Farmacéutica

La industria farmacéutica enfrenta actualmente el importante reto de aprovechar al máximo las oportunidades que se presentan en los grandes mercados emergentes. Ahora, más que nunca, las compañías farmacéuticas necesitan introducir técnicas de fabricación ajustada que mejoren la rentabilidad. Siendo uno de los principales proveedores de automatización en el mundo, Yokogawa asume el compromiso de suministrar las mejores soluciones posibles para sus mejores prácticas de fabricación.

Desafíos

El reto de los clientes

Adaptarse a un mercado en constante cambio
Los fabricantes de productos farmacéuticos se encuentran bajo presión para hacer frente a cambios tales como la transición a medicamentos de bajo costo en mercados emergentes y la demanda de medicamentos que satisfagan eficazmente necesidades médicas no cubiertas. Para operar con ganancias, los fabricantes están buscando opciones para mejorar la eficiencia y aumentar la productividad. La fabricación ajustada es la clave.

Nuestras soluciones

Soluciones de automatización vanguardistas de Yokogawa
Nuestras soluciones permiten la integración y la optimización del ciclo de vida en todas las áreas de la planta en las plantas farmacéuticas. Estas son algunas aplicaciones farmacéuticas para las cuales Yokogawa provee soluciones de automatización integrales, contando además con una red global de expertos a su servicio.

 

Gestión de la producción y control por lotes para plantas multipropósito
La producción de ingredientes farmacéuticos activos (API) involucra procesos por lotes, algunos de los cuales producen una diversidad de productos para varios propósitos. Esto requiere el uso de un sistema integral de control de lotes. CENTUM VP, el sistema integrado de control de la producción, proporciona funciones de lotes con base en el estándar ISA‐88 de control de proceso por lotes y cumple con los requisitos del título 21 parte 11 del Código de Regulaciones Federales de la FDA.

 

Las operaciones "sin papeles" basadas en el título 21 del CFR parte 11 se están volviendo más comunes en la industria farmacéutica.
Los Registradores electrónicos de la serie SMARTDAC+® GX/GP permiten funciones de registro electrónico que cumplen los requisitos de la parte 11. Las firmas electrónicas se pueden agregar a los datos almacenados. Yokogawa puede ofrecer instalaciones completas con todos los documentos de validación esenciales

Control estable para aseguramiento de calidad del producto
Los procesos de esterilización y liofilización requieren una alta resolución y control preciso de la temperatura para garantizar la calidad del producto. El FA‐M3V, Controlador de máquina IT es un controlador lógico programable (PLC) que combina velocidades de procesamiento muy altas con características de control estables.

El reto de los clientes

Cumplimiento de los reglamentos y las normativas globales
Las compañías farmacéuticas operan en un mercado global, y el sector al que pertenecen debe cumplir con iniciativas internacionales como la Guía PIC/S GMP y las Directrices de la ICH. Las plantas GMP (con 'buenas prácticas de fabricación') requieren seguir mejores prácticas establecidas, mientras que los equipos y sistemas computaciones de producción automatizada deben adoptar prácticas de validación de sistemas computarizados (CSV) como GAMP (Buenas prácticas de fabricación automatizadas).

Nuestras soluciones

Aseguramiento de la elaboración de productos farmacéuticos de calidad
A través de los años, Yokogawa ha ejecutado con éxito numerosos proyectos de conformidad con la guía Buenas prácticas de fabricación automatizadas (GAMP). Siguiendo un plan de validación de proyecto (PVP) que sigue el modelo V descrito en la guía GAMP, experimentados ingenieros de Yokogawa entregan resultados para las fases de prueba de especificación funcional, especificación de diseño, implementación, pruebas en fábrica y aceptación en sitio. Los resultados de la verificación y las pruebas, incluyendo las calificaciones de instalación y operativa (IQ/OQ), sirven como indicadores objetivos para determinar si se han cumplido los requerimientos del proyecto.

El reto de los clientes

Necesidad de un método más riguroso para asegurar la calidad del producto
Con las farmacéuticas, es necesario un enfoque científico riguroso para asegurar la calidad del producto. Las directrices de calidad de la ICH exigen una estrategia calidad por diseño (QbD) en el desarrollo y la fabricación de productos farmacéuticos. Las plantas productivas enfrentan el reto de implementar tecnologías innovadoras como tecnología analítica de procesos (PAT) y deben incorporar ensayos de liberación a tiempo real (RTR).

Nuestras soluciones

Solución PAT de Yokogawa a Ensayos de liberación a tiempo real (RTRT)
El método de Yokogawa para el desarrollo de una solución de tecnología analítica de procesos (PAT) se centra en el monitoreo en tiempo real de atributos de calidad críticos (CQA) para lograr la fabricación ajustada. Los atributos de calidad en línea se pueden monitorear directamente por medio de análisis de infrarrojo cercano (NIR). Otro método es el uso de tecnología de modelado de procesos para monitorear las condiciones del proceso.

Recursos

Descripción General:
  • Highlyadvanced biopharmaceutical plant uses CENTUM, VP Batch, Exaquantum and PRM.
  • Total system integration for large-scale biotech production facility.
Descripción General:
  • Yokogawa provides CENTUM VP with Batch Recipe Management Package for new fine chemical plant.
  • Yokogawa's CENTUM VP complies with the requirement of Good Automation Manufacturing Practices(GAMP).
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  • Producción ininterrumpida de oxígeno médico con monitoreo FAST/TOOLS.
  • Las auditorías se realizan periódicamente, lo cual requiere rastreabilidad y el mantenimiento de los registros históricos para todas las actividades de producción por lotes.
Descripción General:
  • El RotaMASS fue elegido para trabajar con medidas de peso y/o transmisores de presión diferencial para mediciones extremadamente precisas.
  • El cliente reconoce las ventajas del producto: confiabilidad, precisión, sistema de drenaje garantizado, sistema de limpieza fácil, sin partes móviles, directamente integrado en las tuberías, bajas pérdidas de carga.
Descripción General:
  • Implementation of control system supported by global maintenance, service, engineering, and technical support capabilities
  • Improved stability and safety of plant operation
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Kyowa Hakko Bio monitors vibration trends with Yokogawa's Sushi Sensors to prevent unexpected equipment failures.
By using eServ, sensor data and maintenance information are shared with everyone involved in manufacturing.

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When used to measure the dissolved oxygen in an aeration tank, sensors tend to quickly become contaminated and need frequent cleaning. A cost-effective solution to this problem has finally been found with the development of the Yokogawa DO402 Dissolved Oxygen Converter system. 

Descripción General:
  • For remote monitoring (of temperature, pressure, and flow volume), installing the SMARTDAC+ GM in the plant and the SMARTDAC+ GX in the office provides for a scalable, pc-free on-site data monitoring solution.
  • You can centralize management of large quantities of data by automatically transferring acquired data to a FTP server.
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High-capacity memory, network, and part 11 compliant paperless data recorders greatly increase work efficiency while eliminating data recording errors.

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Prevent costly downtime and process equipment failures with real-time pressure monitoring. Yokogawa’s Sushi Sensor is the optimal choice for industries depending on bottled gas in essential procedures.

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Avoid flashing issues while loading cryogenic liquids with safe, reliable, and accurate density fluid measurements utilizing Yokogawa’s industry-leading Coriolis flowmeter to eliminate measurement issues and increase the accuracy of inventory. 

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Cell stage categorized using FucciTime lapse imaging of Fucci-added Hela cells was conducted over 48 hrs at 1 hr intervals. Gating was performed based on the mean intensities of 488 nm and 561 nm for each cell. They were categorized into four stages, and the cell count for each was calculated.

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Eliminating the wire using wireless transmitter is the perfect solution for rotating equipment. It establishes data collection between the transmitter and the gateway by reliable communication even though the dryer was rotating.

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SMARTDAC+ GX series records the clean room temperature, humidity, atmospheric pressure, door openings and closings, etc.

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A critical requirement in biopharmaceutical development is the integration and automation of process equipment and analytical instruments used in the laboratory. Bioprocess labs with multiple lab-scale bioreactors often execute cultivation experiments in parallel for research or process development purposes.

As part of a collaboration between Securecell (Zurich, SW) and Yokogawa Life Science (Tokyo, Japan), this application note demonstrates the effective use of the Lucullus® Process Information Management System (Lucullus®) to assist in the control of three Advanced Control Bioreactor Systems (BR1000) to study glucose utilization of CHO cells for optimal monoclonal antibody productivity.

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In semiconductor manufacturing processes, a deficient clean room environment can lead to defects and wasted resources, making a strictly controlled clean room indispensable. Maintaining the environment in the clean room requires control of air filters, HVAC systems, room temperature, humidity, airborne particles, and other factors.

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In the plants of food and beverage manufacturers, there are times when monitoring and recording of production equipment is necessary inside clean rooms. This is an introduction to monitoring and recording in clean rooms using paperless recorders.

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Performing control while changing the set point temperature moment by moment is called running a program pattern (or simply running a program). Sterilization and pasteurization require maintaining specific temperatures for specific durations. 

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The paperless recorder DX series automatically calculate the Fo value from the heating temperature and are useful in managing the sterilization process by displaying and recording the value together with the heating temperature.

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By using the Multibatch function (an option added with SMARTDAC+), you can efficiently record data from multiple devices onto a single SMARTDAC+.

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Using the custom display function that comes standard with DXAdvanced means that you can combine the recorders, displays, and switches used in various kinds of equipment.

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Using the batch name + lot number system, past measured data can be recalled for reference by batch name.

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  • Universal inputs provide support for thermocouple, RTD, voltage, and a variety of other input signals.
  • Lineup of models for up to 450 inputs.
    Allows multipoint monitoring and recording on a single unit.
  • Easily enables network-based data management. 
    file transfers, Web monitoring, and alarm e-mail
Descripción General:

By using the computation function of the SMARTDAC+ series Paperless recorder GX/GP, computation option computes the "F-value," or sterilizing value for the sterilization process, so that the computation results can be recorded in the form of data.

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The sterilization temperature prior to the filling process is monitored in the field or office. The temperature data is recorded in an external storage medium.

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Blending plays a key role in industries such as food, healthcare and chemicals etc. Temperature and vacuum measurements are very important in minimizing the moisture content to ensure the quality of the final product. Strictly maintaining them throughout the process ensures the final product yield.

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With industrial and economic development comes increasingly large and advanced power plants and factories. Nevertheless, we find many cases where the original cables, cable tunnels, and other components of the power infrastructure have languished under continuous operation.

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In this Yokogawa RAP Best Practices eBook, you’ll discover how our wealth of knowledge about Integrated Safe Systems and Control of Work is available to help you and your teams design and implement a system that best suits your needs.

Descripción General:

This technical white paper will discuss Yokogawa's CENTUM VP DCS (Distributed Control System) product, hereafter referred to as "CENTUM VP", and the extent of its compliance with Part 11 of Title 21 of the Code of Federal Regulations, (21 CFR Part 11), the Electronic Records / Electronic Signatures Rule.

Descripción General:

The worlds of process automation and production management have been converging for some time. What once used to be islands of automation and production management functionality connected through highly proprietary integration schemes that were costly to maintain have developed into integrated platforms that provide seamless data exchange between the world of automation and the plant floor, the functions of production and operations management, and integration with business level systems.

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The world of process automation is governed by procedures. While we like to refer to the process industries as being largely "continuous", this could not be further from the truth. Process manufacturing is constantly in flux.

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From engineering to installation, commissioning, operations, and maintenance, FOUNDATION fieldbus offer significant cost reductions of 30 percent or more versus conventional analog systems. Many of these cost reductions come from the advanced functions that fieldbus offers versus analog technology.

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The whitepaper discusses the importance of safety culture in achieving a smarter and safer working environment. It highlights statistics on work-related accidents and diseases, the cost of poor safety culture, and the need for a true safety culture achieved through company leadership.

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This document describes the operation and data flow of the Yokogawa Print Wave software using the DX-P Reporter. It will provide a detailed explanation of the Advanced Alarm Reporter functions. The functions described in this paper were first released in Print Wave version 5.5.

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Discovering your Baseline with OT Security Risk Assessment

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On-site digital champions can drive your operation towards data integration and a more aligned way of working.

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Discovering your Baseline with OT Security Risk Assessment

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The first stage in creating next-generation production control system that achieves innovative plant operation is providing "Visualized operation". "Visualized operation" for the customer means that he can reliably access and visualize plant data regardless of plant location and time.

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Manufacturers that are digitalizing lab information management can improve quality and streamline operations. Read the complete article inside.

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Lonza's Riverside plant manufactures bulk active ingredients for the pharmaceutical industry. A new, fully automated multipurpose reactor train was installed in early 1996. The train includes ten 500 to 1500 gallon vessels used for reaction, distillation, phase separation, and crystallization; two centrifuges for isolating finished products; and two dryers. 

Descripción General:

The critical steps in achieving advanced process control include building an accurate digital twin of a bioreactor, validating it, and establishing communication between the bioreactor and its digital twin. Several of these steps are already mature and Yokogawa is making rapid progress toward realizing ‘smart’ bioreactors for smart manufacturing.

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Unlocking the Keys to a Sustainable Pharma Supply Chain

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Yokogawa Insilico Biotechnology released its Insilico Digital Twin Factory, which can help drugmakers increase productivity and bring down manufacturing costs and time to market by potentially replacing up to 50% of the experiments needed during the process development, characterization and scale-up of biopharmaceuticals.

Documentos y Descargas

Videos

Descripción General:

In this video you will learn about flow imaging microscopy, and how the FlowCam works to deliver digital images of subvisible particles.

Información del Producto
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A demonstration of the FlowCam 8000 and how it works for marine and freshwater research and monitoring

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A demonstration of the FlowCam 8000 for pharma and biopharma applications

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A demonstration of the FlowCam 8000 for industrial applications

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Yokogawa leverages our extensive knowledge and experience in IT, operation and control technology to build an advanced improvement cycle that is useful to all management levels, and eventually aims to achieve Pharma 4.0 together with our customers.

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Discover how to achieve industrial autonomy step by step through one of the 75+ inspiring presentations.

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Sample systems are a crucial component of and have a significant impact on the performance of a process gas chromatograph analyzer. When working on sample systems, you must have a constant awareness of time delays. This fundamentals webinar will take the mystery out of lag times.

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This workshop provided by industry partners Yokogawa and ThreatConnect will show you a way to strategically manage cyber risk within an industrial environment. Learn how to transition from the “break/fix” model of industrial cybersecurity to a business risk management strategy through cyber risk quantification, return on investment (ROI) for industrial cybersecurity solutions calculations, and cyber risk identification.

Noticias

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