Journal Name:
- Advance Research in Pharmaceuticals and Biologicals
Key Words:
| Author Name | University of Author |
|---|---|
Abstract (2. Language):
In the present work, an industrial project procedure has been taken in Cassel research laboratory Chennai. The project was
identified to be validated as cleaning validation of Metformin tablets. The purpose of cleaning validation is to establish the
documented evidence with high degree of assurance that the cleaning process followed as per standard operating procedure
for cleaning the equipment used for the processing of metformin tablets. The research work was carried out by swap cleaning
method and the test has been performed on various equipments which are used for metformin tablet manufacturing of a
particular batch. The cleaning solution was analyzed by UV spectroscopy at 232nm. The different changeover of total residue
carry over metformin in ppm by swab method was found to be 0.21166. All the results were found to be well within the
acceptance criteria of 1.8752 ppm and it’s finally concluded that the swab method is found to be a better sampling technique
when compared to acceptance limit to sampling amount with the satisfactory completion of the cleaning validation.
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