Wednesday, February 11, 2015

Preventative Maintenance for Bioprocess Fermentation is Complex but Possible

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.
1.       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.

2.       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 sterile. 

3.       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.

4.       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?

5.       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?

6.       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?

7.       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 review.
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 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.


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