Abstract
The aim of this work is to develop and validate methods for quantify endotoxins on surfaces and in the air of manufacturing environment of injectable drugs, in order to use them for evaluate the quality of the process and the risk for the products processed therein. The method for recovering endotoxins from surfaces was a direct method which 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 (GFF) and endotoxins extraction with an appropriate diluent.
- Received March 20, 2017.
- Accepted August 7, 2017.
- Copyright © 2017, Parenteral Drug Association
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.