Environmental Monitoring in Clean Rooms

by | Mar 9, 2022 | Compliance, Consulting Group, QMS, Quality, Quality Systems, Regulatory, Standardization, Standards


Environmental monitoring is used to assess environmental conditions and trends. The FDA Aseptic guidelines state that clean area control parameters should be supported by microbiological and particle data obtained during qualification studies. Initial clean room qualification includes an assessment of air quality under as-built, static conditions1. It is important for area qualification and classification to place the most emphasis on data generated under dynamic conditions. An adequate aseptic processing facility monitoring program also will assess conformance with specified clean area classifications under dynamic conditions on a routine basis.

The FDA recommends that an area adjacent to aseptic processing meet ISO 7 classification under dynamic conditions. The entire aseptic filling room can also be held at an ISO 5 classification and areas that are used for less critical activities can be at an ISO 8 classification[1].

The main source of micro-organisms or viable particulates in a clean room is personnel. Some other sources can be water, gases, and raw materials. Some critical areas where contamination can occur are the path of any open containers, manufacturing equipment surfaces, storage containers, gloved hands, and aseptic connections.

Micro-organisms can be limited through Environmental Controls such as facility design, validation, personnel practices, and cleaning. Routine environmental monitoring ensures that systems continue to provide an environment of consistent quality. Monitoring can prove the effectiveness of the cleaning and sanitization, the effectiveness of gowning and training of personnel, provide trending information, and identify excursions.

Ensuring your clean room is always in a state of environmental control can be difficult. EMMA International can assist with setting up routine testing parameters to keep the clean rooms in a state of control. If your company needs assistance with its environmental monitoring, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.


[1] PhEn-602 (2009) Retrieved on March 7, 2022 from https://web.njit.edu/~armenant/PhEn602-102/PhEn602-Spring09-Notes6.pdf


Bano Ahmed

Bano Ahmed

Bano is a Quality Engineer at EMMA International. She has experience in quality control, pharmaceutical and medical device manufacturing, and implementing corrective and preventative actions within the pharmaceutical and medical device industries. Bano has earned a Bachelor of Science in Biology from Pennsylvania State University and a MPH in Population Health Sciences from the University of Michigan.

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

Ready to learn more about working with us?

Pin It on Pinterest

Share This