1. Clean Room (also known as the Buffer Room) is a space in which the concentration of the airborne particles is controlled to meet a specified cleanliness class. For hazardous and non-hazardous clean rooms, mentioned below in Paragraph E with the recommended Option 2, the required level of cleanliness is ISO (International Organization for Standards) Class 7. Class 7 clean room limits the maximum concentration of particles to 10,000 particles per cubic feet (352,000 per cubic meter of 0.5 microns or larger).
2. Anteroom is a space leading into and out of the hazardous or non-hazardous clean rooms. This is a transitional space in which activities, such as, hand hygiene, garbing procedures, and staging of components and other activities are performed. While the ISO classification of the anteroom serving the hazardous clean room shall be same as the clean room, that is, ISO 7, the ISO classification of the anteroom serving the non-hazardous clean room shall be ISO 8 (or ISO 7, if the architectural design in place incorporates a common anteroom for both hazardous and non-hazardous clean rooms). Anterooms are transition spaces, which ensure direction of airflow and help maintain the required pressure relationships. Non-hazardous clean rooms should be maintained at 0.02-inch to 0.03-inch positive pressure with respect to their anterooms, which, in turn, should be maintained at 0.02-inch positive air pressure with respect to the adjoining circulation spaces. Hazardous clean rooms should be maintained at 0.02-inch negative pressure with respect to their anterooms, which, in turn, should be maintained at 0.02-inch positive air pressure with respect to the adjoining circulation spaces. Use of the anterooms prevents large swings in temperature. Each anteroom shall be equipped an automatic hand washing basin. Anteroom serving hazardous clean room should also be equipped with an eyewash station. For the hazardous clean rooms, anterooms can be used for storing the hazardous drugs so that the use of a dedicated storage room can be avoided.
3. Primary Engineering Control (PEC):
This is an ISO Class 5 space or a device in which (Compounded Sterile Preparations (CSPs)) take place. While the choice of the ISO 5 device is left to the discretion of the pharmacists using the facilities, the following two devices are recommended:
3.1 Biological Safety Cabinets (BSC):
Use of these cabinets is recommended for the hazardous clean rooms. These are vented cabinets meant of the protection of personnel, products, and environment. Air drawn by the BSC should be exhausted outdoors after passing through HEPA filters, integral or duct-mounted external, by a dedicated exhaust fan.
3.2 Laminar Airflow Workstation (LAFW):
Use of these devices is recommended for the nonhazardous clean rooms. These devises can be 100% re-circulatory type.
3.3 CAI (Compounding Aseptic Isolator):
This is a form of isolator designed for maintaining aseptic environment within itself. Air exchange into and out of the isolator shall be done through HEPA filters.
3.4 CACI (Compounding Aseptic Containment Isolator):
This is form of CAI, designed to provide worker protection from exposure to unacceptable levels to drug exposure. 100% exhaust of the air is required while dealing with hazardous substances. Air exchange into and out of the isolator shall be done through HEPA filters.
4. Air lock:
A small room or space (“pass-through” chamber or window) between two rooms of different air pressure, with interlocked doors (one tightly closed at all times) to prevent loss of pressure in the higher pressure room. Refer to USP 797 Pharmacy Design Briefing Document @ http://www.rabiamedical.com, for helpful information listed under Pharmacy Safety for ISO Class 5, Class 7 and Class 8 Clean rooms.
ISO CLASS 5 LAMINAR FLOW
The Laminar Flow Hood is utilized across a range of industries for applications that require an ultra-clean work environment. In laboratory settings, they provide the proper sterile work area for many types of laboratory devices. Laminar Flow Hoods are also used to prevent contamination of samples in PCR applications. In hospital and healthcare pharmacies, these clean benches are installed for the preparation of sterile IV solutions.
Laminar Flow Hoods are designed to provide either a horizontal orvertical airflow configuration. The type of unitselected is based on the work being conducted and the available space in the facility. For example, many hospital pharmacies utilize Vertical Laminar Flow Hoods to maximize the work area for use with compounding equipment.
Verical Laminar flow hood
The effectiveness of a Laminar Flow Hood is determined by many factors which include: a well-engineered cabinet and air handling system; ergonomic design for ease of operation and user comfort; fabrication from materials that are durable and easy to clean, typically all-welded stainless steel; high quality HEPA filters that meet the level of filtration required for the application. Many applications call for Laminar Flow Hoods that provide ISO 5/Class 100 HEPA-filtered
air which removes organisms and particulates 0.3 micron in size with an efficiency of 99.99%.
1. Clean Room (also known as the Buffer Room) is a space in which the concentration of the airborne particles is controlled to meet a specified cleanliness class. For hazardous and non-hazardous clean rooms, mentioned below in Paragraph E with the recommended Option 2, the required level of cleanliness is ISO (International Organization for Standards) Class 7. Class 7 clean room limits the maximum concentration of particles to 10,000 particles per cubic feet (352,000 per cubic meter of 0.5 microns or larger).
2. Anteroom is a space leading into and out of the hazardous or non-hazardous clean rooms. This is a transitional space in which activities, such as, hand hygiene, garbing procedures, and staging of components and other activities are performed. While the ISO classification of the anteroom serving the hazardous clean room shall be same as the clean room, that is, ISO 7, the ISO classification of the anteroom serving the non-hazardous clean room shall be ISO 8 (or ISO 7, if the architectural design in place incorporates a common anteroom for both hazardous and non-hazardous clean rooms). Anterooms are transition spaces, which ensure direction of airflow and help maintain the required pressure relationships. Non-hazardous clean rooms should be maintained at 0.02-inch to 0.03-inch positive pressure with respect to their anterooms, which, in turn, should be maintained at 0.02-inch positive air pressure with respect to the adjoining circulation spaces. Hazardous clean rooms should be maintained at 0.02-inch negative pressure with respect to their anterooms, which, in turn, should be maintained at 0.02-inch positive air pressure with respect to the adjoining circulation spaces. Use of the anterooms prevents large swings in temperature. Each anteroom shall be equipped an automatic hand washing basin. Anteroom serving hazardous clean room should also be equipped with an eyewash station. For the hazardous clean rooms, anterooms can be used for storing the hazardous drugs so that the use of a dedicated storage room can be avoided.
3. Primary Engineering Control (PEC):
This is an ISO Class 5 space or a device in which (Compounded Sterile Preparations (CSPs)) take place. While the choice of the ISO 5 device is left to the discretion of the pharmacists using the facilities, the following two devices are recommended:
3.1 Biological Safety Cabinets (BSC):
Use of these cabinets is recommended for the hazardous clean rooms. These are vented cabinets meant of the protection of personnel, products, and environment. Air drawn by the BSC should be exhausted outdoors after passing through HEPA filters, integral or duct-mounted external, by a dedicated exhaust fan.
3.2 Laminar Airflow Workstation (LAFW):
Use of these devices is recommended for the nonhazardous clean rooms. These devises can be 100% re-circulatory type.
3.3 CAI (Compounding Aseptic Isolator):
This is a form of isolator designed for maintaining aseptic environment within itself. Air exchange into and out of the isolator shall be done through HEPA filters.
3.4 CACI (Compounding Aseptic Containment Isolator):
This is form of CAI, designed to provide worker protection from exposure to unacceptable levels to drug exposure. 100% exhaust of the air is required while dealing with hazardous substances. Air exchange into and out of the isolator shall be done through HEPA filters.
4. Air lock:
A small room or space (“pass-through” chamber or window) between two rooms of different air pressure, with interlocked doors (one tightly closed at all times) to prevent loss of pressure in the higher pressure room. Refer to USP 797 Pharmacy Design Briefing Document @ http://www.rabiamedical.com, for helpful information listed under Pharmacy Safety for ISO Class 5, Class 7 and Class 8 Clean rooms.
ISO CLASS 5 LAMINAR FLOW
The Laminar Flow Hood is utilized across a range of industries for applications that require an ultra-clean work environment. In laboratory settings, they provide the proper sterile work area for many types of laboratory devices. Laminar Flow Hoods are also used to prevent contamination of samples in PCR applications. In hospital and healthcare pharmacies, these clean benches are installed for the preparation of sterile IV solutions.
Laminar Flow Hoods are designed to provide either a horizontal orvertical airflow configuration. The type of unitselected is based on the work being conducted and the available space in the facility. For example, many hospital pharmacies utilize Vertical Laminar Flow Hoods to maximize the work area for use with compounding equipment.
Verical Laminar flow hood
The effectiveness of a Laminar Flow Hood is determined by many factors which include: a well-engineered cabinet and air handling system; ergonomic design for ease of operation and user comfort; fabrication from materials that are durable and easy to clean, typically all-welded stainless steel; high quality HEPA filters that meet the level of filtration required for the application. Many applications call for Laminar Flow Hoods that provide ISO 5/Class 100 HEPA-filtered
air which removes organisms and particulates 0.3 micron in size with an efficiency of 99.99%.
