Although regulatory compliance sometimes comes into conflict with scientific effort, cleanroom certification standards offer a range of benefits. Scientists may recognize the value of standards while also considering the added time and cost they introduce to already complex processes.
Cleanroom certification standards are critical for medical and aerospace applications, as health and safety may literally depend on them. Following these standards offers advantages for other uses of cleanrooms, in the form of increasing the quality of data, control over instrument use and condition, and greater certainty in the final result.
Control Contamination
Contamination of a testing program wastes time and money and often generates results of dubious quality. Preventing contamination is one of the primary reasons to follow cleanroom certification standards, such as USP 797 cleanroom standards. The presence of particles can clog instruments or create confounding results. Imprecise environmental controls can promote growth of microbes and other foreign elements that contaminate the test and require extensive mitigation for the next effort. By comparison, strict controls for contamination can improve results and repeatability.
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Manage Particulate Levels
Managing particulate levels is a key aspect of cleanroom certification standards. These standards set limits on the number of particles of specific sizes. The highest allowable particulate level, ISO Class 9, is 35.2 million particles 0.5 microns or larger per cubic meter of air. The cleanest, ISO Class 1, limits the number of particles 0.1 microns or larger to up to 10 per cubic meter of air. Following the right standard is critical to ensuring accurate instrument performance and recording of results.
Minimize Impact of Environmental Variability
Quality of testing and analysis depends heavily on the environment in which the test was conducted. A researcher who performs a test in open air must account for all environmental factors that may have influenced the result, namely humidity, temperature, filtration, air changes, or air pressure. Without control over the environment, there may be too many factors affecting the test for others to have confidence in the result. For effective and accurate analysis, these aspects are useful elements of cleanroom certification standards.
Humidity
For testing, compounding, and other tasks that require cleanrooms, humidity management is a critical component. Humidity that exceeds target levels can encourage growth of microbes or render surfaces no longer sterile. If the humidity drops too low, instruments may develop electrostatic buildup. Even a minor electrostatic discharge can damage equipment and make results untrustworthy. Precise humidity control can reduce the likelihood of suboptimal moisture levels that risk the quality of the final result.
Temperature
Keeping the room at a precise temperature is an important aspect of cleanroom operations, particularly for the people who work in the area. Cleanrooms often specify a narrow range of temperatures to support contamination control and ensure stability of materials and instruments. Excessively high temperatures may cause humans working in the cleanroom to sweat and possibly compromise samples or testing devices.
Air Change Rates
The ventilation of the cleanroom is vital, to manage temperature and humidity and ensure that particulate levels remain below the relevant cleanroom requirements. The HVAC system’s air changes per hour maintain the environment. Air change rates, which may run into the hundreds per hour according to the appropriate standard, depend on the area. Air change rates vary by cleanroom classification, with higher rates required in cleaner, more controlled environments.
Improve Data Quality
Researchers depend on the quality of data to prove their arguments, so the data must be as accurate and verifiable as possible. Although maintaining strict cleanroom standards can be onerous and complicated, requiring regular testing and training, the effort creates the ideal environment for the equipment performing analyses and tests. Organizations that follow these standards as carefully as they design and conduct the tests may be more likely to have data that matches that of others.
Encounter Fewer Instrument Failures
Precise instruments can be damaged under certain circumstances. Something as simple as a slight electrical charge can ruin expensive tools and equipment needed for accurate testing. Excess humidity can cause moisture accumulation and rust certain materials, leading to improper function and eventual failure. Precise environmental control, which can only come from strict adherence to a cleanroom regimen, is key to keeping delicate instruments in peak working order as long as possible.
Increase Confidence in Results
Ultimately, researchers want to have confidence in their own results. They also need their peers and organizations that depend on the data to be confident in them. The quality of the results depends on a variety of factors, including the type of testing, construction of the examination, selection of analytical instruments and materials, and more. Along with these, researchers must choose the appropriate level of environmental and particulate control. By maintaining cleanroom standards, researchers can demonstrate a commitment to accuracy that inspires greater assurance in the findings of each test.
Maintaining a cleanroom requires attention to the standards guiding the level of cleanroom for its planned uses. While some may see it as an unnecessary chore that gets in the way of productivity and efficiency, there are reasons to look at cleanroom certification standards as a path to improved data quality. By paying attention to the cleanroom standards for contamination, particulate levels, and environmental controls, researchers can ensure higher quality tests with more reliable results.
