Vial Inspection

 
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HEUFT spotter II PHS

Straight complete inspection of small size full vials based on the HEUFT SPECTRUM II.

Full equipment and automation for maximum detection reliability in an efficient and space-saving straight-through system:  the HEUFT spotter II PHS not only has sophisticated optical detection procedures as the first vial inspector of its kind.  In addition the fully automatic system offers unique X-ray strobes.  Therefore foreign objects are even identified carefully and reliably when they are hidden in an opaque product.  Furthermore the compact linear machine finds glass defects, contamination as well as deviations in filling quantity in vials containing between 2 ml and 100 ml and checks the integrity of their crimp caps or screw closures precisely.  The result:  a continuous complete inspection of vials filled with parenteral drugs and other pharmaceutical products which does not miss a fault.

 

RICHIESTA

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 PHS 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 vials each by 90° between them in a controlled manner - their bases are photographed from below at the same time. This ensures that the detection pictures processed and combined by the HEUFT reflexx A.I in real time not only cover more than 360° of the walls but the total volume of each individual vial completely. Foreign objects are therefore reliably identified. Provided that they are not hidden in a non-transparent product. The pulsed X-ray technology exclusively available from HEUFT is the first choice for such serious cases: unique X-ray strobes also make glass splinters or small pieces of metal visible which are hidden inside powders, granules and lyophilised products e.g. in opaque liquids such as emulsions and suspensions. And that with such a low level of radiation that even active pharmaceutical ingredients (APIs) can be examined safely and carefully.

The identification of defects and contamination

Covering everything: continuous all-around inspection.

Chips, cracks and product splashing: the redundant optical modules with high-performance cameras and adaptive LED lighting for a sidewall inspection make glass defects and contamination such as these visible everywhere on the container. There are no blind spots because the vials are specifically rotated between the individual inspection units for full coverage and photographs of the whole base area are taken on the way. All glass defects can be detected in this way from chips with loss of material to finest hairline cracks and inclusions. This also applies to material deformation and, for example, spots and streaks on the inner sidewall of the vial caused by product splashing. But other flaws such as variations in the product colour cannot escape the continuous all-around inspection either. Only clean, perfect 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 PHS 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 container alignment 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 full vials 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: the correct dosage is particularly important with regard to medicinal products. Each small 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 PHS carries out a precise fill level detection in order to determine the filling quantity exactly – by means of different optical technologies or using an X-ray measuring bridge depending on the product. Vials with dosages which deviate from the specification because they are either underfilled or overfilled are therefore identified reliably and removed effectively.

Espulsione dei contenitori difettosi

Prevenire i richiami di prodotto: espulsione affidabile dei contenitori difettosi.

Veloce, attenta e accurata: la più alta precisione nel rilevare i difetti è realmente efficace solo se i prodotti difettosi vengono rimossi subito dopo. I sistemi di espulsione a segmento singolo o a multi-segmento della famiglia HEUFT svolgono questo compito con precisione e attenzione.

Easy brand changes

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

Automatic, fast and easy: the HEUFT spotter II PHS 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.

 

Monitoraggio del prodotto e auto-test

Andare sul sicuro: tracciare esattamente il prodotto ed eseguire test di funzionamento a scadenza regolare.

Conoscere sempre la posizione esatta di ogni prodotto grazie a un sistema molto preciso di tracciamento. Questo assicura che nessun contenitore venga trascurato dall’ispezione.

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La verifica integrata di avvenuto scarto controlla che ogni prodotto classificato come difettoso venga effettivamente deviato dal flusso produttivo. Programmi automatici di test assicurano un controllo periodico delle prestazioni di rilevamento. E’ possibile inoltre il monitoraggio continuo tramite rete Ethernet e l’archiviazione a lungo termine dei risultati.

 

Optional additonal funktions

Detecting even more: extensions to the range of functions.

Modular, flexible and multifunctional: there has never been a linear vial inspection system which offers so many possibilities – including pulsed X-ray technology in the fully equipped HEUFT spotter II PHS.

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Up to two X-ray flash modules can be integrated and optimally arranged in the highly automated, self-explanatory system of the HEUFT SPECTRUM II generation as an option. As a result high density foreign objects hidden in the product can be detected reliably and carefully at unequalled low radiation levels. And that even in injection vials containing APIs. There is a choice between two optical modules with different lighting technologies and an X-ray measuring bridge for checking the filling quantity depending on the product and packaging. The redundant use of several fill level detections is also possible for even greater safety. Practically every wish is fulfilled regarding equipment from special buffer tables to lockable reject collection points and modules for the unmistakable marking of rejected faulty vials. And the optionally integrable laser-based headspace analysis for container closure integrity testing in order to identify vials containing an excessive amount of O2, which can cause oxidation and impair the effectiveness of the medicinal product inside them, optimally complements the camera-based 360° closure inspection.  The result:  unprecedented functionality in confined space.

 

 

HEUFT SPECTRUM II

Automazione totale: unità di controllo universale per prestazioni ancora più elevate.

Completamente automatica, potente e universale: la famiglia elettronica HEUFT SPECTRUM II assicura la massima affidabilità di rilevamento durante l’ispezione e garantisce la qualità del prodotto e l’efficienza della linea produttiva. Essa è adatta per lavorare con moduli, sistemi e applicazioni diversi e convince grazie al suo elevato grado di automazione.

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Permette di eseguire cambi formato totalmente automatici, senza alcun intervento manuale. L’interfaccia utente è autoesplicativa e risulta assolutamente intuitiva. In questo modo si attua un grosso risparmio per quanto riguarda le risorse umane. Hardware e software di ultima generazione sono stati sviluppati da HEUFT, mentre connessioni di rete all’avanguardia assicurano la massima potenza di calcolo e di velocità nella trasmissione dati in tempo reale. Il risultato: massima precisione durante il tracciamento, l’ispezione e l’espulsione del prodotto.

 

HEUFT reflexx A.I.

Rilevare ancora di più: elaborazione di immagini in tempo reale con l'intelligenza artificiale.

La disciplina AI dell'apprendimento automatico per la classificazione mirata degli oggetti è stata padroneggiata dalla nostra elaborazione di immagini sviluppata in proprio a partire dal 2010! E da allora ha imparato molto: i filtri intelligenti distinguono le gocce d'acqua sul contenitore dalle bolle d'aria nel vetro e permettono persino di identificare piccoli difetti nascosti dietro ACL o rilievi. HEUFT reflexx A.I. ora utilizza anche il deep learning!

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Le reti neurali opportunamente addestrate vengono utilizzate, ad esempio, per il denoising di immagini a raggi X o per individuare oggetti estranei pericolosi in prodotti strutturati e distinguerli in modo affidabile da oggetti buoni estremamente simili per forma, dimensioni e densità. Grazie a una vera e propria intelligenza artificiale, l'hardware e il software sviluppati e prodotti in proprio aumentano nuovamente l'affidabilità del rilevamento e riducono al minimo il tasso di falsi rifiuti. L'elaborazione intelligente delle immagini può essere integrata direttamente nella telecamera HEUFT reflexx A.I. sviluppata internamente, che elabora e valuta le proprie immagini direttamente in tempo reale e porta l'analisi adattiva delle immagini a un livello superiore.

 

HEUFT NaVi

Sapere sempre cosa fare: la guida utente audiovisiva e autoesplicativa.

Intuitiva, audiovisiva e adatta a tutti: non è richiesta alcuna conoscenza precedente per poter lavorare con affidabilità con i sistemi HEUFT SPECTRUM II. L’interfaccia HEUFT NaVi è autoesplicativa e guida l’utente passo per passo.

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Un sistema di login RFID fornisce accessi riservati per ciascun utente e semplifica decisamente il loro rispettivo lavoro: ogni utente vede solo quello che deve vedere grazie ad un’interfaccia pienamente configurabile, visibile su pannello “touch-screen” e dotata di menù dalla struttura semplice, tutorial integrati e strumenti ausiliari che possono aiutare l’operatore nello svolgimento ottimale dei suoi compiti. Viene in aiuto anche un’assistente virtuale, la quale parla all’utente e gli spiega dove, come e quando intervenire. Concentrata sullo scopo finale e sugli aspetti essenziali – l’interfaccia utente audiovisiva HEUFT NaVi rende il lavoro con i sistemi HEUFT affidabile ed estremamente semplice!

 

HEUFT checkPoints

Vedere chiaramente dove intervenire: localizzazione a prova di errori.

Chiari, diretti e risolutivi: l’utente può uscire indenne dalle rare occasioni in cui viene richiesto il suo intervento manuale. Questo perché gli HEUFT checkPoints, in aggiunta alle informazioni audiovisive fornite dall’HEUFT NaVi, rendono visibile a colpo d’occhio quando è necessario intervenire manualmente.

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Le etichette arancioni non solo lampeggiano sul pannello operatore ma anche sui rispettivi singoli componenti nel caso si arrivi al peggio. L’anomalia viene localizzata facilmente, senza perdere tempo in lunghe ricerche. Tutto ciò comporta un notevole risparmio di tempo e di risorse umane, riduce i fermi di produzione e aumenta la produttività generale della linea.

 

Network technologies

Simply recording everything: network connection for production data 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.

Straight construction

Running linearly: compact straight-through system.

The HEUFT spotter II PHS stands out in particular due to its consistent linear operation in addition to an unprecedented level of equipment, functionality and automation. It needs neither a container carousel nor starwheels, centring bells, grippers or change parts in contrast to rotary machines. This makes it extremely compact, enables fully automatic brand and product changes and reduces storage costs. It is also ensured that the sensitive vials are not handled too harshly with the highest possible throughput. After all they should track down defects and not produce them themselves. Specially constructed conveyors ensure that the sensitive glass containers are handled carefully. A wide range of installation positions can be implemented for the space-saving system due to its flexible, modular construction. Special buffer tables for bringing together and fanning out the container flow and lockable reject collection points are further highlights of the straight construction of the fully equipped vial inspector.

HEUFT CleanDesign

Pulire con facilità: costruzione ottimizzata per l’igiene.

Accessibile, pulito e sicuro: il sistema HEUFT CleanDesign rende possibile l’uso dei dispositivi HEUFT in aree sensibili dal punto di vista igienico. Superfici inclinate facilitano la pulizia e prevengono l’accumulo di sporco.

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Speciali canali e aperture permettono ai liquidi necessari per la pulizia di essere drenati completamente. Di conseguenza i germi e i batteri hanno poche superfici utili di contatto. Speciali alloggi e aperture garantiscono un’ottimale accessibilità. Le parti elettroniche sono totalmente protette. Le aree sensibili, quali i moduli ispettivi, sono a prova di polvere e protette contro spruzzi e getti d’acqua.

 

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 PHS 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 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.

 

 

  • maximum packaging and medicinal product safety due to the continuous complete inspection of up to 600 full vials, containing between 2 ml and 100 ml, per minute
  • reliable identification of safety risks and quality defects such as foreign substances, glass defects, oxidation, 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 using in-house developed particularly low-radiation X-ray strobes
  • optionally integrable container closure integrity testing with headspace analysis for identifying vials with an excessive oxygen content
  • highly automated 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