Krka opens Notol 2 plant – our largest investment to date

“The investment into a new solid dosage forms production plant, Notol 2, which will allow Krka to significantly increase its production capacities, is the result of our desire to increase production due to market needs. With Notol 2 and other investment projects – there are currently around 20 of them underway in the Krka Group – Krka will increase its production capacities by 40% in the next five years, and the scope of production in terms of quantity will increase to 17 billion tablets and capsules per year”, explained Krka’s President of the Management Board and Chief Executive Jože Colarič. He emphasised that Notol 2 is an important achievement for Krka also because it applies the philosophy of the vertically integrated business model. This is one of key strategic advantages in managing the development and production of products from the production of APIs to the production of finished products, and to launching those products to the market.

The investment is worth EUR 200 million, whereby EUR 3 million was contributed by the European Union from the European Regional Development Fund. The Notol 2 plant will provide for the production of strategically important pharmaceutical products, increasing the competitiveness of Krka’s products and consolidating the company’s position on all its markets. Vertically integrated products are the result of Krka’s own development and know-how, representing more than 70% of Krka’s portfolio.

A modern plant with a surface area of 55,000 m² was completed in two and a half years.

The construction of four buildings with a total surface area of 55,000 m² connected with bridges to the solid dosage forms production plant Notol and the Finished Products Warehouse started in June 2012 and lasted two and a half years. The building was built in the autumn of 2013 and facility installations were ready for clean rooms to be set up and logistic and technological equipment to be installed. 

In 2014, qualifications and validations of systems (the logistic system, technological equipment and technological media) were carried out. They were quite challenging due to the complexity of the plant and the high level of automation. In September 2014, the plant passed a technical inspection and in November 2014 it acquired the approval for test operations. Production started in February 2015 after having successfully passed the verification inspection conducted by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.

The result of knowledge of Krka experts

The Notol 2 production buildings include three physically and functionally connected buildings: production, packaging unit and a warehouse. The building dedicated to the production of bulk products has seven levels; the temporary storage room is set up in the high-bay warehouse having seven levels as well. To ensure greater efficiency of the logistic system, the warehouse is located between the production and packaging unit, while in terms of transport it is connected to the receiving area in the Notol plant and the Finished Products Warehouse. The building in which packaging of finished products is conducted includes four levels. Connecting bridges are intended for transporting raw materials and packaging materials, automatic transporting of containers with bulk products, entering of personnel into the canteen, and the passing of visitors. Therefore, Notol and Notol 2 form a technological unit.

The building is constructed on deep foundations of reinforced concrete piles of 100 cm and 125 cm in diameter. It took 31,000 cubic meters of concrete, 2,408 tonnes of reinforcing steel, and 4,720 tonnes of steel for this building to be constructed. In total 8,128 tonnes of steel were used, including the steel construction of the high-bay warehouse. 130 kilometres of hoses and 1,000 kilometres of cables are laid in the plant. Excluding the bridges and the connection with Notol, the main building stands at 127 m in length, 96 m in width and 35 m in height.

The conceptual design of the plant is the result of knowledge of Krka’s experts. All projects for the construction and installation are made by using the Slovenian know-how, apart from the project documentation for the intralogistic system. Technical documentation took one year and a half to be prepared and 12 engineering companies participated in the project. Eight main, exclusively domestic contractors took part in construction.

Gradual installation of equipment: the second phase on the way

The installation of equipment is made gradually, depending on the needs of the market and increase in production volume. During the first phase, at the start-up of Notol 2, approximately one third of technological equipment was installed, which translates into 1.5 billion of tablets, film-coated tablets and capsules per year.

Three weighing rooms, three granulation lines, three container tumblers, two inertisation chambers, seven tablet presses, three coating pans, seven packaging lines, seven robot cells, washers, docking stations, parking stations, air compressors, manual washing facilities, and tablet inspection units were installed in the first phase. The second phase is currently underway, which is aimed to cover two-thirds of installation equipment. The production lines will be gradually bought and capacity will be increased to the total capacity of 4.5 billion tablets and capsules per year.

By late October, Krka cooperated with 107 domestic and foreign suppliers of production, technological, logistic, computer and other equipment; 45% of suppliers were domestic.

Energy efficiency to contribute to lower electric energy consumption

The electric energy consumption for the production of cooling energy is decreased also with free cooling directly in air-conditioning systems, which – in winter – facilitates the use of external air for preparing cold water, which is used for air-conditioning and technology requirements. It is estimated that the consumption of electrical power for producing cooling energy will annually decrease by more than 500,000 kWh (10%).

A new construction solution which is the result of own development has contributed to optimising the moisturisation or preparation of air. The electric energy consumption by air-conditioning systems will annually decrease by more than 200,000 kWh (17%), while the consumption of cooling and heat energy will decrease by more than 5,000,000 kWh (20%) in total.

The new building has its own compressor station for preparing compressed air, which is required in technological processes. Heat energy produced during air compression is thus used for preparing heating water, which is needed for air conditioning and technologies. Annually, the consumption of the primary energy source for preparing heat energy will therefore be reduced by more than 800,000 kWh (8%).

The above measures will reduce CO₂ emissions by 3,130 tonnes per year.

A high level of automation and computer support

Due to technical solutions the building allows the manufacturing process to be compliant with GMP standards and the highest requirements in the pharmaceutical industry.

The production is based on vertical and gravitational flow of materials (raw materials, semi-products and bulk products), which are dosed through docking stations into containers, granulators, tablet presses, coating pans, inspection machines and packaging lines.

The advantage of Notol 2 is its high level of automation and computer support with the emphasis on a computer-controlled production system and an automated computer-controlled system of material flow. A computer-controlled production system includes automated internal transport, which takes care of movements of material between certain production phases, while connecting certain production phases into a comprehensive process.

The automated transport system also includes the high-bay warehouse where 35 m high robot stacker cranes operate with the capacity of 180 pallets per hour. The warehouse is connected with production phases via transport lines and automated guided vehicles. Automated guided vehicles (AGVs) are robot forklift trucks used for transporting various pallets or containers to production islands. They are guided via a computer-controlled system and laser navigation technology. They are equipped with safety systems, thus enabling work also in areas where personnel may be present.

Internal transport is provided also by manual and electric pallet trucks and forklift trucks. All movements of material are recorded in the PAS system.

Personnel safety and environmental protection

When planning the plant, particular attention was devoted to personnel safety and environmental protection; technical solutions were, therefore, adapted to these requirements. The plant has been certified and operates in line with the standards ISO 14001 Environmental Management and ISO 18001 Occupational Health and Safety. Production is carried out in closed systems.

The selected production equipment facilitates efficient consumption of energy and waste materials, while at the same time reducing emission of hazardous substances into the environment. The best available technology was used for reducing impact on the environment. Waste air from production emitted with dust particles is cleaned with dedusting systems and absolute filtration, while the air emitted with volatile organic substances is cleaned with thermal oxidisation on modern and effective devices. Thus, high-quality of air is ensured in the surrounding areas.

Waste waters are treated by a highly efficient waste water plant, while waste is, as much as possible, separated at its source and afterwards handed over to authorised contractors for processing or disposal. Meteoric water and the last rinsing water from cleaning the equipment are gathered in an underground reservoir and used for preparing the water for energy purposes.

A modern fire protection system and other measures reduce the possibilities for fire and other emergencies that could negatively influence the environment. Due to its selected production equipment based on the best available technology and the aforementioned measures, Notol 2 will facilitate the most effective consumption of energy and waste materials as well as keep air emissions as low as possible.

The plant has 127 employees and closely cooperates with many Krka employees from:

• Product Supply (Pharmaceutical Production Division, Supply Chain, Technology Operation Centre, Warehousing and Transport Services),
• Engineering and Technical Services (Environmental Protection, Engineering, Media Supply, Technical Services),
• Research and Development (Pharmaceutical Development),
• Quality Management,
• Information Technology and Telecommunications,
• Health and Safety at Work, and
• Public Services.

 

In the last decade, the Krka Group has allocated EUR 1.2 billion for investment projects, of which EUR 174 million in 2014. There are approximately 20 investment projects underway this year, all of which will help increase the company’s production capabilities in the next few years by more than one third. This will increase the annual scope of production in terms of quantity from nearly 13 billion tablets and capsules to more than 17 billion.