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How Can You Prevent Another Meningitis Outbreak?

The current outbreak of meningitis was caused due to contamination that occurred in a compounding pharmaceutical critical environment. We would like to share with you the top sources of contamination and how to prevent that contamination in controlled environments, helping bring a stop to the potential cause of outbreaks like the current meningitis outbreak.

Top 5 Sources of Contamination in your Controlled Environment

Operators
Process
Mechanical Maintenance
Consumables
Housekeeping

Operating a Cleanroom in a documented stable particle count state is hard work. The most common offenders that will cause your particle counts to climb beyond acceptable levels are easily identifable, and in some cases, an easy fix. Please note that we are making the assumption that the cleanroom is properly engineered with air velocity, volume, and positive pressure adequate for the cleanroom classification and appropriate for the work performed in the space.

Operators are typically the largest source of contamination in a cleanroom. This is because human beings have “free will” and sometimes either deliberately, and sometimes accidently, fail to follow the protocols and procedures for gowning, entry, and operating procedures. A classic example is the operator not properly wearing the facemask, and allowing unfiltered breathing air to “blow-by” the filter media in the face mask. In the event of an operator, who has recently smoked a cigarette prior to entering the cleanroom, who has not rinsed their mouth with a surfactant type liquid (i.e. mouthwash, soda), the residual smoke will be directly introduced into your critical environment. Because of the inherent unpredictability of human behavior, the operator can be a real “wild card” in keeping your cleanroom particle counts consistent.

The lack of Process control can also contribute unwanted particles being released into your controlled environment. The development of….

To view all the top 5 sources of contamination control click here

If you would like to read more about the meningitis outbreak there are a series of  informative article listed below.  Remeber to take the proper steps to maintain your critical environment at the proper standards!

Meningitis Update: FDA says fungus confirmed in 1 of 3 lots of recalled steroid

Meningitis Update: – Behind the Meningitis Outbreak: Pharmacies Fought FDA Regulation

Meningitis Update: – UPDATE 3-Meningitis toll rises; pharmacy owners sued

Meningitis Update: – Ex-workers: Company linked to meningitis outbreak had questionable practices

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