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Pharmaceutical
PSD 166
Process
Equipment
Continuing Education from Plumbing Systems & Design
APRIL 2010
PSDMAGAZINE.ORG
CONTINUING EDUCATION
Reprinted from Pharmaceutical Facilities Plumbing Systems, Chapter 12: “Utilities for Pharmaceutical Process Equipment” by Michael Frankel.
© American Society of Plumbing Engineers, 2005.
Figure 3 Autoclave
clean side. The openings of the autoclave must be large enough to allow
equipment—such as vessels, tanks, or carts with product or smaller
vessels stacked on them—to be wheeled in and out of the chamber.
The door can be a swinging door or a sliding door. In either case, the
door should be dogged, or latched, to sustain the internal pressure. The
chamber usually has a mechanical space placed adjacent to it in which
Figure 2 Vessels the vacuum pump and utility piping and controls reside. This space
must be accessible and is usually arranged by the autoclave vendor.
of applications. Wet heat is the most dependable method of steriliza- The chamber, vacuum pump, and all intercon-necting piping are pro-
tion. Autoclaving (saturated steam under pressure of approximately 15 vided by the autoclave vendor and installed by a contractor under the
psi to achieve a chamber temperature of at least 250°F for a prescribed direction of the autoclave vendor.
time) is the most convenient method of rapidly achieving destruction Because items to be sterilized may be rolled into the chamber of the
of all forms of microbial life. In addition to proper temperature and autoclave, there are chamber drain points, of necessity, below the floor
time, prevention of entrapment of air is critical to achieving sterility. level. For this reason, some autoclaves are built with a depression or
Material to be sterilized must come in contact with steam and heat. An pit in the floor around the chamber and mechanical space. Adequate
airtight seal is required between the aseptic side of the autoclave and drainage for the equipment and the pit must be provided. A general-
its mechanical space to prevent contamination potential. duty floor drain is usually adequate. In addition, the vacuum pump
Autoclaves can vary in size from bench-top to room size. The size may be of the liquid-ring type and a drain with a funnel or similar type
depends on the application for which it is utilized. The simplest auto- receptor must be provided and connected to a pipe of adequate size
claves are similar to those found in almost every doctor and dentist’s to receive the once-through water required for vacuum formation. The
office, where the sterilization of utensils is of primary concern. Larger drainage system to which these drains are connected must be deter-
autoclaves are the focus of this discussion due, in part, to the complex- mined because there may be some contaminants in the waste stream
ity of their arrangement and their utility requirements. That is not to that require special handling or treatment. All equipment drain con-
say, however, the smaller types are not used in a pharmaceutical facil- nections should be made by indirect means.
ity. It is the job of the plumbing engineer to ascertain all types used on a Hard-piped utilities required for proper autoclave operation can
project and furnish the utilities necessary for their proper operation. include com-pressed air for air ballasting, purified water and clean
An autoclave is basically a pressure vessel with a large door or doors. steam for sterilization, condensate returns, vacuum as well as power
(See Figure 3.) The equipment may have an “in-and-out” arrangement, and data I/O ports. The plumbing engineer should review the vendor
with the items to be sterilized entering and exiting the autoclave from cuts and/or equipment drawings for the utilities required, the capac-
the same portal, or be a once-through device, with a dirty side and a ity and size of such utilities, the location and type of each of the con-
PSD 166
tion from other materials may result in a wrong answer.
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