Medical technology

Automated quality inspection for medical devices and healthcare products

In medical technology, products, components and packaging must be inspected reliably – often inline, at high cycle rates and under regulated production conditions. OCTUM develops automated inspection systems for the optical quality inspection of medical devices, laboratory consumables and other healthcare products.

The machine vision systems inspect syringes, pipette tips, wells, wound care products, containers, tubs, trays and other medical technology components for geometry, completeness, surface quality, contamination, assembly defects and marking. Defective products are detected at an early stage, reliably rejected and the inspection results are documented in a traceable manner.

For manufacturers in the medical technology sector, this means greater process reliability, consistent product quality and inspection solutions that can be adapted to product-specific requirements, regulated environments and existing machine concepts. Depending on the application, OCTUM takes relevant requirements from GAMP5, EU-GMP Annex 11 and 21 CFR Part 11 into account – for example with regard to user management, audit trail, traceability and documented inspection results.

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Focus: Medical technology

Our inspection solutions cover areas including:

>> Syringes (glass, plastic)

  • Syringe length measurement
  • Finger flange damage inspection
  • Dispensing tip/attachment assembly inspection
  • Plunger rod assembly inspection
  • LLA check
  • Code reading
  • Safety device assembly inspection
  • Completeness in the syringe nest

>> Pipette tips

  • High-precision inspection of various pipette tip sizes
  • Measurement of inside diameters
  • Detection of overly large or closed inside diameters
  • Tip concentricity check
  • Flash and ridge identification
  • Random sampling or 100% inspection of pipette tips
  • Flexible system design to suit customer requirements

>> Dressing materials

  • Check for correct sealing
  • Detection of impurities
  • Shape and dimension check
  • Layer structure and completeness check
  • Print check

>> Wells

  • Flaws
  • Full shot
  • Dark spots and stains
  • Contamination
  • Completeness in the tray
  • Defect type classification
  • Proof of measuring equipment capability

>> Pharmaceutical rules and regulations

In a regulated environment, countless provisions and guidelines must be followed when using automated inspection systems. With solutions from OCTUM, you can forget your worries concerning the following points:

  • Compliance with national and international standards, laws and directives
  • Documentation of product quality
  • Verifying process reliability
  • Compliant software solution for implementation

>> Other healthcare products

In medical technology, there are already numerous other products that have to undergo quality checks using automated inspection systems.

  • Cups
  • Tubs and trays
  • Plastic bottles
  • Calibrators
  • Containers (glass, plastic, metal)
  • Cleanroom bags
  • Pharmaceutical film
  • Dialysis filters
  • Blood collection tubes
  • Candle filters

OCTUM GmbH

Renntalstraße 16
74360 Ilsfeld, Germany

Tel.: +49 7062 91494-0
Email: info@octum.de

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