Cleaning Validation Procedure of Manufacturing Equipment after Production of Sulfamethoxazole and Trimethoprime Tablets
The purpose of this work is to present a validation protocol of the cleaning method at the end of contained
Sulfamethoxazole and Thrime to prime manufacturing tablets. After cleaning, the new tablets to be produced contained
Amoxycilline as Active Ingredient Products. Acceptance criteria used health-based data such as Maximum Allowable
Carryover (MACO) and No Observable Effect Level (NOEL).Validation of the cleaning method was carried out using swab
technique. HPLC was applied as analytical method with Symmetry C18 column and UV detection at 254 mm. Validation
parameters were : recovery from spiked swab media, precision, linearity/range, limit of detection and limit of quantitation,
specificity, stability of samples and solutions, system suitability criteria, robustness.
Keywords - Cleaning, Sulfamethoxazole and Thrimetoprime, Amoxycilline, Swab, Validation, HPLC.