Vial Inspection

 
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HEUFT spotter II PHL

Straight complete inspection of larger vials based on the HEUFT SPECTRUM II.

Linear, powerful and fully equipped: even the fillers of large size vials do not have to miss out on the unique combination of superior optics, pulsed X-ray technology and maximum automation in an efficient straight-through system. The HEUFT spotter II PHL carries out a truly comprehensive complete inspection of the sensitive primary packaging material with a capacity of between 20 ml and 1000 ml - and finds quality defects and safety risks such as deviations in filling quantity, glass defects, closure leaks, contamination and foreign matter carefully and precisely. The reliable X-ray detection of minute glass splinters or small pieces of metal is even possible in powders, granules and lyophilised products with active pharmaceutical ingredients (APIs).

SOLICITUD

Foreign matter detection

Finding everything everywhere: optimal optics and unique X-ray technology.

Hairs, fibres and glass splinters: foreign matter such as this poses a serious threat to the safety of medicinal products. The HEUFT spotter II PHL identifies contaminated vials in good time. High-performance modules carry out the optical inspection of the sidewalls both in the infeed and in the outfeed. A servo-controlled conveyor belt rotates the injection bottles each by 90° in between - their bases are photographed from below at the same time. This ensures that the detection pictures processed and combined by the HEUFT reflexx2 in real time cover the total volume of the large size vials completely. As a result foreign objects are identified everywhere in the container reliably. The linear system can even detect glass splinters or small pieces of metal hidden in powder, granules or lyophilised products - with an X-ray flash module which is easy to integrate for a top-down inspection with unrivalled care and precision. This is also possible with liquid, opaque products such as emulsions and suspensions. The radiation dose of this unique pulsed X-ray technology is so low that the reliable detection of high density foreign objects is even achieved in parenteral drugs with APIs. This protects the integrity of the medicinal product in two ways.

The identification of defects and contamination

Covering everything: continuous all-around inspection.

Chips, cracks and inclusions: the redundant optical modules with high-performance cameras and adaptive LED lighting for a sidewall inspection make such defects and contamination visible everywhere on the sensitive glass container. There are no blind spots because each individual vial is specifically rotated and precisely aligned between the detections. In addition high-resolution images of the complete base area are produced along the way. The result: continuous complete coverage of all the container areas. All glass defects can be detected in this way from chips with loss of material to finest hairline cracks and inclusions. Other flaws such as variations in the product colour cannot escape the continuous all-around inspection with the HEUFT spotter II PHL either. Only clean, perfect full vials with the correct contents reach the patient.

 

360° closure inspection

Checking the closure integrity: detailed complete inspection.

Correctly positioned, intact and tight: the HEUFT spotter II PHL not only safeguards the functionality of the vial but also the purity and the uncontaminated state of its sensitive contents with a detailed all-around inspection of the flip off closures and crimp caps. The reliable identification of inaccurately positioned, incomplete, incorrectly flanged, dented, defective, leaking and non-brand closures is carried out by two powerful HEUFT FinalView II CAP modules. A continuous all-around inspection is achieved with the correct lighting technologies, optimally arranged, automatically adjustable high-performance cameras and a real-time image processing system capable of learning. The exact alignment of the 20 ml to 1000 ml vials between the two detection stations ensures coverage of far more than 360° in the course of this. In addition the fully equipped vial inspector uses the superior optics for a sidewall inspection in order to examine the position of the stopper with millimetre precision. The respective injection bottles are detected reliably and removed in good time when the stopper is missing, defective or has been positioned too high or too low or varies in colour.

Filling quantity check

Uncovering underfills and overfills: precise inspection of the dose.

Too much, too little or exactly right: it is particularly important with parenteral drugs to have the correct dosage. Each individual injection bottle has to contain exactly the amount of liquid, powder, granules or lyo product which should be in it. No more and no less. The HEUFT spotter II PHL carries out a precise fill level detection in order to determine the filling quantity exactly and to remove incorrectly filled vials consistently. Two X-ray modules have already been integrated in the highly automated linear machine as standard for this. Vials with dosages which deviate from the specification because they are either underfilled or overfilled are therefore identified reliably and removed effectively.

Rechazo de defectos

Disminución de reclamos: el rechazo fiable de envases defectuosos

Rápido, cuidadoso y riguroso: Una elevada precisión es posible, sólo si el producto defectuoso es retirado inmediatamente después de la detección del fallo. Esto lo consigue los rechazos con un único segmento o los sistemas multisegmentos de rechazos pertenecientes a HEUFT.

Easy brand changes

Changing automatically: servo-controlled adjustment of the conveyor belt.

Automatic, fast and easy: the HEUFT spotter II PHL not only carries out a specific rotation and an exact alignment of the containers for an extensive complete inspection with innovative servo technology. In addition it adapts the height and width of the conveyor belt as well as the positions of the cameras exactly to the changed packaging format during brand changes. This is achieved completely automatically due to clearly reproducible brand adjustments. Furthermore this reduces the need for manual intervention, economizes on human resources and not only saves time but money as well: efficiency and productivity losses due to lengthy changeover times are decreased sustainably.

 

Monitoreo de productos y pruebas automáticas regulares

Juego seguro: seguimiento exacto de producto

Siempre se conoce la ubicación actual de un producto en particular: cada envase es localizado.  Esto asegura que nada permanezca sin ser inspeccionado.

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El sistema de verificación de rechazo integrado a la máquina permite que cada producto identificado como defectuoso, sea retirado del flujo de producción.  Programas estandarizados garantizan un examen regular de las unidades de detección.  Sistemas informáticos de red basados en la recuperación continua de datos y su archivo, permiten conocer a largo plazo los resultados de inspección.

 

Optional additional functions

Detecting even more: extensions to the range of functions.

Modular, flexible and multifunctional: the HEUFT spotter II PHL can be fully equipped in order to simply find all the safety risks and quality defects of filled vials. Thus the exclusive pulsed X-ray technology for a top-down inspection can be integrated into the compact system without a problem. Foreign objects made of glass or metal can then be found with certainty when they are covered by the opaque product with such a low level of radiation that even APIs can be examined. Optical modules for a fill level detection can also be integrated in addition to the two X-ray measuring bridges which are fitted as standard. The standardised system from the flexible HEUFT SPECTRUM II modular series fulfils practically every wish regarding equipment from special buffer tables to lockable reject collection points and modules for the unmistakable marking of rejected faulty vials. The result: unprecedented functionality in a confined space.

 

HEUFT SPECTRUM II

Automático simplemente:  plataforma de equipos universales para un máximo desempeño.

 Altamente automatizado, universal y potente: los equipos pertenecientes a la familia HEUFT SPECTRUM II aseguran la detección de defectos con una fiabilidad operacional optima durante la inspección en línea de los envases. De esta manera, se asegura la calidad de los productos y la eficiencia de la línea.

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Gracias al elevado grado de automatización, la unidad de control puede convivir con la elevada capacidad de multiprocesamiento para los diferentes módulos. Los cambios de formatos son llevados a cabo sin intervención manual.  Estas máquinas cuentan también con una interfaz única entre hombre y máquina, que hace evidente las tareas a realizar, por lo que se ahorra en recursos humanos. El uso de hardwares y softwares  de última generación desarrollados en las instalaciones de HEUFT para estas máquinas y la conexión de éstas a una red preparada para el futuro permiten alcanzar una elevada velocidad de procesamiento de datos en tiempo real. El resultado obtenido es una máxima precisión durante la inspección, el seguimiento de envases y la retirada del producto defectuoso del flujo de producción.        

 

HEUFT reflexx²

Simplemente detectando más: procesamiento en tiempo real de imágenes

Rápido, inteligente y con alta resolución: la nueva generación de hardwares y softwares desarrollados en las instalaciones de HEUFT para el procesamiento de imágenes alcanza una velocidad de procesamiento de cuatro veces mayor que sus predecesores. Convierte las imágenes de la cámara individual o de las unidades de rayos X en una imagen clara de alta resolución y en tiempo real.

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Al mismo tiempo, el equipo HEUFT reflexx² no solo permite la detección de una variedad de objetos, sino que también su clasificación al utilizar hasta 50 características diferentes como pueden ser textura o tamaño, las cuales son características no críticas fácilmente enseñadas al equipo como no defectos. Por lo tanto, los envases con características no críticas, ya no son rechazados. Sólo lo que realmente debe ser retirado, es rechazado. Esto reduce la tasa de falso rechazo y mantiene la eficiencia y productividad de la línea.

 

HEUFT NaVi

Simplemente sabiendo qué hacer:  guía audiovisual explicativa para el usuario

Intuitiva, individual y audiovisual: ya no es necesario tener conocimientos previos  para operar los equipos de la serie HEUFT SPECTRUM II. La guía explicativa HEUFT NaVi está diseñada con la finalidad de que el usuario siga paso a paso lo que se le indica.

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Acceso restringido mediante RFID permite realizar las funciones fácilmente, ya que el usuario ve lo que tiene que ver en una pantalla táctil con un menú estructurado  donde se integran tutoriales y herramientas auxiliares para completar la tarea de forma optima. El usuario es ayudado por un asistente virtual en el transcurso de la realización de la tarea. El asistente virtual habla al usuario y explica claramente qué hacer y dónde. Por lo tanto, el operario se enfoca en lo esencial -  la guía audiovisual HEUFT NaVi permite un manejo fiable y cómodo de los sistemas de la nueva serie HEUFT!

 

HEUFT checkPoints

Atención enfocada simplemente en lo necesario: detección de problemas sin más gastos

Claro, directo y resolutivo: el usuario puede resolver inmediatamente una intervención manual, aunque no ocurra con mucha frecuencia. Debido al atractivo HEUFT checkPoints, es posible hacerlo en una ojeada, ya que información audiovisual es suministrada mediante la guía HEUFT NaVi.

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No solo las etiquetas naranjas aparecen en la pantalla, sino que también hacen evidente los componentes, en caso de que la situación se complique. Entonces, se puede localizar los fallos sin necesidad de una larga búsqueda, lo que permite un ahorro en recursos humanos, paradas de línea menos prolongadas y un incremento en la producción.

 

Network technologies

Simply recording everything: network connection for performance analysis and audit trail documentation.

Computer-aided systems for the packaging and quality assurance of pharmaceutical products have to meet strict requirements and documentation obligations. That is also why HEUFT devices are network-compatible. They fulfil the FDA 21 CFR Part 11 requirements with user-related access rights and a detailed audit trail log of all the operating and process information. This protects against unwanted changes to the parameters and makes all user activities permanently traceable. An online connection to higher-level databases and MES systems safeguards real-time transmission, the preparation and complete archiving of detection pictures, batch and production data as well as a reliable audit trail documentation. There is a network connection to the HEUFT TeleService for a reliable remote diagnosis and maintenance.

HEUFT CleanDesign

Limpieza simple: construcción higiénica optima

Accesible, limpio y  seguro:  el HEUFT CleanDesign diseñado especialmente para  ámbitos higiénicos altamente sensibles.

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Las pendientes de las superficies del equipo facilitan la limpieza y evitan la acumulación de suciedades. Los líquidos de limpieza son drenados fácilmente mediante canales y estructuras especiales. En consecuencia, gérmenes y bacterias no tienen contacto con la superficie. El acceso al equipo es fácil mediante su carcasa y sus puertas especiales, donde la electrónica permanece aislada. Además, las zonas sensibles como las unidades de inspección tienen protección optima contra polvo y agua.

 

HEUFT rejector

Removing faulty vials: rejecting without compressed air.

Specific, safe and clean: a special rejection system which manages completely without compressed air is included in the scope of delivery of the HEUFT spotter II PHL as standard in order to sort out all the faulty vials in a timely and reliable manner. The HEUFT e-mono has been designed for the safe use in the hygienically sensitive areas of clean room class B. It practically only uses energy at that moment when its rejection segment is extended in order to transport faulty pharmaceutical containers onto a buffer table, a conveyor which runs parallel or to special reject collections points e.g. a container. The HEUFT e-mono can even adapt the advance force of the rejection segment to the weight of the product during the rejection procedure due to its flexible control system. Faulty containers with different filling quantities are therefore always each rejected the same distance.

 

  • maximum packaging and medicinal product safety due to the continuous complete inspection of up to 250 full vials, containing a maximum of 1,000 ml, per minute
  • reliable identification of safety risks and quality defects such as foreign substances, glass defects, dosing and closure errors
  • fully equipped for an unprecedented functionality, versatility and detection reliability
  • detection of dangerous high density foreign objects in APIs with unrivalled care and precision due to unique pulsed X-ray technology with minimum radiation
  • highly automated, self-explanatory HEUFT SPECTRUM II system in an efficient, space-saving straight-through construction
  • minimal maintenance costs, straightforward program changes and long-term operational reliability due to the absence of change parts subject to wear
  • highly safe technological environment due to state-of-the-art camera systems, superior X-ray technology and in-house developed software tailored to specific inspection tasks
  • future-proof network connection among other things for a continuous audit trail documentation and online remote maintenance
  • reliable fulfilment of the fundamental FDA, GMP, GAMP5 and 21 CFR Part 11 requirements