Follow
• Clean rooms shall be designed and classified into different grades according to the type of activity performed.
• Clean rooms should be maintained with proper cleanliness standards and the supplied air should pass through a series of filters of proper efficiency.
• Cleanliness levels should be maintained so as to minimize the risk of particulate or microbial contamination of the product or material.
• Material preparation compounding and filling operations should be done in a separate clean room within the main area.
• Air cleanliness from top to bottom and air return should be as low as possible to effectively remove any contamination.
• An appropriate number of air changes.
• The pressure difference should be such that air flow is from critical to non-critical / less critical areas.
• Clean room interlocking systems should provide pass-through hatches and airlocks for movement of materials, equipment and other products in and out, so that only one side can be opened at any time.
• Avoid sliding doors.
• In areas where anti-neoplastic products are handled in powder form, they should be immediately exposed to the negative pressure of the external environment and allow effective removal of even small amounts of airborne contaminants.
• Safety cabinets (hoods, isolators) used for sterility testing should be negative for the immediate surroundings but provide suitable HEPA filters in the air flow and flow.
• Where sterility is tested under a laminar flow bench, laminar flow is positive for surround.
Where live cultures (microbes, pathogens) are handled, a negative pressure should be maintained in the immediate atmosphere.
• Reduce penetration
• Access through change room.
• Change to enter the prep room.
• Altering access to aseptic filling area.
• Training on changes to specific operations as well as covering hygiene and basic microbiology.
• Operators must report any illnesses or hazards that may require them to avoid the aseptic area
• Regular health checkups.
• Dedicated clothing for both preparation and filling areas. Nonlinting, capable of repeated wear, sterile laundering without deterioration. The “bellows” effect should be avoided as it increases pollution in the area.
© 2025 Pharmaceuticals Index. All rights reserved.