Machine Vision Systems for Pharmaceutical Manufacturing
Automated inline quality inspection in regulated production processes
Pharmaceutical primary containers, packaging components, and drug delivery systems require reliable inspection at relevant process stages – often inline, at high throughput, and under regulated manufacturing conditions.
OCTUM develops and integrates custom machine vision and AOI systems for the automated quality inspection of vials, ampoules, prefilled syringes, cartridges, closures, labels, and other pharmaceutical products.
Each inspection solution is engineered around the product, relevant quality attributes, inspection criteria, line speed, available installation space, and the conditions within the filling, capping, assembly, labeling, or packaging line.
For manufacturers, this means greater process reliability, consistent product quality, and traceable inspection results. Depending on the application and the customer’s validation approach, requirements associated with 21 CFR Part 11, applicable FDA current good manufacturing practice requirements, GAMP 5, and, where relevant, EU GMP Annex 11 and Annex 15 can be considered.
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Machine Vision Solutions for Pharmaceutical Products
Our inspection solutions cover the following pharmaceutical products and process steps:
Inspecting vials before and after filling
vial.inspect is a modular system for automated inline inspection within pharmaceutical vial filling and capping lines.
Depending on the application, multiple inspection stations can be combined:
- Empty-vial inspection before filling
- Inspection of the vial base and mouth
- Stopper seating and closure inspection
- Crimp cap and flip-off cap inspection
- Print, OCR, and OCV inspection
- Reading and verification of 1D and 2D codes
- Inspection of different vial formats and product variants
The modules are configured based on the vial format, line design, throughput, available installation space, and inspection criteria.
Inspecting ampoules after sealing
ampoule.inspect inspects ISO ampoules immediately after sealing and cooling. This allows relevant defects and process deviations to be detected before the ampoules move to downstream processing or packaging.
Possible inspection criteria include:
- Open or incompletely sealed ampoules
- Breakage and visible damage
- Deformations
- Irregularities in the sealing area
- Visible surface defects
- Geometric deviations
- Print, human-readable text, and codes
The inspection solution is configured for the ampoule format, glass color, line speed, inspection criteria, and installation conditions.
Inspecting prefilled syringes
Prefilled syringes and syringe components can be inspected during filling, stoppering, assembly, labeling, and packaging processes.
The modular inspection systems can be configured for glass and plastic syringes as well as different designs, formats, and product variants. Typical inspection tasks include:
- Presence and completeness
- Assembly status
- Syringe barrel and finger flange
- Luer lock adapter and Luer taper
- Plunger rod and safety device
- Dimensional and geometric inspection
- Surface irregularities
- Label placement and print
- Human-readable text and code verification
- Completeness within the syringe nest
Regulatory Requirements and System Functions
Automated inspection systems used in regulated pharmaceutical manufacturing may need to support requirements relating to electronic records, user access, data integrity, traceability, and documented system operation.
Possible functions include:
- Role-based user and access management
- Audit trails and documented change histories
- Controlled recipe and format management
- Secure storage of inspection and event data
- Product, batch, lot, and work order association
- Data integrity and traceability
- Interfaces to manufacturing and quality systems
- Documentation supporting qualification and validation
The specific requirements depend on the intended use, applicable predicate rules, production environment, data usage, and the customer’s validation approach.
Inspecting cartridges and other pharmaceutical products
In addition to vials, ampoules, and prefilled syringes, OCTUM develops custom inspection solutions for cartridges, containers, closures, seal areas, and other pharmaceutical products and packaging components.
The inspection solution is based on the specific application. Product geometry, material, defect characteristics, format range, line speed, manufacturing environment, integration requirements, and documentation needs are evaluated together.
![[Translate to English (USA):] [Translate to Englisch:] Trostpflaster falls die gesuchte Applikation nicht dabei ist](/fileadmin/_processed_/d/8/csm_Pflaster_375x248_a3ba4efabe.jpg "Optische Inspektion von Pflastern & Patches – OCTUM")
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Code, Variant, and Traceability Inspection
Barcodes, Data Matrix codes, GS1 codes, and other markings are read and verified. The system can also confirm that the product, closure, label, and packaging match the intended variant and associate inspection results with batch, lot, work order, or process data.
Machine Vision for Regulated Pharmaceutical Manufacturing
In regulated pharmaceutical manufacturing, it is not sufficient to classify products solely as pass or fail. Depending on the application, inspection results, parameter changes, user actions, system events, and relevant process data may also need to be documented in a secure and traceable manner.
OCTUM considers regulatory and qualification-related requirements during the initial design of the inspection system – from the inspection task and software architecture to the user interface, access concept, interfaces, data connectivity, and documentation.
Possible system functions include:
- Role-based user and access management
- Audit trail
- Recipe and format management
- Version and change history
- Storage of inspection and event data
- Association with product, batch, lot, and work order data
- Data integrity and traceability
- Interfaces to PLC, line control, MES, or other systems
- Documentation supporting qualification and validation
Depending on the application, these functions can support the customer’s approach to 21 CFR Part 11, applicable FDA CGMP requirements, GAMP 5, and other relevant regulatory expectations.
The final system configuration and documentation scope are defined according to the intended use, applicable requirements, customer procedures, and validation strategy.
>> Learn about pharmaceutical regulations and system functions
Integrated into Machines and Production Lines
Reliable pharmaceutical inspection depends on more than the camera alone. Cameras, optics, and lighting must make the relevant inspection characteristics consistently visible. The inspection software must evaluate the images within the available cycle time.
Product handling, trigger timing, machine communication, pass/fail decisions, reject handling, operator interaction, and data flow must also work together as one coordinated system.
OCTUM integrates machine vision and AOI systems into new equipment as well as existing production lines. Depending on the project, the following aspects are considered:
- Camera, optics, and lighting concept
- Product handling and inspection position
- Line speed and trigger timing
- Connection to PLC and machine controls
- Interfaces to MES or other manufacturing 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 Pharmaceutical Machine Vision?
OCTUM has developed 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 pharmaceutical products
- Proprietary software solutions including OCVis, OCTUMISEr, and CV-Inspect
- Experience with regulated manufacturing environments
- Integration into new equipment and existing production lines
- Coordinated camera, optics, lighting, software, and data concepts
- Support from feasibility studies through commissioning and training
- U.S.-based contact and technical support in Charlotte, North Carolina
- Local support for customers in North, Central, and South America
Is 100% Inline Inspection Possible?
Depending on the product, inspection criteria, line speed, and machine configuration, an inspection system can be engineered to inspect every unit during production. Detectability and achievable inspection performance must be evaluated for each defect type and application.
Can OCTUM Systems Support Regulated Pharmaceutical Manufacturing?
Yes. Depending on the project, OCTUM systems can be configured with role-based user management, audit trails, controlled recipes and formats, data integrity functions, traceability, documented inspection results, and validation-ready system concepts.
The exact requirements and documentation scope are defined according to the intended use, applicable regulations, and the customer’s validation strategy.
Can Existing Production Lines Be Retrofitted?
Yes. OCTUM integrates machine vision and AOI systems into new equipment and existing production lines. Available space, product handling, line speed, interfaces, reject handling, operator interaction, and data requirements are considered during system design.
When Is a Feasibility Study Recommended?
A feasibility study is particularly valuable for new products, difficult-to-detect defects, complex or reflective surfaces, high format variability, demanding line speeds, or limited installation space. It provides a reliable technical basis for decision-making before implementation.
Pharmaceutical and Medical Device Solutions at a Glance
The OCTUM brochure provides an overview of inspection systems, products, and applications for pharmaceutical and medical device manufacturing.
Discuss Your Pharmaceutical Inspection Application
Do you need to inspect a pharmaceutical product, primary packaging component, closure, label, code, or production step automatically?
Tell us about your product, relevant quality attributes, typical defects, line speed, available installation space, interfaces, and documentation requirements. Our team will help determine which inspection solution is technically feasible and can be integrated reliably into your production process.
