Cleaning validation verifies the effectiveness of cleaning processes within pharmaceutical and healthcare facilities. It should be directed to situations or process steps where contamination or the carryover of materials pose the greatest risk to product quality (1), as evaluated to appropriate limits (2). To ensure cleaning process robustness, care must be taken in the selection of cleaning chemicals. This article looks at the choices available and some of the important selection factors for cleaning chemicals.
To determine the most appropriate chemicals, an understanding of the products is needed, especially with the selection of the most appropriate in-process material for the cleaning validation (3). This choice should be based on factors like solubility, difficulty of cleaning, the different types of equipment to be cleaned and the calculation of residue limits based on potency, toxicity, and stability.
Sandle, T.: Key considerations for the selection of pharmaceutical equipment cleaning chemicals, RSSL Insights, April 2023: https://www.rssl.com/insights/life-science-pharmaceuticals/key-considerations-for-the-selection-of-pharmaceutical-equipment-cleaning-chemicals/
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
Pages
- Home
- About Dr. Tim Sandle
- Technical articles (free)
- Publications by Tim Sandle
- Microbiology books by Tim Sandle
- Other books by Tim Sandle
- Pharma Microbiology MSc
- Microbiology Sites
- Presentations by Tim Sandle
- Advertise here
- Write for us
- About this site
- Useful Links
- Science and microbiology videos
- Privacy Policy
Wednesday, 23 April 2025
Key considerations for the selection of pharmaceutical equipment cleaning chemicals
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment
Pharmaceutical Microbiology Resources