We service all types and sizes of cleanrooms and other controlled environments, from small cleanrooms of less than 100 sq. ft. to facilities with 100’s of thousands of sq. ft.  We have the knowledge, equipment and manpower to meet your facility needs.

The standard cleanroom certification includes air velocity testing, HEPA filter integrity testing, particle count testing, and room pressurization.

Additional cleanroom testing may include: visual airflow smoke test, sound level testing, florescent light testing, ultra-violet light testing, temperature testing, parallelism, induction, humidity, and vibration testing.

All reporting is compiled on-site, and a final certification document is delivered within one week from testing.  Electronic copies are also available in the form of a pdf file.

STANDARDS

1. IEST-RP-CC-006.3; Testing Clean Rooms
2. IEST-RP-CC-002.2; Unidirectional Clean Air Devices
3. IEST-RP-CC-007.1; Testing ULPA Filters
4. IEST-RP-CC-034.2; HEPA and ULPA Filter Leak Test
5. FED-STD 290E; Federal Standard 209 E†
6. ISO 14644; Cleanrooms & Associated Environments
7. USP 797; Pharmaceutical Compounding – Sterile Preparations

ADDITIONAL TESTING

1. Room Decontamination Services
2. Filter Repairs & Replacements
3. Motor Replacements
4. Electrical Repairs
5. VOC Monitoring
6. Viable Air and Surface Sampling
7. Airflow Uniformity Testing (parallelism)
8. Air Change Rate Calculations
9. Visual Airflow Testing with Video Documentation
10. Secondary Testing – Noise, Lighting, Humidity, Temperature
11. Consulting Services

  All test reports and compliance certificates will reference a unique tracking number to facilitate accurate record keeping.

We certify all types and styles of cleanrooms.

  Operating Rooms, Laminar Flow Rooms, Processing Rooms, Pharmaceutical Manufacturing Rooms, TB Rooms, Test Chambers, Portable Down flow Units, Modular Cleanrooms, Sterility Room, Hospital Pharmacies USP 797 Compliance, Analytical Rooms, BSL-2,3,4 Rooms, and Patient Rooms to mention a few.

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.

Just because your cleanroom is brand new does not mean it is working properly!

Air Safe can certify and service all types of isolators and gloveboxes.  This includes Compounding Aseptic Containment Isolators (CACI), Compounding Aseptic Isolators (CAI) used in pharmacy settings as well as Class III atmospheric gloveboxes utilized in high containment facilities.  No only can we certify the airflow and integrity of the HEPA filters installed, we can also perform leak test on the chambers.

Other important tests which can be performed are:

Air Safe, LLC. recommends the use of unidirectional airflow isolators versus non-unidirectional (turbulent) airflow isolators for clients wishing to comply with the USP 797 document on pharmaceutical compounding.

It has been our experience when performing recovery testing on non-unidirectional airflow isolators, the recovery time can exceed 30 minutes.  The recovery test provides the user of the isolator information about how long it takes the isolator to “recover” to an acceptable ISO Class 5 environment after an introduction of simulated contamination.  Field testing of unidirectional airflow isolators has shown recovery periods of less than one minute.

Just because your isolator or glovebox is brand new does not mean it is working properly!