Tips for Automated Visual Inspection

Edition 3, March 2024.

Visual Inspection is a difficult aspect of parenteral drug manufacturing.? It’s required – 100% of final product containers must be inspected for particulate.? Most of the world is well aligned here but check out USP 790 if you’re in the U.S. FDA regulatory environment.

The requirement for visual inspection means manufacturers must develop and maintain a manual visual inspection program to inspect every container.? In the world of mass production and large batch sizes – I’ve heard upwards of 1 million containers – it would take an army of human inspectors to inspect every container if you hoped to ever get the batch released for shipment. ??This is where Automation comes in.? Manufacturers can install machinery to replace the human inspectors provided they validate the system to be as good or better than their human inspection capability.? This is really the only way to inspect large batches in an efficient and economical fashion.? It’s worth mentioning automated inspection can often far exceed the manual inspection capability in terms of quality and detection, but it's not without tradeoffs.

Some manufacturers have entire departments dedicated to Visual Inspection (think big pharma), while others treat visual inspection as an afterthought, making resources and time for implementation scarce. ?The implementation of an Automated Visual Inspection system should be given your full attention as mistakes in the visual inspection program can haunt a manufacturing site for years and cause eventually significant issues for patients.

Tips!! Automated Visual Inspection

3 Tips for Setting up your Visual Inspection Project for Success

1.?????? Start with the end in mind!? You need to plan where you are going or else you’ll never get there.??

At the end of the project your goal is to have a validated system which can detect the defects created in your production.? We all know they’re there.? Typically, your target detection rate is derived directly from your manual inspection capabilities by conducting a Knapp Study.? Setting this goal post at the outset of the project provides clear vision to both the internal engineering team and the supplier as well.? When this is unclear prior to ordering equipment, you leave yourself open to misinterpreted specifications, in-the-field design changes, or missing inspection capabilities – all of which will drive the Project Manager crazy (stress, money, and time!).

2.?????? Expect and Plan for vision recipe development & engineering studies on site prior to completing validation.

After the equipment is delivered, installed and the SAT is completed – there will still be more work to do.? This is where the rubber meets the road.? You’ve proven the machine works as intended, now you must optimize the vision recipes to real-world production conditions. ?The defect kit you sent to your machine supplier is only a small sample of what’s coming off of your filling line.

3.?????? Focus!!

This is true for many things in life - when everything is the most important thing, nothing is in focus and the team won’t be able to act cohesively or efficiently.? For manufacturers of a major blockbuster product, this won’t be a problem, but nowadays nearly every production line will handle more than one product.? Many manufacturing sites have over 150 product combinations – product, vial, fill level, etc.? Define which products are most important – often this is the product which is the largest production volume (units per year).? Moving these one or two products to an automated system will lighten the load on your manual visual inspection team to allow them to keep up with production and increase quality of your products.? Getting the inspection system in production with these products, and further developing other products recipes will allow for the quickest ROI – don’t toil away for years trying to get everything on your machine perfect before entering production.

In the Rearview…

February was full of new project conversations – some with immediate plans, and others at the first stages of concept design.? I think this might be my favorite part of being in sales – talking through requirements, discovering priorities no one had thought about yet, and educating new potential clients on technology.? Keep ‘em coming!

Admittedly it’s not always rainbows and sunshine, I had a client cancel a small project as well. It’s a reality of working in the pharma industry eventually you’ll work on a project with a great team and a clear vision only to be interrupted by changing business circumstances.? I consider myself lucky that it took 10 ? ?years to experience it for the first time.? As the great Forest Gump said “Shit Happens”.

Looking Ahead

I’ll be hitting the road a bit more in March for client meetings.? I’m hoping to drop into PackExpo East in Philadelphia for a day – the show is March 18th to 20th.? At the end of the month, I’ll get a little family time around the Easter Holiday.?

Our team is well on its way planning for Interphex New York - from April 16th to 18th.? It’ll be a busy few weeks planning the show, client meetings, and setting up client dinners.? You won’t want to miss this one!

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-Mike Kerbaugh