We provide certification services for all types and sizes of cleanrooms and other controlled environments, from small cleanrooms with just one HEPA filter to facilities with hundreds of HEPA filters. We have the knowledge, equipment and manpower to meet your facilities’ needs.
A standard cleanroom certification will assess air quality and the ability of the engineering controls to remove particulate contamination. Typical testing includes Air Velocity Testing/Air Change Rates, HEPA Filter Integrity Testing, Particle Count Testing, and Room Pressurization.
- Additional cleanroom testing may include:
- Viable Environmental Sampling
- Visual Airflow Smoke Test with optional Video Documentation
- Sound Level Testing
- Lighting Output Testing
- Temperature / Humidity Testing
- Room Decontamination Services
- Filter Repairs & Replacements
- Airflow Uniformity Testing (parallelism)
In our industry, standards are very important. They define the methods which we use to validate the performance of your cleanroom. The following are the standards we utilize in the certification of your cleanroom:
- IEST-RP-CC-006.3; Testing Clean Rooms
- IEST-RP-CC-002.3; Unidirectional Clean Air Devices
- IEST-RP-CC-007.1; Testing ULPA Filters
- IEST-RP-CC-034.4; HEPA and ULPA Filter Leak Test
- ISO 14644; Cleanrooms & Associated Environments (supersedes FED 209E)
- USP 797; Pharmaceutical Compounding – Sterile Preparations
- USP 800; Pharmaceutical Compounding – Hazardous Drugs
- CETA CAG-003-2006-11; REV 31JAN12 – Certification Guide for Sterile Compounding Facilities
All of our test reports and compliance certificates will reference a unique tracking number to facilitate accurate record keeping. We keep records in accordance with ISO 9001 documentation practices.
CLEANROOM CERTIFICATION PROCEDURES
Air Safe utilizes the Institute of Environmental Sciences and Technology Recommended Practice 006.3 and the ISO 14644 Standard as benchmarks for the certification of most standard configuration cleanrooms. Testing may vary if an alternative method would provide a more accurate assessment of the cleanroom’s true performance.
Each individual cleanroom facility manager determines which test(s) he/she is contracting Air Safe to perform. Air Safe cannot ensure total compliance with any standard unless all testing is performed by Air Safe. Air Safe will however guarantee compliance concerning each individual test performed by Air Safe. If deviations from the standard testing procedure(s) are required from the facility manager, a written statement must be signed by the facility manager denoting such deviations.
Air Safe will make recommendations concerning the performance of each facility cleanroom as well as recommendations as to which tests should be performed in order to meet the specific criteria set forth. All data concerning the certification of the cleanroom is presented in a Final Report which contains all raw and calculated data used in assessing the cleanroom’s performance.