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).

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 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 reflexx A.I 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.

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 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.

 

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 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

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 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

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 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