Automated Vial Inspection for Maximum Product Safety

VITRONIC is involved in the fight against COVID-19. The VINSPEC HEALTHCARE solution for automated visual inspection makes it possible to seamlessly monitor the complete process chain—from pre-filling to filling, closing, and packaging. Vaccines are efficiently inspected for contamination and packaging defects without affecting the speed of production. This article focuses on the sealing process of vials and their crimp caps.

Everyone is talking about the complexities of the COVID-19 vaccine supply chain. To ensure continuous access to the vaccine, numerous companies must get involved with the procurement, production, safe filling, and packaging of the vaccine doses. Global projects were initiated at an impressive rate, marked by stable and efficient cooperation within the pharmaceutical industry worldwide.

To live up to the major time pressure and required production quantity, the early detection of packaging defects is essential.

Inline inspection is used to detect defective containers at an early stage and initiate the necessary process adjustments to keep future waste levels low. Defective containers are immediately removed from the production process so that subsequent machine resources are solely used to continue processing flawless containers. At this initial stage of the vaccination process roll-out, the early inline inspection enables the provision of the greatest possible number of flawlessly packaged and therefore usable vaccine doses.

“Ultimately, 100% inspection using machine vision systems has helped create a basic trust in the safe provision of medical supplies, including vaccines.” - Florian Krickl, Product Manager

Quality Inspection by VINSPEC HEALTHCARE

The visual inspection is performed at the place where defects occur, straight after the sealing process: all crimp-cap-related defects and faults are detected. For example, in the case of incomplete crimping, potentially leaking containers are rejected by default. It is even possible to detect the depth of crimping to allow precise conclusions about the closure quality. The combination of high-performance sensors and intelligent machine vision algorithms enables reliable error detection keeping pseudo rejects to a minimum.

Inspection range:

• Crimping of the sealing cap

• Defects on the cap skirt

• High stopper position

• Color and quality of the cap lid

• Cosmetic defects on the cap and cap lid

• 360°-Inspection with a single camera

Advantages in Vaccine Filling

VITRONIC’s inspection solution is characterized by a very compact design with 360° inspection without the need to rotate the vials. The low space requirement in the machine is of benefit with regard to both the simple retrofitting of existing systems and the limited availability of clean room space. With a filling speed of 36,000 vials per hour and full automation, VINSPEC HEALTHCARE offers sufficient performance to meet the cycle requirements of modern systems in the field of vaccine filling. For use in this environment, the smooth, easily accessible stainless steel housing is optimally suited for either wipe disinfection or disinfection by means of gassing with hydrogen peroxide. The geometric design is flow-optimized for use under laminar flow conditions in the isolator.

The software offers visualization of inspection results, comprehensive statistics, and trend analysis. The solution is GMP compliant and can be qualified in accordance with GAMP guidelines. You can rely on having a complete documentation according to regulation to provide the authorities (e.g., FDA) during external audits. The integrated audit trail and user administration fully comply with 21 CFR Part 11.

Based on many years of experience in pharmaceutical inspection processes, VITRONICS hardware and software as well as the user interface are optimally adapted to the typical quality requirements in pharmaceutical filling processes and have been successfully used in many lines for a long time.

VITRONIC is grateful for the opportunity to help provide quality assurance during vaccine production. It works with a global network of subsidiaries and partners to enable all manufacturers to offer a fast and efficient service. In close cooperation with its partners, VITRONIC continues to work actively to ensure and further develop the efficient quality inspection of primary packaging for vaccines using innovative solutions.

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Contact

Peter Daniel, PhD

VP North American Industrial Sales

Phone: +1 502 266 2699 x214

E-Mail: peter.daniel@vitronic.com