Environmental Monitoring (EM)

The objective of an environmental monitoring program is to estimate the microbial and particulate content of room air and surfaces. An effective environmental monitoring program can alert you when conditions contributing to excessive microbial levels arise due to ineffective cleaning, sanitation or other personnel/equipment issues. Cleanrooms and controlled environments are utilized in order to control the levels of non-viable and viable particulates that medical devices and pharmaceutical products are exposed to during the manufacturing process. The objective of an environmental monitoring program is to estimate the microbial and particulate content of room air and surfaces. An effective environmental monitoring program can alert you when conditions contributing to excessive microbial levels arise due to ineffective cleaning, sanitation or other personnel/equipment issues. MicroMed can provide you with the appropriate level of service that you need to ensure your manufacturing environment complies with FDA, USP and ISO requirements.

Modifications to Cleanrooms/Controlled Environments should be evaluated to ensure the existing validation is still applicable. Addition of major components, expansion of the room and addition of more personnel and operations in the room can all affect the performance of the room. At the very least Alert and Action levels should be re-evaluated to ensure realistic cleanliness standards are kept within the room and sterilization validations do not become compromised.

MicroMed can also characterize and identify your bacterial or fungal contaminants associated with on-site Environmental Monitoring should a contamination occur.

Testing Services

Code Test Description
EN-001 Environment Monitoring – Incubation & enumeration
EN-001.1 Environment Monitoring – Incubation & enumeration Volume Discount (31-100 samples)
EN-001.2 Environment Monitoring – Incubation & enumeration Volume Discount (101-200 samples)
EN-001.3 Environment Monitoring – Incubation & enumeration Volume Discount (201-300 samples)
EN-001.4 Environment Monitoring – Incubation & enumeration Volume Discount (301-400 samples)
EN-001.5 Environment Monitoring – Incubation & enumeration Volume Discount (401-500 samples)
EN-001.6 Environment Monitoring – Incubation & enumeration Volume Discount (>500 samples)
EN-001A Anaerobic Incubation and Enumeration of Media Plates
EN-002 Travel Fee (per visit)
EN-002.1 Local Travel Fee (per visit)
EN-003 In-House Sampling Hourly Fee
EN-003.1 Cancellation Fee (<24 hours)
EN-004 Particle Counts – Per Location
EN-005 Compressed Air Line Sampling per line -VIABLE (TSA)
EN-005A Compressed Air Line Sampling per line -VIABLE (SDA)
EN-005B Compressed Air Line Sampling per line – NON-VIABLE Particle Counts
EN-005C Compressed Air Line Sampling per line – Water
EN-005D Compressed Air Line Sampling per line – Oil
EN-005E Media specific for E. Coli and Salmonella spp (up to 10 tests)
EN-006 Media – Air Sampling per Location (TSA)
EN-006A Media – Air Sampling per Location (SDA)
EN-007 Media – Surface Sampling per Location (TSA)
EN-007A Media – Surface Sampling per Location (SDA)
EN-008 Media – Passive/Setting plates per Location (TSA)
EN-008A Media – Passive/Setting plates per Location (SDA)

*ON-SITE Services are only available in Northern California