This production facility for solid medicines began operations in 2000 and is devoted exclusively to the manufacturing of non-antibiotic solid products. It is a key facility both for the company as well as for our country. It is one of the few automated pharmaceutical plants in Latin America and is comparable to the most advanced facilities currently operating in Europe and in the United States.
This facility came about as a result of Roemmers´ commitment to invest in the Argentina’s infrastructure by modernizing the national pharmaceutical industry. This facility will allow Roemmers to meet the growth of local and regional demands for medicines. This in turn positions Roemmers to successfully compete within a new, globalized scenario by fulfilling strong international commitments.
The facility covers a 22,000 m² area and has a production capacity of 85 million units per year. The total investment in the construction of this plant amounted to 65 million dollars and it currently employs 247 highly qualified and trained people to operate the sophisticated processes and control systems.
The plant features a building used for receiving and controlling raw materials and supplies, integrated plants for production and packaging and a fully automated warehouse system.
Key features of this facility include:
- Closed and clean production processes that guarantee compliance with GMP standards (production in sealed intermediate bulk containers or IBC containers).
- Design and documentation required by the FDA in order for products to meet FDA Quality Assurance requirements. This includes a modern three dimensional design which enables the facility to maximize its surface and volume usage with gravity-based vertical and horizontal flow of materials.
- Environmental protection.
- The introduction of new production technologies.
- Separation of primary areas (production, packaging) and secondary areas (social rooms, laboratories, administration, maintenance) thus simplifying services such as air conditioning and ventilation.
- Automation and supervision of all pharmaceutical services through a state-of-the-art Automated Control System featuring DAC (Distributed Automatic Control). Production management is integrated through an SAP R/3 system.
One of the key features of this facility is the way ventilation is handled. There are three very clearly defined ventilation areas: external black areas that are in contact with the external air, internal black areas (“clean” but without any special air quality requirements) and grey areas (“clean” areas with special air quality requirements).
In order to comply with the most demanding international sanitation and health standards, production procedures which formerly used to include manual operations have been replaced by closed sterile technologies which, at the same time, have no negative impact whatsoever on the environment. This eliminates the exposure of medical products to the environment as well as optimizing the use of the raw materials that go into the making of the medicines.
Environmental care occupied a relevant place in the plant’s development. The effluents, mainly from the equipment wash water, are processed in a treatment plant. Gas extraction flow is treated with filtering equipment that turn particle emission to the atmosphere almost null. Solid residues are classified and incinerated.
It has been awarded a certificate of Compliance with Good Manufacturing and Control Practices, issued by the Argentine authority ANMAT, valid in all Mercosur, as well as the equivalent certificate issued by INVIMA of Colombia.