Abstract
In this report we will first discuss the principles behind the practices that are used today in the design and qualification of moist-heat (steam sterilization) microbial-control processes used to produce sterile pharmaceutical products and medical devices. Secondly, we will work through example applications of how to design and qualify processes of three levels of complexity which we call Empirical Overkill, Empirical, and Product Specific. Empirical Overkill is specifically for the microbial-control processes for indirect items, such as tanks, pipes, pumps and other hardware. Empirical is for pharmaceutical and medical-device products that are produced under good manufacturing conditions and, therefore, there is control of the level of the microbial bioburden. Product Specific is for microbial-control processes designed and qualified for a specific product on the basis of the numbers and resistance of the bioburden of that product.We will treat design in this report; however, the major thrust is in setting up and carrying out the biological qualification of the process, which is the mode of control used to assure the adequacy of these microbial-control processes.
Footnotes
-
↵‡Kristen D. Evans, Investigative Engineer US Food and Drug Administration, Philadelphia, PA.
Aportion of this paper was prepared by K. Evans in his private capacity.
No official support or endorsement by the US Food and Drug Administration.
- 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.
