I stumbled across a revolutionary discovery of sorts today that I want to share. The start-up medical device project I’m working with has a disposable component requiring packaging and sterilization. Initial quantities for sterilization are limited; a few hundred parts will last a long time. Sterilization validation is required. However, most sterilization suppliers require large lot sizes in order to validate the cycles. I also have to pay premium pricing to run a few parts through sterilization to support some testing.
The discovery involves a company called Andersen Products, Inc. I was forwarded a contact from Andersen and had a chance to discuss and review their products and services. For a start-up or anyone requiring sterilization of small lot sizes, Andersen seems to have solutions that are extremely cost-effective:
I know this approach will help my start-up client with timeline and cost issues. I plan to utilize Andersen’s services and will be sure to provide feedback via this blog.
You can do small lot sterilization at the major sterilizers, I don’t know the 10993 section number right now, but for ETO it is 1.5 cycles and under both sterilizers we quoted will do it for under $8K. It does take ~60 samples sacrifice for sterility validation, which you have to do every lot until you validate as you would normally. However, it works very well for my company, especially since we don’t have lot composition or layout set and it is likely to change in the future, and we would probably have to revalidate anyway. You might have to directly ask for it because sterilizers would rather you do a $20K or $40K validation. If you want, send me an email and I can get you the section number and more details next time I go to work.
Jacob,
Thanks for your comments! I’ve found your experience to be true. I can run smaller lots through larger sterilizers but at a substantial price, including sacrificing parts. The option with Andersen Scientific is a more economical solution, especially for a start-up with limited funding. Andersen’s turnaround time and cost is very, very reasonable.
I have your email and just added you blog to my feed reader.
Take care,
j