Pharmaceutical heat exchangers are generally sanitary
heat exchangers designed to meet the requirements of the
FDA cGMP's, ASME BPE and sometimes 3A standards as well.
The design of these heat exchangers is such that
lowering of the bioburden and other residue is easier
than with non-pharmaceutical heat exchangers.
Features :
Single Tubesheet/Double Tubesheet
In pharmaceutical or even
food applications where you have a fluid on one side of
the heat exchanger that must not be contaminated by the
fluid on the other side, you must ensure that
contamination can not take place. This may
be done by various methods but whatever method is chosen
it must be reliable (as reliable as gravity). For
the sake of illustration let us consider WFI (Water For
Injection) on one side as the fluid that must not be
contaminated
and on the other side is glycol for cooling the WFI.
Clearly the WFI must never be contaminated by the glycol
because it would create a grave risk to an eventual user
of an injectable or food product. In this case it
would satisfy regulations if the WFI was maintained at a
pressure that was always above that of the glycol.
This pressure must be maintained at all times and
under all circumstances which includes under fault
conditions and failure modes. If an electric pump
is used to maintain the pressure differential then the
regulations would not be satisfied as the pump could
fail or the electrical supply to the pump could fail.
Under those conditions the pressure could be reversed
and, if leakage occurred, it could contaminate the WFI.
If you are not able to
guarantee that the pressure gradient will always protect
your sensitive product then you should use a double
tubesheet design. In this design the failure of a
tube to tubesheet joint will not result in contamination
as the WFI or glycol will simply leak to the environment
without causing a cross contamination.
In none critical applications
or in an application where you can guarantee that you
will maintain a proper pressure gradient, then a single
tubesheet design will work well and is the most
economical solution. In applications where
contamination could result in harm and it is not
possible to guarantee that the pressure gradient will be
maintained then you must use a double tubesheet design.
While double tubesheet designs cost more it is usually
cheaper to use one than to try to engineer a 100%
reliable pressure gradient. (Scroll down for
double tubesheet illustration)
Enerquip manufactures units
with both single and double tubesheet designs and can
help you in deciding which one you need.
Fully Drainable Heat Exchanger
In pharmaceutical and
many food applications you should consider specifying a
fully drainable heat exchanger if any of the following
situations apply:
- If your heat
exchanger is going to be left for periods of time
essentially empty on the tubeside and there is a
possibility of bacteria growing in any pools
of liquid that may be retained in the unit.
- If there is risk of
product carryover and you are trying to reduce the
"holdup" volume in your heat exchanger.
- If the unit is going to be
left for periods in the "drained down" condition,
then it is essential to drain all the fluid out of
the unit to eliminate the corrosion risk at the
liquid interface.
Enerquip's pharmaceutical
designs ensure full drainability of the tubeside of the
unit. In most cases, by simply draining the unit
from the lowest port on the head. Specially
designed channels inside the heat exchanger drain the
upper chambers into the lower chambers to ensure an
absolute minimum "holdup" volume is retained in the
unit.
The proprietary "bow tie"
design of the web in the waterbox of two pass unit gives
greater flexibility during installation. Even if
rotational alignment is off by a few degrees the unit
will still fully drain. Holdup volume remains
constant despite misalignment of up to plus or minus 5
degrees. This is a feature that dramatically
simplifies validation. Scroll down for
illustration.
Surface Finish
In 'high end' sanitary
applications it is common to see very high quality
surface finishes specified. These are expensive to
apply
and are often unnecessary. For example, in
hot, recirculating WFI systems, there should be no
source of carbon, so there should be no food for
bacteria. In addition, the temperatures should
render most bacteria unable to multiply. If this
is so, then why specify a 10 Ra finish? It will
not improve performance of the unit and it will cost
money to apply. It would be much better and
cheaper to specify
a ground finish and electropolish than to specify a 10
Ra finish. See the Technical Bulletins section for
a paper on sanitary surface finishes. Having said
all that, we do our own electropolish so that we can
control the quality of the finish. We can provide
almost any kind of finish you may need and we have a
uniquely skilled electropolish department. In
short it does not matter what your specification says,
we can provide it. If you are looking for a high
performance surface and need to save a little money we
can help you with that as well. We have scientific
and engineering staff who have designed and built the
production facilities of biopharmaceutical plants and
have validated entire plants so we understand your
problems and can speak your language.
Details :
Double Tubesheet Configuration

This illustration
shows the general arrangement of a double tubesheet heat
exchanger. This configuration is ideal where the
product and the process fluid on the shell side must not
be permitted to mix or cross contaminate.
Fully Drainable Water Box

Here you can clearly see the
the features that make the water box super sanitary and
permit free draining, even with a substantial degree of
misalignment or rotation during installation.
These features are a huge aid to system validation as
well as simplifying installation.
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