Blow fill seal infusion bottle inspection

 
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HEUFT spotter II BFSB

A 100% all-round inspection and integrity testing of pharmaceutical blow fill seal infusion bottles based on the HEUFT SPECTRUM II.

 

 

The HEUFT spotter II BFSB achieves full coverage and full detection reliability during the all-round inspection and integrity testing of every single infusion bottle produced using the blow fill seal method even in high-speed operation. The compact linear system identifies deviations in the fill quantity and colour of the products contained such as saline, electrolyte or glucose solutions just as reliably as deformations, missing or excess packaging components, soiling, scratches, scores, inclusions, leaks and cosmetic defects in the container material.

 

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Closure inspection

Ensure closure integrity: Top-down and all-around inspection.

Missing, misaligned and deformed closures, material shortages and excesses in this area: the HEUFT spotter II BFSB detects all this during the top-down inspection of blow fill seal infusion bottles with smart LED illumination and specially adapted camera, image filtering and subtraction technologies. For an even more detailed inspection of closure integrity, an additional detection module can be integrated that performs a complete 360° inspection of the entire closure area to even more reliably detect chipping, scores, scratches, black spots, soiling and cosmetic defects on the closure wall, deformed and misaligned closure ports, incomplete or even protruding or torn sealing foils.

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Sidewall inspection

Covering everything: complete inspection of the BFS bottle body.

Damage, contamination, cosmetic defects, foreign particles and fill level deviations: A full coverage inspection of the side walls of blow fill seal ampoules is essential in order to find such faults everywhere. The HEUFT spotter II BFSB realises this with sophisticated opto-mechanics and intelligent LED adaptive lighting in order to identify all critical faults regardless of their position and location. With the aid of a rectilinear frontal view of the upper body area of each individual infusion bottle especially underfills as well as overfills and particles floating on the fill line become even more clearly visible in addition to cosmetic defects.

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Base inspection

Seeing to the ground: Bottom-up inspection for full detection reliability.

Foreign particles, inclusions, impurities and damage: To find such defects in every case, the full-cover sidewall inspection down to the bottom edge is not always sufficient. Additional safety is therefore provided by another high-performance camera that scans the bottom of the container. Especially foreign particles that have sunk to the bottom of the container, but also black spots trapped in the base, contamination and deformations of this area as well as, for example, defective infusion bottle hangers are reliably identified with this camera. Together with the full-coverage sidewall inspection, this ensures that the entire base area – including its underside – is inspected without blind spots.

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Leakage inspection

Finding leaks: Visual inspection and internal pressure measurement.

Leakages, cracks, leaks: already during the camera-based cap, side wall and base inspection of pharmaceutical blow fill seal ampoules, such leaks are immediately noticeable in most cases. Even more safety is provided by an additional leakage check. For this purpose, the containers are guided in a belt drive that exerts a precisely definable force on them. Special sensors measure their internal pressure twice so that – independent of the electrical conductivity of the product contained – a drop in pressure caused by leaks can be reliably detected. Even the smallest leaks can be reliably detected with the help of this pressure difference method.

Fault rejection

Preventing recalls:  the reliable rejection of faulty containers.

Fast, careful and accurate:  highest precision when detecting faults is only effective if the products in question are also removed afterwards.  The single-segment and multi-segment rejection systems of the HEUFT rejector series deal with this both precisely and carefully.

Simple brand changes

Automatic changeover: Servo-controlled adjustment of the detection and transport units.

Automatic, fast, simple: as is usual with systems based on the HEUFT SPECTRUM II platform trigger photoelectric sensors, cameras, lighting units and transport devices adjust themselves fully automatically to different sizes and types of blow fill seal ampoules. Programme and format changes can thus be carried out without tools and without any human intervention. This not only saves time, but also money: efficiency and productivity losses due to lengthy changeover times are sustainably reduced.

Product monitoring and self-tests

Playing it safe:  exact product tracking and regular self-tests.

Always knowing the current location of a particular product:  each one is tracked precisely for this.  This ensures that none remain uninspected.

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The integrated reject verification checks that each product identified as faulty is really removed.  Standard test programs guarantee a regular examination of the detection performance.  Network-based continuous documenting and long-term archiving of the results.

 

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HEUFT SPECTRUM II

Simply automating:  universal device platform for maximum performance.

Highly automated, universal and powerful:  the HEUFT SPECTRUM II ensures optimum detection and operational reliability during an in-line quality assurance for the sustainable safeguarding of product quality and line efficiency.

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The cross-system control unit with multiprocessing capability for different modules, systems and applications convinces due to its exceptional degree of automation.  Brand and format changes can be carried out without manual intervention.  The unique human machine interface of the universal device platform is self-explanatory.  Human resources are effectively saved in this way.  In-house developed hardware and software of the latest generation and a future-proof network connection achieve highest computing power and data transmission in real time.  The result:  maximum precision during purposeful product tracking, inspection and rejection.

 

HEUFT SPECTRUM II

HEUFT reflexx A.I.

Simply detecting more:  real-time image processing with individual teaching in procedure.

Fast, high-resolution and smart:  the new generation of in-house developed hardware and software for image processing provides four times the processor speed of its predecessor.  It converts the images of the individual camera or X-ray units into high-resolution, noiseless detection pictures in real time.

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At the same time the HEUFT reflexx A.I. not only carries out the specific detection of the most varied objects but also their individual classification using up to 50 different characteristics such as size or texture:  uncritical characteristics can be quite simply taught in as good objects.  The containers in question are therefore no longer rejected.  Only that which really has to be removed is rejected.  This reduces the false rejection rate and upholds the efficiency and productivity of the complete filling line.

 

HEUFT reflexx A.I.

HEUFT NaVi

Simply knowing what to do:  self-explanatory audiovisual user guidance.

Intuitive, individual and audiovisual:  previous knowledge is not required in order to operate the HEUFT SPECTRUM II systems reliably.  The HEUFT NaVi user guidance is self-explanatory and supports the respective user step by step.

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An RFID login with user-related access rights provides an overview and makes the respective user's work simply easy:  he only sees what he really needs to on the clearly arranged touchscreen user interface with a flat menu structure, integrated tutorials and precise auxiliary tools in order to fulfil his specific tasks optimally.  He is supported by a virtual assistant in the course of this.  She speaks to him and clearly explains what has to be done when and where.  Purposeful and focussed on the essentials – the audiovisual HEUFT NaVi user guidance makes the reliable operation of HEUFT systems simply easy!

 

HEUFT NaVi

HEUFT checkPoints

Simply seeing where what has to be done:  trouble-free localisation.

Clear, direct and purposeful:  the user can cope immediately on the rare occasions when manual intervention is needed.  Because eye-catching HEUFT checkPoints make it clear at a glance exactly when it is necessary to take matters in hand in addition to the audiovisual information which the HEUFT NaVi provides.

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The orange tags not only flash on the touchscreen but also at the respective component if the worst comes to the worst.  The problem is located without a long search.  This saves time and human resources, shortens standstills and therefore increases productivity.

 

HEUFT checkPoints

Network technologies

Simply capturing everything: Network connectivity for performance analysis and audit trail documentation.

Computer-aided systems for the packing and quality assurance of pharmaceuticals must fulfil strict requirements and documentation obligations. This is another reason why HEUFT devices are network-capable. With user-related access rights and a detailed audit trail log of all operating and process information they fulfil the FDA’s 21 CFR Part 11 requirements.

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This protects against unwanted parameter changes and makes all logins permanently traceable. An online connection to higher-level databases and MES systems ensures real-time transmission, processing and complete archiving of detection images, batch and production data as well as reliable audit trail documentation. There is a network connection to the HEUFT TeleService for reliable remote diagnosis and maintenance.

 

 

HEUFT Netzwerketechnologien

Linear construction

Running in a linear way: Compact straight-through system.

In addition to its functionality and automation the HEUFT HEUFT spotter II BFSA is above all distinguished by its consistent linear operation. In contrast to complex rotary machines it needs neither a container carousel nor star wheels, centring bells, grippers or format parts. This makes it extremely compact, enables fully automatic type and product changeovers and reduces storage costs. With the highest possible throughput, it is also ensured that the sensitive BFS containers are handled gently. After all, they are supposed to detect defects instead of producing them themselves. Specially designed conveyors ensure gentle handling of the space-saving straight runner.

Geradlinige Konstruktion

HEUFT CleanDesign

Cleaning quite simply:  hygiene-optimised construction.

Accessible, clean and safe:  its HEUFT CleanDesign predestines the system for use in hygienically sensitive areas.

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Sloping surfaces facilitate cleaning and prevent the accumulation of stubborn dirt.  Special channels and openings allow the liquids required for cleaning purposes to be drained off completely.  Consequently dangerous germs and bacteria have no contact surface whatsoever.  Specially constructed casings and doors create optimum accessibility.  The electronics are totally encapsulated.  Sensitive areas such as the inspection units are dust-proof and protected against contact as well as water jets.

 

HEUFT CleanDesign

HEUFT rejector

Sorting out faulty BFS containers: Accurate rejection.

Targeted, safe, reliable: Different single or multi-segment rejection systems can be connected to the HEUFT spotter II BFSB in order to remove individual or bundled blow fill seal ampoules or infusion bottles which have been detected as faulty from circulation in good time. They consistently remove pharmaceutical blow fill seal ampoules with safety and quality defects from the production flow so that only faultless ones reach the patient.

HEUFT e-mono

 

  • complete, full-coverage inspection of every single blow fill seal ampoules with a capacity of up to 1,000 millilitres
  • precise identification of damage, deformations, foreign particles, faulty fillings, product colour deviations and cosmetic defects
  • maximum detection and rejection reliability for error-free primary packaging for the safe administration of infusion solutions and other products
  • highly secure technological environment thanks to adaptive special illumination, state-of-the-art optomechanics and image processing, image filtering and image subtraction technologies developed in-house and tailored to specific inspection tasks
  • 100% high-speed integrity testing of every single infusion bottle
  • internal pressure and pressure drop measurement for leakage checking and reliable leakage detection
  • highly automated HEUFT SPECTRUM II system in an efficient, space-saving straight line configuration
  • minimum maintenance costs, easy programme changes and long-term operational reliability due to the fact that there are no format parts which are susceptible to wear and tear
  • future-proof network connection, e.g. for complete audit trail documentation and online remote maintenance
  • reliable compliance with basic FDA, GMP, GAMP5 and 21 CFR Part 11 requirements