A worldwide leader in the field of minimally invasive surgery (MIS) device development and manufacturing operates state-of-the-art R&D and manufacturing facilities—facilities that depend on today’s most advanced quality assurance/quality testing procedures. To ensure that all equipment leaving its production facilities meets the highest performance and reliability standards, the company relies on a QA/QC system made possible by industrial microscope and analyzer solutions.
In developing specialized surgical devices including energy-based hand instruments, sterile single-use devices and ENT (ear nose and throat) implants, the MIS manufacturer has advanced medical platforms and opto-digital technologies, driving forward the possibilities of MIS devices within many surgical specialties including urology, gynecology, ENT and general surgery. In the manufacture and assembly of these devices, they utilize rigorous QA/QC protocols that employ a number of highly specialized microscopes and analyzers to test device components while enabling an efficient QA/QC workflow across a number of channels and processes.
Analyzing glass lenses at high magnification
The extremely small glass lenses used in a variety of MIS devices must undergo strict quality inspection to ensure they’re free from chips and scratches and meet specified roundness requirements. Requiring 40x magnification or higher, glass lens inspection is performed by the company with OLYMPUS SZ61 stereo microscopes, which offer excellent depth of field, clarity, detail and true-to-life color needed to accurately analyze glass lenses at high magnification. Of additional benefit is the SZ61’s high resolving power, compact design and versatile body options. The SZ61 can be configured with a variety of universal stands, providing engineers on assembly and inspection lines with easy specimen access while reducing stress on their hands and arms.
The SZ61 is also chosen for lens inspection due to its multiple illumination options, as precision lighting is also a crucial aspect of lens inspection. The SZ61 can be configured with LED illumination (a combination of reflected and transmitted light), “off-the-bench” illumination (mounted directly onto the microscope stand), near-vertical illumination (ideal for illumination into cavities) or white LED illumination (minimal thermal effect and superior brightness).
“When looking to eliminate defects within glass lenses, proper lighting is key,” said a company quality manager. “With the illumination allowed by the SZ61, we’re able to thoroughly and accurately inspect every area of a lens from all necessary angles, which is extremely important as even as the smallest defect can classify a lens as damaged and unsuitable for use. The SZ61 is also very effective in that it allows us to open up dialogue between product engineers very early in the inspection process, meaning we can discuss, address and rectify defects as quickly as possible.”
A clear view of suspected defects
At one of its manufacturing facilities, this MIS device company employs around 50 industrial microscopes at any given time, utilizing the scopes across multiple assembly and inspection lines. Within these lines, which include OLYMPUS SZ61 and SZ51 stereo microscopes as well as the OLYMPUS LEXT OLS4000 laser scanning confocal microscope, engineers are able to clearly view their work on large display monitors positioned above the lines that also allow them to compare any suspected defects against non-defective product imagery.
“Inline inspection and assembly both require highly precise imaging to ensure both a defect-free product and the adherence to FDA and MSA guidelines,” said the quality manager. “What we get from our microscopes is a flexible, easy, adaptive imaging solution that allows us to quickly monitor materials and production, then make any necessary adjustments. Superb image quality, accurate 3-D measurement, seamless image processing—we expect and get all of this from our industrial microscope systems.”
Used to inspect product surface finishes, the LEXT OLS4000 is a laser scanning confocal microscope system suitable for situations where parts are extremely small in size. The OLS4000 employs a dual confocal system, which in combination with a high-sensitivity detector allows line engineers to capture precise 3-D surface scans.
Identifying alloy grades and pure metals
Of equal importance within the QA/QC process is the analysis of the metals and alloys that make up product components. For these inspection applications, this manufacturer utilizes the OLYMPUS DELTA Premium Alloy Plus XRF Analyzer, a handheld x-ray fluorescence scanning device used to quickly and accurately identify alloy grades and pure metals. Designed for small parts and components, as well as more sizeable materials, the Premium Alloy Plus is used to confirm product material grades, perform highly focused sample analyses, and analyze joined materials.
From production to patient
While industrial microscopes and analyzers ensure that all products consistently meet specification, the benefits of the QA/QC process ultimately extend all the way to the patient.
“Every product we make sees the patient at some point,” said the company’s senior manufacturing engineer for assembly. “The industrial inspection tools we use in our quality control processes ensure that no defective parts or materials ever make their way into a finished device.”