Considerations for Cleaning Lipid Nanoparticles
While lipid nanoparticles provide many benefits for manufacturers, cleaning them has proven to be a challenge. In this article, our team reveals key takeaways and provides a recommended cleaning method based on laboratory and field testing.
June 2, 2022
Key Takeaways:
- LNPs and NLCs pose cleaning challenges due to complexity and low water solubility.
- Water, sodium hydroxide and alcohol may be ineffective or pose handling risks.
- Cleaning validation should use coupon studies simulating process conditions and materials.
- Key cleaning parameters include agent selection, temperature, time, action, water quality, and rinse conditions.
- A repeatable process ensures equipment integrity and product quality in LNP pharma manufacturing.
Lipid nanoparticles have been used in many vaccines, including the COVID-19 mRNA vaccine. While lipid nanoparticles provide many benefits for manufacturers, cleaning them has proven to be a challenge.
Our expert team recently evaluated the effectiveness of using a formulated alkaline detergent - compared to sodium hydroxide - for lipid nanoparticle cleaning.
In this Pharmaceutical Technology article, the team reveals its key takeaways and provides a recommended cleaning method based on laboratory and field testing.
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