Pharmaceutical Guidelines for Smoke Study in Cleanroom Areas

Posted by amosfred1990 on November 13th, 2019

A smoke study in a cleanroom area lasts longer. During the test, the smoke is also more intense. A portable machine is commonly used for the procedure. Cleanroom areas provide a cleaner work environment as well, which ensures better results. If you are thinking about performing a smoke study, here are a few guidelines you need to keep in mind.

Determine Your Objectives

Airflow visualization studies are done to identify the patterns of unidirectional airflow within a clean processing facility. The test documents the airflows within the class A/ISO 5 zones and how the airflows cascade to areas with lower cleanliness requirements. Before you undertake the test, make sure you are clear about your goals. What would you like to achieve? What will the test results reveal? How will it help your organization?

Be Aware of the Risks

Issues withline design can cause turbulence and lead to inadequate airflow. First air disruptions in important Grade A zones may also be a concern. Knowing the possible problems that may happen will help you prepare for them and allow you to take precautionary measures to prevent any contamination in the first place. That way, products and components remain sterile.

Know What to Do

In case a product or component is contaminated, make sure you know how to eliminate the contamination. That will include proper management of tools, equipment, and components to ensure that no other contaminant is introduced into the sterile drug products.

Include an Analysis

A smoke study in a clean room needs to conclude with a thorough analysis for it to be successful. The report must state that satisfactory airflow conditions were achieved. However, in some cases, first air disruptions that result from faulty equipment use or personnel interventions make the airflow unacceptable. When this happens, an investigation is required to identify the root cause/s of the problem and to develop ways to prevent them in the future. The most common recommended courses of action include modifying the equipment or filling line. Changes in personnel behavior or investing in better equipment are also on the list.

Upgrade the Equipment

Outdated units compromise the results. To ensure accuracy and reduce or eliminate the risk of contamination, buying the proper equipment is a must. Organizations must use proper smoke study tools and units. Many foggers, for instance, are designed for specific activities and can only be used with specific chemicals. These considerations must be taken into account when organizations look for tools and equipment.

Choosing a Manufacturer

Not all brands and manufacturers are equal. Thorough research, though, will help you select the best option. By finding out more about the company before you order a piece of equipment, reading customer reviews and feedback, and taking the time to find out its reputation, you have a better chance of finding the right supplier for your equipment. A company that delivers high-quality equipment at reasonable price points is a much better option than cheap alternatives offered by a firm with a dicey record.

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