As the pharmaceutical community takes on board the sheer scale of
Beneath the profiteering, gross negligence and other layers of criminal activity that led to this ‘killer pharmacy’ manufacturing and distributing deadly medicines, it was the
Aspergillus fumigatus is a fungus that is usually found in decaying organic matter like a compost heap. In this case, it came from a recycling plant situated nearby the illegal NECC manufacturing site.
But how did this lethal fungus find its way into the so-called
Among the facts brought to light by massive investigations led by the United States federal and state health officials, the Justice Department and
- A dirty mat leading into the
- A leaky boiler standing in a pool of stagnant water.
- Air intake vents positioned about 30 yards (27.4 meters) from a dust-spewing recycling plant.
These points alone show how microscopic fungus particles from the external environment found their way into the
Microbiologist and journalist, Tim Sandle, wrote in 2014 for the European Pharmaceutical Review, that as much as 21% of pharmaceutical products were recalled between 2000 and 2012 due to fungal incidents. He warned, “…The contamination risk posed by fungi to pharmaceutical products is greater than the level of industrial and academic interest would suggest.”
The tragic consequences of the NECC case make it abundantly clear that every
In practical terms, there are five key areas that must be assessed, understood and prepared for:
1. Types of contaminants present in environment
Sticking to the validated amount of time and cleaning solution should be standard practice. Where unusual types or quantities of contaminants are found to be present, revalidation of the usual cycle might be required or changes made.
In the case of the NECC
Chemical particles can affect the decontamination cycle by reacting with fumigants to create entirely new particles. These newly created contaminants could be poisonous and corrosive to
The bottom line is that standard decontamination and cleaning practices should be heightened and processes revalidated until the source of unusual contamination has been found and eliminated.
2. Forces that affect distribution of fumigants
The standard rule of switching electrical equipment off for the decontamination period exists for several good reasons. Most staff will be aware of the risk of mixing fluids (fumigants) and electricity, but they might not be aware of the repelling effect that electrostatic charge could have on the distribution of fumigants.
While personal electronic devices are usually banned from the cleanroom and equipment generally switched off, operators must be aware of the impact that exceptions to these rules could have on their decontamination cycle.
3. Soiling and spills
Gaseous decontamination methods, including fumigation, vapour, spraying, and fogging, are a good solution to decontaminating hard to reach nooks and crannies in the
This is why it’s essential for operators to be aware of the presence of contaminants that cannot be removed by air handling. In these cases, soiling and spills, if safe to do so, must be cleaned and particles removed prior to setting up for decontamination.
4. Loss of control over environmental conditions, including temperature and humidity
It might seem to be stating the obvious if I point out the importance of following the manufacturer’s instructions to a ‘T’ when using any type of decontamination device (i.e. fogging, fumigation, vapour, and spraying devices). But there are less obvious factors that could be overlooked if you’re not careful.
In the case of the Minncare Dry Fog systems, for example, the manufacturer supplies an automated calculation sheet that computes an effective decontamination formula (quantities of different solutions and decontamination period) based on cleanroom-specific data provided by the user. ‘Room temperature’ and ‘relative humidity in the room’ are two essential factors in getting the formula right.
Measuring these two factors under stable conditions is easy enough. The tricky part is predicting the room’s condition after the
5. Surface area parameters: Furniture and large objects
Surface area is another of the primary data inputs for calculating the variables of any decontamination cycle. Like any of the factors mentioned above, (presence of unusual contaminants, loss of control over temperature and humidity, etc.), the validated decontamination cycle is bound to be affected by a creep in surface parameter above a certain level. While the addition of a small stool is not likely to result in a significant change, operators must take note of the addition of any larger pieces of furniture to the
Stick to validated parameters and look out for anomalies
Cleanroom decontamination cycles are validated for specific parameters, including the normal range of environmental conditions. By being aware and proactive, operators can ensure that changes in the