It cannot be stressed enough how important it is for research and manufacturing facilities to have cleanrooms in place. Clean room companies exist to make sure that specific standards are met, which vary depending on the classification of the room. Each classification has its own standards of cleanliness and if these standards aren’t met, the consequences could be disastrous. Indeed, the news regularly shows examples of cleanroom procedures not being followed and the tragic results this leads to.
A number of ISO standards are in place for cleanrooms. These standards show how many particulates are allowed to be present in a single sample taken from the cleanroom. These standards have different levels, and various processes will determine which level the cleanroom has to adhere to. Additionally, there are a number of national standards in place that must be adhered to as well. This includes USP 797, which compounding pharmaceuticals and sterile compounding is held to as well. This is because all work done in a pharmaceutical company or laboratory ultimately has an impact on the safety of consumers.
The Tennessee Example
Recently, a number of people received routine steroid injections for a variety of medical conditions. The steroids were manufactured in Tennessee, in a cleanroom facility. Unfortunately, patients quickly started to develop abscesses because the steroids were contaminated with bacteria and fungi. This was a tragic situation, and one that could have had even more disastrous results.
The U.S. Food and Drug Administration (FDA) has official advice in place to ensure cleanroom procedures are followed properly. These procedures are there to ensure that, no matter what the size of the area is, all standards continue to be met. This includes procedures on mopping floors, cleaning surfaces, and cleaning and maintaining the equipment. Furthermore, procedures are in place to cover entry and exit to the cleanroom, and what operatives should wear.
In the Tennessee example, it was demonstrated that these policies were not followed at all. In fact, a catalogue of failings, including spiders and product splatters, was uncovered. The FDA found that written procedures were not followed, including the fact that the wrong cleaning products were used on the various surfaces in the rom. Furthermore, the lyophilization machine was found to be broken, having an oil leak, which had been fixed using a paper towel to collect the oil.
The consequences of these terrible working practices and not following set guidelines were awful, and the Tennessee example is not the only one. In New England, for instance, over a dozen people died and hundreds were sick because a lab didn’t follow the right procedures. This demonstrates just how important it is for cleanrooms to always remain sterile.
To recap, cleanrooms are controlled, sterile environments in which strict protocols have to be followed to maintain those levels of cleanliness. If those are not followed, the consequences could be, and have been, lethal. Hence, every employer and every employee has to be aware of the rules and regulations, and must take responsibility for following them.