Custom Pharmaceutical Inspection Systems
Automated Inline Inspection of Cartridges, Primary Packaging and Packaging Components
Pharmaceutical products and primary packaging vary considerably in geometry, material, surface properties, closure design and manufacturing process. Inspection requirements are equally diverse: dimensions must remain within defined tolerances, components must be assembled correctly, and visible defects or contamination must be detected reliably.
OCTUM develops and integrates custom machine vision and automated optical inspection systems for pharmaceutical applications beyond the modular vial.inspect and ampoule.inspect solutions. These applications include cartridges, pharmaceutical containers, stoppers and closure components, tubs, trays, nests and visible seal characteristics.
Each inspection solution is engineered around the product, relevant quality characteristics, known defect types, product variants, target throughput and available installation space. Cameras, lenses, lighting, inspection software, product handling, machine communication and reject handling are considered as one coordinated system.
Depending on the application, inspection results can be documented, linked to product, batch, work order or process data and made available for quality assurance and process analysis.
OCTUM USA provides regional project coordination, technical support and service for customers across the United States, Central America and South America. Customers also benefit from direct access to OCTUM’s machine vision, application and engineering expertise in Germany.
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OCTUM transfers proven machine vision concepts to new products, primary packaging and production processes. Which characteristics can be inspected reliably is evaluated using the actual product, relevant defect characteristics and real process conditions.
Inspecting Cartridges Inline
Cartridges can be inspected from multiple perspectives during manufacturing, assembly or packaging. Depending on the product and process, possible inspection tasks include:
- Overall length, diameter and contour
- Stopper position and visible seating
- Presence and position of closure components
- Crimping and visible closure characteristics
- Tilting and assembly deviations
- Visible damage and surface defects
- Printed information, human-readable text and 1D and 2D codes
- Product and variant verification
The system design takes the cartridge format, glass color, surface reflections, relevant tolerances, product handling and available inspection window into account.
Inspecting Visible Seal Characteristics on Tubs, Trays and Nests
For sealed tubs, trays, nests and comparable packaging units, the machine vision system can inspect visible characteristics of the lidding material and sealing zone.
Possible inspection characteristics include:
- Presence and correct position of the cover
- Path and visible completeness of the seal
- Interruptions and irregularities within the visible sealing zone
- Wrinkles, inclusions and visible contamination
- Damage to the cover, tray or edge area
- Contour and position of packaging components
- Printed information, human-readable text and codes
The optical inspection evaluates visible seal characteristics. It does not replace physical leak testing, seal integrity testing or seal strength testing.
Inspecting Trays, Nests and Packaging Components
Trays, nests and other packaging components can be inspected for completeness and correct loading before subsequent processing, filling or packaging operations.
Possible inspection tasks include:
- Correct number and arrangement of products
- Presence and completeness of components
- Position and orientation
- Correct product and packaging variant
- Visible damage, foreign objects and unexpected visible characteristics
- Labels, printed information, variable text and codes
The inspection station is adapted to the packaging format, product arrangement, target throughput and intended reject strategy.
Inspecting Pharmaceutical Containers and Closure Components
OCTUM develops application-specific inspection stations for pharmaceutical containers, stoppers, caps, crimp components and other closure components.
Typical inspection tasks include:
- Presence and completeness
- Correct closure or component variant
- Position, orientation and visible seating
- Contour, geometry and dimensions
- Visible scratches, cracks, breakage and deformation
- Visible particles, stains and deposits
- Print, OCR, OCV and code inspection
Transparent, reflective or structured surfaces place particular demands on lighting, lenses and image acquisition. Technical feasibility is therefore evaluated using actual sample parts.
Is Your Pharmaceutical Application Not Listed?
Many inspection applications require an individually configured solution. The decisive factor is not simply the product designation, but whether the relevant quality characteristics are optically visible and can be evaluated reproducibly under actual production conditions.
Together with the manufacturer, OCTUM evaluates product geometry, material, defect characteristics, tolerances, product variants, target throughput, available installation space, interfaces and documentation requirements.
For new or particularly demanding applications, a feasibility study using known-good parts, known-defect parts and, where appropriate, limit samples is recommended.
Surface, Defect and Contamination Inspection
Depending on the material, contrast, defect size and image resolution, the camera system can detect visible scratches, cracks, breakage, chips, deformation, foreign particles, deposits, stains and other deviations.
The achievable detection limit is determined for the specific product, defect characteristic and inspection conditions.
Print, OCR, OCV and Code Inspection
Printed information, batch numbers, serial numbers, manufacturing dates and expiration dates can be read or compared with predefined reference information.
Barcodes, Data Matrix codes and other 1D and 2D codes can be decoded and checked for content and correct product assignment.
Engineered Around the Product, Defect Characteristics and Production Process
A robust inspection solution results from the coordinated interaction of image acquisition, product handling, evaluation software, machine communication and reject handling.
When designing the system, OCTUM considers factors including:
- Product geometry and accessible inspection surfaces
- Material, color, transparency and reflection
- Relevant defect characteristics and required detection limits
- Tolerances and measurement requirements
- Product variants and format changes
- Target throughput and available inspection window
- Installation space and environmental conditions
- Triggers, encoders and other process signals
- Connection to the PLC, machine and higher-level systems
- Pass/fail decisions, reject handling and reject verification
- Operator interaction, recipe management and format management
- Storage and transfer of inspection data
- Maintainability, serviceability and expandability
Depending on the application, different camera technologies, lenses, lighting methods and evaluation algorithms are used. The appropriate components are selected based on actual products and the defect characteristics that need to be detected.
OCTUM integrates inspection systems into both new machine designs and existing pharmaceutical production lines. OCTUM USA coordinates regional project requirements and service activities with machine builders, manufacturers and OCTUM’s engineering teams in Germany.
>> Learn More About System Integration
>> Evaluate Technical Feasibility
Machine Vision for FDA-Regulated Pharmaceutical Manufacturing
In regulated pharmaceutical manufacturing, it may not be sufficient simply to identify defective units. User access, changes to inspection programs, quality-relevant inspection results and system events may also need to be managed in a traceable manner.
For manufacturers subject to US pharmaceutical requirements, the FDA Current Good Manufacturing Practice regulations under 21 CFR Parts 210 and 211 may be particularly relevant.
When an inspection system creates, modifies, maintains, archives, retrieves or transmits quality-relevant electronic records or manages electronic signatures, requirements arising from 21 CFR Part 11 may also apply, depending on the intended use and applicable predicate rules.
For manufacturers operating internationally, additional requirements and guidance such as GAMP 5, EU GMP Annex 11, EU GMP Annex 15 or other national regulations may also need to be considered.
Depending on the project, OCTUM systems can incorporate functions including:
- Individual user accounts
- Role-based access management
- Audit trails
- Controlled recipe and format management
- Version and change history
- Storage of inspection and event data
- Product, batch and work order assignment
- Data integrity and traceability
- Interfaces to machine controls and other systems
- Documentation supporting qualification and validation
Regulatory requirements apply to the manufacturer, the intended use, the applicable regulations and the manufacturer’s quality and validation processes.
An inspection system alone does not establish FDA or regulatory compliance. However, it can provide technical functions and documentation that support qualification, validation and quality processes.
>> Explore System Functions for Regulated Pharmaceutical Manufacturing
2. Evaluate Technical Feasibility
For new or demanding applications, OCTUM examines known-good parts, known-defect parts and, where appropriate, limit samples under realistic conditions.
Image quality, feature contrast, defect detectability, camera technology, lenses, lighting and evaluation methods are assessed.
3. Design and Integrate the Inspection System
Based on the results, OCTUM develops a coordinated concept for image acquisition, inspection software, mechanics, product handling, operator interaction, reject handling, interfaces and data flow.
The inspection system is engineered for reliable integration into the intended machine or pharmaceutical production line.
4. Commissioning and Long-Term Support
OCTUM supports installation, commissioning, system optimization, training, new product formats, additional inspection characteristics, maintenance and long-term operation.
OCTUM USA coordinates regional support and on-site service across the Americas, with additional application, software and engineering expertise available from OCTUM Germany when required.
Why Choose OCTUM for Custom Pharmaceutical Inspection Systems?
OCTUM has been developing machine vision and AOI systems for demanding production environments since 1996. Customers across the Americas benefit from regional coordination through OCTUM USA and direct access to OCTUM’s engineering expertise in Germany.
- Experience in industrial machine vision since 1996
- More than 6,000 systems installed worldwide
- OCTUM USA location in Charlotte, North Carolina
- Regional coordination for the United States, Central America and South America
- US-based technical support and service coordination
- Direct access to OCTUM’s application, software and engineering teams in Germany
- Modular and custom pharmaceutical inspection solutions
- Proprietary software solutions such as OCVis, OCTUMISEr and CV-Inspect
- Experience with pharmaceutical primary packaging, closures and packaging components
- Geometrical, measurement and classification inspection methods
- Integration into new machines and existing production lines
- Experience with regulated pharmaceutical production environments
- Support from feasibility studies and project planning through commissioning, service and training
For manufacturers, this means that the inspection application is not treated as an isolated camera function. Instead, product handling, the production process, machine interfaces, data requirements and long-term operation are considered together.
Which Pharmaceutical Products and Primary Packaging Can OCTUM Inspect?
OCTUM develops inspection systems for cartridges, pharmaceutical containers, stoppers, caps, crimp components, tubs, trays, nests, covers and other pharmaceutical product and packaging components.
For vials and ampoules, OCTUM provides the modular vial.inspect and ampoule.inspect solutions. Syringes and syringe components are inspected using application-specific syringe.inspect systems.
Can Visible Seal Defects Be Detected?
Yes. Under suitable image acquisition conditions, the system can detect interruptions, wrinkles, inclusions, visible contamination and deviations in position or contour within the sealing zone.
The optical inspection evaluates visible characteristics only. It does not replace physical leak testing, seal integrity testing or seal strength testing.
Is 100% Inline Inspection Possible?
Depending on the product, inspection characteristics, target throughput and system design, the inspection system can be engineered to inspect every unit within the production process.
Technical feasibility and the detectability of each relevant defect characteristic are evaluated for the specific project.
Can Dimensions and Geometrical Characteristics Be Inspected?
Yes. Lengths, diameters, distances, heights, contours, angles and other geometrical characteristics can be measured without contact and compared with defined tolerances.
Resolution, part presentation, tolerances, reference parts and measurement system capability requirements are evaluated for the specific application.
Can the Inspection System Be Integrated into an Existing Production Line?
Yes. OCTUM integrates machine vision and AOI systems into both new machines and existing production lines.
Available installation space, product handling, line speed, control interfaces, operator interaction, reject handling and data requirements are considered during system design.
Can OCTUM Systems Support FDA-Regulated Pharmaceutical Manufacturing?
Depending on the project, OCTUM systems can incorporate functions such as role-based user management, audit trails, controlled recipe and format management, data integrity, traceability and documented inspection results.
These functions can support the manufacturer’s quality, qualification and validation processes. The inspection system itself does not establish FDA or regulatory compliance.
When Is a Feasibility Study Recommended?
A feasibility study is particularly valuable for new products, small or low-contrast defect characteristics, transparent or reflective materials, tight tolerances, demanding production speeds or limited installation space.
It provides a reliable technical basis for selecting the camera technology, lenses, lighting, image quality and evaluation methods before implementation.
Discuss Your Pharmaceutical Inspection Application with OCTUM USA
Would you like to inspect a cartridge, pharmaceutical primary packaging, closure component, tray or another production step automatically?
Tell us about the product, relevant quality characteristics, known defect types, product variants, tolerances, target throughput and planned installation conditions. Following consultation, please provide known-good parts, known-defect parts and limit samples wherever possible for technical evaluation.
Please also let us know about any requirements relating to machine connectivity, reject handling, documentation, traceability, measurement system capability or validation.
Together, we will determine which machine vision solution is technically suitable and can be integrated reliably into your pharmaceutical production process.
OCTUM USA coordinates the next steps for customers in the United States, Central America and South America, with additional application and engineering support available from OCTUM Germany.
