Abstract
In pharmaceutical manufacturing some processes and process equipment cause temperature differences relative to the surrounding air, e.g. sterilisation and freeze-drying processes. Generally there is a temperature difference when a door to such equipment is opened. This can cause a flow of room air through the opening, creating a contamination risk, especially when manual handling of material is performed in this area. To minimize this risk, a HEPA-filter unit should be installed above the opening to provide clean air and protect the opening. The airflow needed through the HEPA-filters depends mainly on the temperature difference between the chamber and the room and the size of the opening. The flow of clean air should be greater than that of the theoretically calculated flow in order to minimize contamination hazards. In this paper the theoretical relations are discussed and design criteria are presented in a simplified form with graphical representations. Results from a case study are described and the experimentally estimated air-flow values are compared with the theoretically calculated values.
Footnotes
- Received April 10, 1998.
- Accepted May 27, 1998.
- 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.