Cleanroom Behavior in Pharmaceutical Industry

Cleanroom Behavior is a crucial aspect in preventing contamination in manufacturing areas. Operators must adhere to specific cleanroom behaviors, including the following practices:

Slow and Deliberate Movement

Operators should move carefully to minimize air turbulence, which can lead to particle generation or shedding. This principle should be observed throughout the cleanroom, considering engineering controls and air return locations.

Minimize Conversation

Speaking should be limited to necessary communication and should never occur in critical areas.

Maintain Unidirectional Airflow

Unidirectional airflow is designed to protect sterile equipment, container-closures, and products. Disrupting the path of unidirectional airflow in critical areas can jeopardize product sterility.

Perform Interventions with Care

Operators must use the correct tools and equipment, ensuring that interventions do not compromise product sterility or interrupt unidirectional airflow over sterile components. When utilizing a restricted access barrier system (RABS), barrier doors should only be opened when necessary and for the shortest time possible.

Proper Body Positioning

Operators should avoid blocking the unidirectional airflow by keeping their entire body clear of critical surfaces. Reaching across open containers, exposed products, or components and product contact parts/surfaces should be avoided.

Gown Control

Operators should not engage in activities that pose contamination risks to their gowns, such as unnecessary contact with walls, floors, or cleaned surfaces. Sterile gloves should be regularly sanitized or changed, and any damaged gowns should be immediately replaced.

Protecting Sterile Parts

Proper staging and grouping of parts should be done to facilitate consistent setup order, ensuring the protection of all sterile parts. During setup, sterile product contact parts should remain protected until the setup is completed. Sterile tools should be stored under Grade A conditions or replaced to avoid contamination.

Minimize Surface Contact

Personnel should not directly touch sterile products, containers, closures, or critical surfaces with any part of their gowns or gloves. Sterile tools should always be used whenever possible.

Effective Glove Management

Operators should sanitize gloves regularly and follow proper re-gloving techniques and frequency. Single gloves should be worn in supporting areas, while sterile double-gloves should be worn in all conventional aseptic processing areas. Upon each entry to a Grade A cleanroom, a fresh pair of sterile gloves should be worn. Gloves should be checked for integrity both upon donning and prior to interventions, and damaged gloves should be replaced immediately according to established risk-based procedures.

Adhering to these cleanroom behaviors is essential in maintaining a contamination-free manufacturing environment.

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Resource Person: Seyed Ershad Moradi

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