Smoke Study in Cleanroom Areas: Pharmaceutical Guidelines

Smoke studies – also known as dynamic or static air visualization studies – are critically important in constructing, monitoring, and maintaining facilities designed for everything from pharmacological testing to manufacturing. This testing helps to ensure that final products in processing plants are free from contamination while also helping to create sterile environments for testing and production in pharmaceutical facilities.

Smoke studies in a cleanroom environment are conducted to definitively confirm directional airflow as it exits either HEPA or ULPA filters. Since this is done through observation, the physical properties of smoke play an important part in the test’s accuracy. Using the correct tools and procedures is vital to the accurate outcome of any smoke study cleanroom assessment.

Choosing the Right Tools for the Task

The type of smoke and fogger – or distribution machine – that are chosen for a smoke study are important in ensuring an accurate result. This is why it is important for only trained personnel to execute these tests; some types of smoke and machinery are not suitable for the cleanroom setting, and should not be used for this application.

Some of the most common types of smoke production liquid used in smoke studies for standard settings are glycerin-based. However, these products are known to leave behind an oily residue in the space where they are deployed. This can cause an inaccurate assessment to be rendered, and make these a less than desirable choice for cleanroom testing.

The best choices for cleanroom settings are generally water-based smoke production liquids with additives created from polystyrene, silica, and other synthetic particulates. The water may also be combined with frozen carbon dioxide for a more desirable smoke texture and less lingering effect.

It is also important to note that when choosing tools for gathering information and manipulating samples, easy-to-sanitize stainless steel is an excellent and affordable option that won’t compromise results.

Why Use a cleanroom for Testing?

If you’re wondering why a person would go to the trouble of testing in the cleanroom environment when many tests are conducted in larger, more open areas, there are several advantages to performing at least the initial assessments in these settings.

First, the environment is more controlled, making it a great proving ground for materials, techniques, and tools. Likewise, the smaller area also makes the smoke produced more efficient at doing its job and can render more accurate results. The size of a cleanroom makes collecting these results simpler, too, since there is less ground to cover and the environment has fewer variables.

However, this kind of testing doesn’t account for every important variable, so more dynamic testing is often still required. Smoke study cleanroom assessments are an important part of ensuring the safety and sterility of laboratories and the efficiency of production plants, but they are only part of the picture. Always be sure to conduct thorough testing in line with government requirements for your center!

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