Abstract
The use of biological indicators is integral to the validation of isolator decontamination cycles. The difficulty in setting up the initial qualification of the decontamination cycle and especially the successive requalifications may vary as a function of not only the installation to be qualified and the sterilizing agent and generator used, but also as a function of the type of biological indicators used.
In this article the manufacture and control of biological indicators are analyzed using the hazard analysis and critical control point (HACCP) approach. The HACCP risk analysis, which must take into account the application of the isolator being qualified or requalified, is an efficient simplification tool for performing a decontamination cycle using either hydrogen peroxide gas or peracetic acid in a reliable, economical, and reproducible way.
Footnotes
- Copyright © Parenteral Drug Association. All rights reserved.
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.