Inventi Impact: Pharmaceutical Process Development
publication date: 2012/7/15

PACKAGING VALIDATION OF SOTALOL HYDROCHLORIDE TABLETS
                  Jagruti Malukani*, Rajesh Sen, Hasumati Raj

ABSTRACT
Packing of the drug product is highly important in order to protect it from the surroundings. When there is any change in the packing material, it is highly important to validate the packing process as it may have effect on the product quality and also to have evidence that the packaging process is robust and reproducible. For this purpose, the packaging process was carried out at different speed of the machine and sealing temperature. Various parameters were observed and assay was performed to verify no effect on the product quality due to sealing temperature. The packaging process carried out at lowest speed and highest temperature showed assay results within the limit indicating the packaging process at highest sealing temperature can be carried out.

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