Testing for Life Sciences in compliance with USP 797/800 standards is crucial to ensuring the integrity and safety of sterile compounding facilities. Cleanroom Performance Testing is an essential component, evaluating the environmental conditions of controlled spaces to maintain optimal conditions for pharmaceutical compounding. Sterile Compounding Facility Testing involves comprehensive assessments to confirm the facility’s adherence to strict regulations, safeguarding the production of sterile pharmaceuticals. Biosafety Cabinet Certification and Testing are imperative for laboratories working with hazardous materials, ensuring proper containment and protection for both personnel and the environment. HEPA Integrity Testing verifies the efficiency of high-efficiency particulate air filters, a vital element in maintaining sterile environments. Fume Hood Testing and Certification guarantee the proper functioning of ventilation systems in laboratories, protecting researchers from harmful fumes. Additionally, HEPA Filter Installation involves meticulous procedures to ensure the correct placement and functionality of filters, contributing to the overall safety and compliance of life science facilities.
Read more below to learn more about the different services available.
Cleanroom Performance Testing
- Particle Count Testing
- Filter Airflow Uniformity Testing
- Temperature & Humidity Testing
- HEPA Filter Integrity Testing
- Room Pressurization Testing
- Airflow Visualization Study
- Room Recovery Testing
- Air Change Testing/Verification
- Facility Assessment
- Contamination Control
Sterile Compounding Facility Testing: USP 797/800
- Environmental Monitoring – Surface and Air Sampling
- Airflow Uniformity Testing
- Airflow Visualization Testing
- Temperature & Humidity Testing
- HEPA Filter Integrity Testing
- Room Pressurization Testing
- Media Fill Testing for Sterile Compounding Personnel
- Fume Hood Testing
- Laminar Airflow Workbench/Station Testing
- Compounding Aseptic Isolator Testing
- Compounding Aseptic Containment Isolator Testing
- Bio Safety Cabinet Testing
- Dynamic & Static Airflow Pattern Testing for Primary and Secondary Engineering Controls
- Room Recovery Testing
- Air Change Testing
HEPA Integrity Testing
The HEPA filter integrity test is typically performed on supply air or exhaust air HEPA filters using a photometer to scan the filter surface for pinhole leaks that could allow the transmission of contaminant particles that would be unacceptable in a critical application. Both GMP and ISO 14644-3 guidelines prescribe leak tests at least every 6-12 months.
Fume Hood Testing and Certification
Primary tests include inflow face velocity profiling and airflow smoke pattern testing. These provide a qualitative analysis of air capture at the face of the unit, thus demonstrating the unit’s exposure prevention effectiveness and ensuring operator safety. Tracer gas tests to comply with ASHRAE Standard 110 provide quantitative data evaluating the containment performance of fume hoods.
HEPA Filter Installation
Integrity of HEPA filters is essential to assure required cleanliness levels in a cleanroom.
Testimonials
Learn more about Palmetto Air & Water Balance life sciences services.
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