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

CMC Live - Chemistry, Manufacturing & Controls

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