	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 ï¬rst 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 

Part 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. 

	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 10

Anniversary 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. 

Articles

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

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

	Data integrity is a crucial issue for both the laboratory and the manufacturing floor of a GMP pharmaceutical manufacturing facility. The Parenteral Drug Association’s (PDA’s) Data Integrity Task Force aims to help industry members understand how to maintain data integrity. PDA published 

Elements of a Code of Conduct for Data Integrity

in 2016, which is available for industry members to download from the 

spoke with Els Poff, executive director of Merck & Co.’s Data Integrity Center of Excellence and member of PDA’s Data Integrity Task Force, about data integrity and PDA’s efforts to educate the industry. Poff is currently leading the development of a PDA technical report about data integrity in manufacturing, and as part of 

Keynote Series at INTERPHEX, she will present 

“Regulatory Requirements for Data Integrity, Applying ALCOA+” 

on April 18, 2018 at 11 am on the Innovation Stage.

The need for data integrity in the pharmaceutical laboratory seems clear, but what are the reasons that manufacturing floor personnel must also make data integrity a priority? 

Data integrity is the process of maintenance and assurance of accuracy and consistency of GMP data over its entire lifecycle, which includes data generated in the manufacturing/production areas. Recent citations from [FDA] warning letters include data integrity observations directly related to shop floor systems and processes, such as sharing of username and password, batch records with blanks (not filled in), data in batch records not directly recorded at the time it was generated, and audit trial function not enabled.  Although health authorities focused heavily on the lab systems initially, we do see a shift toward the more holistic expectation to have accurate and complete records, and that includes manufacturing records. 

What are the most important things to understand about data integrity in pharmaceutical manufacturing? 

The reliability of production and control data is dependent on the procedures, systems, processes, and controls that are in place to ensure data integrity. The integrity of production data starts from the point of data creation, and it continues throughout the entire data lifecycle including storage and the ability to retrieve the data at a later point in time to support the quality of the products manufactured. Pharmaceutical manufacturers need to ensure that relevant data are available to document what actually occurred, the data are attributable to the persons who entered the data, and that the data cannot be altered, deleted, omitted, or in any way modified to misrepresent what actually occurred. Data integrity is the cornerstone of establishing and maintaining confidence in the reliability of data to ensure product quality and patient safety.  

Who/what is the PDA Data Integrity Task Force? What are their current projects and future plans? 

The PDA Data Integrity Task Force consists of members from generic [-drug], biotech, large pharma, and consulting firms, plus staff and liaisons to the PDA Regulatory and Quality Advisory Board. Its objective is to define the strategy to deliver data integrity solutions to the pharmaceutical industry and regulatory under the leadership of the PDA, by providing training, publishing technical reports and papers, and organizing conferences and workshops.

	Projects are currently underway to identify data integrity best practices for the laboratory, on the manufacturing shop floor, and for quality systems, in the form of technical reports. Future plans are to continue to foster dialogue between health authorities and industry members to raise awareness and to reach alignment on expectations around data integrity.

Feature

The Parenteral Drug Association’s Data Integrity Task Force helps industry members understand regulatory requirements for data integrity.

Equipment and Processing Report-04-18-2018

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

Keys to Manufacturing Data Integrity