Article

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.

Suggested Content

Technical Tip

Benefits of Pharmaceutical Detergents with Proteinaceous Soils

This technical tip takes a closer look at selecting cleaning detergents.
Technical Tip

Why Choose a Pharmaceutical Detergent?

STERIS's detergents are engineered for your most difficult cleaning challenges. Learn more now.
Technical Tip

Comparison of Pharmaceutical Detergents for Effective OSD Soil Cleaning

STERIS conducted a study to determine the effectiveness of ProKlenz ALIGN Detergent when cleaning common soils found in pharmaceutical OSD manufacturing. This article will review the results of the study and the benefits of ProKlenz ALIGN Detergent compared to other detergents.
1 of 3

You're leaving this site.

You are being redirected off of the STERIS Life Sciences website. If you wish to continue, click "Leave STERIS Life Sciences". Otherwise, click "Take Me Back".