Environmental
Monitoring (EM)

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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 13485 and ISO 14698 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.

*ON-SITE Services are only available in Northern California

Test

Code

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

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