022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly

What We Covered 00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of the elements of filter validation 05:41 – Shelli talks about the process of selecting a filter and why not all filters are the same 09:03 – The evolution and importance of sizing filters 11:26 – Shelli speaks to the shift to single-use disposable filters 13:05 – Qualifying a filter before validation 16:51 – Shelli explains the Bubble Point test 18:53 – Shelli expounds on everything that goes into filter validation 22:57 – How to use filters in a media simulation challenge 25:07 – Shelli’s philosophy on what to include in your filter validation 28:28 – Final recommendations Shelli would give regarding filter validation Tweetable Quotes “I highly recommend reaching out to the filter vendors. They’re your best support, especially with this process.” “Most people when you start with a drug process you’re looking less than a hundred liters, knowing that your commercial back size could actually be 1500 liters. And then the question comes down to are you doing redundant filtration, are you utilizing two filters, are you utilizing one? To understand your product, I think the filter vendor can definitely still help with that.” “Normally if you’re utilizing a sterilizing filter, you definitely have to run it through some type of sterilization process.” “A Bubble Point test is related to the micron-size of your filter, meaning if you have a 0.2 or a 0.45, those bubble points are gonna be different.” “I think utilizing your filter validation in conjunction with your media fill program – whatever that may be – they have to be synced and in alignment.” Relevant Links Design Space InPharmatics – LinkedIn Design Space InPharmatics – Twitter Edward Narke on LinkedIn Shelli Connelly on LinkedIn