2nd Annual Pharmaceutical
Lyophilization Summit 2020
Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring, new products development.
- 12 Feb 2020
- Berlin, DE
- Pharma
Day 2:
Thursday, 13 February 2020
CASE STUDY: No compromises - vial strength by design.
In order to avoid breakage on filling lines or weaken the vials on their way to lyophilization, vial’s optimal strength characteristic plays a crucial role during the fill/lyo and finish process. Especially if the decision is taken to freeze-dry the product, the vial should not be the “disturbing factor” of the process in terms of yield.
There is a solution to increase vial’s strength, but at the same time compromising inner surface characteristics and therefore deteriorating its breaking behavior. This treatment is making the vial that though, that machine parts might break or wear out faster. New machine concepts need to be developed.
We at SCHOTT worked on a solution to increase vial’s strength whilst keeping its superior surface properties, and standard dimensions – no reregistration necessary. Finite element analysis – especially with strengths playing a role during lyophilization, strength testings/ fractography and study outcomes will be presented in this session.
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