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Exclusive Digital Edition eBook  |
| HPAPI Development and Manufacturing Trends
The current trend of increased potency of drug substances is driving the need for better cleaning methods to reduce cross contamination. The Level of Detection (LOD) methods are improving so that cleaning limits can be reduced to further mitigate risk of cross contamination due to retention on the process equipment and containment devices. Cleaning protocols are becoming more complicated to achieve the cleaning limit. In the case of isolator technology, the isolator surfaces add to the overall cleaning requirements while often making the cleaning ergonomically challenging. This is where a single use isolator will provide significant economic advantages, lower costs, and reduce the risks of cross contamination over traditional hard wall isolators. |
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