Medical Device Inspection

 

JLI Medical Device Inspection Systems are custom designed turnkey solutions for measuring dimensions, shapes, surface defects, printing etc.

JLI’s medical device systems cover a range of product types and production processes. All our equipment is designed for the actual environment. This means extraordinary reliability, fail-safe operation and may include high speed and superior accuracy.

General features/benefits of JLI turnkey systems include:

    • Validated and developed according to GAMP5 & 21CFR PART 11
    • Adapted to existing production lines
    • Internet connection for support
    • Excellent reliability track records
    • Custom applications

         

        Examples of Systems Commisioned by JLI

        Pre-filled Syringes pdf

        The system enables detection of small chips and cracks in pre-filled syringes with full coverage of the syringe including areas such as plunger, plungerrod, labels and liquids. Inspection speed up to 120 parts/minute. The system replaces a timeconsuming and often error-prone manual control. 

        • Installed online for 100% inspection
        • Developed according to GAMP5 and 21CFR PART 11
        • Calculates statistical data and displays trend information
        • Innovative ligthing techniques

        Video of pre-filled syringe inspection wmv

        prefilled syringesPrefilled syringes

        Pharma 1 (part measurement) Dimensional/surface inspection carried out on a plastic moulded part 

        		  

        Moulded Parts pdf   

        Production of medical devices is a critical manufacturing process. Making faulty components can cause bodily harm or even death. Precise inspection and accurate records are essential and demanded by the Food and Drug Administration.

         

        • Dimensional accuracy < 1 micron
        • Surface / visual errors are detected with very small contrast
        deviations
        • Calculates statistical data and displays trend information
        • Preventive maintenance

        Tablet dispensers pdf

        A system for inspection of packed tablets. The system inspects tablet dispensers to detect wrong colored tablets, broken or missing tablets, and missing or defective covers on the dispenser.


        • Color inspection
        • Wide variety of tablet types can be integrated
        • Production report generated at batch level

        Tablet dispenser.Tablet dispenser

        pharma 3 (print)Print inspection of cylindrical parts

        Print Inspection 

        Print inspection systems to medical standard. Integrated with production machinery using either
        indexed or continuous motion.

         


        • Optimized for printing process: silk screen, tampon, off-set or laser
        • Choose either a built-in teach function or manual settings
        • 180 or 360 degree coverage on round objects
        • Feedback option for adjusting inking process
        • Individual statistics for sheets, blankets, mandrels, print heads etc.

        Caps

        Pharmaceutical caps are inspected for defects in the rubber insert and in the aluminum cap. As an add-on the system can inspect the holes in the rubber band from which the rubber insert is punched.


        • Measures the shape and dimension of the aluminium part
        • Measures surface errors with an accuracy of 0.01 mm in the
        rubber inserts
        • Add-ons include color inspection of rubber and hole inspection
        • Integrated SPC gives excellent production management possibilities

        Cap mounted on ampoule.Cap mounted on ampoule

        Pharmaceutical ampoule.Pharmaceutical ampoule

         

         

        Ampoules

        Quality assurance of glass ampoules is a vital element of the production process. The Chips & Cracks inspection verifies the completeness of each ampoule, and can be a substantial improvement in fault detection.

         

        • Special designed lighting
        • Locates defects with an accuracy of 10 microns
        • High speed application
        • Production report is automatically generated at batch level

        Catheter Inspection 

        Catheter inspection can be integrated on existing production machinery. Special optics makes it possible to inspect 360 with only a 120 degree rotation.


        • Typical inspections include: tip, eyes and surface impurities
        • Systems are available for inspection of coated catheters
        • Batch controlled
        • Production report for documentation purposes

        Catheter inspection.Catheter inspection

         

         

        Measurements on needle tip.Measurements on needle tip

        Needle Inspection 

        A system for precision measurements of details on needles. The system inspects a macro area of the needle tip, and detects dimensional errors and the surface of the needlepoint after grinding. Precision is better than one micron.

        • Can be integrated with automatic handling equipment
        • Detects burrs from multiple angles
        • Single camera system
        • High accuracy < 1 micron

        Label Inspection 

        The JLI label inspection system is a compact stand alone unit that automatically verifies all your printed labels, including variable text, numbers and barcode fields. When a defective label is detected the operator is informed so that the label can be manually inspected and removed.

        • Accepts printer imperfections
        • High speed - One system can service many printers
        • Improve your label quality by eliminating human “error”
        • Smart teach function for new labels
        • Works with any printer
        • Easy setup via user friendly software
        • Shortens your label checking time
        • Interface to PMX and other systems
        • Automatic report generation

        Video of clinical trials inspection 

        Link to reference publication (DANISH). 

        Clinical trials label inspection.Clinical trials label inspection