Cleanroom Smoke Testing Services

Also known as air flow visualisation, the goal is to demonstrate visual evidence of air flow direction. Airflow patterns minimise contamination in a controlled environment. Smoke visualisation of air patterns is a direct way of assessing a cleanroom design and the suitability of HVAC AC system in relation to HEPA filtered air diffusion. The results highlight the efficacy of air contamination control and could be required by a regulatory body such as the MHRA.

Saakvee Technologies carries out smoke testing in your controlled environment or cleanroom with a pharmaceutical grade smoke chemical consisting of pure water and Glycerine BP grade. They aim to

• Locate faults in areas of excessive contamination buildup in one area
• Check design and performance specs of a controlled space or environment
• Monitor the effect of operator interventions on unidirectional airflow into controlled environment enclosures.

Humans and machinery are the major sources of contamination in a cleanroom. Airflow patterns could be easily disturbed with equipment design, machine guarding, necessary interventions and inappropriate component specifications.

Through a smoke test, it is easy to see where an airborne contaminant will likely end up using visual evidence of air flow direction.

Saakvee Technologies Smoke Testing Services

• Smoke studies are used to maintain aseptic conditions when sterile products are manufactured under aseptic conditions. Smoke studies demonstrate sweeping action and unidirectional airflow over and away from the product, and the testing is conducted under both dynamic and static conditions.
• Smoke testing should be well planned. It should include the evaluation of the impact of equipment design and aseptic manipulations such as interventions. Recorded videotapes serve as objective evidence that shows that the cleanroom is a proper manufacturing environment to external regulators and internal auditors.

At Saakvee Technologies we carry out smoke testing and critical airflow visualisation studies. Our experience extends to planning, consulting and execution of smoke testing projects.

We provide services such as project management, protocol development and execution, data analysis, digital recording and summarisation of interventions. Other services include

dynamic and static airflow visualisation studies of biological safety cabinets, cleanrooms, isolators, clean benches and related clean air devices to ensure they comply with regulatory bodies and international aseptic guidelines

• smoke testing to evaluate BSC placement and performance
• evaluating the impact of alternative BSC usage scenarios through bespoke containment testing of bio-safety cabinets.
• thoroughly documented test results with quality Smoke testing also includes a DVD recording.

At Saakvee Technologies, our services are offered by certified staff. We also offer customised report documentation made to fit your needs and management of your service records and equipment inventory.