Abstract
In the present work Process validation of Ceftriaxone and Sulbactam as a dry powder injection was carried out. As the manufacturing process of dry powder injection is mainly dependent on blending process. In the present investigation, blending process was validated at different speeds of blender and the % assay was estimated by HPLC method. The octagonal blender was operated at 13, 17 and 20 rpm samples were taken from 10 different locations inside the blender. At 13 rpm there is much variation in assay results, at 17 rpm there is very less variation and also at 20 rpm there is slight variation occurs with reference to the acceptable ranges of assay {i.e. 90-110 %}. The obtained results clearly indicated that the optimum rpm is often necessary for the proper mixing of the drug. Therefore, 17 rpm was considered for the proper mixing at blending stage and it can be successfully employed to manufacture of dry powder injections for further manufacturing. The content uniformity of the net filled content was found to be in ± 5 % of average net content. Hence, it was concluded that process stands validated for the preparation of dry powder injection.
Highlights
Validation is a concept that has been evolving continuously since its formal appearance in the United States in 1978 [1]
The objective of the present work is a) to provide documented evidence for the operation sequencing and scheduling of manufacturing processes and to determine the critical parameters of the manufacturing process of dry powder injection. b) to provide assurance that manufacturing process is suitable for intended purpose and consistently meets its predetermined specifications and quality attributes, as per Master Formula Record (MFR) and c) to systematically conduct the validation studies pertaining to the manufacturing activities of Ceftriaxone and Sulbactam dry powder injection and to conclude on a high degree of assurance that manufacturing process, consistently meets the predetermined specifications and quality attributes
In the process validation of dry powder for injection, the main focus was done on Blending stage
Summary
Validation is a concept that has been evolving continuously since its formal appearance in the United States in 1978 [1]. Validation is documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality attribute. Validation study in evitably leads to process optimization, better productivity and lower manufacturing cost. Validation has become one of the pharmaceutical industry’s most recognized and discussed subjects It is a critical success factor in product approval and ongoing commercialization. B) to provide assurance that manufacturing process is suitable for intended purpose and consistently meets its predetermined specifications and quality attributes, as per Master Formula Record (MFR) and c) to systematically conduct the validation studies pertaining to the manufacturing activities of Ceftriaxone and Sulbactam dry powder injection and to conclude on a high degree of assurance that manufacturing process, consistently meets the predetermined specifications and quality attributes. The quality product output can be increased, leading to increase in quality, productivity and decrease the need of reprocessing [3,6]
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