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.
“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.”
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