New Equipment and Software Meet Needs for Fill/Finish, Serialization, and Data Traceability

Equipment and Processing Report

Equipment and Processing Report, Equipment and Processing Report-04-18-2018, Volume 11, Issue 5

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization.

Exhibitors from across the globe will gather at INTERPHEX (April 17–19, 2018, Javits Center, New York, NY) to present the latest technology for pharmaceutical packaging equipment.

Container filling and robotic equipment innovations

Fully automatic RPF rotary piston fillers from Cozzoli Machine accommodate different viscosities of cough syrups. Available in various frame sizes and models, the filler offers standard 2.75-in.-diameter cylinders, 4–36 filling nozzles, and speeds from 60–540 containers/min. Overhead-driven pistons with fill ranges from 5–21 fluid ounces feature a fine-fill adjustment, achieve ±0.5% fill accuracy, and remove easily for cleaning and changeover (1). 

For solid-dosage forms, the compact Uniline counting monoblock from IMA Safe integrates container loading, desiccant insertion, counting and filling, cotton insertion, capping, coding, and rejection. A positive transport system positively holds and tracks each container, ensuring traceability at every stage of the packaging cycle. No size parts are required for changeover to a container with a different diameter or height (2). 

TX2 collaborative robots and TX Stericlean cleanroom robots from Stäubli Automation can minimize manual handling and interventions. First launched in 2008, the TX Stericlean series was the world’s first robot designed to operate in aseptic areas. The TX2 robots are designed to work side-by-side with human operators and are compatible with smart factory operation and Industry 4.0/Lab 4.0 (3). 

Software tools for serialization and data traceability

With deadlines looming, serialization is a major theme at this year’s INTERPHEX. Antares Vision will display its enterprise-level (Level 4) ATS Four serialization software ecosystem, as well as inspection and serialization modules, including components of its Quick Compliance Program for expedited 10-week compliance with the US Drug Supply Chain Security Act. The enterprise-level, track-and-trace software manages serialization data-flow connecting production plants, contract manufacturing organizations, third-party logistics providers, and government agencies. Data storage and exchange tools support operation with a variety of software and hardware options. Engineered to run at high speed, the software operates in the Cloud or on an onsite server with the same high degree of data security (4).

Another new serialization tool, the Cloud Solution Demo Platform from Adents, allows prospective users to test drive its Prodigi enterprise level (Level 4) serialization software. With an easy-to-use “if/then” setup, users can build and add manufacturing facilities, “work” with hypothetical trading partners, add or subtract regulations and target markets, and explore other situational factors to showcase an array of supply-chain scenarios. The demo also allows users to see how the software ties unit levels to bundles and pallets per the industry-standard parent–child relationship. Christophe Devins, CEO of Adents, explains, “By offering this unique way of testing Adents Prodigi, we want to prove to the Life Science Market that they can address the challenges of connecting multiple trading partners, managing dozens of countries regulations, and take advantage of their serialization data with a very user-friendly platform.” The Adents Prodigi platform is a certified gateway to the European Medicines Verification System. Having joined the pilot program, Adents is in the process of connecting Prodigi with the Russian Hub. Integration with Origin-a central data repository in the United States, operated by the Healthcare Distribution Alliance-is underway (5).

In other software developments, VisionVault software from Integro Technologies supports FDA 21 Code of Federal RegulationsPart 11 compliance (6). The software simplifies data archiving and user traceability and provides full traceability for Cognex In-Sight cameras that is searchable from any web browser on the network. Using MS Active Directory for user authentication, the system provides data regarding who logged in, the log-in terminal, the changes made, and whether the changes were saved or used to test a setup. As a result, access is limited to authorized individuals, and it’s easy to identify invalid or altered records. Other capabilities include the delivery of time-stamped audit trails and generation of complete, accurate copies for FDA review. 

References

1. Cozzoli Machine Co., “Cozzoli Machine Company to Exhibit at INTERPHEX 2018,” Press Release, March 5, 2018. 

2. IMA Group, “The IMA Group at INTERPHEX 2018, Discover IMA’s Innovation!” Press Release, Feb. 26, 2018. 

3. Stäubli Automation, “Stäubli’s Stericlean Series Celebrates 10thAnniversary at INTERPHEX,” Press Release, April 2, 2018. 

4. Antares Vision, “Antares Vision Introduces ATSFOUR, a Comprehensive, Scalable, Level 4 Track & Trace Solution,” Press Release, April 5, 2018. 

5.Adents, “Adents to Give Two Featured Presentations on Vital Serialization Challenges,” Press Release, March 27, 2018. 

6. Integro Technologies, “Integro Technologies to Showcase FDA: 21 CFR Part 11 Compliant Data Archiving Software at INTERPHEX 2018,” Press Release, March 27, 2018. 

About the Author

Hallie Forcinio is Pharmaceutical Technology’s Packaging editor, editorhal@cs.com.