Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly
Regulatory Odd Couple with Ed Narke & Meranda Parascandola
February 12, 2021
Episode Summary
Shelli Connelly is a Senior Drug Product Consultant at Design Space InPharmatics. With over 20 years of long- term success in the pharmaceutical manufacturing industry, Shelli has expertise in pharmaceutical process validation, business development activities, strategic planning, and more. In this episode, Shelli shares her thoughts on filter validation, including what to do if you pick the wrong filter, how filter vendors represent the best resources and the importance of having a partner with experience in filter validation.
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. Click To Tweet 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,… Click To Tweet Normally if you’re utilizing a sterilizing filter, you definitely have to run it through some type of sterilization process. Click To Tweet 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. Click To Tweet 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. Click To TweetLinks Mentioned
Design Space InPharmatics – LinkedIn
