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Classifications: The 4 Elements of Cleanroom Construction Part 3

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AM Technical Solutions, Inc
AM Technical Solutions, Inc

One way AMTS is “Constructing an Intelligent Tomorrow” is through the work of our Cleanroom Performance Solutions group. In this 4-part series, our very own Emil Bordelon, a NEBB Certified Professional, outlines the four main elements of a cleanroom that are considered during the design, certification and maintenance phases. http://amcleanroombuild.com/

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1 AM Technical Solutions ConfidentialAM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved The 4 Elements of Cleanroom Construction FILTERS AIRFLOW CLASSIFICATIONS ROOM PRESSURE AMTS is a National Environmental Balancing Bureau (NEBB) Certified Firm Copyright AM Technical Solutions, Constructing an Intelligent Tomorrow www.amts.com HEPA Minimum Efficiency of 99.9997% ISO Class 5 (100) – ISO Class 8 (100,000) ULPA Minimum Efficiency of 99.9997% ISO Class 1 – ISO Class 4 (10) 1 2 43 Design Unidirectional, Non-Unidirectional, Mixed Testing Airflow Velocity, Airflow Volume, Airflow Visualization ISO 14644-1 Classes 1 – 9 Formerly referred to as the Federal Standard 209E Facility Certification Semi-annual or annual Differential Room Pressure Create airflow from a clean area to a less clean area Recommended Pressure .03 to .05 inches of water gauge
2 AM Technical Solutions ConfidentialAM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved The 4 Elements of Cleanroom Design, Certification and Maintenance Part 3
3 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved In this 4-part series, AM Technical Solution’s very own Emil Bordelon, a NEBB Certified Professional, outlines the four main elements of a cleanroom that are considered during the design, certification and maintenance phases. The 4 elements are: HEPA/ ULPA filters Airflow Cleanroom Classification Room Pressure
4 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Element 3: Cleanroom Classification • In November, 2001, the GSA cancelled the cleanroom certification standard, Federal Standard 209E (FS) and replaced it with ISO 14644-1. • In the last 13 years, Federal Standard 209E has not been an active specification but its terminology is still around. • If a customer is asked, “What is the classification of your cleanroom?” 8 out of 10 times they will use a FS 209 E classification even if the cleanroom is being certified to ISO 14644-1. • Why after all this time is this still happening? • One reason is the ISO 14644-1 cleanroom classification does not do much to identity the class. • For example, an ISO Class 6 shows 35,200 particles at 0.5 µm per cubic meter of air, whereas the Federal Standard class 1,000 (which is the equivalent of ISO class 6) means 1,000 particles at 0.5 µm per cubic foot of air. • The second reason is almost all particle counters have a one cubic foot of air per minute sample rate. • The results are reported in cubic feet per minute which means you have to think of class limits in cubic feet which leads you back to the Federal Standard 209E classification. • One cubic foot per minute sample must be multiplied by 35.315 to reach one cubic meter. • ISO 14644-1 requires all the results to be reported in cubic meters.
5 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Cleanroom Classification There are major differences between the two specifications: • The first is ISO 14644-1 is based on 0.1 µm whereas Federal Standard 209E was based on 0.5 µm thus the reason that the two specifications do not match up (see the chart below). • Two cleaner classes, ISO Class 1 & 2, and one less clean class, ISO Class 9 (room air), were added. • The ISO Class 1, 2 or 9 are rarely used.
6 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Cleanroom Classification • Another major change is that ISO 14644-1 is not a standalone specification. • It is one of 10 parts in the ISO 14644 series (see the list below). • There are plans to add more parts – ISO 14644-11 and 12 are in draft form right now. • Part 1: Classification of air cleanliness • Part 2: Specification for monitoring to prove continued compliance with ISO 14644-1 • Part 3: Test methods • Part 4: Design, construction and start-up • Part 5: Operations • Part 6: Vocabulary • Part 7: Separative devices( clean air hoods, gloveboxes, isolators, and mini-environments • Part 8: Classification of air cleanliness by chemical concentration • Part 9: Classification of surface cleanliness by particle concentration • Part 10: Classification of surface cleanliness by chemical concentration
7 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Design • As stated in Part 1 of this series, the dividing line between pharmaceutical and semiconductor cleanrooms is ISO Class 5. The majority of pharmaceutical cleanrooms are between ISO Class 5 and Class 8. • The majority of semiconductor cleanrooms are between ISO Class 3 and Class 5. • To determine the proper ISO Class the following requirements must be considered: 1. Type of product and process 2. Particle sizes and quantity that is detrimental to your product 3. Choose an ISO Class that fits that parameters of 1 and 2. • The next step in the cleanroom design phase is compliance to ISO 14644-1 which means meeting the requirement in ISO 14644-2. • There are different ways to stay compliant and the first step is to develop a monitoring program. • ISO 14644-2 defines what cleanroom monitoring is and what intervals are allowed.
8 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Monitoring • Observations made by measurements in accordance with a defined method and plan to provide evidence of the performance of an installation. • Below are listed the intervals: 1. Continuous: updating that occurs constantly 2. Frequent: updating that occurs at specified intervals not exceeding 60 minutes during operation 3. 6 Months: updating that occurs at an average interval not exceeding 183 days throughout periods of operational use, subject to no interval exceeding 190 days 4. 12 Months: updating that occurs at an average interval not exceeding 366 days throughout periods of operational use, subject to no interval exceeding 400 days 5. 24 Months: updating that occurs at an average interval not exceeding 731 days throughout periods of operational use, subject to no interval exceeding 800 days
9 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Monitoring • In section 4 of ISO 14664-2 as stated below in 4.2.4 and 4.2.5, if the facility is equipped with monitoring instruments the testing in Table 1 and 2 can be extended. • The most efficient way to install these monitoring instruments is during construction. • It can be retrofitted after construction but will be more costly and may involve down time for the facility. 4.2.4 • Where the installation is equipped with instrumentation for continuous or frequent monitoring of the airborne particle concentration, and air pressure difference, where applicable, the maximum time interval as stated in Table 1 may be extended, provided that the results of continuous or frequent monitoring remain within the specified limit(s).
10 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved •4.2.5 In those installations that require additional tests, and where the installation is equipped with instrumentation for continuous or frequent monitoring of the test parameter applicable, the maximum time interval(s) as stated in Table 2 may be extended, provided that the results of continuous or frequent monitoring remain within the specified limit(s). •The second way to stay compliant is to have the facility certified semi-annual or yearly depending on the cleanliness classification. •This may be a more cost efficient solution depending on the size of the facility and cost of the monitoring instrumentation. •Testing in Table 1 and 2 must be performed at the stated time interval for the cleanliness classification. Monitoring
11 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Testing • In Federal Standard 209E, the number of locations required to certify a cleanroom is based on cleanroom class and type of airflow design- unidirectional or non-unidirectional. • In ISO 14644-1, the number of locations is solely based off the size of the cleanroom in square meters. • The formula is the square root of the square meters of the cleanroom. • A 100 square meter (1076 Sq. Ft.) cleanroom would have a minimum of 10 locations. • The minimum number of locations is one with 3 samples or 3 locations. • The locations should be evenly distributed throughout the cleanroom. • For the sample volume, you should sample a sufficient volume of air that a minimum of 20 particles would be detected if the particle concentration for the largest considered particle size were at the class limit for the designated class. • For an ISO Class 1 cleanroom (10 particles @ 0.1 µm per cubic meter) the sample volume would be 2 cubic meters or 71 minutes with a 1 cubic foot per minute counter. • The minimum sampling time is one minute. • The particle counter industry has come out with some new particle counters with new features. • One is the ability to normalize the count to 1 cubic meter. • The counter will sample one cubic foot of air but would report the results in cubic meters which eliminates the need to multiply the results. • The other is a 50 liter per minute counter which would allow a 20 minute sample time for a cubic meter.
12 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Putting this to use: • For over twenty years, our Cleanroom Performance Solutions team has provided cleanroom testing, certification, reporting, construction and consultation services across multiple markets, such as Semiconductor, Life Sciences, Technology and Research. • With over 30 years of experience, and the NEBB Certification, the AM Technical Solutions Engineers and Technicians can identify and analyze cleanroom performance problems; and suggest the most effective solutions or self-perform the corrections. • Our Engineers and Technicians are experienced in the most sensitive environments such as ISO 14644, Class 1 through Class 9, and have helped develop the industry’s standard protocols and testing specifications, as well as some of the key instrumentation, testing media, and standard documentation in use today. View previously posted The 4 Elements of Cleanroom Construction Part 1 & Part 2

More Related Content

Classifications: The 4 Elements of Cleanroom Construction Part 3

  • 1. 1 AM Technical Solutions ConfidentialAM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved The 4 Elements of Cleanroom Construction FILTERS AIRFLOW CLASSIFICATIONS ROOM PRESSURE AMTS is a National Environmental Balancing Bureau (NEBB) Certified Firm Copyright AM Technical Solutions, Constructing an Intelligent Tomorrow www.amts.com HEPA Minimum Efficiency of 99.9997% ISO Class 5 (100) – ISO Class 8 (100,000) ULPA Minimum Efficiency of 99.9997% ISO Class 1 – ISO Class 4 (10) 1 2 43 Design Unidirectional, Non-Unidirectional, Mixed Testing Airflow Velocity, Airflow Volume, Airflow Visualization ISO 14644-1 Classes 1 – 9 Formerly referred to as the Federal Standard 209E Facility Certification Semi-annual or annual Differential Room Pressure Create airflow from a clean area to a less clean area Recommended Pressure .03 to .05 inches of water gauge
  • 2. 2 AM Technical Solutions ConfidentialAM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved The 4 Elements of Cleanroom Design, Certification and Maintenance Part 3
  • 3. 3 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved In this 4-part series, AM Technical Solution’s very own Emil Bordelon, a NEBB Certified Professional, outlines the four main elements of a cleanroom that are considered during the design, certification and maintenance phases. The 4 elements are: HEPA/ ULPA filters Airflow Cleanroom Classification Room Pressure
  • 4. 4 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Element 3: Cleanroom Classification • In November, 2001, the GSA cancelled the cleanroom certification standard, Federal Standard 209E (FS) and replaced it with ISO 14644-1. • In the last 13 years, Federal Standard 209E has not been an active specification but its terminology is still around. • If a customer is asked, “What is the classification of your cleanroom?” 8 out of 10 times they will use a FS 209 E classification even if the cleanroom is being certified to ISO 14644-1. • Why after all this time is this still happening? • One reason is the ISO 14644-1 cleanroom classification does not do much to identity the class. • For example, an ISO Class 6 shows 35,200 particles at 0.5 µm per cubic meter of air, whereas the Federal Standard class 1,000 (which is the equivalent of ISO class 6) means 1,000 particles at 0.5 µm per cubic foot of air. • The second reason is almost all particle counters have a one cubic foot of air per minute sample rate. • The results are reported in cubic feet per minute which means you have to think of class limits in cubic feet which leads you back to the Federal Standard 209E classification. • One cubic foot per minute sample must be multiplied by 35.315 to reach one cubic meter. • ISO 14644-1 requires all the results to be reported in cubic meters.
  • 5. 5 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Cleanroom Classification There are major differences between the two specifications: • The first is ISO 14644-1 is based on 0.1 µm whereas Federal Standard 209E was based on 0.5 µm thus the reason that the two specifications do not match up (see the chart below). • Two cleaner classes, ISO Class 1 & 2, and one less clean class, ISO Class 9 (room air), were added. • The ISO Class 1, 2 or 9 are rarely used.
  • 6. 6 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Cleanroom Classification • Another major change is that ISO 14644-1 is not a standalone specification. • It is one of 10 parts in the ISO 14644 series (see the list below). • There are plans to add more parts – ISO 14644-11 and 12 are in draft form right now. • Part 1: Classification of air cleanliness • Part 2: Specification for monitoring to prove continued compliance with ISO 14644-1 • Part 3: Test methods • Part 4: Design, construction and start-up • Part 5: Operations • Part 6: Vocabulary • Part 7: Separative devices( clean air hoods, gloveboxes, isolators, and mini-environments • Part 8: Classification of air cleanliness by chemical concentration • Part 9: Classification of surface cleanliness by particle concentration • Part 10: Classification of surface cleanliness by chemical concentration
  • 7. 7 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Design • As stated in Part 1 of this series, the dividing line between pharmaceutical and semiconductor cleanrooms is ISO Class 5. The majority of pharmaceutical cleanrooms are between ISO Class 5 and Class 8. • The majority of semiconductor cleanrooms are between ISO Class 3 and Class 5. • To determine the proper ISO Class the following requirements must be considered: 1. Type of product and process 2. Particle sizes and quantity that is detrimental to your product 3. Choose an ISO Class that fits that parameters of 1 and 2. • The next step in the cleanroom design phase is compliance to ISO 14644-1 which means meeting the requirement in ISO 14644-2. • There are different ways to stay compliant and the first step is to develop a monitoring program. • ISO 14644-2 defines what cleanroom monitoring is and what intervals are allowed.
  • 8. 8 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Monitoring • Observations made by measurements in accordance with a defined method and plan to provide evidence of the performance of an installation. • Below are listed the intervals: 1. Continuous: updating that occurs constantly 2. Frequent: updating that occurs at specified intervals not exceeding 60 minutes during operation 3. 6 Months: updating that occurs at an average interval not exceeding 183 days throughout periods of operational use, subject to no interval exceeding 190 days 4. 12 Months: updating that occurs at an average interval not exceeding 366 days throughout periods of operational use, subject to no interval exceeding 400 days 5. 24 Months: updating that occurs at an average interval not exceeding 731 days throughout periods of operational use, subject to no interval exceeding 800 days
  • 9. 9 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Monitoring • In section 4 of ISO 14664-2 as stated below in 4.2.4 and 4.2.5, if the facility is equipped with monitoring instruments the testing in Table 1 and 2 can be extended. • The most efficient way to install these monitoring instruments is during construction. • It can be retrofitted after construction but will be more costly and may involve down time for the facility. 4.2.4 • Where the installation is equipped with instrumentation for continuous or frequent monitoring of the airborne particle concentration, and air pressure difference, where applicable, the maximum time interval as stated in Table 1 may be extended, provided that the results of continuous or frequent monitoring remain within the specified limit(s).
  • 10. 10 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved •4.2.5 In those installations that require additional tests, and where the installation is equipped with instrumentation for continuous or frequent monitoring of the test parameter applicable, the maximum time interval(s) as stated in Table 2 may be extended, provided that the results of continuous or frequent monitoring remain within the specified limit(s). •The second way to stay compliant is to have the facility certified semi-annual or yearly depending on the cleanliness classification. •This may be a more cost efficient solution depending on the size of the facility and cost of the monitoring instrumentation. •Testing in Table 1 and 2 must be performed at the stated time interval for the cleanliness classification. Monitoring
  • 11. 11 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Testing • In Federal Standard 209E, the number of locations required to certify a cleanroom is based on cleanroom class and type of airflow design- unidirectional or non-unidirectional. • In ISO 14644-1, the number of locations is solely based off the size of the cleanroom in square meters. • The formula is the square root of the square meters of the cleanroom. • A 100 square meter (1076 Sq. Ft.) cleanroom would have a minimum of 10 locations. • The minimum number of locations is one with 3 samples or 3 locations. • The locations should be evenly distributed throughout the cleanroom. • For the sample volume, you should sample a sufficient volume of air that a minimum of 20 particles would be detected if the particle concentration for the largest considered particle size were at the class limit for the designated class. • For an ISO Class 1 cleanroom (10 particles @ 0.1 µm per cubic meter) the sample volume would be 2 cubic meters or 71 minutes with a 1 cubic foot per minute counter. • The minimum sampling time is one minute. • The particle counter industry has come out with some new particle counters with new features. • One is the ability to normalize the count to 1 cubic meter. • The counter will sample one cubic foot of air but would report the results in cubic meters which eliminates the need to multiply the results. • The other is a 50 liter per minute counter which would allow a 20 minute sample time for a cubic meter.
  • 12. 12 AM Technical Solutions Confidential © AM Technical Solutions, Inc. All rights reserved Putting this to use: • For over twenty years, our Cleanroom Performance Solutions team has provided cleanroom testing, certification, reporting, construction and consultation services across multiple markets, such as Semiconductor, Life Sciences, Technology and Research. • With over 30 years of experience, and the NEBB Certification, the AM Technical Solutions Engineers and Technicians can identify and analyze cleanroom performance problems; and suggest the most effective solutions or self-perform the corrections. • Our Engineers and Technicians are experienced in the most sensitive environments such as ISO 14644, Class 1 through Class 9, and have helped develop the industry’s standard protocols and testing specifications, as well as some of the key instrumentation, testing media, and standard documentation in use today. View previously posted The 4 Elements of Cleanroom Construction Part 1 & Part 2