This is the most complete information about cleanrooms on the internet.
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A cleanroom is a specially designed enclosed space where airborne particulates have been limited or removed by a highly sophisticated filtration system. They are used by industries that require a highly controlled and monitored environment for the production of delicate instruments or medical supplies and medicines. For a room to be classified as a cleanroom, it has to meet a precise set of international standards regarding the number of microns per cubic meter.
According to ISO 14644-1, a cleanroom is:
"… room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room. Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0.1 µm to 5 µm are considered for classification purposes." From ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration. https://www.iso.org/obp/ui/#iso:std :iso:14644:-1:ed-2:v1:en
The standards regarding a cleanroom are measured in micrometers. The above image compares a hair follicle to a 90 µm particle of fine sand. The maximum particulate content per cubic meter for a classification ISO 1 cleanroom is 5 µm.
There are three methods used to ensure that a Cleanroom can maintain its classification.
The primary method of ensuring that the air in a Cleanroom is at the appropriate cleanliness level is the installation of an air filtration system that complies with the certified standards of the International Standards Organization (ISO). Three forms of air flow systems are:
Below is a description of each:
Air is ducted directly into the cleanroom and ducted directly out. This form of cleanroom is common with manufacturers who have strict guidelines such as the pharmaceutical industry.
The ducted supply and open return air is a cost-effective and efficient method of air delivery. Air is ducted directly into the cleanroom and freely flows out into an open air plenum.
Unidirectional, or laminar, airflow systems force air in one direction. It has controlled airflow with steady air velocity from the laminar airflow hoods that direct air downward. In most Cleanrooms, the downward airflow pushes particulates out to prevent them from landing on surfaces. With a laminar system, air is pushed through filters that catch microscopic particles.
The filtration system for a cleanroom is its most important component, since it is what keeps it clean. Cleanrooms can have single or multiple filters depending on their design and ISO classification. Most systems have filters located in the ceiling. Air travels downward from the ceiling to the floor and exits through ducts in the floor.
High efficiency particulate (HEPA) air filters with the capability of capturing 99.97% of dust, pollen, mold, bacteria, and airborne particles with a size of 0.3 μ are standard air filters for cleanrooms and come in various designs to fit the needs of each type of cleanroom. They are made of interlaced fibers that have diameters that are less than 1μ with the distance between the fibers being smaller than 0.5 µ. The random placement of the fibers is disorganized, twisted, and turned to avoid forming any type of pattern.
The complexity of HEPA filters creates pressure drop in the airflow, which has to be compensated for by a fan system that assists in maintaining an even and constant flow. This aspect of the filtration process can be expensive due to the amount of power necessary to maintain airflow. As dirt and debris are captured by the filter, the pressure drop rises since pressure drop is directly related to the HEPA filter’s air flow rate.
The pre-filter removes larger particles from the air before the air reaches the HEPA or ultra-low particulate air (ULPA) filters. By removing the larger particles, pre-filters help extend the life of a HEPA or ULPA filters but must be checked regularly since they can reach their capacity rapidly.
ULPA filters are very similar to HEPA filters but are far more efficient. They remove 99.95% of contaminants 0.12 µm in diameter. The efficiency and quality of ULPA filters makes them more expensive. They come in assorted sizes and supply maximum efficiency with the lowest pressure drop.
HEPA-filter filters out 99.99% of particles at 0.3 µm. They are the most popular filter option and can last for many years depending on the particulate count. HEPA filters have minimal pressure drop with maximum airflow. The image below is of a HEPA filter with an aluminum frame designed for industrial use.
The fibers of a HEPA filter are randomly arranged to form a dense mat. As can be seen in this image.
The difficulty in capturing microscopic particles is their flight path. Unlike blown dust that moves in the direction of the wind, the Brownian motion of microscopic particles causes them to travel erratically. The multiple directions of the fibers of a HEPA filter are able to capture and trap microscopic particles. The image below shows the placement of HEPA or ULPA filters in a unidirectional system.
The classification of a cleanroom is determined by the amount of particulate matter (PM), a descriptor for particles and liquids in the air, it has per cubic meter. The air we breathe has about 35 million particles in a cubic meter with an estimated size of 0.5 μm.
The most accepted classification method for cleanroom is the International Organization of Standards (ISO), an international standards setting group that has representatives from nations around the world. ISO 14644 and ISO 14698 list the standards for cleanroom, as seen in the chart below.
| Class | FED STD 209E Equivalent | Maximum Concentration limits for particles equal to and larger than the sizes listed below | |||||
|---|---|---|---|---|---|---|---|
| 0.1micron | 0.2micron | 0.3micron | 0.5micron | 1micron | 5micron | ||
| ISO 1 | 10 | 2 | |||||
| ISO 2 | 100 | 24 | 10 | 4 | |||
| ISO 3 | 1 | 1000 | 237 | 102 | 35 | 8 | |
| ISO 4 | 10 | 10000 | 2370 | 1020 | 352 | 83 | |
| ISO 5 | 100 | 100000 | 23700 | 10200 | 3520 | 832 | 29 |
| ISO 6 | 1000 | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 |
| ISO 7 | 10000 | 352000 | 83200 | 2930 | |||
| ISO 8 | 100000 | 3520000 | 832000 | 29300 | |||
| ISO 9 | 8320000 | 293000 | |||||
ISO 14698 establishes the methodology and procedures for the elimination of biocontaminants from cleanroom. ISO 14644 specifies the number of particulates allowed in a cubic meter of air and has macroparticle descriptions. It was last revised in 2015 to deal exclusively with particle concentration.
Cleanroom classifications start with grade ISO 1, for extremely clean, and go to ISO 9, satisfactorily clean, which is normal room air. The chart below details the size and number of particles allowed per cleanroom class.
| ISO 14644-1 and ISO 14698 | |||||||
|---|---|---|---|---|---|---|---|
| Class | maximum particles/m3 | FED STD 209E equivalent |
|||||
| ≥0.1 μm | ≥0.2 μm | ≥0.3 μm | ≥0.5 μm | ≥1 μm | ≥5 μm | ||
| ISO 1 | 10b | d | d | d | d | • | |
| ISO 2 | 100 | 24b | 10b | d | d | • | |
| ISO 3 | 1,000 | 237 | 102 | 35b | d | • | Class 1 |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83b | • | Class 10 |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | d,e,f | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO 7 | ⁃ | ⁃ | ⁃ | 352,000 | 83,200 | 2,930 | Class 10,000 |
| ISO 8 | ⁃ | ⁃ | ⁃ | 3,520,000 | 832,000 | 29,300 | Class 100,000 |
| ISO 9 | < | < | < | 35,200,000 | 8,320,000 | 293,000 | Room air |
The United States classification system for cleanrooms was Federal Standard 209E published by the Institute of Environmental Sciences and Technology (IEST) in 1963, which can be seen in the chart below. The IEST used a classification system that ran from Class 1, an ISO 3 class, to Class 100,000, an ISO 8 classification. Though several countries still use the IEST system, it was formally retired in 2001 as being obsolete.
| US FED STD 209E | ||||||
|---|---|---|---|---|---|---|
| Class | Maximum particles/ft3 | ISO | ||||
| ≥0.1 μm | ≥0.2 μm | ≥0.3 μm | ≥0.5 μm | ≥5 μm | Equivalent | |
| 1 | 35 | 75 | 3 | 1 | 0.007 | ISO 3 |
| 10 | 350 | 75 | 30 | 10 | 0.07 | ISO 4 |
| 100 | 3500 | 750 | 300 | 100 | 0.7 | ISO 5 |
| 1000 | 35000 | 7500 | 3000 | 1000 | 7 | ISO 6 |
| 10000 | 350000 | 75000 | 30000 | 10000 | 70 | ISO 7 |
| 100000 | 3.5x108 | 750000 | 300000 | 100000 | 700 | ISO 8 |
Though ISO standards have been widely accepted and serve as a guide for most nations, individual countries have developed their own systems. Below are descriptions of those systems.
EU GMP classifications are used as a method of inspection for all phases of the production process. Inspections are held by the participating member experts in the individual European Nations. Their purpose is to ensure public safety. The EU GMP worked with the United States Food and Drug Administration to establish Annex 1 as standards for cleanroom as seen in the chart below.
| EU GMP Guidelines for Cleanrooms | ||||
|---|---|---|---|---|
| Room Grade | at rest (b) | noperation (b) | ||
| maximum permitted number of particles/m3 equal to or above (a) | ||||
| 0.5 μm (d) | 5 μm | 0.5 μm (d) | 5 μm | |
| A | 3,500 | 1(e) | 3500 | 1(e) |
| B (c) | 3500 | 1(e) | 350,000 | 2,000 |
| C (c) | 350,000 | 2,000 | 3,500,000 | 20,000 |
| D (c) | 3,500,000 | 20,000 | not defined (f) | not defined (f) |
BS 5295 has ten classes of standards for cleanliness as seen in the chart below. Each classification has a range of particulate counts for a more specific definition of particle size. The BS 5295 standards were established by the British Standards Institute (BSI), which creates codes and specifications for management quality requirements. They assist companies in meeting certification standards for other countries as well as Great Britain.
| BS 5295 Classification | ||||||||
|---|---|---|---|---|---|---|---|---|
| Maximum permitted number of particles per m3 | Maximum floor area | Minimum pressure difference | ||||||
| Class of environmental cleanliness | 0.3 μm | 0.5 μm | 5 μm | 10 μm | 25 μm | Per sampling position for cleanrooms (m2) | Between classifed areas and unclassified areas (pa) | Between classifed areas and adjacent areas of lower classification (pa) |
| C | 100 | 35 | 0 | NS | NS | 10 | 15 | 10 |
| D | 1000 | 350 | 0 | NS | NS | 10 | 15 | 10 |
| E | 10000 | 3500 | 0 | NS | NS | 10 | 15 | 10 |
| F | NS | 3500 | 0 | NS | NS | 25 | 15 | 10 |
| G | 100000 | 35000 | 200 | 0 | NS | 25 | 15 | 10 |
| H | NS | 3500 | 200 | 0 | NS | 25 | 15 | 10 |
| J | NS | 350000 | 2000 | 450 | 0 | 25 | 15 | 10 |
| K | NS | 3500000 | 20000 | 4500 | 500 | 50 | 15 | 10 |
| L | NS | NS | 200000 | 45000 | 5000 | 50 | 10 | 10 |
| M | NS | NS | NS | 450000 | 50000 | 50 | 10 | NS |
USP 800 is a set of published standards for the handling of hazardous drugs (HD), which went into effect in December of 2019. The definition of a hazardous drug was established by the National Institute for Occupational Safety and Health (NIOSH), which states that a drug is considered hazardous if it has carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity, or genotoxicity. USP 800 is a cleanroom standard that was issued in 2017 by the USP as a revision of USP 795 and USP 797.
| USP 800 Standards | ||||||
|---|---|---|---|---|---|---|
| HD Receipt/Unpacking | HD Storage | Non-Sterile HD Compunding | Sterile HD Compounding | |||
| Ante Room | Buffer Room | C-SCA (category 1 Risk) | ||||
| C-SEC OR ROOM REQUIREMENTS | ||||||
| ACPH | No Requirement | Min 12 | Min 12 | Min 30 | Min 30 | Min 12 |
| External Ventilation | No Requirement | Required | Required | Required | Required | Required |
| Room Pressure | Neutral/ Negative with respect to adjacent areas | Negative with respect to adjacent areas | Negative with respect to adjacent areas (0.01-0.03' water column) | Positive with respect to Buffer | Negative with respect to adjacent areas (0.01-0.03' water column) | Negative with respect to adjacent areas (0.01-0.03' water column) |
| ISO Classification | No Requirement | Not Allowed | Not Requirement | ISO 7 | ISO 7 | Min.1 meter from C- PEC or directly outside C-SEC |
| Sink Placement | Not Allowed | Not Allowed | Min.1 meter from C- PEC or directly outside C-SEC | Min.1 meter from Buffer Room Entrance | Not Allowed | Min.1 meter from C- PEC or directly outside C-SECA |
| Surface | Smooth, Seamless, Impervious | Smooth, Seamless, Impervious | USP<797>Compliant (Smooth, Seamless,Impervious) | USP<797>Compliant (Smooth, Seamless,Impervious) | USP<797>Compliant (Smooth, Seamless,Impervious) | Smooth, Seamless, Impervious |
For Cleanrooms, USP 800 requires negative pressure, external ventilation, and air changes of 12 ACH per hour for drug storage areas. The standards further stipulate that drugs may not be received, stored, mixed, prepared, compounded, or dispensed in positive pressure environments.
To meet the need for compliance with USP 800, ionization and polarization are used to collect particles, viruses, bacteria, volatile organic compounds, and gases. Those systems cause contaminants to adhere to a media material and use electric fields to charge and ionize or polarize the contaminants. For the protection of workers, ionization and polarization units polarize any ambient HD material.
A cleanroom is an enclosed space where airborne particulates are controlled using advanced filtration. Classification, such as ISO 1–9, depends on the number and size of particles per cubic meter, with ISO 1 being the cleanest.
HEPA and ULPA filters are standard, capturing up to 99.99% of particles as small as 0.12 µm. Pre-filters remove larger particles, extending the lifespan of HEPA and ULPA filters and optimizing air cleanliness.
The three main types are duct supply and duct return, duct supply and open return, and unidirectional (laminar) flow. Each maintains cleanliness by managing air direction and filtration according to cleanroom standards.
Besides ISO, standards include EU GMP, BS 5295, and USP 800. Each defines particle limits, pressure, and design criteria based on local industry requirements, but ISO classifications are widely accepted globally.
USP 800 mandates negative pressure, external ventilation, and at least 12 air changes per hour for hazardous drug storage areas. It prohibits positive pressure environments for receiving, storing, or compounding hazardous drugs.
Cleanrooms use specialized air filtration, construction materials that emit no contaminants, and protective garments for staff. Ionization and polarization technologies can be added to further reduce particles and biocontaminants.
Though there are many different construction methods for cleanrooms, all manufacturers have to follow the guidelines of ISO 14644-1, ISO 14698-1, and FED STD 209E. In some cases, modular and portable cleanrooms are specially designed to assist testing facilities. When planning Cleanroom construction, there are several factors that need to be considered, which include:
Each of these factors are described below:
Cleanroom surfaces are smooth and impervious and will not peel, flake, corrode, create dust, or have places for microorganism to grow. They must be able to be easily cleaned and accessible. In microelectronic and semiconductor Cleanrooms, surfaces are required to be smooth and free of potential ESDs. Surface materials are shatter, dent, and crack resistant as well as crease repellent.
Floors in Cleanrooms are either epoxy resin or PVC. Resin floors are used where there is high mechanical loads since resin has high resistance and strength. The most common use of resin floors is in rooms that have water or high humidity.
PVC floors are more economical and are laid out in tiles. They are used in low little traffic areas where there aren‘t heavy loads.
Cleanroom equipment is manufactured from easy-to-clean materials such as stainless steel, polycarbonate, or plastic laminates. The type of equipment used in a cleanroom is anything that is not attached to the walls or floor, which includes a wide range of items from simple hand tools to showers and pass throughs.
Below are some of the types of equipment that are commonly found in a Cleanroom:
Cleanrooms require a great deal of air and sometimes need to have the temperature and humidity controlled. Air handling units (AHU) use 60% of a sites power. The cleaner the room the more power that is used. To control the expense of air control units, systems are designed to recirculate the air, which keeps the temperature and humidity stable.
Air control system is the most essential part of a cleanroom. Cleanrooms have positive air pressure, which results in air exfiltrating into adjoining spaces with lower pressure and leaves through electrical outlets, light fixtures, window frames, ceiling and floor interfaces, and doors. In the majority of cases, leakage is at a rate of 1% to 2%.
When planning a cleanroom, it is necessary to study how much exfiltration there is, or the amount of air that will escape the room. In a supply, return, and exhaust system, there needs to be a 10% difference between supply and return airflow.
A common exit path is through doors. The amount of exfiltrating through a door is determined by the size of the door, pressure across the floor, and how well the door is sealed. For a normal door, air exfiltrates at 190 cfm to 270 cfm.
In order to compensate for exfiltration, the airflow needs to be balanced where the amount exfiltrating matches the amount of infiltrating. During the startup of a cleanroom, adjustments need to be made for exfiltration. Turbulence, eddies, equipment, and pressure influence the air exchange rate, which is the key factor in airflow design.
The diagram below shows the exfiltration and infiltration or the air exchange rate of a unidirectional air flow system, where 1 represents the infiltration and 2 is exfiltration. These two factors are critical for the development and construction of the air control system.
The major source of cleanroom contamination is from the people who work in them since a person sheds one billion skin cells per day that are 33 µm x 44 µm x 4 µm 10% of which carry microorganisms. The amount of possible contamination from people makes controlling their numbers a critical consideration.
According to academic studies, only select and trained personnel should be allowed in a cleanroom. Added to this factor is the need for adequate training in cleanroom procedures such as proper attire and protection. Studies indicate that the higher the number of personnel, the greater the amount of contamination.
Cleanroom lighting is designed to meet specialized environmental requirements. Unlike the air control system, lighting represents 1% of the total cost of operating a cleanroom. Since instruments in a cleanroom are highly precise, the foot-candle, light intensity at one lumen per square foot, is very high. Each type of cleanroom has lighting specifically designed for its purposes.
As with all cleanroom factors, the air control system takes preeminence making the planning of lighting demanding, requiring careful planning and design. For energy efficiency, cleanrooms use LER lamps, which are easy to maintain and have a long life.
Other types of lighting are incandescent, high intensity, and LED. UV lighting provides extra bacterial and contaminant control for certain types of cleanrooms.
The housing for lighting is normally steel that has its holes and openings sealed with gaskets. In most cleanrooms, ballasts and lamp holders are easily removed to avoid disturbing cleanroom conditions.
Below is an example of a well-lit cleanroom.
A recent development is automated lighting that uses a passive infrared sensor motion detector to avoid waste of energy, while ensuring constant illumination for users.
In the design phase of a cleanroom, engineers determine the necessary lux level, unit of illuminance, that is necessary. The lux level depends on the types of work to be completed. The chart below is a brief explanation of the lux level for various tasks.
| Lux Table | ||
|---|---|---|
| Luminance (lux) | Activity | Area |
| 1000 | Visual tasks very difficult | General inspection, electronic assembly, paintwork, supermarkets |
| 1500 | Visual tasks extremely difficult | Fine work and inspection, precision assembly |
| 2000 | Visual tasks exceptionally difficult | Assembly of minute items, finished fabric inspection |
Other factors that are involved in developing proper lighting are the IP rating for the enclosure and lighting color, which are also determined by the type of work. Part of the IP rating is how well the lights are sealed from contaminants in the environment.
Cleanroom doors are responsible for keeping the room sealed from external contaminants and maintaining the controlled environment. As with every detail of a cleanroom, the doors have to be specially designed to exacting standards. Below are some of the details to consider when examining a cleanroom door. The first thing to note, as with all cleanroom surfaces, doors have to be smooth and impenetrable.
The purpose of viewing panels is for operators to work more efficiently and have visual contact. They are strategically located for ease of access for supervision inspection and the elimination of the supervisor performing entry protocols.
Viewing panels must be flush to both sides of the wall, shatter proof, with a drying agent in the void between the glass panels, and fire resistant. In ultraviolet lit rooms, they have a coating that filters the ultraviolet wavelengths.
The visual display below has examples of various types of view panels.
The relative humidity (RH) for a cleanroom should be between 30 to 60% at a balanced level to protect against overly moist or dry conditions. Well balanced humidity suppresses the potential for electrostatic discharge (ESD) that could ruin products. Humidity control is necessary as a means of preventing bacterial growth. Two methods of humidity control are air conditioning and desiccants, a substance that induces dryness.
Air conditioning lowers the surface temperature in a cleanroom, while the desiccant process absorbs moisture in the air. Desiccants significantly reduce dew points to five times lower than an HVAC system. Below is a diagram of a desiccant humidity filter.
The level of a cleanroom is determined by its air. All cleanrooms are built the same with airtight walls, doors, windows, and very clean air. To move from one classification to another, there has to be an increase in airflow since air removes the contaminants. The cleaner the room, the higher rate of air exchange.
Lower levels of cleanrooms such as ISO level 9 to ISO level 6, cleanliness is based on the amount of air exchanged each hour, while rooms at ISO levels 1 through 5, airflow is measure per second. Equipment and furniture can block airflow and raise a cleanroom‘s level of classification.
There are three different states in the determination of the level of a cleanroom: as built, at rest, and operational. As built refers to the cleanroom‘s performance without people, equipment, or furniture, its built state. At rest is when everything has been added before performing processes.
The change in level takes a significant up or down move when it is in full operation. It is at this state that its classification level will be determined.
The biggest problem with Cleanrooms is people since they carry contaminants and microorganisms on their skin. There are several steps that companies take in an attempt to control the amount of contaminants released by personnel. The first rule is the use of specially designed clothing produced by cleanroom suppliers.
The image below is of clothing for a strictly monitored Cleanroom.
The ISO class of a Cleanroom determines the type of clothing that personnel are required to wear. OSHA has guidelines for Cleanrooms but does not have standards for protective clothing.
Listed below are the ISO 14664 clothing requirements for Cleanrooms.
Disposable clothing is the most common option for Cleanroom clothing, which is disposed of in designated bins. The image below is of a "bunny suit" that is normally white and covers the whole body. All of the labeled items are disposable.
Every company has their own set of rules for Cleanroom use. The list below is a general overview.
There are a combination of factors that determine the classification of the type of cleanroom. Airflow for cleanrooms is crucial since it determines the AHC and air movement, which enhances the removal of detrimental particles from the air. Aligned with airflow is the construction of a cleanroom, which influences the smoothness of the air exchange rate.
The two types of airflow for cleanrooms are unidirectional and turbulent. With unidirectional airflow, air enters a cleanroom from the filtration system and exits through the venting system. The direction of the airflow is normally downward but can take other formats depending on the design of the cleanroom.
With turbulent airflow, or vortex airflow, the input air mixes with the air in the cleanroom and exits through vents in the wall where it is filtered and recycled. After air enters the cleanroom, it mixes, swirls, and forms eddies as it collects particles in a non-directional air flow pattern.
With unidirectional or laminar airflow, air moves in an unobstructed straight streamline parallel pattern that is directed downward horizontally. The process sweeps across a cleanroom gathering contaminants in its flow in a parabolic velocity profile. Laminar airflow hoods direct air jets that move the air downward.
The term cleanroom is a generic term that covers a wide range of designs, configurations, and concepulations, which run the gamut from small mobile soft walled rooms to large production cleanrooms. Regardless of the type of construction, all cleanrooms are required to comply with ISO standards.
Hardwall modular cleanrooms have aluminum supports and rigid walls for increased air pressure. The solid walls are three inches thick made of various materials that are coated with a plastic resin for easy cleaning. Modular cleanrooms are portable with hardwalls that can be disassembled for repositioning.
Softwall cleanrooms have walls made of vinyl or other plastic materials. They are small and portable, capable of being positioned close to assembly operations and manufacturing processes. Softwall cleanrooms are an inexpensive method for providing a controlled environment and have ISO ratings of 5 and above. Like modular cleanrooms, softwall cleanrooms have an aluminum or coated steel frame with all of the components of larger cleanrooms in smaller sizes.
Powder containment cleanrooms are a safety measure designed to protect workers from hazardous and harmful substances. They are designed to meet the weighing, capsule filling, and compound creams requirements for containment and filtration. Powder containment cleanrooms have airflow and filtration for the handling of hazardous powders, dust, and fumes.They have a recirculation system that maintains continuous washing of particles in the air.
All cleanrooms are designed to be explosion proof as a sealed and self contained environment. For industries that handle volatile substances, additional features are added to offer greater protection for workers. Explosion proof cleanrooms have explosion proof ceiling components, control panels, and wall panels as well as non-sparking lighting with static dissipative PVC to protect against ESDs.
The frames of explosion proof cleanrooms are made of extra strength powder coated steel.
Fire resistance is a common feature for all cleanrooms since the walls of cleanrooms are chemical, thermal, and fire resistant. For a cleanroom wall to be classified as fire resistant, it must meet the standards of ASTM E 84 Class A smoke and fire rating and ISO classifications 2 to 9 requirements.
Typical wall construction for fire resistance includes an outer layer of gypsum over a polyurethane core that has a vinyl, steel, or aluminum surface. Gypsum supplies the fire resistance while the surfaces are easy to clean.
Biosafe cleanrooms are designed to handle aseptic processes and meet ISO standards from ISO 4 to ISO 8. Walls for biosafe cleanrooms are made of stainless steel or powder coated steel for easy cleaning. As with all types of cleanrooms, biosafe cleanrooms have interlocking panels that can withstand or prevent vibration and instability.
Since most cleanrooms have air supply systems to deal with bio materials, the systems used for biosafe cleanrooms have the same HEPA filtration systems as are found in all other types of cleanrooms. In most cases, biosafe cleanrooms have a unidirectional airflow pattern.
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