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MS-Series High-performance inspection for ampules, vials and cartridges MS-series Purity and sterility of parenterals – vital to patients’ health Increasing manufacturing capacities are continuously leading to higher production speeds requiring highly sophisticated technologies to inspect product at all levels. Compared to other pharmaceuticals, the production of parenteral products is much more complex and bears the risk of many contaminations. Since parenterals are typically injected and directly enter the bloodstream, particulates might cause adverse Camera inspection Leak detection ¡for particles ¡for cosmetic defects High voltage for micro-cracks and pinholes Laser for pressure in head space Cap Tip Leak Detection reactions. However, one of the most challenging aspects of container quality control is the assurance of container/ closure integrity. Whatever your requirements: inspection for particles in the product or cosmetic defects of the container, as well as verification of container integrity – we offer the appropriate inspection technology for your needs. Color Code Ring Particles OPC Cap Cap Crimp Stopper/Neck Crimp Stopper/Neck Shoulder Shoulder Sidewall Sidewall Sidewall Sidewall Particles Beads Particles Cake Plunger Bottom Bottom Ampule 2 | Seidenader Heel Bottom Bottom Cartridge Vial Liquid Vial Lyo The modular design of major machine functions for infeed, inspection and outfeed enables us to build customized machines from standardized modules. The MS platform is equipped as standard with vision systems for the inspection of solutions, suspensions and emulsions as well as oil-based or lyophilized products in ampules, cartridges and vials up to 100 ml. To complement camera inspection, additional technologies such as high voltage can be included, to reliably verify container integrity and product sterility. your Benefits ¡Inspection of up to 24,000 containers per hour ¡Handling of ampules, vials and cartridges up to Ø 52 mm, and up to 100 ml ¡Inspection of solutions, suspensions, emulsions, oil-based and lyophilized products ¡Minimized false reject rate thanks to integrated automatic re-inspection of defined defect parameters ¡Maximized inspection performance thanks to - up to 24 images per particle station - up to 3 light techniques per particle station - up to 3 particle stations ¡Individual rotation profiles thanks to servo drives on each position in the inspection carousel ¡Large inspection turret to optimize rotation and inspection time, even for viscous and suspension products ¡Quick changeover thanks to fewer format parts Seidenader | 3 MS-series 850 1500 Design Features 1 2 1010 “Hyseptic” standard ¡Sealed and covered optical elements ¡Column concept for good access and easy cleaning ¡Trimmed edges, hidden cables ¡Strict separation of product handling and machine engineering areas ¡GMP compliant 2 PRODUCT HANDLING ¡Vacuum transport for smooth product handling ¡Reduced number of side guides to avoid friction ¡Vacuum pump for reduced air consumption Infeed 1 3 CAMERA INSPECTION Infeed via split timing screw which creates empty positions for the re-inspection process and stops infeed to empty machine without leaving uninspected products. ¡Continuous motion – no moving cameras, no moving lights – thanks to a central oscillating mirror moving in synchronization with the transport of the container ¡Servo drives for each position in the inspection carousel allow individual rotation profiles: ¡Manual loading from trays with Seidenader A-MAG, with tight splitting at infeed starwheel to slow down its rotation speed at same throughput ¡Inline interface with upstream machine to transport stable containers directly to the infeed timing screw ¡Inline connection, with turntable for manual loading 4 | Seidenader - Different kind of liquids require different rotation speeds to be brought into the dedicated motion - Different kinds of particles require different rotation speeds to be whirled up - Rotation speed and brake point are stored in the indivi- dual product configuration (recipe) 400 1400 3 1050 6 7 5 4 1400 1400 4 Automatic Re-inspection Integrated re-inspection (short) for defined defect categories ¡To minimize false reject rate ¡To avoid uninspected products during a production run 5 High voltage leak detection Integrated high voltage leak detection (HVLD PRO or HVLD SLIM) for liquid filled containers, with one operator interface for camera and HV inspection – 360° inspection of the container guaranteed 980 All units are in millimetres. Footprint illustrated is example only. 6 Head space analyzer Head space analyzer (HSA), for 100% testing of containers, inline and at high speeds, to verify container integrity of lyofilled vials Outfeed 7 Each inspection result and each defect category can be allocated to a dedicated outfeed channel. ¡ Up to 8 channels for good products, rejects or not inspected ¡Inline connection to downstream machine Seidenader | 5 MS-series Technical Data Seidenader MS-40 max. throughput containers/h 24,000 max. number of camera stations (in carousel) 9 (6) servo-driven positions in carousel 60 range of container Ø up to 52 mm range of containers ampules, vials, cartridges range of products solutions, suspensions, emulsions, oil-based and lyophilized products combo machine liquid and lyo yes automatic re-inspection short dimension of base machine (excl. cabinet) 1,400 x 1,900 mm vacuum transport technology with external electrical vacuum pump yes Seidenader | 7 Seidenader Services Tailored to Your Needs Seidenader Customer Support Our Customer Support Team is available during business hours to help you with urgent questions you may have about your Seidenader machine or any other technical issues. 24/7 support is also available as an additional option. Seidenader After Sales Services Maintenance, spare part orders or retrofit requests – your direct contact is a designated customer support team to coordinate all your inquiries regarding our comprehensive range of after sales services. Seidenader Academy Reduce your installation time to a minimum by taking advantage of customized training sessions for integrators and users of our products – from the basics to the tips & tricks to run your machine in the most efficient way. Seidenader 04.2014 Seidenader Qualification Support Profit from our validation support package and minimize validation and start-up time. Our specialists develop test plans and qualification protocols and provide support during execution. Seidenader Maschinenbau GmbH Lilienthalstr. 8 · 85570 Markt Schwaben · Germany · www.seidenader.com T +49 8121 802-0 · F +49 8121 802-100 · [email protected] www.seidenader.com