The importance of cleanroom cleanliness cannot be understated. Cleanrooms must adhere to a strict standard and are rated according to their level of cleanliness. If cleanrooms do not maintain their cleanliness standard, the consequences could be quite serious. Recently, a pharmacy in Tennessee had tragic results when cleanliness procedures where not adhered to.
Cleanrooms are measured by the ISO standard which limits the amount of particulates that can be in an air sample of the cleanroom. There are various levels within the ISO standard and they are ranged based on what types of processes are being conducted in the room. Rooms that work in sterile compounding or compounding pharmaceuticals are held to an additional standard called USP 797. The USP 797 regulations are most often seen in pharmacies and are ultimately designed to help keep consumers safe.
Several people received routine steroid injections in which the steroids had been produced in a Tennessee cleanroom facility. Unfortunately, many of these patients developed abscesses due to fungus and bacteria which had contaminated the steroids. Although this situation is tragic, it could have been significantly worse.
The FDA advises that all cleanrooms follow written procedures. Cleanrooms can vary greatly in size, and in order to keep these rooms running up to standard, procedures must be followed. Surfaces need to be cleaned, floors need to be mopped and equipment may need maintenance or cleaning. There are also additional procedures for wearing the proper clothing and how to correctly enter and exit the cleanroom.
A report regarding this Tennessee cleanroom showed some horrifying findings. In addition to product splatters and spiders, the FDA’s findings also showed that the cleanroom wasn’t following written procedures. Furthermore, the FDA’s report showed many surfaces within the room were stained and not cleaned using the appropriate materials.
Worst of all a lyophilization machine was leaking oil from the motor, and a paper towel was simply placed underneath to absorb the oil.
All of these factors from not cleaning regularly and properly to not following a written procedure had terrible consequences. Other instances of contaminated materials from a New England- based facility led to the sickness of hundreds and the death of over a dozen people. Following written procedures to maintain cleanliness is of the utmost importance.
In conclusion, cleanrooms are controlled environments that have a strict set of protocol for cleanliness. Understanding that if these protocols are not followed in the cleanroom, drastic consequences could follow. Remember to always follow procedures to keep your cleanroom operating at the appropriate level.
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