Industrial Image Processing for Medical Technology
Automated quality inspection for medical devices and laboratory consumables
Medical devices, components and consumables for diagnostics and laboratory automation must be inspected reliably – often inline, at high production speeds and under regulated manufacturing conditions.
OCTUM develops and integrates customized machine vision and AOI systems for automated quality inspection in medical technology, diagnostics and life sciences. Typical products include syringes, pipette tips, wells, microplates, trays, wound dressings, patches and other medical components.
The inspection solutions are tailored to the product, the relevant quality characteristics, the material, the cycle time and the conditions within the assembly, production or packaging machine.
For manufacturers, this means greater process reliability, consistent product quality and traceable inspection results. Depending on the application, functions for user management, audit trails, data integrity, traceability and documented quality data can be incorporated.
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OCTUM develops modular and customized inspection systems for different product groups and production processes.
Inspecting Syringes and Syringe Components
syringe.inspect enables automated inline inspection of glass and plastic syringes, prefilled syringes and various syringe components.
The modular inspection systems can be integrated into assembly, filling, closing, labeling and packaging processes. Typical inspection characteristics include:
- Presence and completeness
- Assembly status and orientation
- Finger flange and syringe barrel
- Luer lock adapter and Luer cone
- Plunger rod and safety device
- Geometry and dimensional accuracy
- Surface irregularities
- Siliconization
- Label position and print
- Human-readable text and codes
- Completeness within the syringe nest
Inspecting Pipette Tips and Pipette Racks
pipette.inspect examines pipette tips from different perspectives and detects quality-related geometry, flash, filter and shape characteristics.
Possible inspection tasks include:
- Inner and outer diameters
- Roundness and concentricity
- Radial and axial flash
- Short shots and overmolding
- Filter presence and position
- Shape and contour deviations
- Completeness and arrangement within the rack
- Different tip and tray formats
The inspection systems can be adapted to the material, color, format, tray concept and machine cycle time.
Inspecting Wound Care Products and Transdermal Systems
patch.inspect enables inline inspection of wound dressings, wound care patches, medicated patches and transdermal systems – both as continuous web material and as individual cut products.
Depending on the product and manufacturing process, the system can inspect characteristics including:
- Product contour and dimensions
- Material layers and product structure
- Position and completeness
- Visible contamination
- Surface and material defects
- Active ingredient application
- Print and labeling
- Human-readable text, variable data and codes
Inspecting Wells, Microplates and Trays
well.inspect examines wells, cups, microplates and trays directly within the production, assembly or packaging process.
Typical inspection characteristics include:
- Geometry and dimensional accuracy
- Surface quality
- Contamination and foreign particles
- Completeness and component presence
- Position and orientation
- Shape and contour deviations
- Product- and format-specific defects
Detected defects can be classified according to predefined defect types and made available for quality assurance or process analysis.
Other Medical Devices and Healthcare Applications
In addition to its modular product solutions, OCTUM develops customized inspection systems for other medical and diagnostic products.
Examples include:
- Blood collection tubes
- Eye-drop bottles
- Dialysis filters
- Tubs and trays
- Medical containers made of glass, plastic or metal
- Calibrators
- Cleanroom bags
- Pharmaceutical and medical films
- Filter cartridges
- Closures and assembly components
The specific inspection task is decisive. Product geometry, material, defect characteristics, variants, cycle time, production environment and documentation requirements are considered together.
Machine Vision for Regulated Production Environments
In medical device manufacturing, it is not sufficient simply to classify products as good or defective. Depending on the application and quality process, inspection results, changes, user actions and relevant production data may also need to be documented in a traceable manner.
For medical device manufacturers, relevant requirements may include the European Medical Device Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR) and ISO 13485. For products and production environments intended for the US market, the FDA Quality Management System Regulation under 21 CFR Part 820 may also apply.
If quality-relevant electronic records or electronic signatures are maintained, requirements arising from 21 CFR Part 11 may also be relevant, depending on the intended use.
These regulations apply to manufacturers and their quality management systems. An inspection system alone therefore does not establish regulatory compliance. However, OCTUM can provide technical functions and documentation that support the operator’s quality, qualification and validation processes.
Possible system functions include:
- User, role and rights management
- Audit trail
- Recipe and format management
- Version and change history
- Storage of inspection and event data
- Product, batch and order assignment
- Data integrity and traceability
- Interfaces to machine controls, MES and higher-level systems
- Documentation supporting qualification and validation
The specific system configuration depends on the intended use, the product, the operational processes and the user’s validation concept.
>> Learn more about regulatory system functions
Measurement System Capability and Reproducible Inspection Results
For geometrical or dimensional inspection tasks, resolution, repeatability, tolerances, part handling, environmental conditions and reference parts are considered during the system design phase.
Depending on the application, OCTUM can provide project-specific support for measurement system capability studies and supporting evidence. The specific procedure and acceptance criteria are defined jointly with the operator.
Integrated into Machines and Production Lines
Reliable quality inspection depends on more than the camera alone. The camera, optics and lighting must make the relevant inspection characteristics consistently visible. The inspection software must evaluate the images within the available cycle time.
At the same time, product handling, triggering, machine communication, pass/fail decisions, reject handling, operation and data flow must be coordinated with one another.
OCTUM integrates machine vision and AOI systems into both new machine concepts and existing production lines. Depending on the project, the following aspects are considered:
- Camera, optics and lighting concept
- Product handling and inspection position
- Material and surface properties
- Machine cycle time and trigger behavior
- Connection to the PLC and machine control system
- Interfaces to MES or other higher-level systems
- Pass/fail decisions and reject handling
- User interface and format management
- Storage and transfer of inspection data
- Long-term maintainability and serviceability
>> Learn more about system integration
>> Evaluate technical feasibility
Why Choose OCTUM for Medical Technology Inspection Systems?
OCTUM has been developing machine vision and AOI systems for demanding production environments since 1996.
- Experience in industrial machine vision since 1996
- More than 6,000 systems installed worldwide
- Modular inspection solutions for medical devices
- Proprietary software solutions such as OCVis, OCTUMISEr and CV-Inspect
- Experience with regulated production environments
- Geometrical, dimensional and classification-based inspection methods
- Integration into new machines and existing production lines
- Combination of camera technology, optics, lighting, software and data connectivity
- Support from feasibility studies through to service and training
Which Inspection Tasks Can Be Automated Using Machine Vision?
Typical tasks include presence and completeness inspection, assembly inspection, position and orientation inspection, geometry and dimensional inspection, surface inspection, contamination inspection, print inspection, OCR, OCV, code inspection and variant verification.
Is 100% Inline Inspection Possible?
Depending on the product, inspection task, cycle time and machine concept, inspection systems can be designed to inspect every product during the production process. Technical feasibility and the detectability of individual defect characteristics are assessed for each specific project.
Can Visible Contamination Be Detected?
Yes. Depending on the product, material, contrast, particle size and installation conditions, camera systems can detect visible foreign particles, stains, deposits and other contamination. The achievable detection limit is investigated for the specific application.
Are OCTUM Systems Suitable for Regulated Production Environments?
Depending on the project, OCTUM systems can support functions such as user management, audit trails, controlled recipe and format management, data integrity, traceability and documented inspection results. The specific configuration depends on the intended use and the operator’s validation concept.
When Is a Feasibility Study Recommended?
A feasibility study is particularly useful for new products, difficult-to-detect defect characteristics, transparent or reflective materials, tight tolerances, a high number of variants or demanding cycle times. It provides a reliable technical basis for decision-making before implementation.
Pharma and Medical Technology at a Glance
The OCTUM brochure provides a concise overview of inspection systems, products and applications for pharmaceutical and medical technology production.
Your Inspection Task in Medical Technology
Would you like to inspect a medical device, laboratory consumable or production step automatically?
Tell us about your product, the relevant quality characteristics, typical defect patterns, tolerances, the intended machine cycle time and the planned installation conditions. Please also let us know about any requirements relating to documentation, data connectivity, measurement system capability or validation.
Together, we will determine which inspection solution is technically suitable and can be integrated reliably into your production process.
