Second Sourcing EO Sterilization: From the desk of Jim Kasic
Jim Kasic, CEO & Chairman, Boulder iQ
I’m a pilot. My son and I flew to the Sawtooth Mountains over Labor Day to do a 4-day backpacking trip. The air strip that we landed on is only accessible by plane, foot or horse. If anything went wrong, we were going to be in trouble. In preparing for the adventure, I checked and rechecked all the systems of the plane and every piece of our camping equipment.
Everywhere possible we had redundant backup equipment including socks, radios, water purification, smart phone batteries and chargers, etc. On the first day, while hiking into one of the alpine lakes and feeling the weight of the backpack, I started thinking “am I carrying too much, not enough”, “did I bring the right things”, and “how would I pack differently next time”.
Of course, no matter how hard I tried to unplug from work, my thoughts wandered back to the office, and I started thinking about one of Boulder Sterilization’s clients. This particular client approached us in a panic. They had 8 pallets of product sitting on the dock of their contract sterilization facility since before Memorial Day. Our client’s contract facility had been overwhelmed with the sterilization demand and to add insult to injury was short staffed due to the pandemic.
Prior to COVID hitting in early 2020, the biggest medical device concern from the FDA was the U.S. capacity to Ethylene Oxide sterilize the U.S. supply of medical devices due to several large sterilization facilities closing.
As the old saying goes “if you put all your eggs in one basket, watch that basket”. The first rule I learned as a young engineer was to second source all critical components and processes. One of the worst things to happen to a successful company is to have customers but no product to sell them because the supply chain broke down.
How many companies have more than one sterilization contractor? I’ll bet you, not many. This brings up the question of second sourcing your sterilization.
Boulder Sterilization offers “quick turn” sterilization validations and continues to add sterilization capacity to meet the market’s growing needs. Because our chambers are small, they have short cycle times and allow for 4-day turnaround times (a day to receive the product, a day to sterilize, a day to ship and an extra day in our estimate – just in case).
It’s always better to have a second source before you need one. Contact Boulder Sterilization to see how we can help to de-risk your supply chain.