Issue 20, August 2006

How to conduct you contamination investigation the right way, the first time.

Get the right team!  Your investigating team needs the ability not just to fix the problem, but also to prevent its recurrence, and if possible, recommend improvements. Your technical team needs to know aspects of quality management, microbiology, chemistry, physics, engineering and the range of available scientific techniques. In addition, your team needs to effectively communicate, interrogate, analyze and negotiate to get to the crux of the problem.

Team members should discuss all information in regular meetings and must have the full support of management behind them to ensure that as much information about the process/problem is available. Time is a factor in investigations - contaminants of a chemical and biological nature can change within hours and the sooner the team is able to identify and individuate the source of the contamination the better.

Step 1.  Promptly collect information about the how, when and where of the contamination. It is crucial to do this as promptly as possible.  Such information will help define the scope of the investigation.

Step 2. Animal vegetable or mineral? Characterize your contaminant, conditions and environment.   

When characterizing particles it is important to gather as much information as possible. Don't make the fatal mistake of only concentrating in the contaminant particle and forgetting to look at the conditions surrounding it.  

During investigations, we have often seen that the people closely involved in the process believe they know the source of the contamination and it’s remedy. Be wary! In our experience such anecdotal evidence without proper scientific proof is risky at best and disastrous at worst.

A number of basic preliminary tests should be performed initially. Remember to keep an open mind and don't rely solely on the preliminary test!

Step 3. Microscopy and microphotography - a picture tells a thousand words and a good microscopist can save you millions of dollars. High quality micrographs sorted into a library are probably the most powerful individuation tool available.

Step 4. Mass - Determine how much contaminant there is relative to the batch size. This can give you an indication of the scope and likelihood of recurrence.

Step 5. Infrared Spectroscopy - One good FTIR spectrum can usually individuate an organic compound from most other potential sources.

Step 6. Electron Microscopy / Energy Dispersive X-ray Spectroscopy.  A good qualitative elemental and morphology analysis can eliminate many potential red herrings.

Once the data is collected, it should be analyzed by all your investigating team. This prevents data choosing and potential misdirection. Compare against existing spectral and identification libraries and at this point your contaminant should be revealed.

The Next step - WHY - Tracking down the reason for your contamination.

Would you like to know more about how to investigate your contamination problem?  Contact us on 03 9544 911. 

Other related articles
Contamination in the Pharmaceutical Industry: Part 1
Digging the Dirt - Soil Contamination
Determining The Failure Mechanism

	Radioactive Contamination
	What Could be Affecting the Lung Health of your Employees?
	Office Productivity and Payback - The Holy Grail Discovered?