The Roemmers production facility for penicillin based antibiotics opened in 1992 and was recognized as a model plant. It was later expanded in 2007 to increase the storage areas, incorporate new technology and optimize industrial processes. These upgrades also reduced contamination risks while increasing its total productive capacity.
This facility produces products like AMOXIDAL, AMOXIDAL RESPIRATORIO, OPTAMOX, OPTAMOX DÚO as well as products for export according to national (ANMAT) and international standards (FDA – Food and Drug Administration - and EU – European Union).
This facility meets IRAM certification in GMP “Good Manufacturing Practices in Penicillinic Antibiotics for Oral Use” as well as ISO 14001 certification granted by DNV (Det Norske Veritas) for its environmental efficiency system and the GMP MERCOSUR Certification issued by the Argentine government as well as the equivalent certificate issued by INVIMA of Colombia.
This facility covers a 4,800-m2 area and has a production capacity of 35 million units per year. It operates with a staff of 90 highly qualified and trained people which include professionals, technicians and other employees.
All pharmaceutical services are controlled and supervised by a state-of-the-art Distributed Automated Control (DAC ) system. Production management is integrated by means of an SAP R/3 supervisory system which uses bar code methodology for pharmaceutical management during all its operations.
This facility features a modern three dimensional design which enables the facility to maximize in surface and volume usage with gravity-based vertical and horizontal flow of materials. Unitary operations (grinding, granulation, mixing) are performed in closed circuits with direct transference of powder from special stainless steel containers into production equipment for the various pharmaceutical shapes.
Production is carried out in high-speed equipment utilizing high-quality electronic control systems, an automatic monitoring system that controls all variables. All production is done in low humidity and controlled temperature conditions (22 to 28 % HRA: 20 to 25° C).
Key features of this facility include:
- Manufacturing: closed and clean grinding /granulation and mixing processes using vacuum loading systems and stainless steel containers guarantee compliance with GMP standards and minimize environmental impact. Transferences of mixtures by gravity go directly to the generating equipment that produces the various pharmaceutical shapes.
- Suspensions: fractionation equipment for powder in bottles fed under controlled gravity from the transference area. Vacuum Fractionator system – pressure on the line, with a continuous box-making machine featuring sensors for supplies, product and bar codes. Final control of the finished product through dynamic weighing systems.
- Tablets: high-speed rotating tablet - making fed by a gravity controlled system from the transference area. A compression system with forced feeding featuring controls for automated variables (weight, hardness, and thickness) with metal detectors and tablet selector.
- Arrangement in blisters: equipment for arrangement in continuous sealed blisters for PVC – Aluminum and Aluminum – Aluminum with special feeding and product control via color CCTV. The system includes presence sensors for all components, bar code readers and final control by dynamic weighing systems.
- Quality Control: The Laboratory for Quality Control has all the necessary testing instruments available as well as high-resolution automatic equipment. All equipment is properly maintained and calibrated. Fully-trained technicians that comply with GLP standards (good laboratory practices) guarantee the quality of products by applying quality control systems according to international standards.
Samplings and analyses are performed throughout the production process to include raw materials, products in process and finished products thus ensuring the quality of the products that are released to market.