Validation process of EDTA for infusion/ injection with ceftriaxone and sulbactam

Abstract

The validation of the manufacturing process to produce ceftriaxone/ sulbactam with EDTA1.5 g/ vial powder for solution for injection/ infusion. Ceftriaxone works by inhibiting the mucopeptide synthesis in the bacterial cell wall. The beta-lactam moiety of Ceftriaxone binds to carboxypeptidases, endopeptidases, and transpeptidases in the bacterial cytoplasmic membrane. These enzymes are involved in cell- wall synthesis and cell division. By binding to these enzymes, Ceftriaxone results in the formation of defective cell walls and cell death. Sulbactam is an irreversible inhibitor of beta-lactamase; it binds the enzyme and does not allow it to interact with the antibiotic. The validation confirms that each stage of the manufacturing process is in control and will consistently produce a product of acceptable quality, as defined by the specifications of product. It is planned that operating variables and control parameters of processes shall be studied and documented. The associated critical product attributes and characteristics shall also be studied. Process validation of ceftriaxone/ sulbactam 1.5g/ vial powder for solution for injection. Process for manufacture of ceftriaxone/ sulbactam 1.5g/ vials powder for solution for injection/ infusion is said to be in state of control. Hence this product can be manufactured by using this process without modifying any parameters

Keywords

• validation
• process validation
• prospective validation
• concurrent validation