Some maintenance plans call for running a process until it
is broken. These “run until it fails”
plans cost money and can place production behind schedule. Whether it is a fermentation process,
distillation or an organic growth process, routine maintenance and leak
certification can provide the assurance that your sterile boundary remains in
place when its needed.
The first in maintaining your sterile boundary is identifying
where it could be breached.
Are all of the elastomers that you can see
working well? O-rings and gaskets are
some of the most common spots for microbial intrusion. They wear out and can be hard to test. Sometimes they only leak under pressure, and
can not be seen to leak with the naked eye.
Have you checked the input utilities? Input water and air are often causes for
contamination. They must be tested
individually from the rest of the process to determine if they are truly
Steam used for sterilization is a common cause
for microbial intrusion. Saturated steam
is steam that is in an equilibrium state with water of the same pressure. It has not been heated past the boiling point
of water of the same pressure. That
would be superheated steam is not efficient to sterilize surfaces, and can even
cause condensation in the process that can lead to additional
contamination. Steam at 121o
at 15 psig is frequently used. At this temperature,
one log of bacteria is killed for each minute of exposure. The time is much
longer and much less efficient if the steam used is super-saturated.
Are all of the drains from the process working
properly? They should be only used to
drain a single product. Using a drain
for two or more products can allow for cross contamination. Do the drains drain
the entire process completely?
Have all of the filters been tested? There are many different kinds of filters
that can be used for many different types of process. A process may have been designed years ago
with the newest filters of the time.
When a better filter comes on the market, it may have replaced the old
filter, but also may change the balance of pressure in the system. Does it provide more resistance or provide
increased airflow into the process?
Are all of the gravity drain lines from the
process sloped appropriately? Do they
drain completely when the process is complete?
Are all check valves and pressure control valves in good working order?
Welded joints or threaded connections can all
leak. Even if they worked fine last
year, they may leak by now. It can be
hard to test all of these connections but they should be part of an annual
With a little planning, process downtime
can be minimized and sterility can be more easily assured. Time is, of course,
money, and United Leak Detection can help save both. 888-422-5325 or visit www.unitedleak.com to talk to a real
person about how we can tailor solutions to your bioprocess. The solutions can be cost effective and fit in with your schedule. Call today for more information today.
Labels: bioprocess leak, fermentation processes, helium leak testing, leak detection, microbial contamination, pure culture processing, sterile boundary, trace gas, upstream processing