IDC Books - Technical Training that Works

    CR-E - Practical Cleanroom Technology and Facilities for Engineers and Technicians

    Price: $65.95
    Ex Tax: $59.95

    Available Options

    * Options:
    - +

    This manual covers working in a controlled environment; handling, storing and using hazardous materials, wet chemicals and gases; increasing your product yield; understanding different cleanroom concepts; controlling contamination from interfering with the production of your product and its end-use performance; codes and legislation governing the design and operation of cleanrooms; hi-purity water; its uses, generation and distribution waste water treatment and personnel safety practices in the cleanroom environment.

    Download Chapter List

    Table of Contents

    An Overview - Practical Cleanroom Technology and Facilities for Engineers and Technicians

    1       Overview of Cleanroom Technology

             Overview

    Cleanrooms are rapidly becoming a regular feature of the modern industrial landscape. From medicine to semi-conductors, their use is proliferating. Modern processes demand higher and higher yields, in manufacturing, reliability and post manufacturing from their product. In parallel, the drive for miniaturization is making the products more sensitive to contamination. This trend is set to continue. The developing field of ‘nanotechnology’ is likely to even accelerate the demand for cleaner and cleaner cleanrooms. In truth, modern life would be much different without the cleanroom and its products. Supporting the cutting edge cleanrooms is a series of other cleanrooms for the manufacture of cleanroom equipment, materials and consumables.

    This book has been developed for students who intend getting involved with cleanrooms. This includes future process engineers, production engineers, research engineers, scientists, project engineers, technicians, operators and maintenance staff.

    The subject matter of this course is broad. Complex theory is avoided. Cleanrooms are a combination of series of complex systems. They require of a number of support operations with all their unit operations and sub systems that all have to operate together. A major task in the construction, operation and maintenance of the cleanroom is the interaction of all these supporting operations all the way down to their sub systems.

    Achieving today’s standard of cleanliness did not happen overnight. It has been an iterative process driven on by the increased sensitivity of products to contamination.

    Understanding Micro-contamination reveals that pure cleanliness is not attainable or even desirable. We can only achieve degrees or classes of cleanliness. Therefore managing Micro-contamination is the name of the game in designing a ‘clean’ manufacturing facility.

    The manufacture of ultra pure water is a major process in itself. In a modern facility the production of ultra-pure water and the treatment and disposal of water waste is the greatest investment second to that required for the air handling systems.

    The amount of water consumed by today’s UPW plants is very high. The lack of water availability is a constraint to the expansion of cleanroom facilities in certain parts of the world.

    Finally the cleanroom is required to handle a large variety of hazardous chemicals (gases and wet chemicals) while maintaining the safety of the personnel and the facility. These chemicals often have an extremely high purity standard. This high purity has to be maintained all the way to their point of use.

    Despite all the hardware, it is people who make these facilities function. Extensive life safety systems are needed to make it safe for them to work in the facility. Training is vital for the productivity of these people. Personnel are also major source of contamination. Those who work inside a cleanroom need to be fully trained for the task in hand and have a full appreciation of cleanroom technology and facilities. This manual aims to impart this appreciation.

    1.1          History of cleanrooms

    Contamination control may be traced to the surgical rooms of the early 1900s and the First World War.

    The problems were with airborne germs and surface contamination of an infectious nature. New methods of sterilization and decontamination were developed to defeat these microscopic sources of infections. Today operating theatres are considered to be cleanrooms.

    The demand for precise navigational devices and missile control systems developed from the 1940s onwards led to the introduction of white rooms. These were the forerunners of today’s cleanrooms. This is because efforts were made to control the dust contamination and surface deposits.

    During the same period developments were made in high efficiency filters that are vital in the creation and maintenance of today’s cleanrooms. NASA was the builders and operators of the world’s first cleanrooms.

    In the 1990s there were 10,000 cleanrooms in the United States and nearly 30,000 worldwide.

    The number of cleanrooms and other controlled environments are growing rapidly due to the continual introduction of contamination sensitive products and processes.

    1.2          The need for a cleanroom

    Cleanrooms are defined as controlled environments. They and other controlled environments, such as sterile areas, are necessary because of increased product sensitivity to contamination.

    Contamination can cause a variety of problems to material, processes and products.

    Examples are:

    • Surface imperfections such as bumps and dents.
    • Mechanical damage such as scratches.
    • Optical defects caused by light scattering and blocking.
    • Chemical damage or positioning of the material.
    • Pathogens, bacteria and other micro-organisms, which lead to infection in food and pharmaceuticals.
    • Surface film adhesion or non-adhesion.
    • Static electricity destruction by sudden discharges or static electricity.

    Reducing contamination will mean an increase in:

    Yield: the percentage of devices, which are of an acceptable quality at the end of the manufacturing process.

    Reliability: the ability to survive in service.

    Integrity: repeatability and accuracy of results in the area of science and research.

    The controlled environment is also vital in the field of medicine. When the body’s immune system is compromised by injury or disease, procedure or treatment, a controlled environment must be used to minimize the chances of infection. Hence today’s operating theatres are also controlled environments.

    The world without cleanrooms would mean that we could not manufacture, analyze materials or devices or utilize the processes, which are sensitive to the environment.

    Quite simply, without cleanrooms the products we take for granted would not exist.

    The personal computer would be a pipe dream; medical implants and bacteria free preparations and pharmaceuticals would be prohibitively expensive.

    The world we live in is a contaminated place. Contamination in a cleanroom context is defined as:

    ‘Any substance or form of energy that is unwanted and/or produces an adverse effect.’

    Put another way:

    ‘Contamination in a cleanroom can also be defined as anything that interferes with the production of the product or its performance.’

    A cleanroom is a place where we can control this contamination. A controlled environment is where we can control the temperature, humidity, vibration, static electricity and dust levels.

    Our very own little world, like the real world, our cleanroom is highly complex and very dynamic consisting of many interacting parts and systems. All these systems have their own specialization and technologies.

    In addition to the physical plant there is the soft side that is vital to the functioning of a cleanroom and that is the human and organization element like safety systems, employee skills and the management of people who work there.

    Today’s users of cleanrooms include the following industries and services:

    • Microelectronics (the control of dust and static).
    • Semiconductor (the control of dust temperature, humidity and vibration).
    • Data storage (the control of dust).
    • Aerospace (the manufacture of aeronautical, electrical and mechanical components).
    • Recording studios (the control of noise and vibration).
    • Material science (the control of contamination).
    • Food processing (the control of contamination and pathogens).
    • Research laboratories (the control of cross contamination).
    • Precision mechanical & metrology (the control of temperature and humidity).
    • Optical, the manufacture of high resolution components (the control of temperature).
    • Pharmaceutical (the control of pathogens and cross contamination).
    • Biotechnology (the control of cross contamination).
    • Medical (the control of infection).
    • Hospital operating theatres (the control of infection).
    • Nuclear (the control of containment of radioactive escape).
    • Automobile components (the control of particle contamination).
    • Universities research laboratories (the control of particle contamination).
    • Government laboratories (the calibration of equipment for standards).
    • Forensic science laboratories (the control of cross contamination).
    • The manufacturers of cleanroom material (cleanroom doors, walls, components etc.).
    • The manufacturer of cleanroom equipment (HEPA filters pipe material, valves, tools etc.).

    The area of interest to each user is placed in the brackets after the description.

    1.3                 How the cleanroom works?

    The cleanroom is a workplace area where the manufacturing process takes place in a controlled environment or medical, pharmaceutical processes take place. Since the outside ambient air contains many forms of contaminations in terms of Particulate contamination or molecular contamination, we must provide a clean working area in which contamination particles or molecules are reduced to a minimum, so that they do not create a disastrous effect on the product or process being carried out.

    In a building of manufacture, a separate area is earmarked to have clean environment suitable for the process and sub divided into various bays, chases, equipment and laboratory according to contamination cleanliness class (ISO-14644) and the rooms are pressurized by air flow supplied by the sub systems like HVAC, and assisted systems like Ventilation system chillers, humidifiers, process water systems, make-up and exhaust systems, compressed air systems, electrical systems, safety systems, acid fume exhaust system, etc.

    Airflow control changes the room pressurized air as many times as possible, so that the induced, ingressed contamination are carried away from the cleanroom and maintaining proper humidity and temperature. The proper cleanroom procedures adopted right from the design stage to final validation and certification. Since the majority of contaminations are from personnel discipline and movement, certain etiquettes are formulated and adhered to within the cleanroom environment

    1.4          Clean rooms and the semi-conductor industry

    The purpose of a cleanroom in semiconductor industry is simple – to protect the process wafers from all forms of contaminations – whether it is an Airborne particulate contamination, or Airborne Molecular contamination or Surface molecular contamination. As the semiconductor features goes down smaller and smaller, there are more stringent contamination controls are adopted and yet not so simple to control. The contributing elements for contaminations, such as human, automated equipments and even process itself bring in lot of chemical contamination in a steady stream; require an absolute control in modern day semiconductor industry.

    Microelectronic facilities manufacturing semiconductors have required cleanrooms providing ISO Class 3 and cleaner for wafer fabrication and Class 5 to 8 for auxiliary manufacturing rooms.

    Semiconductor cleanrooms today are of two major configurations: clean tunnel or open-bay (ballroom). The clean tunnel is composed of narrow modular cleanrooms that may be completely isolated from each other. Fully HEPA- or ULPA-filtered pressurized plenums, ducted HEPA or ULPA filters, or individual fan modules are used. Production equipment may be located within the tunnel or installed through the wall where a lower cleanliness level (nominally ISO 14644-1 Class 7 or cleaner) service chase is adjacent to the clean tunnel. The service chase is used in conjunction with sidewall return or a raised floor, possibly with a basement return.

    The energy consumption in cleanroom in maintaining stringent contamination control is the highest among the other utilities, process machinery.

    The cleanroom layout for semiconductor industry needs to be thoroughly analyzed in terms of process flow; airflow pattern, occupancy rate and the contamination control must be brought into even before starting the production. Improving the cycle time and process flexibility must be given enough importance in the layout. Remember an open ballroom type layout may a better option, but the processes demand a Bay & Chase type construction, as well as minienvironments, which may require separate air handling system and other control utilities designed for it. The contamination control must balance the requirements incorporated to achieve a sustainable and quality productions.

    Environmental concerns in semiconductor industry

    A tremendous amount of raw materials is used in the manufacturing of semiconductors. Many chemicals used in the production process are not expensive but the cost of maintaining these materials in an ultra-clean state can be quite high. This envisages the close monitoring of usage, the minimization of consumption, the contaminations emanating from these chemicals and their control in cleanroom. Incorporating the relevant equipments, machinery for the process of recycling and reprocessing techniques may involve additional expenditure.

    The factual information is that a typical semiconductor industry producing six inch (150mm) wafers uses not only 240,000 kilowatt hours of electricity, but also uses 2 million gallons (525,000 litres) of water every day. These figures may shoot up for 8 inches and 12 inches wafers production even more. On average, the manufacturing of just 1/8-inch of a silicon wafer requires about 3,787 gallons (1000 litres) of wastewater, not to mention 27 pounds (12.2 kg) of chemicals and 29 cubic feet (0.8 cu.m) of hazardous gases. The fab facility design must take into account of these facts, which are essential guidelines for cleanroom in semiconductor industry.

    We will study more in details in subsequent chapters about cleanroom construction. Just remember that the cleanrooms are not identical in all form of semiconductor products and the design must be varied to suit the different process and products.

    1.5          Cleanrooms and the pharmaceutical industry

    The cleanroom design in Pharmaceutical industry differs from the cleanroom design in semiconductor industry. The preparation of pharmaceutical, biological and medical products require cleanrooms to control the viable (living) particles that would produce undesirable bacterial growth and other contaminants.

    In general, the pharmaceutical cleanrooms must follow the US based GMP (Good Manufacturing Process) and the product must pass the inspection of US based FDA (Food and Drug Administration).

    In a Biomanufacturing and pharmaceutical cleanrooms, the aseptic process area is arranged from highest pressurization to other areas arranged with lesser pressurization. The pressure difference can be in the range of 0.05 to 0.06 inches of water between adjacent rooms. The rooms are separated by air classification and air pressure differences via airlocks.

    The cleanrooms require lower pressurization than the adjacent area of containments area with Pathogens and toxic materials and the airlocks are maintained at a slightly higher pressure than the adjacent rooms.

    GMP standard suggests a minimum of 20 air changes per hour (ACH) for rooms with an air particulate classification, with exposed sterile product under a unidirectional flow hood or inside an ISO 14644-1 Class 5 barrier enclosure. US GMP standard currently require only two classes: ISO 14644-1 Class 5 for sterile product exposure, and ISO 14644-1 Class 8 for adjoining spaces. However, it is common practice for places with exposed products to have an ISO 14644-1 Class 5 unidirectional flow zone inside an ISO 14644-1 Class 7 room.

    The Barrier technology is another cleanroom within a cleanroom, where higher pressure levels are maintained in smaller areas to reduce capital and operating cost. Applications vary widely based on product, process equipment, and throughput volume. Sterile barriers are typically positive-pressure envelopes around the filling equipment with multiple glove ports for operator access, constructed of polished stainless steel with clear rigid view ports.

    Other barrier applications offer operator protection from potent compounds while maintaining a sterile internal environment. These tend to be total containment isolators with completely contained product transfer ports. All internal surfaces are sealed from the external environment or operator exposure. Because of potential chamber leaks, its internal pressure may be kept negative compared to the ambient space, via exhaust fans.

    Pharmaceutical product manufacturing facilities require careful assessment of many factors, including HVAC, controls, room finishes, process equipment, room operations, and utilities. Flow of equipment, personnel, and product must also be considered.

    1.6          Cleanrooms and Medical and life sciences

    Medical Device Manufacturing is an organization dedicated to the assembly, packaging and sterilization of medical devices.

    Under USP 797 regulation, all compounding pharmacies are required to protect their products by utilizing laminar flow benches within a cleanroom. Cleaner facilities are required for compounded Sterile Preparations.

    Cleanroom compliance

    The current air cleanliness requirement for a Compounding Cleanroom is an ISO Class 8. A separate ISO Class 5 Device is required for the compounding of patient preparations. All sterile compounding is to be performed in an ISO Class 5 Device surrounded by an ISO Class 7 or ISO Class 8 Cleanroom Buffer Zone. “Risk Level” determines the required ISO cleanroom air cleanliness classification. In order to set your ISO Cleanroom Classification you must first determine your Risk level.

    The Risk level can be classified as:

    Low risk level – requiring ISO Class 5 Laminar flow workbenches, which are to be located inside a ISO Class 7 or 8 cleanrooms and the anteroom leading into cleanroom must be an ISO Class 8 cleanroom.

    Medium risk level – requiring ISO Class 5 Laminar flow workbenches, which are to be located inside a ISO Class 7 cleanrooms and the anteroom leading into cleanroom must be an ISO Class 7 cleanroom.

    High-risk level – requiring ISO Class 5 Laminar flow workbenches, which are to be located inside an ISO Class 5 cleanrooms and the anteroom leading into cleanroom must be an ISO Class 7 cleanroom.               

    Barrier Isolator Compliance

    The ISO Standard for Barrier Isolators is addressed in ISO 14644-7.

    A Choice between a Cleanroom and a Barrier Isolator must be determined based upon your process. Cleanrooms can be expensive spaces. A self-contained, controlled, clean environment enclosure, called a Barrier Isolator, around a critical care process area can be an economical alternative to a Cleanroom.

    This separative device is a generic term defined as “equipment using constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume.”

    Process isolation enclosures called Q/PECS units are designed to control of air cleanliness, airflow speed and direction, temperature, relative humidity, exhaust flow, sterilization and neutralization, and inert atmosphere. Such units have enclosed laboratory experiments; pilot plant processes, and fully integrated manufacturing processes – all without people inside. Operators interact through air curtains, glove ports, transfer devices, half suits, and remote manipulators.

    The life sciences industry calls them isolators or barrier technologies. No matter what they are called or where they are used, these are the common benefits: They protect product from people contamination and people from product contamination; they protect product from product cross-contamination; they assure protection by reducing or eliminating outside influences; and they provide an enclosed process environment for quality-level achievement. End-use applications include compounding IV solutions, sterility testing, preparing live vaccines, high-accuracy powder weighing, plant tissue laboratory research, robotic sampling, cell culture operations, ampoule filling, nuclear medicine compounding, handling of toxic substances, micro mechanical work, and microchip processing.

    1.7          The cleanroom as a system and unit operations

    To achieve and operate/maintain the cleanroom environment a combination of many different systems must function together. It is a dynamic system but has to operate in a stable manner to be effective. See Figure 1.1 for a system description of a cleanroom.

     

    Figure 1.1

    Typical Wafer fab systems and sub-systems.

    In all types of cleanrooms, the main parameters to be controlled are:

    • Temperature must be controlled at 22.3°C with plus or minus 0.3°C tolerance.
    • Relative humidity must be controlled e.g. 40% RH with plus or minus 3% variation.
    • Pressure control positive 0.0125 mm water column (WC) relative to entry corridors and subfab.
    • Vibration e.g. 2000 micro inches per second.

    To achieve the above parameters the following systems are required:

    • Air-conditioning system (chillers and boilers)
    • Make up air systems (scrubbed exhaust systems)
    • Exhaust Systems
    • Cooling water and backup cooling water systems
    • Sprinklers and Fire Control Systems
    • Cooling water
    • Condenser water system
    • Smoke detection systems
    • Electrical system
    • Emergency power systems
    • UPS (Uninterruptible Power Supply)
    • BCDS (Bulk Chemical Delivery Systems)
    • Waste collection systems
    • Waste treatment plant Acid treatment plant (AWN)
    • High Purity Water Treatment
    • FMS (Factory Management System) for the control of all the process plant
    • LSS (Life safety systems Public address gas detection)
    • Fire safety systems (sprinklers/smoke protection systems)
    • Environmental protection systems
    • Boiler house
    • Chiller house
    • Ultra pure water (UPW) production facility
    • Nitrogen plant or storage facility
    • Bulk gas storage facility
    • Gas pad
    • Waste water treatment facility (AWN)
    • HPM rooms. Hazardous production material rooms
    • Bulk chemical storage facility
    • Warehousing for gases and wet chemicals

    Depending on the processes involved in manufacture within a cleanroom environment, some of the above facilities, systems may be added or deleted. A cleanroom designer will specify the requirements once the need is determined.

    1.8             Cleanroom Standards – Old and New

    USA Semiconductor/microelectronics Company needed a standard set up for their manufacturing activities and products as early as 1960. Subsequently, Federal Standard 209 was formulated in 1963.

    This Federal standard is a document which gives mainly information on the airborne particles required to specify the quality of cleanrooms, and also gives the methods used to check what concentrations are present. It does not give any information on how a cleanroom should be operated.

    This information had been included in a series of Recommended Practices written by the Institute of Environmental Sciences, the same Institute as has written the Federal Standard 209.

    Table 1.1 shows Federal standard 209 class limits started with 0.5 microns or larger. It gives only inch units for measurement, not in metric measurements.

    Table 1.1

    Federal Standard 209

    Class

    Maximum number of particle /cft

    Typical uses

     

    0.1mm

    0.2mm

    0.3mm

    0.5mm

    5 mm

     

    1

    35

    7.5

    3

    1

     

    NA

    Integrated circuits

    10

    350

    75

    30

    10

     

    NA

    Integrated circuits

    100

    NA

    7502

    300

    100

     

    NA

    Miniature ball bearing,  photo labs

    Medical implants

    1000

    NA

    NA

    NA

    1000

    7

     

     

    10000

    NA

    NA

    NA

    10000

    70

    Colot TV tubes, Hospital operating rooms

    100000

    NA

    NA

    NA

    100000

    700

     

    Ball bearings

    Federal standard 209 E was revised in 1992, including even lesser particle than 0.5 microns and included a metric measurement too.

    Table 1.2 shows the final version of FS 209 E with FS 209 A to D classification included and SI version of classification with letter “M”:

    Table 1.2  

    Federal Standard 209E Class Limits

    FS 209E-CLASS LIMITS

    Class Name

    >=0.1mm

    >=0.2mm

    >=0.3mm

    >=0.5mm

    >=5.0mm

    SI

    Eng

    m3

    ft3

    m3

    ft3

    m3

    ft3

    m3

    ft3

    m3

    ft3

    M1

     

    350

    9.91

    75.7

    2.14

    30.9

    0.875

    10.0

    0.283

    ---

    ---

    M1.5

    1

    1240

    35

    265

    7.50

    106

    3.00

    35.3

    1.00

    ---

    ---

    M2

     

    3500

    99.1

    757

    21.4

    309

    8.75

    100

    2.83

    ---

    ---

    M2.5

    10

    12400

    350

    26.5

    75

    1060

    30.0

    353

    10.0

    ---

    ---

    M3

     

    35000

    991

    7570

    214

    3090

    87.5

    1000

    28.3

    ---

    ---

    M3.5

    100

    ---

    ---

    26500

    750

    10600

    300

    3530

    100

    ---

    ---

    M4

     

    ---

    ---

    75700

    2140

    30900

    87.5

    10000

    283

    ---

    ---

    M4.5

    1000

    ---

    ---

    ---

    ---

    ---

    ---

    35300

    1000

    247

    7.00

    M5

     

    ---

    ---

    ---

    ---

    ---

    ---

    100000

    2830

    618

    17.5

    M5.5

    10000

    ---

    ---

    ---

    ---

    ---

    ---

    353000

    10000

    2470

    70.0

    M6

     

    ---

    ---

    ---

    ---

    ---

    ---

    1000000

    28300

    6180

    175

    M6.5

    100000

    ---

    ---

    ---

    ---

    ---

    ---

    3350000

    100000

    24700

    700

    M7

     

    ---

    ---

    ---

    ---

    ---

    ---

    1000000

    283000

    61800

    1750

    Table 1.3 

    ISO Standard 14644-1 Class Limits

    ISO Classification Number

    Maximum concentration limits( Particles/m3 of air) for particles equal to and larger than the considered sizes shown below

     

    >= 0.1µm

    >= 0.2m

    >= 0.3µm

    >= 0.5µm

    >= 1µm

    >= 5.0µm

    ISO Class 1

    10

    2

     

     

     

     

    ISO Class 2

    100

    24

    10

    4

     

     

    ISO Class 3

    1000

    237

    102

    35

    8

     

    ISO Class 4

    10000

    2370

    1020

    352

    83

     

    ISO Class 5

    100000

    23700

    10200

    3520

    832

    29

    ISO Class 6

    1000000

    237000

    102000

    35200

    8320

    293

    ISO Class 7

     

     

     

    352000

    83200

    2930

    ISO Class 8

     

     

     

    3520000

    832000

    29300

    ISO Class 9

     

     

     

    35200000

    8320000

    293000

    Though the new standard is being adopted internationally, there are countries where older version of standards are followed and slowly changing over to ISO 14644.

    Tables 1.4-1.7 are shown to assist in this conversion.

     

    1.9          Comparison of Cleanroom Standards

    Table 1.4

     ISO 14644-1

    ISO 14644-1

    Classification Number

     

    Maximum Concentration of Particles (Particles/m3)

     

    ≥0.1mm

    ≥0.2mm

    ≥0.3mm

    ≥0.5mm

    ≥1mm

    ≥5mm

    ISO Class 1

    10

    2

    ---

    ---

    ---

    ---

    ISO Class 2

    100

    24

    10

    4

    ---

    ---

    ISO Class 3

    1000

    237

    102

    35

    8

    ---

    ISO Class 4

    10000

    2370

    1020

    352

    83

    ---

    ISO Class 5

    100000

    23700

    10200

    3520

    832

    29

    ISO Class 6

    1000000

    237000

    102000

    35200

    8320

    293

    ISO Class 7

    ---

    ---

    ---

    352000

    83200

    2930

    ISO Class 8

    ---

    ---

    ---

    3520000

    832000

    29300

    ISO Class 9

    ---

    ---

    ---

    35200000

    8320000

    293000

     

    Table 1.5

     FS 209E

    Federal

    Standard

    209E

     

    Maximum Concentration of Particles (Particles/m3)

    SI

    ENG

    ISO

    ≥0.1mm

    ≥0.2mm

    ≥0.3mm

    ≥0.5mm

    ≥5mm

    M1

     

     

    350

    75.7

    30.9

    10

    ---

    M1.5

    1

    Class 3

    1240

    265

    106

    35.3

    ---

    M2

     

     

    3500

    757

    309

    100

    ---

    M2.5

    10

    Class 4

    12400

    26.5

    1060

    353

    ---

    M3

     

     

    35000

    7570

    3090

    1000

    ---

    M3.5

    100

    Class 5

    ---

    26500

    10600

    3530

    ---

    M4

     

     

    ---

    75700

    30900

    10000

    ---

    M4.5

    1000

    Class 6

    ---

    ---

    ---

    35300

    247

    M5

     

     

    ---

    ---

    ---

    100000

    618

    M5.5

    10000

    Class 7

    ---

    ---

    ---

    353000

    2470

    M6

     

     

    ---

    ---

    ---

    1000000

    6180

    M6.5

    100000

    Class 8

    ---

    ---

    ---

    3350000

    24700

    M7

     

     

    ---

    ---

    ---

    1000000

    61800

     

    Table 1.6

    EU cGMP Grade

    EU

    CGMP

    Grade

    ISO

    14644-1

    Fed Std

    209E

     

    Maximum Concentration of Particles (Particles/m3)

     

     

     

    At Rest

    In Operation

     

     

     

    ≥0.5mm

    ≥5mm

    ≥0.5mm

    ≥5mm

     

    A

    Class 5

    (at Rest)

    100(M3.5)

     

    3500

    0

    3500

    0

    B

    Class 5

    (at Rest)

    100(M3.5)

     

    3500

    0

    350000

    (Class 7)

    2000

    C

    Class 7

    (at Rest)

    10000

    (M5.5)

    350000

    2000

    3500000

    (Class 8)

    20000

    D

    Class 8

    (at Rest)

    100000

    (M6.5)

    3500000

    20000

    Not defined

    Not defined

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Table 1.7

    BS 5295

    BS 5295

    Maximum permitted number of particles per m3

    Cleanliness Class

    ISO

    14644-1

    0.3 mm

    0.5 mm

    5 mm

    10 mm

    25 mm

    C

    Class 3

    100

    35

    0

    NS

    NS

    D

    Class 4

    1000

    350

    0

    Ns

    NS

    E

    Class 5

    10000

    3500

    0

    NS

    NS

    F

     

    NS

    3500

    0

    NS

    NS

    G

    Class 6

    100000

    35000

    200

    0

    NS

    H

     

    NS

    35000

    200

    0

    Ns

    J

    Class 7

    NS

    350000

    2000

    450

    0

    K

    Class 8

    NS

    3500000

    20000

    4500

    500

    L

    Class 9

    NS

    NS

    200000

    45000

    5000

    M

     

    NS

    NS

    NS

    450000

    50000

     

    Go to top