Bosch’s pharmaceutical vision inspection center of competence has developed and launched its 4th generation Static Division (SD4) particle inspection technology on flagship platform AIM 8 series automatic inspection machines.
The origin of Static Division (SD) technology dates back to the early 1970’s, when Eisai Co., Ltd. developed its first AIM machine to support particle inspection of its injectable medicines. 1st Generation SD was a revolutionary method in the pharmaceutical industry, using light transmission method and a diode array to detect light reduction (shadows) caused by moving particles in solution blocking light. The first SD system converted light intensity to a voltage signal and judged against a pre-determined sensitivity using analog data processing.
Performance of AIM was superior to human inspection, news spread quickly within the pharmaceutical community and soon a machinery division (future name Eisai Machinery) was born from a pharmaceutical company. Today, hundreds of 1st generation SD technology fitted AIM machines built in the 1970’s and 1980’s are still in production and known to be the most reliable machine in many pharma manufacturing sites world-wide.
Enter the 1990’s and the digital age, 2nd generation SD technology was developed with digital signal processing under the Eisai Particle Inspection (EPI) PC based platform and offering additional functionality: meniscus following, automatic light intensity adjustment and monitoring of signal measurement data. This 2nd generation of SD coincided with the addition of camera systems to AIM models for cosmetic inspection; providing a complete automated visual inspection system. Though camera systems were becoming more common in the industry for particle inspection, the SD technology was still the preferred choice by many; known for ease of recipe set-up, reliable performance, and unaffected by particulate color/reflectivity or exterior container influences.
At Interpack exhibition 2008, 3rd generation SD technology (SDx) was introduced on the EIS-A206S model, inspecting syringes at 600 per minute. Improvements on the SD technology included: a change from a halogen light to red LED, 2 additional sensitivity settings for heavy and floating particles, and plunger stopper following to adjust for variation in position.
After the acquisition of Eisai Machinery by Bosch in 2012, the AIM 8 series platform was developed and introduced at the 2014 Interpack exhibition. The new flagship model promoted a unique, and later patented, puck material handling system and latest Halcon vision technology for cosmetic inspection and flexibility for particle inspection of solutions to highly viscous liquids. However, the benefits of SD technology still remain strong, and soon after, SD4 was completed and applied to AIM 8 machine orders. SD4 leverages the benefits of SDx and with further improvements: change from red to white LED to allow flexibility for clear and amber glass containers and moving the digital processing onto the HALCON vision PC and allowing for SD4 images to be created and analyzed. In addition, spin rpm, spin direction and stopping (braking) are now controlled by individual servo motors; providing increased capability to create and sustain particulate motion for SD4 detection.
Bosch’s Inspection Technology group is focused on continuing the legacy of Eisai Machinery by providing the highest quality inspection technology and contributing to safe medicines world-wide. Product Safety Is Our Passion.
To learn more about the benefits of SD4, please call (201) 760-5100 to connect with your local Sales Representative.