Validation of Swab Sampling and HPLC Methods for Determination of Meloxacam Residues on Pharmaceutical Manufacturing Equipment Surfaces for Cleaning Validation

Development and Validation of RP-HPLC-UV Method for Determination of Diclofenac Sodium Residues on Surfaces for Cleaning Validation

In recent years, cleaning validation has achieved a position of increasing in the pharmaceutical industry. It provides assurance to the cleaning procedure that ensures equipment is consistently cleaned from the product, detergent and microbial residues to an acceptable level to avoid cross-contamination and adulteration of drug product with other active ingredients. The aim of this study was to...

Cleaning level acceptance criteria and HPLC-DAD method validation for the determination of Nabumetone residues on manufacturing equipment using swab sampling

Prevention of cross contamination with active pharmaceutical ingredients is crucial and requires special attention in pharmaceutical industries. Current method validation describes the determination of Nabumetone (NAB) residue on a stainless steel surface using swab sampling with a sensitive HPLC-DAD analysis. The acceptance limit was decided as 2 μg swab per 100 cm2. Cotton swabs impregnated w...

a validated hplc method for determining of inhaler residues on pharmaceutical manufacturing equipment surfaces

Development and Validation of a UPLC Method for the Determination of Albendazole Residues on Pharmaceutical Manufacturing Equipment Surfaces

In Pharmaceutical industries, it is very impo remove drug residues from the equipment and areas used. The cleaning procedure must be validated, so special attention must be devoted to the methods used for analysis of trace amounts of drugs. A rapid, sensitive and specific reverse phase ultra chromatographic (UPLC) method was developed for the quantitative determination of Albendazole in cleanin...

Determination of Residual Ceftazidime in Pharmaceutical Product line: A Cleaning Validation Study by HPLC

The manufacturing equipment in pharmaceutical industry, could be used in multiple and sharedproduction lines, therefore there is the possibility for the products components and active ingredients tointermix and pollute one another. In this purpose the cleaning methods are used, to reduce the residueslevels from the machinery surfaces and decrease the residues to acceptable level but these metho...