2014.12.30.TUE

New Tech for Bio

Sampling From a Bioreactor

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Author:GMP Platform


Author: TamaraFridman
 

Sampling From a Bioreactor;

Important Factors to Look For When 'Shopping' for Sampling Systems
 

There are many types of systems and process equipment used in the upstream process of manufacturing biopharmaceuticals. Although the quality of each system and piece of equipment is highly important for medicines to be produced with their safety and efficacy intact, there is one system that cannot be emphasized enough; the importance of a proper sampling system.  All other systems and equipment have to work but it is the system of sampling that leads to other decisions that may or may not be correct if the sampling system isn't reliable. Sampling tells us the story of what is going on in your bioreactor- faulty system; faulty story. Decisions following the sampling data can either save or cost the company thousands of dollars. In addition, an unreliable sampling system could lead to an opening in what is supposed to be a closed system. This could affect the health of the operators and the environment as well as risking contamination to the process.
 

Another problem with an unreliable sampling system; it could allow a product to move forward down the path of production with a potential problem that might have been overlooked if the sampling procedure did not catch the out of specification parameter, only to be realized in the clinical trials leading to the failures of clinical trials or potentially risking patients' lives or perhaps product recalls if the product managed to get to market. Sometimes when operators receive out of specification results, they keep sampling until they get the results they want. They don't realize that an unreliable sampling system could be the reason for out of specification results.
 

Besides being reliable, a sampling system needs to be cost-effective. Many companies based their equipment choice on costs. The fact that there are plenty of complaints about the prices of biopharmaceuticals, cutting costs seems to becoming a more necessary action when choosing new manufacturing equipment. Although it is not a sufficient to make a choice based on costs alone, it is often a critical part of the decision making when choosing which equipment to implement.
 

Also, easy to use equipment is becoming more and more a requirement; not just an option, especially with the complications being brought in by some of the new equipment coming into the market. Too many steps to a system, too many locations; too many pieces; too much tubing-  all these could lead to mistakes, complications, contamination, and time between taking the sample and actually testing it. Time is critical for some of the various parameters being tested, like CO2 and DO2. If too much time passes, the sample is no longer a true representation of the process being tested.
 

What do you have to look for in a sampling device to ensure its reliability, cost-effectiveness and ease of use?

The most important factors to look for are its design, its materials, the documentation supplied in support of the system and the system's operation and procedures.
 

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