Medical Device Link.

Originally Published PMPN February 2004

Interview

Ignatius Manning President Print Vision Systems

With a focus on ensuring quality, pharmaceutical and medical packagers are relying on inspection systems for every aspect of their packaging line. Editor Daphne Allen spoke with Ignatius Manning, president of Print Vision Systems, about developments in inspection systems and what these mean for industry. 

What trends do you see in inspection? 

Manning: Many leading pharmaceutical packagers and packaging producers are now using automated inspection for 100% verification of all text and graphics on packaging materials. This is because more pharmaceutical firms are demanding that their packaging suppliers certify the quality of their products. The only way to do this is to use true 100%-inspection technology that can find any and all defects on every inch of what is printed. These are in contrast to the web sampling systems that are able to find errors only if these defects repeat enough times to be caught by the sampling regimen. These web sampling systems still play a role in minimizing the start-up costs for jobs. 

How have inspection systems changed in the last five years? 

Manning: Web sampling systems have become less important, and true 100%-inspection systems have taken over. 

If you are supplying cut labels to the pharmaceutical industry, FDA requires pharmaceutical manufacturers to double-check human inspection processes. Some manufacturers have attempted to achieve this double inspection by running labels twice through their web transport machines. Others have two workers inspecting simultaneously. It may be more effective inspection, but look at the additional cost to do the second round of human-eye inspection. Obviously, either of these routes entails extra costs for double duty.

However, the same FDA regulation that requires 200% inspection by the human eye only requires 100% inspection (i.e., a single run) if done by machines. This press to meet regulatory standards while maintaining a profitable production output is driving manufacturers to seek automated inspection technology. 

The biggest impact on inspection systems is the PC. The ever-increasing performance of the PC has made it possible for manufacturers of inspection systems to concentrate on the requirements of actual inspection applications (software), instead of the more expensive and less flexible reengineering of hardware. 

How have you helped a pharmaceutical or medical device packager add (or upgrade) an inspection system? 

Manning: We just helped one company that was still doing character-by-character manual inspection of inserts in several languages. The process was a mind-numbing and expensive labor-intensive task. The solution that matched this company’s requirements was the PV ImageCompare, a tool both for inspection at prepress and press stages of production. 

PV ImageCompare is an off-line system designed for proofing of both electronic and printed documents to ensure product integrity. This system automatically verifies all data against the associated electronic file or an approved proof. Then, it verifies all printed materials against the corresponding electronic file or an approved proof. 

Instead of manually inspecting at every stage, this pharmaceutical company now uses the PV ImageCompare system to proof plates and to look at the first-off press samples. It is then used throughout the printing process to inspect samples. 

This quality assurance tool benefits everyone. At the pharma level, it offers quicker turnaround time. There is now a fixed quality standard because machines are objective compared with their subjective human counterparts. At the printer level, the PV ImageCompare ensures that what is being printed is exactly what was approved. There is a much quicker job approval turnaround as well.  

Copyright ©2004 Pharmaceutical & Medical Packaging News