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Medical Device Tools: Needle Inspection

Needle-Inspection2

Needle inspection is a critical safeguard in ensuring the effectiveness of autoinjectors and other needle dependent delivery systems.  These medical devices, whether delivering medication or implantable devices, depend on needle integrity for treatment to be successful.  Needle alignment and tip quality are among the most important elements demanding validation during the production of such devices, and X-ray inspection provides an ideal solution for rapid and reliable evaluation.

Injectables inspected through sealed primary packaging  w/ measurement tools applied

 

Bent or misaligned needles can cause an array of problems.  Depending on the severity of the defect, the result can be pain or bruising at the injection site, injury to the patient, or failure to deliver the intended treatment.  A robust inspection protocol, including X-ray validation, can help prevent substandard devices from reaching patients.  X-ray inspection is particularly adept at such inspection, as supporting software can evaluate images for conformity to required standards, even after devices have been packaged.

Similar issues can arise from non-conforming needle tips, and again X-ray inspection can be a powerful tool in ensuring quality.  High resolution imaging can easily reveal burrs, and blunted or bent needle tips.  Such inspections can even be automated, and integrated into a production line at virtually any stage in your process.

Evaluating fill level by measuring air bubble

 

Of course, needle integrity is not the only consideration when dealing with injectables.  Spring presence/absence, nesting, proper location and compression, are among the critical features that require validation.  For injectable medication, proper fill level is also essential.  Likewise, for implantable devices, presence or absence and location can be key.  X-ray inspection is well suited to support validation of all these critical device characteristics, and more.

Top needle deviates .02 degrees, bottom needle .001 degrees

 

X-ray inspection of autoinjectors, their needles and other components and features can complement a robust quality process, and prevent substandard product from reaching patients.  Inspection can be manual, semi-autonomous, or fully automated.  Inspection systems can be seamlessly integrated at any stage of production, and supported with a wide variety of material handling options, as well as barcode scanning and ERP integration.

Bent needle, deviates .02 degrees from centerline

 

Creative Electron supports a number of medical device manufacturers with X-ray inspection systems, across a wide variety of products.  From off the shelf solutions to custom integrations, we are happy to tailor inspection equipment to your exact needs.  Please reach out to discuss your inspection requirements and learn how X-ray inspection can help support your quality assurance goals.

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