Aseptic filling techniques for highly viscous drug products
Автор: Sharp Sterile Manufacturing
Загружено: 2022-09-07
Просмотров: 3927
Описание:
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About this event:
Viscous drug products requiring aseptic filling present a host of unique challenges in formulation, sterile filtration, and filling. These products require special equipment to be able to move the solution, special filters to sterilize the product, and uncommon techniques to maintain consistent fill volumes across a fill and reduce product volume loss.
In this webinar, we describe common challenges of viscous filling from solutions that are 100 cP to those reaching 1,000,000 cP to get the desired result: a sterile drug product that is safe to inject.
What you will learn:
– How to determine equipment and process requirements for a viscous drug product
– Formulation and filling techniques for viscous filling
– Other considerations of viscous filling (e.g. non-Newtonian vs Newtonian solutions)
00:00 - Intro
01:18 - The challenge of filling viscous drug products
02:22 - Piston pumps (what are they/how do they work)
03:54 - Pressure vessels (what are they/how do they work)
04:57 - Selecting tubing
06:00 - Fill setup (rule of thumb)
08:56 - Shawn Kinney intro & background
10:17 - Determining formulation requirements
12:33 - Safety considerations
13:45 - Determining sterile filling requirements
14:59 - Picking a pump
16:50 - Setting the pump speed
17:45 - Determining pressure requirements
18:54 - Reducing stress
20:03 - Bubbles
21:44 - Newtonian fluids
22:57 - Non-newtonian fluids
25:01 - Transition Q&A
26:07 - Q&A
29:47 - Conclusion
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