Environmental Monitoring
Environmental monitoring testing evaluates the microbial contamination and quality of an area. Environmental monitoring testing ensures that medical device products meet appropriate safety standards and are not manufactured, assembled, packaged, sterilized, or stored in areas with high contamination risk.
Our Tests
M750
RODAC Surface Touch Plates, Tryptic Soy w/Lecithin and Polysorbate, each
M750A
RODAC Surface Touch Plates, fungi, Sabouraud Dextrose w/Lecithin and Polysorbate, each
M750B
RODAC Surface Touch Plates, anaerobic, Trypic Soy w/Lecithin and Polysorbate, each
M751
Settling (fall-out) Plates, Tryptic Soy w/5% Sheep Blood, each
M751A
Settling (fall-out) Plates, Sabouraud Dextrose, each
M752
Impact Viable Air Sampler Plates, aerobic, Tryptic Soy w/Lecithin and Polysorbate, (m3 of air) each
M752A
Impact Viable Air Sampler Plates, fungi, Sabouraud Dextrose w/Lecithin and Polysorbate, (m3 of air) each
M752B
Impact Viable Air Sampler Plates, anaerobic, Tryptic Soy w/Lecithin and Polysorbate, each
M753
Surface – Swab Test Method, each
M754
Viable count of Compressed Air System, each point of use
M755
On-site sample collection, per hour, plus expenses (minimum 2 h)
M756
Incubation and Analysis of customer supplied environmental plates, each —includes characterization of the (1) most predominant organisms observed)
M757
Characterizations and gram stain of each additional isolate
M759
Clean Room total particulate air counts, per hour
M775
Viable Environmental Program – Monitoring Validation Protocol development
Sample Submission
Purchase Order
In line with current ISO/QSR purchasing requirements, all orders should be sent with a signed completed Purchase Order. This will help expedite the processing or your order. Standing Purchase Orders will be gladly accepted for routine continuing orders.
Sample Submission Form
Final Reports
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
Isolators Vs. Restricted Access Barrier Systems
Learn what isolators and RABS are, and if they can be useful in the manufacturing, filling, testing, or packaging processes for medical devices.
What Are Restricted Access Barrier Systems (RABS)?
Learn what restricted access barrier systems (RABS) are and how are they useful in manufacturing or packaging processes for medical products.
How to validate isolators used for medical device testing?
Learn about isolators and isolator validations and how to validate ISO Class-5 isolator systems used for medical device testing and sterile products.