Höchste Qualitätsanforderungen, komplexe Rahmenbedingungen und kurze Markteinführungszeiten. Moderne Life Science-Projekte sind anspruchsvoller denn je.

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Los requisitos más altos de calidad, condiciones marco complejas y cortos tiempos de lanzamiento al mercado. Los proyectos modernos de Biociencias son más exigentes que nunca.

Klare Projekt- und Zielvorgaben, die während des Kick-Off-Meetings mit allen Projektbeteiligten besprochen werden
Ein fairer, klarer und ausgewogener Projektvertrag
Eindeutig festgelegte Verantwortlichkeiten auf Seiten des Kunden und von Chemgineering
Ein konsequentes Controlling für die Bereiche Kosten, Termine und Qualität

";s:6:"layout";s:1:"0";s:11:"frame_class";s:18:"big-box-grey-light";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;s:13:"tx_mask_links";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"text","header":"Así es como llevamos su proyecto GMP al éxito:","header_position":"","bodytext":"

Especificaciones claras del proyecto y de los objetivos, que se discuten con todos los participantes del proyecto durante la reunión inicial.
Un contrato de proyecto justo, claro y equilibrado
Responsabilidades claramente definidas por parte del cliente y de Chemgineering
Control coherente en las áreas de costes, plazos y calidad

Ehrgeizige Terminpläne, anspruchsvolle Prozesse und sich überschneidende Bauphasen kennzeichnen den Realisierungsprozess von Industrieanlagen im GxP-regulierten Umfeld. Mit einer sorgfältigen Planung und Vorbereitung der Montagephasen steht der erfolgreichen Fertigstellung eines Bauvorhabens dennoch nichts im Wege.

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Plazos ambiciosos, procesos exigentes y fases de construcción superpuestas caracterizan el proceso de implantación de plantas industriales en un entorno regulado por GxP. Con una cuidadosa planificación y preparación de las fases de instalación, nada se interpone en la realización con éxito de un proyecto de construcción.

Die Inbetriebnahme verfahrenstechnischer Anlagen muss Gewerke übergreifend koordiniert und organisiert werden. Mit dem Site Acceptance Test (SAT) überprüfen wir den ordnungsgemässen Betrieb und die vollständige Lieferung Ihrer Anlage direkt am Aufstellort.

";s:5:"image";i:0;s:13:"tx_mask_links";i:0;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"Puesta en marcha de plantas GMP","header_position":"","bodytext":"

La puesta en marcha de las plantas de proceso debe coordinarse y organizarse con todos los sectores. Con el Site Acceptance Test (SAT) comprobamos el correcto funcionamiento y la entrega completa de su planta directamente en el lugar de instalación.

Klar. Mit unseren Spezialisten an Ihrer Seite.

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Claro. Nuestros especialistas están a su lado.

Die Anforderungen an versorgungstechnische Installationen für den GxP-regulierten Bereich sind hoch. Weder schwer zu reinigende Stellen, noch unversiegelte Öffnungen und Oberflächen dürfen entstehen. Die Wartung sollte von ausserhalb des Produktionsbereiches möglich sein und alle verwendeten Materialien müssen strengen Anforderungen entsprechen. Zudem verändern sich die komplexen Rahmenbedingungen regelmässig.

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Los requisitos para las instalaciones de suministro en el área regulada por GxP son elevados. No se deben crear áreas difíciles de limpiar ni aberturas y superficies no selladas. El mantenimiento debe ser posible desde fuera de la zona de producción y todos los materiales utilizados deben cumplir estrictos requisitoa. Además, las complejas condiciones generales cambian regularmente.

Klima- und Lüftungstechnik (HVAC)
Abluftbehandlung
Sanitärtechnik
Reinstmedientechnik
Schwarzmedientechnik
Elektrotechnik
Gebäudeautomation inklusive GxP-Monitoring
Sicherheitstechnik
Energiemanagement
Erzeugungsanlagen für Primärenergie

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Tecnología de aire acondicionado y ventilación (HVAC)
Tratamiento del aire de salida
Ingeniería sanitaria
Tecnología de materiales de gran pureza
Tecnología de la comunicación
Ingeniería eléctrica
Automatización de edificios incluyendo control GxP
Ingeniería de seguridad
Gestión de la energía
Plantas de generación de energía primaria

Personenfluss, Materialfluss, Logistik. Die GMP-konforme Konzeption von Gebäuden wie Reinräumen, Laboren und Produktionsflächen erfordert Gewerke übergreifende Planung und umfassende Kenntnisse des Produktionsprozesses.

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Flujo de personal, flujo de materiales, logística. El diseño de edificios como salas estériles, laboratorios y áreas de producción que cumplen con GMP requiere una planificación completa de todos los trabajos y un conocimiento exhaustivo del proceso de producción.

Ob Umbau bei laufendem Betrieb oder Neubau auf der grünen Wiese, die komplexen Rahmenbedingungen für Prozess und Betriebsabläufe im GxP-regulierten Umfeld planen wir von Anfang an mit ein. So werden alle Gebäudeteile entsprechend ausgelegt und logistisch angebunden.

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Planificamos desde el principio las complejas condiciones marco para los procesos y las secuencias operativas en el entorno regulado por GxP, ya se trate de una modificación durante la operación en curso o de una nueva construcción en un terreno no urbanizado. Así todas las partes del edificio estarán diseñadas en consecuencia y conectadas logísticamente.

Produktions- und Herstellflächen
Reinräume
Labore
Lager und Logistik
Spitalpharmazie

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Áreas de producción y fabricación
Salas estériles
Laboratorios
Almacén y logística
Farmacia hospitalaria

Energieverbrauch, Temperatur, Feuchte, Druck, Partikelanzahl. Um nachweislich GMP-konform und zudem wirtschaftlich zu produzieren, müssen die Produktionsbedingungen im Gebäude permanent kontrolliert und dokumentiert werden.

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Consumo de energía, temperatura, humedad, presión, número de partículas. Para que la producción cumpla con GMP y sea rentable, las condiciones de producción en el edificio deben estar permanentemente controladas y documentadas.

Mit moderner Gebäudeautomation haben Sie die Produktionsbedingungen im Griff. Sie können Energiekosten einsparen, Wartungszeiten minimieren und schützen Mitarbeiter, Umwelt und die Qualität Ihrer Produkte. Chemgineering entwickelt mit Ihnen das passende Automationskonzept für Ihr Gebäude.

Con la moderna automatización de edificios usted tiene las condiciones de producción bajo control. Puede ahorrar costes de energía, minimizar los tiempos de mantenimiento y proteger a los empleados, el medio ambiente y la calidad de sus productos. Chemgineering trabaja con usted para desarrollar el concepto de automatización adecuado para su edificio.

Aufnahme der Verbraucher und Erstellung der Verbraucherlisten
Einliniendiagramme / Schaltpläne
Planung von Kabeltrassen, Messgeräten und elektrischen Verbrauchern
Detaillierte Netzwerkpläne mit MS Visio
Gebäude-Automations-, BMA, ELA, CCTV, TK, Schleusensteuerungs- & Monitoring- Systeme
Unterstützung bei Ausschreibungsunterlagen für Gebäudeautomations- Systeme
Basisplanung der elektrotechnischen Ausstattung der Prozessräume, Gebäudeleit- und Messwarten

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Registro de los consumidores y elaboración de listas de consumidores
Diagramas de línea simple/diagramas de circuito
Planificación de rutas de cables, dispositivos de medición y consumos eléctricos
Planes de red detallados con MS Visio
Automatización de edificios, BMA, ELA, CCTV, TK, Lock Control y Monitoring Systems
Apoyo con documentos de licitación para sistemas de automatización de edificios
Planificación básica del equipamiento electrotécnico de las salas de proceso, de las salas de control de los edificios y de las estaciones de medición

Sicher. Und automatisiert.

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Sin duda. Y de un modo automatizado.

Die Rahmenbedingungen in den Life Sciences verändern sich schnell. Mergers & Acquisitions, technische Innovationen, steigende behördliche Auflagen. Mit integrierter und effektiver Fabrikplanung können Sie flexibel auf Veränderungen reagieren und effizient produzieren.

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Las condiciones generales en las Biociencias están cambiando rápidamente. Fusiones y adquisiciones, innovaciones técnicas, aumento de los requisitos reglamentarios. Con una planificación de fábrica integrada y eficaz, puede reaccionar de forma flexible ante las modificaciones y producir de forma eficiente.

Chemgineering unterstützt Sie bei der Planung Ihrer GMP-konformen Fabrik. Dazu werden alle Anforderungen an Labors, Produktionsbereiche, kritische Hilfssysteme, Lager und Infrastrukturanlagen analysiert und in gut durchdachten Schritten dokumentiert. Mit einem interdisziplinären Team entwickeln wir verschiedene Varianten und beurteilen diese mit der Simulation Ihres Produktionsprozesses.

Chemgineering le apoya en la planificación de su fábrica conforme a GMP. Todos los requisitos para laboratorios, áreas de producción, sistemas auxiliares críticos, almacenes e instalaciones de infraestructura se analizan y documentan en pasos bien pensados. Con un equipo interdisciplinario, desarrollamos diferentes variantes y las evaluamos simulando su proceso de producción.

Nach Fusionen oder Firmenkäufen werden Werke oft anders genutzt. Neue Bedürfnisse und Anforderungen ziehen jedoch meist einschneidende Umstellungen der Werkslogistik und insbesondere der Personen- und Materialflüsse nach sich. Mit dynamischer Simulation lassen sich verschiedene Szenarien virtuell aber fundiert in der Site Master Planung vergleichen und bewerten – lange bevor es die kostspielige Erfahrung in der Realität aufzeigen würde.

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Después de las fusiones o adquisiciones de empresas, las plantas se utilizan a menudo de forma diferente. Sin embargo, las nuevas necesidades y requisitos suelen dar lugar a cambios drásticos en la logística de la planta y, en particular, en el flujo de personas y materiales. Con la simulación dinámica, se pueden comparar y evaluar diferentes escenarios de manera virtual pero bien fundamentada en la planificación maestra de la obra, mucho antes de que se revele la costosa experiencia en la realidad.

Neue Markt- und Marketinganforderungen lösen Umstellungen und Anpassungen im Produktionsprogramm aus. Die technische und finanzielle Beurteilung der Machbarkeit von Umbauten und Upgrades innerhalb bestehender Lokalitäten und vorhandener Infrastruktur ist somit eine zentrale Aufgabe der Fabrikplanung.

Las nuevas exigencias del mercado y del marketing provocan cambios y ajustes en el programa de producción. La evaluación técnica y financiera de la viabilidad de las conversiones y mejoras en las instalaciones e infraestructuras existentes es, por tanto, una tarea central de la planificación de las fábricas.

Die Möglichkeit von Produktionsstandorten für den globalen Bedarf, durch abgebaute Handelsbarrieren und neue Steueranreize begünstigt, beeinflussen Produktionskonzepte, Chargengrössen, Supply Chain und Lagerkapazitäten. Fabrikplanung kann gerade diesen Anforderungen frühzeitig und flexibel gerecht werden.

La posibilidad de contar con centros de producción que respondan a la demanda mundial, favorecida por el desmantelamiento de las barreras comerciales y los nuevos incentivos fiscales, influye en los conceptos de producción, el tamaño de los lotes, la cadena de suministro y las capacidades de almacenamiento. La planificación de la fábrica puede cumplir estos requisitos de forma flexible y en una fase temprana.

Fabrikplanung
Investitionsbeurteilung
Site Master Planung
Produktionssimulation
Prozessarchitektur
Zonenkonzepte
Feasibility Study

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Planificación de fábricas
Evaluación de la inversión
Planificación maestra de obra
Simulación de producción
Arquitectura de procesos
Conceptos de zona
Estudio de viabilidad

Die Planung und Realisierung einer modernen Anlage zur Herstellung von APIs (Active Pharmaceutical Ingredients) ist eine komplexe Aufgabe. Bereits in der Konzeptphase ist interdisziplinäres Know-how notwendig, um vorausschauend und fachübergreifend zu planen. Dies gilt nicht nur für den Neubau von Produktionsanlagen, sondern auch für Umbauten oder Umnutzungen bestehender Einrichtungen und für die erforderlichen Infrastrukturanlagen, z. B. zur Reinstmedienerzeugung oder Abgasbehandlung.

";s:5:"image";i:0;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"Plantas de síntesis API","header_position":"","bodytext":"

La planificación y realización de una planta moderna para la producción de API (principios activos farmacéuticos) es una tarea compleja. Ya se requieren conocimientos interdisciplinarios en la fase de concepto para planificar con antelación y entre diferentes sectores. Esto se aplica no solo a la construcción de nuevas plantas de producción, sino también a la transformación o conversión de instalaciones existentes y a las instalaciones de infraestructura necesarias, por ejemplo, para la generación de medios ultrapuros o el tratamiento de gases de escape.

Durch eine strukturierte und methodische Vorgehensweise können wir Ihre individuellen Anforderungen ermitteln und zielgenau umsetzen. Wir arbeiten in allen Planungsphasen eng mit Ihnen zusammen, um die wesentlichen Informationen zu Herstellprozess und Produktanforderungen zu ermitteln. Unsere Experten verfügen über fundierte Kenntnisse in allen relevanten Fachgebieten und bringen die Erfahrung aus vielen erfolgreich umgesetzten Projekten mit zu Ihnen.

A través de un enfoque estructurado y metódico, podemos determinar sus necesidades individuales y abordarlas con precisión. Trabajamos estrechamente con usted en todas las fases de planificación para determinar la información esencial sobre el proceso de fabricación y los requisitos del producto. Nuestros expertos tienen un profundo conocimiento en todos los campos relevantes y le aportan la experiencia de muchos proyectos implementados con éxito.

Galenik, kontinuierliche Produktion, Endfertigung, Verpackung. Ein sicherer und stabiler Produktionsprozess ist die Voraussetzung für hohe Wirtschaftlichkeit sowie konstante Qualität. Unzählige Technologielösungen sind am Markt verfügbar, schon die Auswahl setzt viel spezifisches Know-how und Erfahrung in der pharmazeutischen Produktion voraus.

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Galénica, producción continua, acabado, envasado. Un proceso de producción seguro y estable es el requisito previo para una alta rentabilidad y una calidad constante. En el mercado existen innumerables soluciones tecnológicas y la propia selección requiere un gran conocimiento y experiencia específicos en la producción farmacéutica.

Indem wir alle Betreiberinformationen zusammenstellen und überprüfen, können wir für Ihre Anlage das optimale Verfahren auswählen. Dabei finden auch Laborversuche und Pilotanlagentests Anwendung, um die Erfüllung aller Nutzerkriterien sicherzustellen. Von der Machbarkeitsstudie bis zur Inbetriebnahme: Wir erarbeiten für Sie individuell zugeschnittene Technologielösungen für einen GxP-konformen und zuverlässigen Prozess.

Al recopilar y verificar toda la información del operador, podemos seleccionar el proceso óptimo para su planta. También se utilizan pruebas de laboratorio y pruebas de planta piloto para asegurar que se cumplan todos los criterios de usuario. Desde el estudio de viabilidad hasta la puesta en marcha: Desarrollamos soluciones tecnológicas personalizadas para un proceso fiable y conforme a las normas GxP.

Fest, halbfest, flüssig, steril und nicht steril. Chemgineering plant und optimiert Ihren Prozess und setzt ihn technisch um. Von der Entwicklung bis zu Verpackung.

";s:5:"image";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_quote","header":"Bernhard Binnwerk","header_position":"","bodytext":"

Sólido, semisólido, líquido, estéril y no estéril. Chemgineering planifica y optimiza su proceso y lo implementa técnicamente. Desde el desarrollo hasta el embalaje.

Seit einigen Jahrzehnten sind die Produktionskapazitäten für biopharmazeutische Produkte, meist Antikörper, begrenzt. Daher werden weltweit Produktionskapazitäten ausgebaut. Zudem erfordern neue, patientenbasierte Therapien, wie Stammzell- oder CAR-T-Zell-Therapien, neue Produktionskapazitäten.

";s:5:"image";i:0;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"Producción biotecnológica","header_position":"","bodytext":"

En las últimas décadas, la capacidad de producción de productos biofarmacéuticos, principalmente anticuerpos, ha sido limitada. Por lo tanto, las capacidades de producción deben ampliarse a medida que aumenta la demanda. Además, están surgiendo nuevas terapias basadas en el paciente, como las terapias con células madre o las autocélulas T, para las que hay que generar capacidades de producción.

Chemgineering unterstützt Ihre Planungsprojekte mit einem gut ausgebildeten Team von Spezialisten.

Chemgineering apoya sus proyectos de diseño con un equipo de especialistas bien capacitados.

Die Anforderungen an Produktionsprozesse steigen kontinuierlich. Mehr Effizienz, grössere Mengen und zudem noch GMP-konform. Durch manuelle Steuerung ist das kaum mehr möglich.

";s:5:"image";i:0;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"Automatización de procesos","header_position":"","bodytext":"

Las exigencias a los procesos de producción aumentan continuamente. Más eficiencia, mayores cantidades y cumplimiento de las normas GMP. Esto es casi imposible con el control manual.

Schaltpläne
Planung von Kabeltrassen, Messgeräten und elektrischen Verbrauchern
Detaillierte Netzwerkpläne mit MS Visio
Planung im Ex-Schutz-Bereich,
Planung und Erstellung von MES-, PLS- & Monitoring- Systemen
Realisierung von Personen- und Materialschleusen

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Diagramas de circuitos
Planificación de rutas de cables, dispositivos de medición y consumos eléctricos
Planos de red detallados con MS Visio
Planificación en zonas con peligro de explosión
Planificación y desarrollo de sistemas de vigilancia MES, PLS y monitorización
Realización de esclusas de personal y materiales

SPS-Steuerungen: Siemens Simatic Step 7 & TIA V13 oder Allen Bradley RS Logix 5000
Visualisierung für HMI: Siemens WinCC flexible, Pro Tool, WinCC unter TIA V13
Visualisierung für SCADA: Siemens WinCC, Wonderware Intouch, GE Proficy IFix
Leitsysteme: Siemens PCS7

";s:6:"layout";s:1:"0";s:11:"frame_class";s:8:"grey-box";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:545;s:23:"tx_gridelements_columns";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"text","header":"Desarrollo de software","header_position":"","bodytext":"

Controles SPS: Siemens Simatic Step 7, TIA V13 o Allen Bradley RS Logix 5000
Visualización para HMI: Siemens WinCC flexible, Pro Tool, WinCC bajo TIA V13
Visualización para SCADA: Siemens WinCC, Wonderware Intouch, GE Proficy IFix
Sistemas de guiado: Siemens PCS7

Definition der Messverfahren und Auslegung der Messgeräte
Auslegung der Aktuatoren
Erstellung der Gerätelisten
Erstellung der Ausschreibungsunterlagen
Detailplanung und Realisierung in
Zusammenarbeit mit den Herstellern

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Definición de los métodos de medición y diseño de los instrumentos de medición
Diseño del accionamiento
Creación de listas de dispositivos
Preparación de los documentos de la licitación
Planificación detallada y realización en
cooperación con los fabricantes

Am besten mit unseren fortschrittlichen Konzepten.

";s:5:"image";i:1;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"¿Necesita encontrar rápidamente la solución adecuada?","header_position":"","bodytext":"

Mejor con nuestros conceptos avanzados.

Die GMP-konforme Herstellung von Arzneimitteln und Wirkstoffen, Kosmetika und Lebensmitteln ist Voraussetzung für eine erfolgreiche Markzulassung und die Vermarktung der Erzeugnisse. Die Qualitätssicherung spielt eine zentrale Rolle, da Qualitätsabweichungen direkte Auswirkungen auf die Gesundheit der Verbraucher haben. Um den strengen Richtlinien der Behörden zu entsprechen, z.B der Europäischen Union oder der US-amerikanischen Food and Drug Administration (FDA), ist die Validierung der Herstellungsverfahren und die Qualifizierung von Ausrüstung, Gebäuden und Räumlichkeiten Voraussetzung.

";s:5:"image";i:0;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"Cualificación y validación","header_position":"","bodytext":"

La fabricación de productos farmacéuticos y principios activos, cosméticos y alimentos que cumplan las normas GMP es un requisito previo para la autorización del mercado y la comercialización de los productos. El control de calidad desempeña un papel central, ya que las desviaciones en la calidad tienen un impacto directo en la salud de los consumidores. Para cumplir con las estrictas directrices de las autoridades, como la Unión Europea o la Food and Drug Administration (FDA) de los Estados Unidos, la validación de los procesos de fabricación y la homologación de los equipos, edificios e instalaciones es un requisito previo.

Mit einem erfahrenen Team entwickelt Chemgineering kundenspezifische Massnahmen zum Erreichen eines Status, der die erforderlichen regulatorischen Anforderungen erfüllt. Wir erstellen alle relevanten Qualifizierungs-, Validierungs- und Compliance-Dokumente sowie Standard Arbeitsanweisungen in Form von SOP Templates. Für revisionssichere Systeme und Prozesse, die Audits im ersten Anlauf standhalten.

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Con un equipo experimentado, Chemgineering desarrolla medidas personalizadas para lograr un estatus que cumpla con los requisitos regulatorios requeridos. Preparamos todos los documentos relevantes de certificación, validación y cumplimiento normativo, así como las instrucciones de trabajo estándar en forma de plantillas SOP. Para sistemas y procesos que cumplen con las normas de las auditorías y que las superan en el primer intento.

Mit unseren Spezialisten an Ihrer Seite können Sie einer Behördenprüfung ganz gelassen entgegensehen und bringen Ihr Medizinprodukt sicher und compliant in Ihre Zielmärkte.

";s:6:"layout";s:1:"1";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"text","header":"","header_position":"","bodytext":"

Con nuestros especialistas a su lado, no tiene que preocuparse por ninguna inspección de las autoridades y puede lanzar su producto sanitorio de forma segura y conforme a la normativa a sus mercados objetivo.

Fehlerhafte Medizinprodukte gefährden die Sicherheit von Patienten und Anwendern und ziehen weitreichende Konsequenzen für die Hersteller nach sich. Aufgrund der Vorkommnisse der Vergangenheit wurden die regulatorischen Anforderungen verschärft und die Umsetzung vorhandener Regularien & Standards wird strenger überprüft.

";s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"text","header":"Para la seguridad de los pacientes y usuarios, para el éxito de su empresa","header_position":"","bodytext":"

Los productos sanitarios defectuosos ponen en peligro la seguridad de los pacientes y los usuarios, y tienen consecuencias de gran alcance para los fabricantes. Debido a incidentes pasados, los requisitos reglamentarios se han hecho más estrictos y la aplicación de los reglamentos y las normas existentes está sujeta a un escrutinio más severo.

Die Anforderungen an Qualitätssicherungssysteme in der Life Science Industrie (Pharma, Kosmetik, Medizinprodukte und Lebensmittel) nehmen ständig zu. Aktuelle Vorfälle führen zu entsprechenden Verschärfungen und Anpassungen durch den Gesetzgeber bzw. die relevanten Behörden. Effizienz und Effektivität sollen bei immer komplexeren Arbeitsabläufen und Lieferketten weiter verbessert werden. Häufig fehlt es in Unternehmen an Erfahrung und personellen Ressourcen, um all diese Anforderungen umzusetzen.

";s:5:"image";i:0;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"Consultoría sobre cumplimiento normativo en el sector farmacéutico","header_position":"","bodytext":"

Las exigencias a los sistemas de control de calidad en las Biociencias son cada vez mayores. Los incidentes actuales en las industrias farmacéutica, cosmética y alimentaria hacen que las exigencias de las autoridades sean cada vez mayores. La eficiencia y la efectividad deben mejorarse aún más con flujos de trabajo y cadenas de suministro cada vez más complejos. Las empresas a menudo carecen de la experiencia y de los recursos humanos para implementar todos estos requisitos.

Mit der Erfahrung aus vielen erfolgreich abgewickelten Compliance-Projekten unterstützt Chemgineering Sie dabei, im Spannungsfeld von behördlichen und unternehmerischen Anforderungen den Überblick zu behalten und langfristig effizient und compliant zu produzieren.

";s:6:"layout";s:1:"1";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"text","header":"","header_position":"","bodytext":"

Con la experiencia de muchos proyectos de cumplimiento normativo realizados con éxito, Chemgineering le ayuda a mantener una visión general frente a las tensiones entre los requisitos oficiales y corporativos y a producir de forma eficiente y según la normativa legal a largo plazo.

Los responsables de TI están cada vez más preocupados por los costes y la eficiencia de sus sistemas de gestión, infraestructura y procesos de servicios internos. Los sistemas de información y su tecnología llevan años bajo presión. Cambio de tecnología, procesos de servicio eficientes y eficaces, seguridad y cumplimiento, requisitos normativos cambiantes. Otros temas incluyen redes sociales, cloud computing, ByoD (Bring-you-own-Device), BIG-DATA e industry 4.0. Esto significa que la TI corporativa, que antes tenía un carácter más interno, se está abriendo cada vez más al mundo exterior. Sin embargo, debe cumplir la normativa.

Mit einem eingespielten Team erfahrener IT-Experten und einem methodischen, risiko-basierten Ansatz aus dem GAMP5 Leitfaden gehen wir Ihre Herausforderungen systematisch an. Unsere umfangreichen Vorlagendokumente haben sich in vielen Projekten bewährt und werden stetig weiter verbessert. So finden wir zukunftsfähige IT-Lösungen für hoch regulierte Unternehmen der Life Sciences Branche.

";s:6:"layout";s:1:"1";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"text","header":"","header_position":"","bodytext":"

Con un equipo bien coordinado de expertos en TI experimentados y un enfoque metódico y basado en los riesgos de la guía GAMP5, abordamos sus retos de forma sistemática. Nuestros extensos documentos de plantilla han demostrado su eficacia en muchos proyectos y están siendo mejorados constantemente. Así es como encontramos soluciones de TI sostenibles para empresas altamente reguladas en la industria de las Biociencias.

Análisis FIT/GAP de los sistemas existentes y de los procesos de servicios de TI, definición de medidas correctivas
Comprobación, corrección y desarrollo de los POE CSV y plantillas necesarios en el proceso de servicios de TI
Propuestas para mejorar el sistema de validación (Lean Validation)
Preparativos de auditoría (por ejemplo, auditorías de la FDA, de las autoridades o de los clientes)
Auditorías de TI para nuestros clientes con los proveedores
Gestión de proyectos de TI/validación
Formación en la empresa

Procesos de negocio soportados por TI, por ejemplo, ERP (SAP, MS-Dynamics, GUS-OS, otros)
LIMS para procesos de laboratorio y automatización/control de equipos de laboratorio
MES/SCADA/SPS en producción
Soluciones Track & Trace
Sistemas QM
Sistemas de gestión de documentos
Validación de hojas de cálculo Excel

Änderung der regulativen Anforderungen
Änderung des Geschäftsmodells, Hinzunahme von Produkten oder neuen Märkten
Merger-/Demerger-Situationen

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Cambios en los requisitos reglamentarios
Cambio de modelo de negocio, incorporación de productos o nuevos mercados
Situaciones de fusiones y escisiones

Gemäß Schweizer Arzneimittelrecht ist die fachtechnisch verantwortliche Person (FvP) für die Einhaltung der arzneimittelrechtlichen Vorschriften (GxP Compliance) bei Herstellung, Großhandel sowie Ein- und Ausfuhr verantwortlich. Sie trägt damit die Verantwortung für die fachliche Aufsicht über den pharmazeutischen Herstellungsbetrieb. Darüber hinaus ist die FvP auch für die lückenlose Dokumentation und Einhaltung der gesetzlichen Vorschriften verantwortlich. Sie ist die entscheidende Schnittstelle zwischen Betrieb und Behörden. In Ausübung Ihrer Funktion muss die FvP unabhängig sein.

";s:5:"image";i:0;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"Qualified Person Switzerland","header_position":"","bodytext":"

According to Swiss pharmaceutical law, the Qualified Person for Switzerland is responsible for compliance with pharmaceutical regulations (GxP Compliance) in manufacturing, wholesale, import and export. He or she is thus responsible for the technical supervision of the pharmaceutical manufacturing operation. In addition, the Qualified Person is also responsible for complete documentation and compliance with legal regulations. It is the decisive interface between the company and the authorities. In the exercise of its function, the Qualified Person must be independent.

Mit einer erfahrenen FvP für die Schweiz unterstützen wir Sie bei der Herstellung und dem Vertrieb Ihres Arzneimittels. Wir bilden für Sie die Schnittstelle zu sämtlichen Behörden und halten Ihnen für das Tagesgeschäft den Rücken frei

";s:5:"image";i:2;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_quote","header":"Natalie Thurner","header_position":"","bodytext":"

With an experienced Qualified Person for Switzerland, we support you in the production and distribution of pharmaceuticals in Switzerland. We act as your interface to all swiss authorities and keep your back free for the day-to-day business.

Performing all tasks arising from Article 5 of the AMBV.
Ensuring the required quality of the manufactured medicinal products.
Interface to the regulatory authorities (e.g. Swissmedic).
Market release of pharmaceutical end products and active ingredients.
Technical release or decision on non-release of product batches Preparation of audits and inspections.
Examination of legal requirements for the import and export of starting materials, packaging materials and medicinal products.
Quality control.
Quality assurance.
Review and approval of GxP relevant SOPs.
Reviews of critical deviations and OOS.
Handling of complaints and recalls.

Ihre Möglichkeiten waren nie grösser.

";s:5:"image";i:1;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"¿Dirige su negocio de forma eficiente y sin preocupaciones?","header_position":"","bodytext":"

Sus posibilidades nunca han sido tan grandes.

Geht - mit frischen Ideen von uns.
Wir planen Ihre GxP-konforme Anlage und und koordinieren alle Gewerke, die Sie brauchen, um Ihr Projekt von A bis Z zu realisieren. Von Beratung bis Turnkey.

";s:5:"image";i:1;s:13:"tx_mask_links";i:1;s:6:"layout";s:1:"0";s:11:"frame_class";s:7:"default";s:12:"sectionIndex";i:1;s:16:"sys_language_uid";i:0;s:6:"hidden";i:0;s:10:"categories";i:0;s:25:"tx_gridelements_container";i:0;s:11:"l18n_parent";i:0;s:9:"starttime";i:0;s:7:"endtime";i:0;}","t3ver_oid":0,"t3ver_wsid":0,"t3ver_state":0,"t3ver_stage":0,"CType":"mask_pageheader","header":"¿Económico y compatible con GxP?","header_position":"","bodytext":"

Con nuestras nuevas ideas.
Planificamos su planta conforme a GxP y coordinamos todas las operaciones necesarias para realizar su proyecto de principio a fin. De la consultoría a la llave en mano.

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Wir beweisen es Ihnen. Seit 1996 haben wir für unsere Kunden mehr als 6000 Projekte erfolgreich abgewickelt.

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También se lo demostramos.
Desde 1996, hemos hecho a nuestros clientes más eficientes con más de 3.500 proyectos de consultoría. Hemos pasado con éxito más de 750 plantas a través de la inspección oficial. Estamos orgullosos de un total de más de 6.000 proyectos de ingeniería y consultoría realizados con éxito.

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Von Beratung über Konzeptstudien bis hin zu Turnkey-Lösungen bieten wir das volle Leistungsspektrum in den Bereichen Pharma, Biotechnologie, Feinchemie, Medizintechnik, Kosmetik, Diagnostika und Lebensmittel an. Mit mehr als 400 hoch qualifizierten Mitarbeitern in Mitteleuropa sind wir bevorzugter Partner für viele multinationale und lokale Unternehmen und lösen Aufgaben mit Erfahrung, Können und den frischen Ideen unserer hoch motivierten Teams.

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Desde consultoría y estudios de concepto hasta soluciones llave en mano, ofrecemos una gama completa de servicios en los campos de la farmacia, biotecnología, química de precisión, tecnología médica, cosmética, diagnóstico y alimentación. Con más de 400 empleados altamente cualificados en Europa Central, somos el socio preferente de muchas empresas multinacionales y locales, y resolvemos sus problemas con la experiencia, las capacidades y las ideas innovadoras de nuestros equipos altamente motivados.

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Als GxP-Planer und -Berater ist das Erfüllen von Normen unser tägliches Geschäft. Dabei vergessen wir eine ganz wichtige Norm nicht, bei der es um die Auswirkungen des eigenen unternehmerischen Handelns auf Menschen und Umwelt geht.

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Como planificadores y consultores de GxP, cumplir con los estándares es nuestra actividad diaria. No olvidamos una norma muy importante, que trata de los efectos de nuestras propias acciones empresariales sobre las personas y el medio ambiente.

Die komplexen Regelwerke des hoch regulierten GxP Bereichs sind eine Herausforderung für unsere Kunden aus den Life Science Industrien. Ob FDA, EU-GMP-Leitfaden und die Annexe oder die Division of Drug Management and Policies der Weltgesundheitsorganisation WHO. Um sich im Dschungel der GMP Anforderungen zurechtzufinden, muss man immer am Ball bleiben. Hinzu kommen neue, digitale Planungsmethoden wie BIM sowie immer neue Produktionsverfahren und Prozesse wie zum Beispiel individuelle Arzneimittel (ATMPs). Nur wenn wir die Erfahrungen der vielen Projekte, die wir für unsere Kunden durchführen strukturiert sammeln, regelmäßig aktualisieren und gruppenweit zur Verfügung stellen, können wir unseren Kunden die beste Lösung bieten.

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The complex regulations of the highly regulated GxP sector are a challenge for our clients from the life science industries. Whether FDA, EU GMP guidelines and annexes or the Division of Drug Management and Policies of the World Health Organization (WHO). To find your way through the jungle of GMP requirements, you always have to be on the ball. In addition, there are new, digital planning methods such as BIM as well as ever new production methods and processes such as individual medicinal products (ATMPs). We can only offer our customers the best solution if we collect the experience from the many projects we carry out for our customers in a structured manner, update it regularly and make it available throughout the group.

Mit 25 Jahren Erfahrung sind wir routiniert in den Life Sciences und trotzdem frei genug für innovative Ideen. Egal, welche Herausforderung auftaucht - wir haben die richtige Lösung dafür.

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Con de 25 años de experiencia, tenemos experiencia en las Biociencias y, sin embargo, también somos flexibles para ideas innovadoras. No importa cuál sea el desafío: tenemos la solución correcta.

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Sie haben einen naturwissenschaftlichen Abschluss in der Tasche, konnten möglicherweise bereits erste Erfahrungen im Bereich Life-Sciences sammeln und wollen nun richtig loslegen?

Berufseinsteiger sind bei uns goldrichtig! Je nach Unternehmensbereich starten Sie innerhalb der Chemgineering Gruppe als Projektingenieur oder Junior Consultant und begeben sich damit gleich mitten ins Projektgeschehen. Spannende und abwechslungsreiche Kundenprojekte warten bereits auf Sie, mit einem Mentor an Ihrer Seite.

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¿Tiene un título de grado en Biociencias, quizá ya con experiencia en este campo y ahora desea empezar su andadura profesional en serio?

Los principiantes están en el lugar correcto con nosotros. Dependiendo del área de la empresa, comenzará dentro del Grupo Chemgineering como ingeniero de proyectos o consultor junior y, por lo tanto, estará justo en el centro del proyecto. Desde el principio, le esperan proyectos de clientes interesantes y variados, con un mentor a su lado.

Sie verfügen bereits über Berufserfahrung, streben nun den nächsten Karriereschritt an oder möchten sich beruflich verändern?

Ingenieure und Berater mit Berufserfahrung in der Life Science Industrie oder verwandten Industrien verantworten gleich zu Beginn spannende Projekte bei unseren Kunden vor Ort. In Abhängigkeit von der fachlichen Ausbildung und der gesammelten Berufserfahrung haben Sie zudem die Möglichkeit, als Fachexperte oder Führungskraft einzelne Projektteams zu leiten oder Gruppen oder Abteilungen zu führen.

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¿Ya tiene experiencia profesional pero quiere avanzar en su carrera o le gustaría cambiar profesionalmente?

Ingenieros y consultores con experiencia profesional en la industria de las Biociencias o industrias relacionadas son responsables de proyectos interesantes en las instalaciones de nuestros clientes desde el principio. Dependiendo de su formación especializada y de la experiencia profesional que haya adquirido, también tendrá la oportunidad de dirigir equipos de proyecto individuales o dirigir grupos o departamentos como especialista o director.

Kein Projekt ist wie das andere. Kein Kunde ist wie der andere. Da die Mitarbeitenden unseren internationalen Erfolg ausmachen, ist es uns besonders wichtiger Leistungsbereitschaft und Leistungsfähigkeit zu fördern.

Dazu zählen:

ein hohes Maß an Flexibilität bezüglich der Arbeitszeitgestaltung, um Berufs- und Privatleben optimal vereinbaren zu können
die Möglichkeit eines mobilen Arbeitsplatzes
günstige Verkehrsanbindungen an sämtlichen Standorten
individuelle fachliche Weiterbildungen nach den persönlichen Entwicklungszielen
regelmäßige Team- und Firmenevents
offenes Kommunikationsklima und flache Hierarchien
Großer Fokus auf Nachhaltigkeit, Sicherheit und Umwelt
Schaffung von Synergien aus dem internationalen Umfeld
attraktive Sozialleistungen

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No hay dos proyectos iguales. Ningún cliente es como otro. Dado que nuestro éxito internacional se basa en nuestros empleados, es particularmente importante para nosotros promover la motivación y la eficiencia.

Esto incluye:

un alto grado de flexibilidad en la organización del tiempo de trabajo para poder conciliar de la mejor manera posible la vida profesional y la privada
la posibilidad de un lugar de trabajo móvil
conexiones de transporte favorables en todos los emplazamientos
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clima de comunicación abierta y jerarquías planas
gran atención a la sostenibilidad, la seguridad y el medio ambiente
creación de sinergias desde el entorno internacional
beneficios sociales atractivos

No hay dos proyectos iguales. Todos los clientes son únicos. Dado que nuestro éxito internacional se basa en nuestros empleados, es particularmente importante para nosotros promover la motivación y la eficiencia.

Esto incluye:

un alto grado de flexibilidad en la organización del tiempo de trabajo para poder conciliar de la mejor manera posible la vida profesional y la privada
la posibilidad de un lugar de trabajo móvil
conexiones de transporte favorables en todos los emplazamientos
formación profesional individualizada en función de sus objetivos de desarrollo personal
eventos regulares del equipo y de la empresa
clima de comunicación abierta y jerarquías planas
gran atención a la sostenibilidad, la seguridad y el medio ambiente
creación de sinergias desde el entorno internacional
beneficios sociales atractivos

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