Webinar: Solving API Manufacturing Challenges with Flexible Containment

 Webinar named “Solving API Manufacturing Challenges with Flexible Containment” was organized by ILC Dover. This webinar discussed some of the common challenges faced in handling powders during HAPI/API manufacturing. Key strategies to mitigate risks associated with these issues was shared including how flexible containment solutions can optimize powder handling during chemical synthesis. Ms. Kayla Hager was the guest speaker.

Firstly, she introduced the whole process of chemical synthesis of Active Pharmaceutical Ingredients (APIs) from “Materials arrive” to “Pack off to oral solid dosage process”.

Then she briefed some common challenges including powder containment and dust mitigation, operational efficiency, sustainability and others.

Some controls for the contain at the source include “Control of the environment”, “Reduce airborne particulate”, “Protect operators”, “Reduce risk of cross contamination” and “Consider ergonomic”. Some steps of chemical synthesis under contain at the source showed as following diagram.

An intermediate bulk container (IBC) is a pallet mounted, industrial grade reusable container that is used for storing and transporting bulk liquids and powders. Cleaning IBC’s and Disposal of Flexible intermediate bulk containers (FIBC) were then discussed.

Ms.Hager said disposal of FIBC is more sustainable than stainless steel IBC for cleaning based on water consumption and energy consumption, as well as, cost of capital expenditure. For project time and complexity, IBC project needs 22 to 30 weeks but FIBC project only needs 8 to 10 weeks.

After that she briefed flexible containment solutions optimized powder handling during chemical synthesis under API process train.

Finally, she introduced the concept of “Quality by Design (QbD)”. She said the DoverPac and D100 systems maintain closed charging minimizing the risk of contamination and particularly cross contamination in a shared facility.

Reference:

ILC Dover - https://www.ilcdover.com/

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