Additional note on Bioreactor Contamination Control: Some Simple Strategies to Consider

Further to my earlier post on using process data for troubleshooting and control of bioreactor contaminations, I recently came across a wonderful article in Pharmaceutical Engineering for simple strategies to keep a check on contamination events published by Ryan Schad and his team (from Eli Lilly & Co.) back in June 2010 issue of the magazine.

I especially liked the following checklist provided in this article.

The article elegantly describes the following considerations in good detail:

• handling of steam and condensate
• air removal
• cold spots
• equipment drains
• piping slopes
• elastomers
• methods of data collection from reactor for monitoring
• offline monitoring: sterile sampling techniques
• online monitoring: reactor probes and its sterility
• valves and dead lags
• agitator shaft seals

In addition to these I also recommend considering these:

• Incorporating a Helium Leak Test: Since helium can penetrate very small cracks and crevices, filling the bioreactor with helium prior to a batch and snooping for leaks is very quick and easy way to identify potential leaks especially in deteriorated elastomers. Most of the leak testing methods that are usually employed are bubble test or pressure decay. Helium can be a good alternative if you find any of the current methods that you employ are not effective.  
• Using inexpensive Tempilstik temperature crayons: If your plant is old or there is no way to install additional temperature sensors on your valves to check for effectiveness of your SIPs, you may consider good old temperature sticks to confirm the effectiveness of sterilizations each time and record the checks in your SIP batch records. (Note: This process is laborious but can be an easy cost effective solution for contamination check and also historizing SIP data for future troubleshooting)

If you think you already have incorporated these checks and still are having problem in controlling your contamination events its high time you take help of external consultants as they will help provide a third eye to the investigation. Most of the time taking the help of consultants who have already solved similar problems in various contexts earlier can help you overcome your own organizations' blind spots, internal politics or lack of expertise (internal transfers, attrition etc.).

Simplyfeye team can be one such resource to you that you can rely and can utilize our years of experience in solving such problems. Our team will help you implement effective CAPAs (and data systems) for future checks on such events.