Omori Attains 21 CFR-Compliant Pharma Packaging

Breaking Barriers to Achieve 21 CFR Compliance for Pharma Market Entry

Omori manufactures wrapper machines for the food and beverage and consumer packaged goods customers. The company wanted to expand into wrapping solutions for the pharmaceutical segment. The biggest roadblock to achieving this for Omori was ensuring that the machine complied with the 21 CFR Code of Federal Regulations.

The 21 CFR and its recommendations are critical in today’s pharmaceutical industry. Title 21 of the CFR, or the Code of Federal Regulations, governs food and drugs in the United States under three regulatory bodies: the FDA (Food and Drug Administration), DEA (Drug Enforcement Administration), and ONDCP (Office of National Drug Control Policy). It consists of three chapters, each specializing in codes for these organizations. Most OEMs must comply with 21 CFR Part 11.

Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. It requires implementing controls such as system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that FDA require them to maintain. A predicate rule is any requirement set forth in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.

Smart, Compliant, and Connected Blister Packaging Solution

Omori collaborated with Rockwell Automation to develop a new machine for the pharmaceutical segment – blister packaging solutions.

This machine runs on FactoryTalk® Optix™ SCADA software, complying with 21 CFR Part 11 through controls that include audits, system validations, audit trails, electronic signatures, and documentation required for compliance purposes.

CompactLogix™  controllers provide higher performance, increased capacity, improved productivity, and enhanced security to meet the growing demands of smart machines and manufacturing equipment. These controllers use a common, easy-to-use development environment. Tighter integration between the programming software, controller, and I/O modules reduces development time and cost during commissioning and normal operation. This commonality enables cost-effective integration of a machine or safety application into a plant-wide control system because it consolidates capabilities into one controller.

Kinetix® 5500 Servo Drives EtherNet/IP connect to and operate with CompactLogix™ controllers, supporting Integrated Motion on EtherNet/IP. With its innovative, compact design, the Kinetix® 5500 drive helps minimize machine footprint and simplifies system wiring.

Kinetix® VP Servo Motors provide smooth, integrated motion control over EtherNet/IP networks and are optimized to run alongside the Kinetix® 5500 and 5700 servo drives. Kinetix® VPL low-inertia servo motors deliver higher dynamic performance.

The multi-axis machine is now smarter, as seamless data transfer is possible via Ethernet communication. Based on the type of product, the end user can select a recipe from the human-machine interface, and the system will make automatic offset adjustments. The absolute position of the servos can be retained in case of a power failure.

End users benefit from higher accuracy and lower maintenance with a reduced mechanical system, and scalability is achievable through axis addition or deletion. Integration with upstream systems is now easier than ever.