Cleanroom

Product Description

Cleanroom Classification Grades A–D in Pharmaceutical Manufacturing

High-risk pharmaceutical operations—such as filling zones, rubber stopper storage, open ampoules, open vials, and aseptic assembly or sterile connection areas—must be conducted in controlled cleanroom environments. These areas are typically maintained through laminar airflow workstations or laminar flow hoods.

Laminar airflow (unidirectional flow) must provide uniform air distribution across the working zone at a validated airflow velocity of 0.36–0.54 m/s (guideline value). This airflow performance must be verified through documented testing.

In enclosed isolators or glove boxes, unidirectional airflow or appropriately reduced airflow velocities can be used depending on system design.

Grade B

Grade B is the background cleanroom environment for Grade A operations. It supports high-risk processes such as aseptic preparation and aseptic filling.

Grades C and D

Grades C and D are used for less critical stages of sterile drug manufacturing. These zones typically include solution preparation, equipment washing areas, and non-high-risk processing steps.

Additional Notes

Grade A corresponds approximately to Class 100.
Grade B corresponds to Class 10,000.
Grade C corresponds to Class 100,000.
Grade D corresponds to approximately Class 300,000.

Grade A requires the strictest environmental control, with Grade B serving as the background environment. Grades C and D apply to less stringent clean zones used for non-aseptic stages.