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        新聞來源: 發布時間:2019-08-12 21:56:00

         

        Detecting metal particles, glass splinters and other solid foreign objects precisely? Much more is possible with the HEUFT eXaminer technology! The second part of the series about the unique X-ray procedure focuses on its wide range of applications in the pharmaceutical sector.

        精確檢測金屬顆粒、玻璃碎片和其他固體異物?HEUFT eXaminer技術能夠實現更多的可能性!該系列的第二部分關于獨特X射線程序集中于其在醫藥領域的廣泛應用。

        It has become almost indispensable in the food and drink industry. More and more fillers are relying on X-ray technology to identify safety and quality defects in-line. Much more than just a metal detection is possible with it especially when detecting dangerous foreign particles – and that independent of the product's own signal and metal packaging components. In contrast the proposal to create medicinal product safety by means of a radiometric inspection often raised a few eyebrows among pharmaceutical manufacturers. After all irradiating sensitive medicines can involve certain risks! There was too much concern that this would impair or unpredictably change the way they work. The range of application possibilities for an X-ray inspection in the pharmaceutical sector was correspondingly low.

        它在食品和飲料工業中幾乎是不可或缺的。越來越多的灌裝機依賴X射線技術以及在線識別安全及質量缺陷。特別是在檢測危險的異物顆粒時,不僅僅能檢測金屬異物——而且獨立于產品本身的信號和金屬包裝元件。相反,通過輻射檢測來創建醫藥產品安全的建議常常在制藥制造商中引起一些反對。畢竟,射線照射會引起一定的風險!很多人擔心這會傷害或不可預見地改變它們的作用方式。X射線在醫藥行業的應用可能性也相應較低。

         

        Little radiation and numerous applications

        低輻射和多種運用

        An alternative to the classic line scanner emitting radiation continuously was needed: the pulsed X-ray technology available exclusively from HEUFT! It achieves an impressive detection reliability with a radiation exposure far below the limit values. A safe X-ray examination of active pharmaceutical ingredients (APIs) is often even possible. And that with an incredible variety of applications! This is because the unique X-ray flash modules of the 21 CFR Part 11 compliant HEUFT eXaminer series can be arranged flexibly so that one or more inspections can be carried out from the side just as well as a top-down arrangement or a pulsed radiometric measurement from below. The multiple flash option ensures a complete examination of particularly large size pharmaceutical products and primary packaging materials. The dual beam technology with two optimally arranged X-ray strobes makes the analysis of two overlapping single images possible – and with that a 3D reconfirmation and refinement of the examination results from different perspectives.

        一種替代傳統線性連續放射檢測的掃描儀引領需求:那就是HEUFT特有的脈沖X射線技術!它能達到令人贊嘆的檢測性能,輻射量遠低于限值。能夠對活性藥物成分(APIs)進行安全的X射線檢測。還有多種多樣難以置信的應用!這是因為21 CFR Part 11的獨特X射線閃光燈模塊符合HEUFT eXaminer系列能夠靈活放置,以便從一側進行一個或多個檢測,就像從上而下的布局或者從底部進行脈沖輻射測量。多重閃光燈選項確保了特別大尺寸的藥品和初級包裝材料的全面檢查。擁有兩個X射線閃光燈的雙光束技術可以分析兩個重疊的圖像——并且從不同的角度對結果進行3D再確認和細化。

        The advantages of the X-ray flash modules also include their compactness in addition to radiation protection and outstanding detection accuracy. They can be integrated in the smallest of spaces – partly directly in the packaging machine. The best example: the HEUFT Syringer for inspecting pre-filled syringes and cannulas. It reveals bent needles and pierced protective covers immediately after packaging. Missing or defective tamper evident closures are identified just as reliably as glass splinters or metal particles on the inside and damage to the surface of the sensitive injection instruments. It also checks that they are correctly and fully assembled.

        X射線閃光燈模塊的優點除了輻射防護和出色的檢測精度外還有其緊湊性。它們可以集成到最小的空間內——部分還可以直接在包裝機中。最好的例子是:HEUFT Syringer可以檢測預灌裝的注射器和插管。它可以在包裝后立即發現彎曲的針頭和穿孔的保護蓋。如同識別內部的玻璃碎片或者金屬顆粒以及敏感注射器械表面的損壞一樣,也能可靠地識別缺失或者有防盜環缺陷的封蓋。它還能檢查它們是否正確并裝配完好。

         

         

        From cannula to vial

        從插管到小瓶

        The pulsed radiometric pre-filled syringe inspection will be demonstrated live at ACHEMA 2018 with the HEUFT eXaminer II XB which carries out a top-down examination of different pharmaceutical products and primary packaging materials. However it will mainly inspect blister packs and make solid foreign objects just as visible as empty cavities and defective tablets at the exhibition. It also checks the presence and completeness of the blister packs and the package inserts in the folding carton. The above-mentioned multiple flash option ensures the complete inspection of oversized products. However on the other hand if they are particularly small the simultaneous examination of two products at once is possible with a split conveyor belt. Performance ranges of up to 2,400 units per minute are thus possible.

        脈沖的輻射預灌裝注射器檢測和能夠針對不同醫藥產品和初級包裝材料進行自上而下檢測的HEUFT eXaminer II XB將在ACHEMA 2018現場展示。然而,在展會上它將主要檢測泡罩包裝,并且讓固體異物和空腔及有缺陷的片劑一樣可見。它還能檢查泡罩包裝的缺失和完整性以及折疊紙盒中的包裝說明書。上述多重閃光選項確保了超大尺寸產品的全面檢測。然而,另一方面,如果它們特別小,則同時檢測分開的輸送帶上的兩種產品也是可以的。性能范圍可達到每分鐘2400件。

         

        The top-down X-ray flash technology can also be integrated in the new HEUFT spotter IIPHL. Therefore it also finds the smallest metal particles, glass splinters and other high-density objects even in non-transparent products as well as chips or cracks at the bottom of the container in addition to the camera-based crimp cap, sidewall and base inspection. The fully equipped HEUFT spotter II PHS carries out a double radiometric sidewall inspection of smaller vials – the exhibition highlight at ACHEMA! The identification of the smallest foreign objects is even possible in the lyo product. The same applies to product inhomogeneities and packaging defects. Furthermore initial knowledge about the correct dosage can be gained with it which can be further clarified by using optical technologies or an additional X-ray measuring bridge for detecting the fill level.

        自上而下的X射線閃光技術也能集成到新型HEUFT spotter II PHL中。因此,除了基于相機的褶皺蓋、側壁和瓶底檢測,它還能發現微小的金屬顆粒,玻璃碎片和其他高密度異物甚至是在不透明的產品以及容器底部的裂縫和破裂。裝備齊全的HEUFT spotter II PHS能夠進行小瓶的雙輻射側壁檢——ACHEMA展會的亮點!甚至可以在凍干產品中識別微小的異物。這同樣適用于產品的不同類型和包裝缺陷。此外,可以獲得關于正確劑量的初步認知,也可以進一步通過光學技術明確或者額外的X射線測量橋測量液位。

         

        From foreign object to defect

        從異物到缺陷

        The HEUFT eXaminer II XOS also offers a combination of camera and pulsed X-ray technology. For example it finds all types of foreign objects in freshly filled syrup and medicine bottles. The X-ray pulses also carry out a precise glass in glass detection while special optics identify low-density foreign matter such as fibre or film. Even particles hidden by container structures such as the base dome and thus difficult to identify with the naked eye are identified reliably.

        HEUFT eXaminer II XOS同樣結合相機和脈沖X射線技術。例如,它能找到新鮮灌裝的糖漿和藥品瓶中的所有種類的異物。X射線脈沖還能進行精確的玻璃中的玻璃檢測,特殊光學識別低密度異物例如纖維或者薄膜。甚至能可靠識別用肉眼很難識別的隱藏在容器結構(例如瓶底穹頂)后面的顆粒。

        In addition the X-ray technology available exclusively from HEUFT detects deviations in the shape and size of the product and packaging, closure faults or spray bottles without riser pipes / with defective finger flanges as well as numerous other safety and quality defects. Therefore it ensures the full integrity and tolerability of a wide variety of medicinal products with minimum radiation – for an unbelievable variety of applications!

        此外,HEUFT獨有的X射線技術能夠檢測以下偏差:產品形狀、尺寸包裝,封蓋缺陷或者沒有升流管的噴霧瓶/有缺陷的指型法蘭以及許多其他安全和質量缺陷。因此,它以最小的輻射確保了各種醫藥產品的完整性和耐受性——難以置信的多樣化應用。

         

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