Cleanroom Certification

Cleanrooms are a controlled environment where pollutants such as dust and airborne particles are filtered out in order to reduce contamination in critical areas. Cleanrooms are mostly used for manufacturing products such as electronics, pharmaceutical products and medical equipment. Cleanroom Certification must be performed routinely to ensure classification requirements are being maintained. If a uniformity specification is not being met during room certification, MESA3 can investigate and adjust the supply airflows to meet design criteria.

Cleanroom Certification

MESA3 prides itself as a “one-stop” shop in finding solutions regarding HVAC performance in clean/critical production spaces. The unique pairing of balance and certification disciplines allows us to address issues and improve on the performance of critical systems rather than simply issuing PASS or FAIL test results.

MESA3 prides itself as a “one-stop shop" in finding solutions regarding HVAC performance in clean/critical production spaces. The unique pairing of a balance and certification disciplines allows us to address issues and improve on the performance of critical system rather than just simply issuing a PASS or FAIL to test results.

HEPA/ULPA Filter Leak Testing

HEPA/ULPA Filter Leak Testing is a procedure designed to inspect the filters surface for leaks that could allow transmission of contaminated particles into a highly critical area. MESA3 provides Annual Certification services (Airflow verification with air change rate calculation, Leak Testing of HEPA filters and Airborne Particle testing) to verify that a room performs or continues to perform as designed. Typically to meet an intended design class (per ISO 14644 or EU GMP Annex-1:2008).

We understand that your production operational time is critical and will try to minimize the impact of testing. As such we have implemented some best practices:

When testing HEPA/ULPA filters, MESA3 prefers to patch any leaks detected while on-site rather than waiting for another quote and separate dispatch.
We recommend performing Airborne Particle Certification while in operation (Dynamic condition) as this evaluation would be the most useful to an owner.
When replacing physically damaged HEPA filters, we prefer to use a gas hoist to install room side replaceable filters which ensures uniform pressure to seat the gel track.

Viable Organism Microbial Testing

Viable Organism Microbial Testing is the process of detecting living bacteria, pathogens and other microbes within a sample. Routinely performing this testing is essential for environmental monitoring to ensure safety from foodborne illnesses. We incubate these samples in-house which gives us the opportunity to notify clients if any sample exceeds alert/action limits before the end of the incubation period.

Beyond the typical quantitative analysis (count), we can also offer gram stain and species identification.

Hood Certification

MESA3 offers comprehensive testing on a variety of hoods for proof of compliance and to verify the hood is performing sufficiently to contain hazardous gases and chemical fumes. All annual testing is performed in accordance with our established SOPs.

Biological Safety Cabinets
Laminar Flow Hoods/Clean Benches
Fume Hood (Class 1 – General use, toxic, or radioisotope)
Glove Box Isolators (Class III) for either positive or negative isolation

Specialty Cleanroom Tests

Most often, a newly built cleanroom has additional testing requirements to document the systems performance. We have the experience to perform these specialized tests:

Temperature/RH Trending
Sound Level Testing
Light Level Testing
Airflow Parallelism
Floor Conductivity

CDA and Compressed Gas Testing and Monitoring

Testing and monitoring of compressed air and other process gasses that come into direct contact with pharmaceutical drugs during manufacturing is crucial to assuring the quality and safety of certain products. CDA and Compressed Gas Testing and Monitoring per ISO-8573:

Moisture – pressure dew point measured down to -76°F
Hydrocarbons – oil vapor measured down to 0.1 mg/m3
Airborne Particle Concentrations
Airborne Viable Organism Concentration – using TCI-y agar, specifically validated for CDA use.