Effective cleaning for lab commodities or instruments

ISBN-13: 9786139936304 / Angielski

Jean Paul Umuhire

Opis

The KABGAYI Eye Unit has been producing eye drops since 2003. Among the cleaning procedure used until now, none has not already been validated. Sodium Cromoglycate, one product manufactured chosen as the worst case has been considered in order to validate the cleaning procedure of the filtration unit. After the determination of acceptance criteria, the experiment has been conducted using a validated method in terms of accuracy, precision, linearity, repeatability, selectivity, limits of detection and quantitation. For the validation of cleaning, three campaign of production of sodium cromoglycate have been organized and the collection of rinse samples obtained after usual cleaning have helped to validate the cleaning procedure after comparing the quantity of residue recovered with acceptance criteria already established. The procedure used for cleaning has been found to be accurate and effective as long as it removes the residue on the equipment under the acceptance criteria. The method of cleaning as laid down in SOP of cleaning of filtration unit, being effective can be used routinely in cleaning of filtration unit.

O autorze

Umuhire, Jean Paul
Jean Paul Umuhire - Master Degree in Pharmaceutical Sciences(Quality Control & Quality Assurance). National Universtity of Rwanda, Faculty of Medecine, Department of Pharmacy.