Oxygen-based Headspace Analysis added to inspection portfolio
Seidenader has now added a new laser absorption process configured for oxygen to its portfolio of solutions for leak detection in pharmaceutical containers: the HSA O2 system can detect leaks produced by the finest cracks, in applications in which regular high voltage leak testing is not possible due to insufficient electrical conductivity. Using this process, containers with an internal diameter of 22 mm or more can be inspected reliably.
HSA O2 is a spectroscopic process that detects leaks indirectly, by analysing the oxygen content in the gas zone of the container, i.e. between product and stopper, using a laser beam and photographic sensor. Freeze-dry products are generally sealed at low pressure in a controlled atmosphere, with no or only a small, defined oxygen content. This means that after closure, leaky containers are susceptible to penetration from ambient air, the quantity of which is determined by two parameters: the interval between lyophilisation and inspection, and the ambient pressure upon closure. The greater the vacuum in the container, the quicker the ambient air is able to penetrate by way of pressure equalization. And the less oxygen the controlled atmosphere has from the start, the clearer will be the measurable discrepancy in the event of a leak. Depending on the underlying conditions, even the smallest leaks can be detected in this way. An inspection rate of 24,000 containers per hour can be attained, depending on how the machine is configured. The name 'HSA O2' stands for 'Head Space Analyzer' and oxygen (O2).
One basic advantage of the HSA system is that as an inspection station, it can be integrated into any standard automatic machine from Seidenader. The expenditure for investment and maintenance is comparatively low, as no separate machine is needed, and moreover no additional production space is required. Subject to individual testing, it is also possible to retrofit the system to existing Seidenader machines. If required, an HSA O2 system can also be configured as a standalone HSA SOLO unit on the smallest Seidenader machine platform.
Seidenader 3D Inspection: particle inspection for highly viscous products
With the common camera inspection it has always been a challenge to distinguish between inside and outside contamination of pharmaceutical containers filled with highly viscous products. Seidenader has now developed a special method for inspecting these products: a completely new approach, but based on the same hardware.
This method uses the third dimension to create virtual images from measured data and assumptions, compares these virtual images with the real image taken by the camera, and gets the final result through crosswise image subtraction.
Seidenader’s semi-automatic inspection machines guarantee the highest standards in quality testing of pharmaceutical products to be administered by injection. With the new generation V90+ Seidenader, inventor of this process, has further improved the original – and set new standards in visual inspection.
The new V90+ was consistently designed for maximum support and to relieve the strain on the operator in visual inspection. In addition to ensuring the highest quality standards, the superior ergonomic design of the machine effectively prevents premature fatigue.
The V90+ enables simultaneous inspection of several criteria in one machine and by only one individual. The prerequisite for this is created by various illuminations and mirrors. At a glance, the operator can identify foreign matter in the product, impurities or cracks and glass damage on the bottom, shoulder and cap zone. At the request of a customer, the machine can be designed so that the inspection angle is adjustable to 60° or 75° depending on the task.
Perfectly synchronized components on the infeed minimize pressure on the container and reduce friction. The risk of glass breakage is reduced and resulting downtimes are eliminated. Containers can be fed continuously or intermittently through the cabin for inspection.
A variable high-speed rotation, driven by servo motors, stirs up any particles in the container. In the operator’s field of vision the container to be inspected rotates around its own axis at an individually adjustable speed. This not only facilitates 360° inspection, but enables inspection of the closure zone and bottom by means of additional mirrors. A magnifying glass and the Tyndall effect additionally facilitate detection: scattered light makes particles glow like dust in font of a film projector.
The machine can be intuitively operated via a user-friendly widescreen touch panel. Software and control panel (HMI) conform to the high standards of fully automatic Seidenader machines. Inspection parameters such as rotation speed or light intensity are stored in the HMI with the respective recipe and can be automatically loaded. This enables the reproducible setting of inspection parameters for each individual batch. Furthermore, the risk of setting errors on the occasion of a product change is eliminated.
The V90+ can transport up to 9,000 pharmaceutical containers per hour, and the machine is capable of handling different container shapes with volumes of 0.5 to 1,000 milliliters. Depending on the format set, ampules, cartridges and vials with liquid and/or lyophilized contents as well as syringes can be inspected. The diameter may be between 6.85 and 95 millimeters and the height up to 240 millimeters. When retooling for a different container type or format, all format specific parts can be changed in the shortest of times without special tools.
Seidenader develops high-tech solutions for the inspection of pharmaceutical containers for liquid and dry sterile products. State-of-the-art camera systems for visual control, high voltage leak detection (HVLD) or laser-based headspace analysis (HSA). For patient safety, Seidenader develops serialization solutions enabling the traceability of your products, covering the complete production and distribution process.
Since 1895, Seidenader has been committed to manufacturing high-quality equipment for the pharmaceutical industry. For more than 20 years, we have also been developing in-house the intelligent vision systems for our automatic inspection machines. Expertise on material handling and inspection of a vast variety of pharmaceutical containers filled with liquid and dry sterile products, combined with the experience and feedback of our customers has helped us to create a full line automatic inspection machines: from handy table top units for laboratory applications to high-performance inspection machines for large production environment. Exterior washing machines as well as inspection and sorting machines for tablets and capsules complete the Seidenader product range. Seidenader meets the increasing requirements of the pharmaceutical industry by developing complementary inspection technologies, automation solutions for the control of complex packaging lines as well as comprehensive track and trace solutions.
The head office of Seidenader Maschinenbau GmbH is located in Markt Schwaben near Munich, Germany. Seidenader is part of Körber Medipak Systems.