The talk will consist of an account of the Pharmaceutical Market in Latin America:

- Growth of the countries in the area;

- Most sold drugs and new products;

-  Fastest growing Laboratories; 

- Current market situation and needs of the Pharmaceutical Industry for drug supply     to a growing population;

- Technological developments in the manufacture of pharmaceutical products;

- Biosimilar products in the Latin American markets.

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What is changing in Pharmaceutical world? How the new business model and the request of harmonization can impact the Pharmaceutical Business and the way to manage project?

The implementation of new rules to improve products quality & product Knowledge, increase product quality, harmonizes international standard requirements and requires evidence of Internal Knowledge from R&D to industrial process.

EMA Europe, as FDA USA, starts to apply PQLI principles so, Quality by Design Rules for Product development and Product changes, with direct impact on new Product Registration and variation.

A direct impact on the Region is due to Mexico and Brazil, which starts to apply restrictive inspection mechanism, new audit’s requirements for product, starting from the application of new restrictive GMP, up to specific Computer System Validation requirements.

To stay competitive in International Pharma Business, it’s necessary to follow the evolution of GMP and Validation Requirements, which make the International Rules of different countries even more similar, in terms of quality and controls.

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Aseguramiento de calidad en el proceso estéril EZ Fill, es una visión general del rol que tiene la función de aseguramiento de calidad en los distintos procesos involucrados en entregar al cliente un producto listo para uso.

Se muestran y explican:

• los certificados de calidad con los que se cuenta en la empresa
• una visión a la organización de Aseguramiento de Calidad en Stevanato Group
• una breve descripción de las instalaciones involucradas en los procesos para este producto además de diagramas donde se muestras los controles de calidad que se tienen implementados en cada una de las operaciones desde que llegan las materias primas hasta que se hace la liberación final después de la esterilización.
• Por último se da una muestra y explicación de lo que OMPI puede entregar al cliente con cada embarque de producto EZ Fill entre muestras representativas del lote y el Certificado de Calidad.

Glass containers are the primary packaging choice for drugs and vaccines in the pharmaceuticals market due to the intrinsic inert nature of glass Type I.

Essential requirements of the new biotech formulations are high hydrolytic resistance, high neutrality and chemical resistance of the inner surface to preserve drugs potential, increase shelf life and reduce rejection rate for leachable.

The “ready to fill” concept is gaining market shares not only for syringes but also for cartridges and vials and asserts the need of a new quality level based on highly controlled dimensional accuracy for automating processes and the highest cosmetic level to reduce more expensive end-of-line rejection rate and assuring market acceptability.

In the conservative, data-driven industry of pharmaceutical packaging, market trends clearly indicate a growing demand for fluoropolymer coated elastomeric closures, primarily in order to mitigate risks related to drug stability and compatibility.

The Omniflex fluoropolymer coating is highly differentiated from traditional film coatings as it is the first coating to simultaneously provide barrier properties and to eliminate the closure as a source of silicone oil-based subvisible particles.

The Omniflex performance advantages are rooted in the coating’s chemical composition and its method of application to the elastomer closure.

Los estándares de producción biofarmaceutica incrementan constantemente sus requerimientos en seguridad y aseguramiento de esterilidad.

Una forma efectiva de mejorar los procesos es mediante el uso de tecnologías de Puertos de Transferencia Rapida.

En 1960 La Calhène desarrollo el sistema DPTE®, para la contención y manipulación de material radioactivo. Hoy en dia este sistema es ampliamente usado en la industria biofarmaceutica a nivel mundial para asegurar los mas altos estandares y flexibilidad en procesos de produccion.

Una versión desechable mitiga los riesgos de contaminación cruzada, y elimina la necesidad de validación de limpieza. En caso de que estén disponibles sistemas apropiados de lavado y esterilizado, existen versiones reusables.

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A new generation of machines with continuous handling at high speed increases the Optrel portfolio for the next years.

New high speed and high resolution sensor technology in conjunction with more powerful real-time dedicated processing electronics open opportunities to increase the performances of the inspection machines by implementing not only detection algorithm but also classification strategies in real-time.