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Pharmaceutical validation & Knowledge Management
Ahmed Ramy, PhD
Mar 18, 20233 min read
Equipment grouping for cleaning validation
Equipment grouping is an essential aspect of cleaning validation in pharmaceutical and biopharmaceutical manufacturing. The objective of...
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Ahmed Ramy, PhD
Mar 18, 20232 min read
Cross-Contamination: Causes, effects and prevention
Cross-contamination is a major concern in the pharmaceutical industry. It occurs when one product or material comes into contact with...
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Ahmed Ramy, PhD
Mar 12, 20233 min read
A brief history of cleaning validation in the pharmaceutical industry
#cleaningvalidation #pharmaceutical Cleaning validation is an essential process in the pharmaceutical industry to ensure that drug...
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Ahmed Ramy, PhD
Mar 11, 20233 min read
HBEL Approach for cleaning validation
The Health-Based Exposure Limits (HBEL) approach is a method used to calculate cleaning limits in pharmaceutical manufacturing...
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Ahmed Ramy, PhD
Sep 4, 20224 min read
The "rocket-science" behind CSV
21 CFR part 11 has been considered for many years the corner stone of computer systems validation and the basis for regulating electronic...
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Ahmed Ramy, PhD
Aug 29, 20222 min read
Is visually clean = clean?!
One of the common misconceptions about cleaning that visually clean surfaces are by default clean. While any equipment need to be visibly...
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