There’s no such thing as a cheap fill equipment in medical device manufacturing.

At a previous company, an engineer purchased a cheap industrial filling machine that was designed for mainstream applications like filling bottles of glass cleaner. They wrongly assumed that fill equipment would not require validation and that cleaning the equipment was simple.

Since they decided not to follow a GAMP process in favor of saving money, they were unable to adequately answer subsequent questions from the Quality team:

1. How do we validate this machine?
2. How do we make sure that lot to lot contamination can be tested and proven?
3. How do we sample to make sure fill volume is within spec?
4. What requirements are we validating against?
5. How do we document and defend it when FDA shows up?

All valid, mandatory questions in med device manufacturing. In this instance, there were no satisfactory answers, and that’s when the fireworks started. Crunched deadlines escalated the issues from engineering to management and the old adage was once again proven true: “You can have it cheap, fast, and good. Pick two.”

I was tasked to construct a process that would enable validation of the filling machine and release it to manufacturing. The first step was to address all product contact components. This required me to design and build a novel five-channel pinch valve with an E-Stop feature, as well as special nozzles and processes to restrict foaming.

After that, I reprogrammed the HMI and controls for the changes to operate reliably and repeatedly within spec.

Retrofitting off-the-shelf manufacturing equipment to operate within a validated process was not easy, inexpensive, or fast. But it was successful. We were able to validate and release the machine to Manufacturing.

Moral of the story: within our industry, there are no shortcuts. Following GAMP and getting the right skillsets from day one is the only path to a successful outcome. I loved watching John Wayne in the movies, just charging on and getting things done, but he belongs in the movies and not in medical manufacturing activities.

Have you felt this pain as well? Feel free to contact me to discuss your med device project before the fireworks start.