Cleanroom Guide
Liberty Industries GUIDE FOR A CLEAN ROOM
Liberty Industries has been in the contamination control industry a LONG time, and they have MANY resources available at a range of prices to make sure your laboratory or specialized manufacturing area is “top drawer.” Some of these materials would be good to give to ALL personnel who are involved and, of course, especially all managers responsible for proper cleanroom cleaning procedures, regardless of your cleanroom classification.
So, as just one of the many cleanroom supplies you and your staff utilize, consider the following, described in greater detail at Liberty’s website, www.liberty-ind.com:
•#7525; “Your Guide to an Ultra Clean Film”
•#7338; “Cleanroom Primer”
•#7332; “Your Guide to a Cleanroom”
•#7333; “Design and Operation of a Cleanroom”, by Philip Austin
•#7471; “How to Save $1,000′s on your Cleanroom”
•#7430; “Air Shower Primer”
•#7363; “Static Electricity in the Electronics Industry”, by AQ Testone
•#7455; “Maintenance Primer”
•#7453; “Cleanroom Encyclopedia”
•#7478; “Primer Binder”, which includes six booklets, #7338, 7332, 7430, 7455, 7471 and 7525
•#7555; “VLO Primer”
Cleanroom terms and definitions
There is a WORLD of information in existence on everything from processes for cleanroom packaging to how to store and suit-up in cleanroom gowns to all the various steps to keep every square millimeter of your area within the required specs…which are many: ISO 3, ISO 5, ISO 7, ASHP, USP 797, SUP 797, Joint Association of Hospitals and NARD recommendations for risk level III sterile compounding, etc. However, here are just a few of the tips that may be of help:
•Air lock: buffer zone that’s attached to the clean room, having interlocking doors to separate the two environments. This keeps contamination out as people and equipment enter the room, as well as keeps the positive pressure in the cleanroom which is necessary for the purpose of keeping out particulate.
•Air shower: a walk-through chamber which is designed to blow off particulate from cleanroom personnel and their cleanroom garments by way of high-velocity air nozzles, prior to their entering a controlled area.
•Clean room: also called a cleanroom, controlled, enclosed area, or white room. A specialized, enclosed area that utilizes environmental control methods regarding temperature, humidity, atmospheric contamination and pressure.
•Cleanroom garments: Garments that are lint-free are needed for a clean room, and are typically made from synthetic fabrics such as Nylon, Tyvek®, Dacron® and the like. These are critical in order to limit the entrance of contamination into the controlled area, especially from the greatest source of particulation–the human! In addition to skin cells, hair, and dandruff, high quality clean room garments minimize lint and other particulates personnel introduce. As a result, ALL people involved with contamination control, including those who are not regular personnel, MUST be required to wear cleanroom attire.
•HEPA filters: The word “HEPA” is an acronym standing for a High Efficiency Particulate Aire filter. These specially-made filters are able to capture particles which are .3µm (0.3 microns) or greater at an efficiency of no less than 99.97% or even 99.99%.
•Laminar flow: Refers to air that flows unidirectionally in a parallel plane.
•Micron: This is a unit of measure equal to 0.00003937 inch, which is 1 millionth of a meter.
•Particle size: This is the maximum dimension of a particle, and is measured by its diameter for a spherical particle, or linearly for a fibrous particle.
•Pass-thru window, (sometimes called a pass-through window, pass-thru chamber, or pass-through chamber). This is a cube-shaped box which has 2 interlocking doors and is used allow cleanroom personnel to pass materials in or out the primary area. By doing so, the positive pressure of the room is maintained and traffic is limited.
•Shoe cleaner: A device located in a gowning room or at the entrance to a cleanroom to remove footborne particulate from the shoe covers, shoes or boots of personnel. The unit is semi-automated or fully automated, and has four or five brushes on the top, sides and bottom, as a well as high-quality, filtered vacuum system (e.g. a HEPA filter) and collection pan.
•Tacky Mats®: Generically called adhesive mats, cleanroom mats, peel-off mats, tack mats, stick mats or sticky mats, Liberty’s trademarked Tacky Mat® is an important clean room barrier for footborne particulate, (e.g. dirt, dust, and, to a more limited degree germs such as bacteria, virus, and fungus microbes). Manufactured by Liberty since the early 1960′s, their famous mats are multiple layers of specially-treated film with either strips of dual-sided tape or a full-width adhesive on the bottom to anchor the mat to the cleanroom floor, typically at its entrance and usually used in conjunction with a shoe cleaning machine.
•ULPA filters: The word “ULPA” is an acronym for an Ultra Low Particulate Air filter. Like HEPA filters, ULPA filters are capable of removing particulate of .12µm (0.12 microns) or greater at an efficiency rate (measured by a laser scanner) of no less than 99.9999%.
•Uni-directional flow bench. Sometimes called a workstation, a work bench of this sort has its own air supply which is filtered. These units are typically described as a horizontal flow workstation or vertical flow workstation depending on the direction of the air over the work area. The air velocity (which ranges from 72-108 FPM (feet per minute) and make an ultra-clean work space for specialized processes.
TYPES OF CLEAN ROOMS
Type 1. The Conventional Cleanroom
Standard air flow
A “conventional” room is enclosed, has incoming air that is both conditioned and filtered to create a positive pressure within the room. This air comes in via ceiling diffusers and exhausts through the wall-mounted registers which is the air return to the A/C system. Under the specs of Federal Standard 209C, this room could produce a Class 100,000 environment, assuming personnel entering it maintain proper cleanroom attire, appropriate contamination control equipment is utilized, and there is a regular maintenance and cleaning procedure done to eliminate contamination which enters or is produced inside the cleanroom.
Type 2. The Semi-Laminar Flow Cleanroom
Non-unidirectional, semi-turbulent airflow
This type of enclosed, clean area also has air that is both conditioned and filtered, where the air comes in via a ceiling plenum. At that point, the air is diffused throughout the room by way of many “slots” in the flow-thru ceiling tiles. Then the air is pushed vertically at low velocities, and exhausts near or at the level of the floor. As with the conventional cleanroom, this style is able to make a Class 100,000 atmosphere to the specifications of Federal Standard 209C, and it also requires rigid personnel control, high-quality, specialized equipment, and a cleaning routine consistent with maintaining that level of cleanliness.
Type 3. Horizontal Uni-directional Flow Cleanroom
Non-turbulent airflow
This kind of enclosed, controlled environment has the treated air enter through a HEPA filter wall. The horizontal air velocity is 72-108 feet per minute (FPM) and it’s exhausted through an air return on the opposite wall. The design works for several class cleanrooms per Federal Standard 209C: Class 1, 10 or 100, with regard to the air “upstream” from the work area as, naturally, the air downstram depends on how contaminating the workstation is, though should exit via the return air wall. Finally, this room, as with all others, must be subject to rigid cleanroom techniques of the personnel, as well as a routine, diligent cleaning program.
Type 4. Vertical Uni-directional Flow Cleanroom
Vertical, unidirectional airflow
This enclosed cleanroom design has the conditioned air enter by way of a HEPA filter ceiling. The filtered air moves straight downward at 72-108FPM as the design above, but the air is then exhausted via a grate system in the floor. Further, like the prior unit, it, too, can produce a Class 1, 10 or 100 atmosphere per Federal Standard 209C upstream from the work bench.
THIS design is generally thought to be the one to use for “the optimum clean room” but requires VERY stringent cleaning techniques, done continually as part of the operating process, in addition to specialized cleaning performed for each area in the cleanroom.
GUIDELINES FOR AIR CLEANLINESS CLASSES
Particle numbers by class:
Max. no. of particles/ft³ > 0.5µ and larger Class Max. no. of particles/ft³ > 5.0µ and larger
•10 & 100 10 & 100 0
•1,000 1,000 7
•10,000 10,000 65
•20,000 20,000 130
•100,000 100,000 700
•1,000,000 1,000,000 6,500
Below is a helpful chart from Liberty regarding the appropriateness of which class cleanroom to what kind of air flow, in light of the material presented above.
Air cleanliness classes guidelines
AIRFLOW METHODS IN A CLEAN ROOM
Cleanroom with wall-to-floor airflow
Cleanroom with wall-to-wall airflow
Cleanroom with ceiling-to-floor airflow
Cleanroom with wall-to-open-end airflow
Cleanroom with non-unidirectional, turbulent airflow
THINGS TO REMEMBER REGARDING A CLEANROOM
In
Cleanroom Guide
Liberty Industries GUIDE FOR A CLEAN ROOM
Liberty Industries has been in the contamination control industry a LONG time, and they have MANY resources available at a range of prices to make sure your laboratory or specialized manufacturing area is “top drawer.” Some of these materials would be good to give to ALL personnel who are involved and, of course, especially all managers responsible for proper cleanroom cleaning procedures, regardless of your cleanroom classification.
So, as just one of the many cleanroom supplies you and your staff utilize, consider the following, described in greater detail at Liberty’s website, www.liberty-ind.com:
•#7525; “Your Guide to an Ultra Clean Film”
•#7338; “Cleanroom Primer”
•#7332; “Your Guide to a Cleanroom”
•#7333; “Design and Operation of a Cleanroom”, by Philip Austin
•#7471; “How to Save $1,000′s on your Cleanroom”
•#7430; “Air Shower Primer”
•#7363; “Static Electricity in the Electronics Industry”, by AQ Testone
•#7455; “Maintenance Primer”
•#7453; “Cleanroom Encyclopedia”
•#7478; “Primer Binder”, which includes six booklets, #7338, 7332, 7430, 7455, 7471 and 7525
•#7555; “VLO Primer”
Cleanroom terms and definitions
There is a WORLD of information in existence on everything from processes for cleanroom packaging to how to store and suit-up in cleanroom gowns to all the various steps to keep every square millimeter of your area within the required specs…which are many: ISO 3, ISO 5, ISO 7, ASHP, USP 797, SUP 797, Joint Association of Hospitals and NARD recommendations for risk level III sterile compounding, etc. However, here are just a few of the tips that may be of help:
•Air lock: buffer zone that’s attached to the clean room, having interlocking doors to separate the two environments. This keeps contamination out as people and equipment enter the room, as well as keeps the positive pressure in the cleanroom which is necessary for the purpose of keeping out particulate.
•Air shower: a walk-through chamber which is designed to blow off particulate from cleanroom personnel and their cleanroom garments by way of high-velocity air nozzles, prior to their entering a controlled area.
•Clean room: also called a cleanroom, controlled, enclosed area, or white room. A specialized, enclosed area that utilizes environmental control methods regarding temperature, humidity, atmospheric contamination and pressure.
•Cleanroom garments: Garments that are lint-free are needed for a clean room, and are typically made from synthetic fabrics such as Nylon, Tyvek®, Dacron® and the like. These are critical in order to limit the entrance of contamination into the controlled area, especially from the greatest source of particulation–the human! In addition to skin cells, hair, and dandruff, high quality clean room garments minimize lint and other particulates personnel introduce. As a result, ALL people involved with contamination control, including those who are not regular personnel, MUST be required to wear cleanroom attire.
•HEPA filters: The word “HEPA” is an acronym standing for a High Efficiency Particulate Aire filter. These specially-made filters are able to capture particles which are .3µm (0.3 microns) or greater at an efficiency of no less than 99.97% or even 99.99%.
•Laminar flow: Refers to air that flows unidirectionally in a parallel plane.
•Micron: This is a unit of measure equal to 0.00003937 inch, which is 1 millionth of a meter.
•Particle size: This is the maximum dimension of a particle, and is measured by its diameter for a spherical particle, or linearly for a fibrous particle.
•Pass-thru window, (sometimes called a pass-through window, pass-thru chamber, or pass-through chamber). This is a cube-shaped box which has 2 interlocking doors and is used allow cleanroom personnel to pass materials in or out the primary area. By doing so, the positive pressure of the room is maintained and traffic is limited.
•Shoe cleaner: A device located in a gowning room or at the entrance to a cleanroom to remove footborne particulate from the shoe covers, shoes or boots of personnel. The unit is semi-automated or fully automated, and has four or five brushes on the top, sides and bottom, as a well as high-quality, filtered vacuum system (e.g. a HEPA filter) and collection pan.
•Tacky Mats®: Generically called adhesive mats, cleanroom mats, peel-off mats, tack mats, stick mats or sticky mats, Liberty’s trademarked Tacky Mat® is an important clean room barrier for footborne particulate, (e.g. dirt, dust, and, to a more limited degree germs such as bacteria, virus, and fungus microbes). Manufactured by Liberty since the early 1960′s, their famous mats are multiple layers of specially-treated film with either strips of dual-sided tape or a full-width adhesive on the bottom to anchor the mat to the cleanroom floor, typically at its entrance and usually used in conjunction with a shoe cleaning machine.
•ULPA filters: The word “ULPA” is an acronym for an Ultra Low Particulate Air filter. Like HEPA filters, ULPA filters are capable of removing particulate of .12µm (0.12 microns) or greater at an efficiency rate (measured by a laser scanner) of no less than 99.9999%.
•Uni-directional flow bench. Sometimes called a workstation, a work bench of this sort has its own air supply which is filtered. These units are typically described as a horizontal flow workstation or vertical flow workstation depending on the direction of the air over the work area. The air velocity (which ranges from 72-108 FPM (feet per minute) and make an ultra-clean work space for specialized processes.
TYPES OF CLEAN ROOMS
Type 1. The Conventional Cleanroom
Standard air flow
A “conventional” room is enclosed, has incoming air that is both conditioned and filtered to create a positive pressure within the room. This air comes in via ceiling diffusers and exhausts through the wall-mounted registers which is the air return to the A/C system. Under the specs of Federal Standard 209C, this room could produce a Class 100,000 environment, assuming personnel entering it maintain proper cleanroom attire, appropriate contamination control equipment is utilized, and there is a regular maintenance and cleaning procedure done to eliminate contamination which enters or is produced inside the cleanroom.
Type 2. The Semi-Laminar Flow Cleanroom
Non-unidirectional, semi-turbulent airflow
This type of enclosed, clean area also has air that is both conditioned and filtered, where the air comes in via a ceiling plenum. At that point, the air is diffused throughout the room by way of many “slots” in the flow-thru ceiling tiles. Then the air is pushed vertically at low velocities, and exhausts near or at the level of the floor. As with the conventional cleanroom, this style is able to make a Class 100,000 atmosphere to the specifications of Federal Standard 209C, and it also requires rigid personnel control, high-quality, specialized equipment, and a cleaning routine consistent with maintaining that level of cleanliness.
Type 3. Horizontal Uni-directional Flow Cleanroom
Non-turbulent airflow
This kind of enclosed, controlled environment has the treated air enter through a HEPA filter wall. The horizontal air velocity is 72-108 feet per minute (FPM) and it’s exhausted through an air return on the opposite wall. The design works for several class cleanrooms per Federal Standard 209C: Class 1, 10 or 100, with regard to the air “upstream” from the work area as, naturally, the air downstram depends on how contaminating the workstation is, though should exit via the return air wall. Finally, this room, as with all others, must be subject to rigid cleanroom techniques of the personnel, as well as a routine, diligent cleaning program.
Type 4. Vertical Uni-directional Flow Cleanroom
Vertical, unidirectional airflow
This enclosed cleanroom design has the conditioned air enter by way of a HEPA filter ceiling. The filtered air moves straight downward at 72-108FPM as the design above, but the air is then exhausted via a grate system in the floor. Further, like the prior unit, it, too, can produce a Class 1, 10 or 100 atmosphere per Federal Standard 209C upstream from the work bench.
THIS design is generally thought to be the one to use for “the optimum clean room” but requires VERY stringent cleaning techniques, done continually as part of the operating process, in addition to specialized cleaning performed for each area in the cleanroom.
GUIDELINES FOR AIR CLEANLINESS CLASSES
Particle numbers by class:
Max. no. of particles/ft³ > 0.5µ and larger Class Max. no. of particles/ft³ > 5.0µ and larger
•10 & 100 10 & 100 0
•1,000 1,000 7
•10,000 10,000 65
•20,000 20,000 130
•100,000 100,000 700
•1,000,000 1,000,000 6,500
Below is a helpful chart from Liberty regarding the appropriateness of which class cleanroom to what kind of air flow, in light of the material presented above.
Air cleanliness classes guidelines
AIRFLOW METHODS IN A CLEAN ROOM
Cleanroom with wall-to-floor airflow
Cleanroom with wall-to-wall airflow
Cleanroom with ceiling-to-floor airflow
Cleanroom with wall-to-open-end airflow
Cleanroom with non-unidirectional, turbulent airflow
THINGS TO REMEMBER REGARDING A CLEANROOM
In
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