Prefilled Syringe Inspection
Published: July 30th, 2013
For automated inspection of prefilled syringes, Bosch Inspection Technology’s machine line includes the EIS A206S for inspecting glass syringes 1.0 to 3.0 ml, and the EIS 2962 for prefilled glass and plastic syringes 1.0 ml to 10 ml.
In a Q&A with PMP News, Peter Spinelli, sales director, Bosch Inspection Technology North & South America, addresses current trends in prefilled syringe inspection.
Q. How is the trend of prefilled syringes replacing multidose vials impacting inspection solutions?
A. Both container types require foreign particulate and cosmetic inspection. However, for syringes, air bubbles are more prevalent in the liquid and sticking to the plunger stopper as a result of the nested filling process. Bosch Inspection Technology machines provide a solution that utilizes several high-speed spins to help remove bubbles that may cause false rejection. Syringes also require equipment for denesting and renesting the syringe with connection to the inspection machine.
Q. Is the trend of higher flexibility, slower lines for handling multiple products driving different inspection choices?
A. While most applications for automated inspection machines are due to higher volumes (usually 300 ppm and higher), we have received several requests for flexible, hybrid-type machines. Bosch offers combined equipment for ampoules and vials, and also for vials and syringes at speeds below 300 per minute. Such equipment also offers Hybrid Inspection technologies, which combine patented Static Division (SD) light transmission sensor technology and CCD camera technology to effectively detect foreign particles in solutions, suspensions, and viscous products. For lower production, we offer semi-automatic machines that are built in New Jersey, including the VIS series, which provides automatic adjustable inspection angle and can inspect liquid, freeze-dried, and powder-filled products in ampoules, vials, cartridge, and syringes.
Q. What are the determining factors in the use of manual, semi-automatic, and automatic inspection?
A. All three share similar factors for inspection, including spinning the liquid to create particle motion, proper illumination, and proper material handling of the container to the inspector, camera, or sensor. The choice of which technology to use typically depends on production volume, batch sizes, product mix, budget and qualified personnel for inspection, operation, and maintenance.
Q. How, for example, are regulations/ guidance influencing adoption of inspection technology?
A. Agencies have been encouraging automated technologies for their benefit of accuracy and repeatability and challenges of pharmaceutical manufacturers to train and maintain a human inspection workforce. Groups like the PDA’s Visual Inspection and Glass Task Force have brought heightened awareness to glass defects that may compromise product and container quality. This awareness has resulted in increased projects to automate product and container defect inspection, as well as help minimize glass-to-glass contact in the production process.
Q.Which Bosch inspection solutions are best positioned to meet emerging trends/requirements? A. Hybrid Inspection technologies continue to grow in interest and provide capability for inspecting a wide range of liquid and freeze-dried products. Bosch’s lighting and camera experience has benefited automated freeze-dried and powder vial applications as well as products filled into dual-chamber cartridges. Soon, Bosch Inspection Technology will introduce its next-generation automatic inspection machine platform, which expands on these technologies and capabilities even further. Bosch also has extensive high voltage leak detection experience, and this area is continuing to grow in interest at the end-user sites globally.