UPDATE: The point isn't to install air-breaks at all costs. The point is to use the correct BioSafety Level for your process, recognizing that a lot of facilities are overly-conservative for the processes they run.
On multiple consulting assignments, we are seeing an alarming trend where CIP manifolds and process piping are piped directly to drain. We have identified direct piping to floor drains as contamination risks. And our experience mitigating floor drain contamination risk is to cut the piping.
On multiple consulting assignments, we are seeing an alarming trend where CIP manifolds and process piping are piped directly to drain. We have identified direct piping to floor drains as contamination risks. And our experience mitigating floor drain contamination risk is to cut the piping.
The main objection to this recommendation is that it would compromise the Class 100,000 clean room status of the process space.
With the cut in the piping, the worry is that contaminants from the drain are now able to enter the processing suite and will send your viable airborne particles beyond your environmental monitoring action limits.
But of the unfavorable options available, there's one that's obvious to us.
Your choices are as follows:
It turns out that that we aren't the only ones who think this is true. In a 2006 article on biocontamination control, @GENBio reported the "original views" of chemical engineer, Jim Agalloco:
We're aware that managing perceived action is as important as managing action. But taking the action that keeps cell cultures from contamination is always defensible even if it flies in the face of perception.
Zymergi Bioreactor Sterility Consulting
With the cut in the piping, the worry is that contaminants from the drain are now able to enter the processing suite and will send your viable airborne particles beyond your environmental monitoring action limits.
But of the unfavorable options available, there's one that's obvious to us.
Your choices are as follows:
- Keep the bioreactor sipping drain water, but hey, you've got a Class 100,000 processing suite.
- Cut the pipes and get your bioreactor sipping fresh, 20 air-changes-per-hour filtered air.
It turns out that that we aren't the only ones who think this is true. In a 2006 article on biocontamination control, @GENBio reported the "original views" of chemical engineer, Jim Agalloco:
...Trying too hard to protect the bioreactor environment can adversely affect the ability to sterilize equipment. For example, a steam sterilizer normally requires an atmospheric break between its drain and the facility drain, but some biotech companies object to that layout because it compromises the controlled environment.Somehow, the viable airborne particles of the environment matter more than the ability to sterilize equipment. They further state:
Eliminating the atmospheric break introduces more piping and surfaces, which leads to more opportunities for microbes to grow. To protect the outside of the tank, they purposely risk contaminating the inside.Which is exactly our position on the matter.
We're aware that managing perceived action is as important as managing action. But taking the action that keeps cell cultures from contamination is always defensible even if it flies in the face of perception.
Zymergi Bioreactor Sterility Consulting
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