Cleaning validation in the pharmaceutical industry
In recent years, the demands placed on pharmaceutical manufacturers by the pharmaceutical authorities have increased significantly. Special attention should be focused on those facilities where several different pharmaceutical products are produced (so-called multipurpose facilities). Thus, to avoid product contamination, manufacturing equipment must be cleaned using validated methods. Thus, documented evidence must be provided that a production facility cleaning method is effective over the long-term and the required degree of purity is achieved. The cleaning must ensure that, regardless of the secondary product the preliminary product was sufficiently removed to below an established toxicological threshold. Possible contamination is a concern: production residues that in the worst case involve a risk of cross-contamination, residues of cleaning agents or microbiological contaminants.
If the validation conducted was successful, sampling and analytical controls can be reduced to a minimum and hence save on costs and time.
A summary of cleaning Validation:
In multipurpose facilities cleaning must be performed after cleaning procedures
For this, documented evidence must be provided demonstrating that the required degree of purification has been achieved
The toxicological threshold must be safe
Successful validation saves time and money
Benefit from our expertise and many years of experience in cleaning validation + toxicological assessment. Contact us today!
SYNLAB Umweltinstitut GmbH
pharma institute Aachen
Auf der Hüls 183
+49 (0)241 475 736 0