Design and operation of pharmaceutical cleanrooms are regulated by federal standards USP 797 and USP 800.

USP 797 is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed. The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products.

USP 800 Clean Room Guidelines & Standards provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.

Basic differences in the design of a USP 797 and USP 800 cleanroom in that a USP 797 cleanroom is positively pressured to keep outside contaminants from entering the area and the USP 800 cleanroom is negatively pressured to keep hazardous materials from escaping the area.

Clean Zone Technology has a vast amount of experience designing and installing USP 797 and USP 800 Pharmacy cleanrooms either independently or in combination, separated by a common Ante Room.

Design requirements:

USP 797 Compounding Cleanroom

1. Ante Room designed to accommodate the number of personnel working in the compounding cleanroom.
• Generally designed as an ISO Class 8 (Class 100,000)
• Recirculating air flow system with “low wall” return grills
• Pressurized negative to the main compounding cleanroom to keep contaminants from infiltrating into the Compounding Area
• Will have a sink for hand washing during the gowning process
• Doors should have automatic door openers to avoid door handles from being touched.
• Walls should be smooth , generally Fiber Reenforced Plastic (FRP) to withstand harsh cleaning compounds.
• All seams will be sealed to include walls, tee grid, ceiling tiles, fan powered HEPA’s, LED light panels.
• Seamless Vinyl or Epoxy floor covering will include coving up to 6” for containment.
• If the Ante Room is designed to service the Compounding and Negative Pressure Rooms it will be large enough to separate operators working in each area and with the ability to separate operator gowning materials.


2. Compounding Room
• Generally designed as an ISO Class 7 (Class 10,000)
• Pressurized positive to the Ante Room to keep out contaminants Recirculating air flow system with “low wall” return grills
• Will be large enough to accommodate an ISO Class 5 (class 100) flow bench
• In many designs the Ante Room is not large enough to allow passage of the flow bench.
• In these cases we recommend adding a “demountable wall section” in the Compounding Room so the flow bench can be brought in and removed as required.
• Operated between 68 and 70 degrees F for operator comfort
• Room is designed without Humidity Control BUT this can be added if the compounding process requires it.
• Walls should be smooth, generally Fiber Reenforced Plastic (FRP) to withstand harsh cleaning compounds.
• All seams will be sealed to include walls, tee grid, ceiling tiles, fan powered HEPA’s, LED light panels.

USP 800 Hazardous Chemical Cleanroom

1. Ante Room designed to accommodate the number of personnel working in the hazardous chemical cleanroom.
• Generally designed as an ISO Class 8 (Class 100,000)
• Recirculating air flow system with “low wall” return grills
• Pressurized positive to the hazardous chemical cleanroom to keep contaminants from exiting the negative flow cleanroom
• Will have a sink for hand washing during the gowning process
• Doors should have automatic door openers to avoid door handles from being touched.
• Walls should be smooth , generally Fiber Reenforced Plastic (FRP) to withstand harsh cleaning compounds.
• All seams will be sealed to include walls, tee grid, ceiling tiles, fan powered HEPA’s, LED light panels.
• Seamless Vinyl or Epoxy floor covering will include coving up to 6” for containment.
• If the Ante Room is designed to service the Compounding and Negative Pressure Rooms it will be large enough to separate operators working in each area and with the ability to separate operator gowning materials.


2. Hazardous Chemical Cleanroom
• Generally designed as an ISO Class 7 (Class 10,000)
• Single Pass air flow system with “low wall” return grills
• Returns are connected to a building chemical exhaust system
• Pressurized negative to the Ante Room to prevent contaminants from exiting the area
• Will be large enough to accommodate an ISO Class 5 (class 100) exhaust bench that is also connected to the building exhaust system
• In many designs the Ante Room is not large enough to allow passage of the flow bench.
• In these cases we recommend adding a “demountable wall section” in the Compounding Room so the flow bench can be brought in and removed as required.
• Operated between 68 and 70 degrees F for operator comfort
• Room is designed without Humidity Control
• Walls should be smooth, generally Fiber Reenforced Plastic (FRP) to withstand harsh cleaning compounds.
• All seams will be sealed to include walls, tee grid, ceiling tiles, fan powered HEPA’s, LED light panels.