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Review Article Open Access
Equipment’s are very important factor which can affect the quality of the formulation to a great extent, therefore design, construction, installation, location, cleaning and the maintenance of equipment should be followed the guidelines of cGMP, FDA, WHO and considered very carefully equipments used in manufacturing processing or holding of drug product should be of adequate size and suitable location to facilitate operation for its internal use. Pharmaceutical equipment are nothing but the any piece of plant, machinery which is used to carry out specific activity or operation such as mixer, granulator, dryer, U.V, H.P.L.C, etc. and should work on the principle to minimize the risk of errors, to permit effective cleaning and maintenance, and to avoid cross contamination, dust and dirt build up. Validation of cleaning system of equipment is done by SWAB technique (involve the use of swabbing material saturated with the solvent to physically sample the surface), solvent rinse method (passing a known volume of solvent over a large area and analysing the recovery solution), placebo rinse method (to detect residue on equipment through the processing of a placebo batch subsequent to the cleaning process). This method involves passing a known volume of solution over a large area and analysing the solution. These factors should be considered, while selecting the equipment and operating condition.
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Author(s): Sharma Pawan Kumar, Priyadarshani R. Kamble, Ravindra Kamble, Chetan Singh Chauhan, Sissodiya S. S., Mahendra Singh Ranawat
Cleaning validation, design, installation protocols, maintenance, principle, purchasing, selection, Pharmaceutical Sciences