Whether infusion bottles or ampoule strips: newly developed HEUFT spotter II BFS systems are proving their worth during the all-around inspection of aseptically produced blow fill seal containers filled with sterile pharmaceutical liquid dosages.
Large volume parenterals (LVPs) such as saline, electrolyte and glucose solutions or even inhalation products, eye drops and other small volume parenterals (SVPs): sensitive preparations such as these are preferably administered from blow fill seal bottles and ampoules made of polypropylene or polyethylene. They are aseptically manufactured and considered to be superior primary packaging for such applications – provided that they are free from defects, deformations or cosmetic faults, correctly filled and hermetically sealed. New HEUFT spotter II BFS devices check this along an efficient linear system.
They achieve full coverage and precision during the in-line inspection of such primary packaging with smart lighting, optomechanics, image filtering and subtraction as well as image evaluation adapted to different fault categories. They are subjected to 100% integrity testing as required by the Good Manufacturing Practice (GMP). For this every single blow fill seal container is inspected all around from the closure to the base in order to find deformations, missing or excess packaging components, contamination, scratches, grooves, inclusions and cosmetic defects in the container material just as safely as foreign particles inside it. Deviations in the filling quantity and the colour of the liquid parenterals inside are also detected reliably.
Gapless inspection of bundled BFS ampoule strips
The HEUFT spotter II BFS inspects bundled blow fill seal ampoule strips not only top-down and but also bottom-up in order to rule out blind spots during the SVP inspection. Furthermore it also carries out a gapless optical sidewall inspection. Therefore the conveyor belt which clamps the bundles and guides them straight through the device is specially designed to alternate: they are “gripped” at the top in the infeed in order to examine their complete lower part including the base edge and then at the bottom in the outfeed so that the complete top half is covered up to the closures.
Intelligent optical technologies and the HEUFT reflexx2 image processing create full detection reliability. For instance special lighting has been integrated into the modular system specifically for the reliable detection of ampoule strips with greasy contamination. And inverted evaluation images, for example, make black spot inclusions clearly visible everywhere in the SVP container material as white dots on a black background.
Precise all-around inspection and leakage check for BFS infusion bottles
All this is also possible during the gapless complete inspection of blow fill seal infusion bottles which are filled with 100, 150, 250, 500 or even 1,000 millilitres of LVP. And much more: the HEUFT spotter II BFS also carries out a leakage check in order to detect minute leaks. The bottles are guided between two belts for this purpose which exert a precisely definable force on them. At the same time two sensors measure their internal pressure so that a fall in pressure caused by a leak can be determined reliably – regardless of the electrical conductivity of the product inside them.
The infusion containers, clamped in this way, “float” above the optical module for a base inspection in the middle of the device so that this area can be inspected completely without gaps in order to identify, among other things, cosmetic defects, foreign particles or defective bottle hangers there. The modules for an optical 360 closure and sidewall inspection which also detect torn sealing film, deformed or incorrectly aligned twist-off caps as well as underfilling or overfilling are in the infeed and outfeed where the containers are not yet or no longer transported in the belt drive. Therefore their full volume is covered without any blind spots. A HEUFT X-ray measuring bridge can be integrated into the modular system of the new generation as an option for even more precision during the fill level detection.
Fully automatic format change and error-free operation
Based on the current HEUFT SPECTRUM II platform it not only achieves maximum precision during container tracking, in-line inspection and fault rejection with a wide variety of rejection systems but also the fully automatic adaptation of the trigger photocells, cameras, lighting units and conveyor belts to the different sizes of blow fill seal containers. Therefore program and format changes are carried out without tools and completely without human intervention.
The first installed systems already inspect up to 30,000 ampoules or up to 12,000 infusion bottles per hour. At the same time the audiovisual HEUFT NaVi user guidance ensures simple, error-free operation. The HEUFT spotter II BFS meets 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. Connection to higher-level databases and MES systems makes the real-time transmission, preparation and complete archiving of detection images, batch and production data possible. There is a network connection to the HEUFT TeleService for reliable remote diagnosis and maintenance. Therefore the newly developed but already field-proven pharmaceutical inspection system fulfils fundamental GMP and GAMP5 requirements consistently.
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