RT Journal Article
SR Electronic
T1 Development of Methods for Recovering Endotoxins from Surfaces and from Air in Production Environment of Injectable Drugs
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 502
OP 510
DO 10.5731/pdajpst.2017.007674
VO 71
IS 6
A1 Frucci Fiammetta
A1 Annalaura Carducci
A1 Giulia Davini
A1 Marco Macchia
A1 Simone Bertini
A1 Sandra Vecchiani
A1 Stefano Ceccanti
YR 2017
UL http://journal.pda.org/content/71/6/502.abstract
AB The aim of this work is to develop and validate methods for quantifying endotoxins on surfaces and in the air of the manufacturing environment of injectable drugs, in order to use them to evaluate the quality of the process and the risk for the products processed therein. The method for recovering endotoxins from surfaces is a direct method that provides sampling surfaces by swabbing and extraction of endotoxins from the swabs with an appropriate diluent, while the method for airborne endotoxins provides an air-active sampling on a glass fiber filter and endotoxins extraction with an appropriate diluent.LAY ABSTRACT: Bacterial endotoxins are present in the environments devoted to the manufacturing of injectable drugs and could be a real risk for the quality and the safety of such drugs. So the quality control laboratories should have analytical methods to recover bacterial endotoxins from environmental samples. The aim of this publication is to show how we succeeded in developing and validating methods to quantify bacterial endotoxins on surfaces and in the air.