We serve major industries including pharmaceuticals, medical devices, food, compounding pharmacies, and healthcare.
Environmental monitoring is a critical component of a company’s overall activity. It can be performed in cleanrooms or any other associated controlled environment. Gibraltar Laboratories starts out with creating a protocol that describes the locations and specifications with respect to airborne viable and non-viable particulates and surface colonies.
As per ISO 14644, this testing is especially applicable to industries such as aerospace, microelectronics, pharmaceuticals, medical devices, food and healthcare.
The USP <1116> states that products manufactured in such environments for monitoring should include:
- Pharmaceutical sterile products
- Bulk sterile drug substances
- Sterile intermediates
- Medical devices (in some cases)
Establishing your program
When beginning an environmental monitoring program, you need to consider all aspects of the cleanroom or controlled environment, as well as personnel, equipment and other key factors. Once the program is established, it should be continued on a regular basis.
Our mobile microbiologists will come to you
Gibraltar Laboratories has a traveling group of microbiologists with the necessary expertise to perform sampling of:
- Compressed air
Note: When preparing compound sterile preparations (CSPs), it is particularly important to perform environmental monitoring.
What we do on-site
At your facility, our microbiologists will investigate for particulate debris, hydrocarbons, airborne particulate matter and contaminating microorganisms that are often present in such environments. USP Chapter <797> pays special attention to the evaluation, provision and maintenance of air quality.
We can train your personnel, as well
Additional mention is given to personnel and their garbing and gloving, along with aseptic technique, all of which are part of environmental monitoring. Our traveling microbiologists can train your personnel on location as an additional service.
Our Golden Thread™ report ties everything together.
In addition to this sampling, data can then be subjected to graphical trend analysis in a comprehensive report known as the Golden Thread™.
This valuable report can provide information about trends seen during seasonal periods of the year. It can also enable other trends to be seen much more easily.
If microbial isolates are recovered from the cleanroom, microbial identifications of the indigenous organisms can be performed upon request down to species level.
This data can be used together with verification of the cleaning and disinfecting agents employed to control the microorganism load in the facility. Mold isolates recovered can also be identified to genus level.
Contact us today!
To learn more, please call us at (973)-227-6882 or submit a contract form by clicking here.