HVAC and layout/flows (as such equipment are described below). The Plant will be constructed in accordance with GMP standards and in accordance with EMEA guidelines. Details of the terms of the contract between the Company and Biopharmax are set out in Legal Section under Key Contracts.

Production Plan

The production plan provides for 30 workers working across two shifts, five days a week and 220-230 days a year. Maintenance of the Facility will require approximately 20 – 30 days in a year. The total staff requirement by 2013 (when the Facility comes online) would be 89 and abovementioned 30 staff members would be needed for production of Insulin and other 59 staff members would be required for handling different functions in the organisation like finance, marketing, business development, administration etc.

Process Equipment

Process equipments will be bought for suspension preparation system, filling lines for vials, cartridges and syringes and packing line for vials, cartridge & syringes.

Suspension preparation system would be used to produce Insulin and the other products. Eight tanks would be needed to produce Insulin. The different tanks that would be ordered for this system are preparation tanks of 200L, 400L, 2 x 750 L and 4 x 1,500 L for final solutions.

The vial filling line will consist of the washing machine, sterilization machine, filling machine, freeze dryer and a capping machine. The cartridge filling line consists of the washing machine, sterilization tunnel and a filling and capping machine. The syringe filling line consist of a de-nesting machine and a filling and closing machine.

In regards to the packaging line, the vial & cartridges will have an automatic visual inspection, a labelling machine, a blister machine, a cartooning machine, a manual case packing, and cold room storage. While the syringes packing line will consists of a semi-automatic visual inspection, labelling + rod insertion machine, cartooning machine, manual case packing, and a cold storage.

Plant Utilities

The Plant utilities will consist of 2 chillers (250 TR each), a hot water system, a compressed air system
(which is comprised of 3 compressors and 3 air dryers) and nitrogen which will be supplied from N2
generators.

Clean Room HVAC

The Plant will also contain a clean room HVAC in which class room walls will be made from HPL
modular panels and the ceiling will be of a walkable type. The HVAC system will contain pre -cooling
and pre-filtration unit (OSA), an air drying (dehumidifier) and humidifier, air handling unit and a
terminal HEPA filter.

Clean Utilities

The plant will also contain clean utilities which will consist of soft water (production, storage, and
distribution system), PUW (production system), WFI (production, storage and distribution system)
and pure steam production system.

Layout

The layout of the plant will have two floors with the following functions; a dressing room, compounding rooms, filling suites, packing rooms, operation offices, laboratories (chemical, analytical, micro biological) and a utility area.

Strategy of Saudi Bio

The Company plans to build the Facility and sell Insulin in KSA and other countries. Acertus Pharma, the technology and raw material provider, will bring on board the strategic planning and technology for the Project as well as providing future technologies to Saudi Bio, while Biopharmax, the construction partner of the Company, will bring the engineering capabilities to do all phases of work needed to complete the “turn-key” project. These two companies bring together key personnel with hands-on experience in all phases of biotechnology management from strategic planning to successful execution of projects.

The first floor will consist of a production area, storage, and offices. The picture below shows a clear illustration. 

The second floor consists of the technical area and the laboratories. The picture below shows a clear illustration. 

The picture below is the side layout of the plant with both the first and second floor.