Final answer:
To demonstrate maintenance of ISO 5 laminar flow when transporting from the PEC to the lyophilizer, smoke studies and particle count tests are performed. Techniques such as angling containers, flaming openings, and using pre-sterilized equipment ensure minimal risk of contamination.
Step-by-step explanation:
In a controlled environment such as a pharmaceutical setting, maintaining an ISO 5 laminar flow of air during transport from the Primary Engineering Control (PEC) to the lyophilizer is crucial to prevent contamination. To demonstrate that transport can be accomplished while maintaining ISO 5 conditions, a smoke study or particle count test may be conducted. During these tests, the maintenance of unidirectional airflow is verified, ensuring that no contaminants enter critical areas.
Proper transfer techniques must be employed during this process, including the handling of tubes or bottles at an angle and flaming the openings to prevent the ingress of airborne contaminants. Additionally, the use of a protective suit with its own air supply might be required in certain high-grade areas to maintain the integrity of the environment.
Training on aseptic techniques is essential; the use of pre-sterilized equipment and practices, such as flaming inoculating loops and needles, helps ensure an aseptic condition throughout the transport and subsequent processes.