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Visual inspection is an essential part of ensur-ing the safety and quality of injectable drug products. Product inspection is not only a

critical lot-release testing activity, but it also pro-vides important information that can drive pro-cess improvement.

Options for accomplishing product inspection have expanded tremendously as the field ad-vances toward sophisticated, fully automated visual inspection (AVI) solutions. Such systems have significant advantages over manual or semi-automated techniques. This paper explores how new developments in the field of AVI are advanc-ing pharmaceutical production and quality control and discusses some key considerations for se-lecting an AVI system for vials, IV bags and blow-fill-seal (BFS) containers.

Advancements in Processing Equipment Spurs New Developments in AVI

Recent manufacturing technology break-throughs have spurred the simultaneous devel-opment of next-generation AVI systems. High-speed vial filling lines, for instance, can process up to 600 units per minute, thus creating a need for inspection systems that perform extremely complex and rapid inspection tasks involving large volumes of data.

Vial inspection should include quality control checks throughout the filling and closing pro-cess, from the time vials are empty until they are filled and sealed. To ensure patient safety, it is also critical to identify the presence of par-ticles (e.g., hairs, fibers, and particles from the packaging or process materials) in containers down to the 100 µm level and below. In addition to size, the geometry, material, and color of par-ticles must also be considered when defining the inspection set up.

Without excellent equipment and methodology, low-contrasting particles can hardly be identified. Moreover, once the vials are filled, disturbances such as air bubbles must be safely distinguished from potentially harmful contaminants in order to keep the number of false rejects low. Fibers such as hair are often even more difficult to detect than larger surface particles for low-end systems.

Product inspection does not end with particle de-tection, however. It must also include the evalua-tion of vials for defects like cracks, scratches, and cosmetic deformations. Correct stopper position-ing and proper vial crimping and sealing must all be checked. Any signs of defects in the cap must be flagged as part of the screening process for container closure integrity. Finally, one- and two-dimensional codes on the vials must be read and verified as a base for serialization. Vials that fall short of any of these criteria must be reliably ex-cluded from further processing and release.

Clearly, this is a sizeable number of highly detailed inspection criteria to evaluate, and all must keep up with high-speed cycle times of up to 10 vials per second. Usually, smart cameras can identify basic and less demanding defects (e.g., correct cap color or the presence of a cap). Advanced PC-based systems like VINSPEC HEALTHCARE solutions from VITRONIC that combine high-end hardware with innovative software tools can de-tect a much wider range of demanding defects and deviations. Software like VITRONIC’s also in-corporates sophisticated classification capabilities tailored to the inspection requirements at hand.

Another example for complex inspection tasks performed by AVI are BFS containers. VINSPEC HEALTHCARE inspects such containers once they are filled and sealed. The visual inspection system can be integrated seamlessly in produc-

Advancements in Automated Visual

Inspection Solutions Elevate Quality Assurance and Process Control

By Florian Krickl, Product Manager, VITRONIC Machine Vision

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tion lines to monitor each process step. The inline inspection is 100% accurate and ensures that de-fective containers are rejected from the produc-tion line directly and defective products are not processed further.

As an automated inspection system, VINSPEC HEALTHCARE is used for cycles of more than 14,000 BFS containers per hour. The system per-forms all BFS filling and sealing inspection tasks for BFS containers and ensures that the final prod-ucts are of high quality and reliably defect-free.

VINSPEC HEALTHCARE also inspects BFS con-tainers for particles that may enter the contain-er while it is being shaped or when it is filled through the mouth area or tubes. Therefore, the system checks that there are no floating or sus-pended particles in the product solution, a key cri-terion for reliable patient care when BFS infusion bottles are used.

Improving IV Bag Inspection

The inspection of other parenteral’s packaging such as infusion bags have their own set of challenges. Bags bulge and have irregular, curved shapes that distort printed text, codes, and logos and make it difficult to distinguish whether the print is correct or relevant characters or symbols are wrong. Thus, sophisticated data processing and intelligent tools are required to read and verify the print on IV bags.

In addition, large-volume containers like IV bags and BFS bottles are difficult because the larger the container and the image field, the higher the re-quired resolution of the vision sensor. To address this issue, VITRONIC implemented a new high-resolution technology with ability to identify the smallest defects on large-volume parenterals.

VITRONIC recently put this technology to use in an innovative multi-stage inspection solution op-timized for inspecting the printing of IV bags for a leading manufacturer. The system includes VIT-RONIC’s newest software release with next-gen-eration of Symbol Verification. In combination with a smart customized teach-in tool for a large num-ber of formats, a significant reduction in downtime and increase in productivity for the company was realized. Together with the client’s qualification and validation department, the fully automatic vi-sion system was successfully implemented in the first half of 2019.

Using AVI Solutions for Trend Analysis

As providers of machine vision and data technol-ogy are pushing the envelope with flexible AVI solutions, it is important to consider the signifi-cant opportunity for the data collected to be used for process control and improvement.

One promising application that VITRONIC focus-es on is data usage for fast feedback loops, which can help manufacturers draw conclusions about machine parameter settings based on findings from the inspection process. Data collected dur-ing product inspection is visualized as a trending graph to immediately identify the need for pro-cess adaptations. The inspection data is also fed back to the machine control unit for direct pro-cessing. Operators are alerted by the system if certain thresholds are exceeded; if needed, they can easily make corrections to the parameters based on this early feedback from the filling and closing process. This invaluable information de-rived through this fast process could very well help to reduce systematic packaging defects and subsequent production downtimes.

The Future of AVI

AVI solutions are in a period of significant growth and expansion, and VITRONIC is con-tinuously exploring where the next steps in this technology may lead. One area the company is working on is suitable applications for artificial intelligence (AI) and deep learning methods in specific inspection environments.

The data captured by automated inspection sys-tems offer huge possibilities. One of the greatest challenges of the future is to use this information even more intelligently. VITRONIC places spe-

“It is important to

consider the significant

opportunity for the data

collected to be used

for process control

and improvement.”

Florian Krickl Product Manager VITRONIC Machine Vision

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COMPENDIAL REQUIREMENTS FOR VISUAL INSPECTION

Requirements for particulate matter testing for injectable products are de-scribed in various regulations and stan-dards, including:

• USP <1>, “Injections and Implanted Drug Products”

• USP <1790><790>, “Visual Inspection of Injections”

• USP <1788>, “Particulate Matter in Injections and Ophthalmic Solutions”

• USP <788>, “Particulate Matter in Injections”

• USP <1787><787>, “Sub-visible Particulate Matter in Therapeutic Protein Injections”

• PhEur Chapter 2.9.20, “Particulate Contamination: Visible Particles”

• JP Chapter 6.06, “Foreign Insoluble Matter Test for Injections”

cial focus on this when developing its products. One promising application is what is known as closed loop, which can be used to draw conclu-sions about machine parameter settings based on findings from the inspection process. In the automated application, data from the inspection is fed back directly to the machine control unit, which can automatically make corrections to ma-chine parameters there.

Summary

Automated visual inspection solutions must fol-low the speed requirements of the filling/packag-ing process. Providers of machine vision and data technology like VITRONIC are addressing this challenge with sophisticated AVI solutions that are more flexible and able to capture significantly more data than ever before.

Advanced AVI systems like VITRONIC’s VINSPEC HEALTHCARE solutions are intended for in-line use directly after individual process steps. Thus, they provide earliest possible process feedback to minimize systematic defect rates. A wide va-riety of detailed information can be collected with AVI solution. Importantly, data can be rap-idly analyzed and the system alerts operators when thresholds are exceeded so that process modifications can be made as necessary. The intuitive interface of the vision software is de-signed for easy and on-demand customization of parameter sets. The compact VITRONIC sys-tem needs only a very small amount of space on the line, so valuable production space in the cleanroom will not be needed for a separate in-spection area. The systems can usually be easily retrofitted into existing lines.

AVI software experts like VITRONIC are also in-vestigating the use of neural networks to identify and implement new approaches for inspections solutions. Though this is still not in real-life pro-duction, the use of artificial intelligence will con-tinue to elevate traditional inspection classifica-tion in healthcare production processes.

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