Pharma Coding Challenges

Nov. 5, 2013
NeilMed Relies on Videojet to Ensure Regulatory Compliance

In January 2000, Dr. Ketan C. Mehta, M.D. formed NeilMed Pharmaceuticals and began marketing the Sinus Rinse kit. Due to the product’s effectiveness and widespread acceptance by doctors, Sinus Rinse is now one of the top selling nasal irrigation products in the United States and Canada. It is also widely available at retail pharmacies and grocery stores in Australia, New Zealand, Singapore, UK, Ireland, Turkey and a growing number of European countries.Today, NeilMed Pharmaceuticals offers a full line of nasal irrigation and moisturizing products designed to help both children and adults breathe more freely and comfortably.

NeilMed’s customers include leading retailers such as Walgreens, Wal-Mart, CVS, Rite Aid and Longs, as well as wholesalers such asMcKesson, Cardinal and AmerisourceBergen. In addition, the firm’s products are used in renowned medical institutions, includingthe Mayo Clinic, University of Michiganand Stanford University Medical School.

Assuring Coding Compliance
NeilMed Pharmaceutical manufactures, packages and codes its own pharmaceutical products at its 54,000-sq-ft manufacturing facility in Santa Rosa, CA. The firm also provides contract packaging and point-of-sale package coding for products supplied by CVS and Walgreens.The Santa Rosa facility employs about 250 people and usually operates one shift daily, Monday through Friday. They will also run second or weekend shifts in order to meet growing customer demand.

Regulatory and quality requirements call for NeilMed to apply precise coding to all of its products and these codes need to be clear, legible, lasting and accurate. Compliance is assured by employing an ISO 13485 process, which is a Quality Management System that ensures compliance with regulatory requirements for medical devices,and using Videojet printing solutions.

Dinesh Patel, NeilMed, Vice President of Quality/Regulatory states: “We have been relying on Videojet printing solutions for over four years for clear, accurate and compliant marking and coding. About 20 of our employees use 10 Videojet 3320 laser marking systems and three Videojet 1510 small character continuous ink jet printers in various manufacturing and packaging areas. We have found Videojet systems to be cost-effective, easy to operate and highly reliable.”

Integrated Production and Packaging Solutions
The Videojet continuous ink jet printers are located in NeilMed’s manufacturing room, a clean room environment where even the inks used are odorless. The ink jet printers apply codes to sterilized products, which must be produced in a clean room to comply with Current Good Manufacturing Processes (CGMP). The ink jet printers also apply a lot number and expiration date, with this information being applied to metal cans and plastic Polypropylene (PP) or Polyethylene (PE) bottles.

NeilMed wanted a fully integrated solution where the packaging line system assembled a complete coated cardboard box and the integrated laser marking system printed the required data on the outside of the point-of-sale packaging. Videojet worked closely with NeilMed and their cartoner manufacturer to facilitate the integration of the Videojet 3320 lasers into the host machine. Code content including lot and date codes are input into the host machine’s human-machine interface(HMI) and communicated via commands to the Videojet lasers. In this manne, codes and code content can be set up by a line supervisor and approved by NeilMed’s Quality department.

The software inside the 3320 laser marking systems, Videojet SmartGraph, provides important features to NeilMed’s operations. The network functions connect the printer with a computer, so operators can see the printer functions remotely. Also, the date and time function calculates the expiry date for them, avoiding manual calculation errors.

According to Patel, “Improving the personal health and safety of people worldwide who use our products is one of NeilMed’s core values. Having crisp, readable codes clearly visible on our products is not only critical to meeting the industry’s regulatory and quality requirements, but also valuable for our retailers and wholesalers. Proper coding allows for rapid response should it ever become necessary to recall or replace a specific lot number, and it also helps to ensure our products are not sold to consumers beyond their stated expiration date.”

Valued Technical Service and Support
Patel reports that, in the few years since deploying the Videojet equipment, NeilMed has experienced zero downtime due to coding problems. “The printers have delivered highly reliable, trouble-free performance, thanks to the service and support Videojet provides as a vendor partner. They help us quickly resolve any problems, deliver immediate replacement parts and provide maintenance training and calibration of printing operations when needed ‒ in short, Videojet delivers great value-added service.”

The need to have engineering knowledge for each area of production can be difficult from both a financial perspective as well as competency management, states Patel. Videojet service support provides NeilMed with the expertise to ensure the coding and marking equipment runs efficiently and reliably, allowing NeilMed personnel valuable time to focus on other tasks. Patel continues, “We experienced zero downtime while on a service contract and any issue reported to Videojet during the contract was resolved in the stipulated time span. This was over a period of one and a half years.”