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Equipment and Processing Report
A new machine is designed for inspection of prefilled syringes.
With a rising number of recalls associated with visual defects in parenteral products, and new and pending regulatory requirements, such as United States Pharmacopeia(USP) General Chapter <790> “Visible Particulates in Injections,” USP <1790> “Visual Inspection of Injections” and USP General Chapter <1207>, “Sterile Product Package-Integrity Evaluation,” drug makers are seeking ways to improve the inspection process (1, 2, 3, 4). Although automated inspection systems are available, the equipment may not be practical for lower volume products or lines that handle many different products (1). However, manual inspection involves repetitive motion and can cause ergonomic issues (5). Automating the movement of parenteral products for presentation for manual inspection not only improves ergonomics, but also maximizes flexibility and involves lower capital investment and qualification costs than fully automated inspection systems (5).
One example of automated material handling, the servo-equipped HPI-30-M machine from Luciano Packaging Technologies, transports bright (unlabeled) prefilled syringes so inspectors can check the product for particles and syringes for damaged or missing components. Designed for a major maker of parenteral products, the compact, two-station unit moves prefilled syringes so two operators can each perform a manual inspection of 100% of the product. The equipment fits in a niche between tabletop hoods or floor-standing work stations and semiautomatic systems.
The integrated machine represents a departure from the systems currently available for handling prefilled syringes through the inspection processes. Existing systems typically consist of three separate machines-denesting, inspection (linear trunnion conveyor format), and renesting-and tend to occupy a considerable amount of floor space. “The driving motivation for this system was to accomplish these processes within a single, compact, and efficient machine configuration,” Larry Luciano, president of Luciano Packaging Technologies, told Pharmaceutical Technology.
Larry Luciano, president of Luciano Packaging Technologies, demonstrates the HPI-30-M automated material handling system for manual inspection of prefilled syringes at PACK EXPO East (Feb. 16-18, 2015, Philadelphia).
Photo courtesy of MilesBoonePhotography.com
On the HPI-30-M machine, a gantry picks up a nest of syringes and places it on an indexing conveyor. The nest indexes forward so an Adept robot can lift out five syringes at a time and place them in a star wheel, needle-side up. Meanwhile, the empty tub is conveyed below the indexing conveyor so it can be reunited with the nest at the conclusion of the inspection process.
In the first inspection, a camera and infrared lighting checks the needle shield to ensure all components are present and nothing is punctured or bent. Any faulty syringes are rejected. As the star wheel rotates, syringes arrive at the first operator station and are spun as an inspector looks through a magnifier to check for particles. If particulate contamination is detected, the inspector can activate a reject. A verification system confirms the reject. Approved syringes pass to the second inspection station where the examination process is repeated. Syringes move at a rate of up to 30 per minute, the top speed of experienced inspection personnel.
After the second inspection station, the robot removes syringes from the star wheel and passes them above the camera to inspect the flange. If the flange passes inspection, the syringe is replaced in its original space in the nest or in a discharge chute for transfer to labeling and pouching operations.
The HPI-30-M machine features controls from Beckhoff Automation and Halcon machine vision from MVTec.