Environmental Monitoring (EM) is a basic requirement throughout numerous industries; food, cosmetics, drugs and medical devices. It is intended to measure the cleanliness of an area, therefore verifying the biological safety of products being manufactured. The depth of your EM program will be determined by the industry you’re in, whether or not you claim your product is sterile, and what kind of regulations you are required to comply with.
The US Pharmacopeia (USP) states that “An environmental control program should be capable of detecting an adverse drift in microbiological conditions in a timely manner that would allow for meaningful and effective corrective actions.”
With the FDA, their requirements are documented in 21 CFR 820.70. There’s even a part of that section that discusses Environmental Control. They describe EM as “Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions.” The EM program must be set on a routine schedule – whether that is weekly, monthly, semi-annually, etc.
When selecting sites for your sampling, focus on areas people and equipment come together. Identify areas that are critical, that would have a negative impact on your product if it gets compromised, and areas that could have minimal air movement. Prior to implementing an EM program within your company, a study should be performed to identify normal ranges of microorganism activity in the area. From there, you can set Alert and Action limits for your program. An Alert level is the level of microorganisms that would show a potential drift from your normal ranges. An Action level identifies the point where the acceptable level of microorganisms has been exceeded and requires immediate follow-up. The Action and Alert limits should be evaluated periodically, and adjusted as needed.
There are several methods for EM. Some of the most common methods include:
- Air Sampling: This method uses an instrument (such as the Surface Air System) to draw air through the instrument and deposits particles onto an agar.
- Settling Plate: This method uses a prepared agar plate. The plate is left open to the manufacturing process for a specified period of time. At the end of the defined time, the plate is covered and then incubated.
- Surface Sampling: This method can be accomplished using a swab and/or a contact media plate.
To learn more about Mesa’s BGI Environmental Monitoring line of products, visit bgi.mesalabs.com.