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.
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.
Little radiation and numerous applications
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.
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.
From cannula to vial
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.
The top-down X-ray flash technology can also be integrated in the new HEUFT spotter II PHL. 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.
From foreign object to defect
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.
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!