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Test and Certify

We are cleanroom professionals. We know the target industries, classifications, and the standard and regulations that your controlled environments are required to comply with. Our expertise in design, build, and evaluation of cleanrooms, put us ahead of many other companies involve in just testing.

We test according to CETA application guides (CAG-00x), NSF 49, or NEBB procedural standards.

While above three institutions are covering the requirements of ISO 14644, IEST RP-CC-xxx, USP 797, 800, NAPRA model standards, and Euro GMP, we offer tailor made testing according to your internal policies and requirements.

By utilizing most advanced and frequently calibrated testing equipments, not only we test your cleanroom, and CACI/CAI/BSC/LAFW, we will also guide and advise you till you have them fully certified according to the relevant standards and regulations for your application.

Cleanrooms, Controlled Environments, SEC and C-SEC

The backbone standard and publications on requirements and how-to’s of your cleanroom controlled environment) evaluation are ISO 14644-1 and IEST RP-CC001.5, IEST RP-CC-006.3 and IEST RP-CC-034.3. However most industries rely on, per say, second layer of guides and procedures. As an example while the core/base standards are defined by ISO and IEST, NAPRA adheres to CAGs (put forward by CETA). Although it’s not mentioned and required by NAPRA, NEBB is also providing a procedural guideline for testing of cleanrooms.

At stellartec solutions we offer testing of cleanrooms and controlled environment in full compliance with the guidelines defined by CETA and NEBB: CETA CAG-002, CETA CAG 003, CETA CAG-008, NEBB Procedural Standards for Certified Testing of Cleanrooms.

How does it relate to NAPRA model standards, and USP 797 & 800?

– NAPRA Model Standard for Pharmacy Compounding of Non-Hazardous Sterile Preparations
Appendix 5: Minimum Indicators for Certification of Controlled Areas and Primary Engineering Controls
Appendix 6: Certification of Controlled Areas, Laminar Airflow Workbenches and Biological Safety Cabinets
– NAPRA Model Standard for Pharmacy Compounding of Hazardous Sterile Preparations
Appendix 5: Minimum Indicators for Certification of Controlled Areas and Containment Primary Engineering Controls
Appendix 6: Certification of Controlled Areas and Biological Safety Cabinets
– USP <797> Pharmaceutical Compounding – Sterile Preparations
Appendix I: Principal Competencies, Conditions, Practices, and Quality Assurances
– USP <800> Hazardous Drugs
Appendix 2: Examples of Designs for Hazardous Drug Compounding Areas

CAI, CACI, LAFW, BSC

Similar to testing of cleanrooms, ISO 14644-1 and IEST RP-CC001.5, IEST RP-CC-002.3 and IEST RP-CC-034.3 provide the core standards. NSF/ANSI 49, CETA CAG-003, CETA CAG-005, and CETA CAG-002 provide procedures and complementary guides for testing of PEC and C-PEC.

Some of the other standards that may come in to play for C-PEC are ASHRAE Standard 110 (Method of Testing Performance of Laboratory Fume Hoods, and ANSI Standard Z9.5 (Laboratory Ventilation).

How does it relate to NAPRA model standards, and USP 797 & 800?

– NAPRA Model Standard for Pharmacy Compounding of Non-Hazardous Sterile Preparations
Appendix 5: Minimum Indicators for Certification of Controlled Areas and Primary Engineering Controls
Appendix 6: Certification of Controlled Areas, Laminar Airflow Workbenches and Biological Safety Cabinets
– NAPRA Model Standard for Pharmacy Compounding of Hazardous Sterile Preparations
Appendix 5: Minimum Indicators for Certification of Controlled Areas and Containment Primary Engineering Controls
Appendix 6: Certification of Controlled Areas and Biological Safety Cabinets
– USP <797> Pharmaceutical Compounding – Sterile Preparations
Appendix I: Principal Competencies, Conditions, Practices, and Quality Assurances
– USP <800> Hazardous Drugs
Appendix 2: Examples of Designs for Hazardous Drug Compounding Areas
Appendix 3: Types of Biological Safety Cabinets

 

Below are some of the tests done in evaluation and certification of PEC, SEC, C-PEC, and C-SEC:

— Primary Tests

 

Thermal anemometer, electronic manometer, and a capture flow hood

– Airflow velocity and volume

Airflow volume is one of the most important tests in a cleanroom and is a test that can ultimately define the cleanliness class. The airflow volume can define the air change rate in a room, and can change the pressure, temperature and humidity levels. We will use a flowhood to measure airflow volume which is most trusted method available today. Airflow velocity is a secondary element to the airflow volume in ISO 6, 7, and 8. However in ISO 5, 4, 3, 2, has to abide by certain range.

 

 

 

 

Aerosol photometer

 

– HEPA filter leak test

Filter leak test is highly crucial as the HEPA filter is where all the infiltration of external/internal particulates happen. If the HEPA filter is broken, none of the other test would matter in a sense that main concept for having filtered air for purpose of cleanroom is breached.

 

 

 

– Room/Chamber pressurization

Room pressurization is important to avoid infiltration and cross-contamination, i.e., in a positively pressured room the unfiltered external air and air particulates are avoided.

 

Particle counter

 

 

– Particle counting and air cleanliness and classification

This test can verify the ISO classification of a cleanroom. Based on number and size of air particulates, we can define the cleanliness level.

 

 

 

 

– Secondary Tests

Although these tests are optional, they provide valuable information on air movement, particles and ancillary systems. Beside the primary tests, it is best to choose a package of tests, based on your cleanroom classification and configurations. Ask us, and we will be happy to guide you through them.

– Temperature and Humidity

While modern cleanrooms – and in fact those complying with new USP 797/800 and NAPRA standards – show the real-time temperature and humidity a secondary test for purpose of accuracy and calibration takes the quality control to a higher level.

– Parallelism

This test determines the direction of airflow within the cleanroom. Although there is not much weight on this test for general application, it becomes a definitive test for some of the specific-function cleanrooms.

– Lighting level

Lighting level pertains to the comfort level of personnel. Adequate lighting whether in terms of intensity, uniformity or the light color may play a role. However when it comes to the test the element to be measured is illuminance.

– Sound level

We may have all experienced a work place with background or any continuous sound making the place uncomfortable. Hence the purpose of this test is to recognize the objectionable source. For example a fan filter unit at 50-55 dB is widely accepted. Any higher level may cause discomfort considering a cleanroom that has not considered an acoustic design.

– Recovery

As the name may suggest, this test is to define the amount of time required for a cleanroom to gain its steady state of certain cleanliness class in case of any event disturbing the cleanliness.

– Airflow Visualization

This test in a sense is the illustration of hood’s capture performance. This is performed using a smoke source.

– Tracer Gas Containment

This test will verify the containment capabilities of the hood.

 

If you have any questions or require a quote, please contact us.

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