Cleanroom Standards and Updates

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Magdalene Shaw
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1 Cleanroom Standards and Updates

2 Cleanroom Standards / Environmental Guides FED-STD 209E: Established Sept, 1992: Cancelled November 2001 ISO : Established May 1999 (replaces Fed-STD 209E, BS 5295) EU GGMP Annex 1 ISO DRAFT

3 Federal Standard 209E CLASS NAME FED-STD µM 0.2µM 0.3µM 0.5µM 5.0µM VOLUME UNITS VOLUME UNIT VOLUME UNIT VOLUME UNIT VOLUME UNIT S.I. ENGLISH (M 3 ) (FT 3 ) (M 3 ) (FT 3 ) (M 3 ) (FT 3 ) (M 3 ) (FT 3 ) (M 3 ) (FT 3 ) M M M M , , , M3 35, , , , M , , , M4 75,000 2,140 30, , M ,300 1, M5 100,000 2, M5.5 10, ,000 10,000 2, M6 1,000,000 28,300 6, M ,000 3,530, ,000 24, M7 10,000, ,300 61,800 17,500 IEST WG 100 has recommended to the GSA (U.S. General Services Group) that they (GSA) discontinue the use and maintenance of FED-STD-209. The next step is for GSA to poll the U.S. Federal Agencies on the proposal that FED-STD-s09 be dropped and that the Federal Agencies use ISO and 2. Many organizations refuse to change, stating the cost of document changes are too expensive to warrant replacement of the standard. It is commonly accepted still in some facilities in the United States and in Asia.

4 ISO ISO Classification Number ISO Cleanroom Classification 0.1µM 0.2µM 0.3µM 0.5µM 1.0µM 5.0µM VOLUME UNITS VOLUME UNIT VOLUME UNIT VOLUME UNIT VOLUME UNIT VOLUME UNIT (M 3 ) (M 3 ) (M 3 ) (M 3 ) (M 3 ) (M 3 ) ISO ISO ISO 3 1, ISO 4 10,000 2,370 1, ISO 5 100,000 23,700 10,200 3, ISO 6 1,000, , ,000 35,200 8, ISO 7 352,000 83,200 2,930 ISO 8 3,520, ,000 29,300 ISO 9 35,200,000 8,320, ,000

5 EU Guide to Good Manufacturing Annex 1 Manufacture of Sterile Medicinal Products Maximum permitted number of particles / m 3 Grade A 0.5µM 3,520 at rest equal to or above in operation 5µM 0.5µM 5µM 20 3, B 3, ,000 2,900 C 352,000 2,900 3,520,000 29,000 D 3,520,000 29,000 Not defined Not defined

6 Comparison ISO FED STD EU GMP (At rest) EU GMP (Operation) Grade A/B Grade A ,000 Grade C Grade B 8 100,000 Grade D Grade C 9

7 ISO Draft International Standard ISO Technical Committee 209 (TC 209) has been working on the revision of the basic airborne cleanliness classification standard for the last 4 years and has voted in favor of revision to update and improve the standard specifically to address the following: Simplify the classification process Remove the need to evaluate the 95% UCL for 2-9 sample locations Review the classification procedure and make it more applicable to rooms in operation. Generally update the standard as required to current thinking and industry requirements Avoid any radical change to the principles of the current ISO cleanliness classes 1-9

8 ISO Draft International Standard The DIS (draft International Standard). The revised standard has some important new and revised requirements: The classification would be based on a table (see fig.1.), With the well known formula used for the intermediate decimal classes In the current standard, the table is provided in an informative annex (see fig.3.). By using a look-up table as the basis for classification, it is easier to constrain the reader to appropriate particle sizes for specific classes

9 Fig.1 The basic classification table proposed in ISO DIS :2010 ISO Classification Number (N) Maximum allowable concentrations (particles / m³) for particles equal to and greater than the considered sizes shown below ISO &- 2 Draft ISO Class 1 10 International Standards 0.1µm 0.2µm 0.3µm 0.5µm 1.0µm 5.0µm ISO Class ISO Class 3 1, b 8 ISO Class 4 10,000 2,370 1, ISO Class 5 100,000 23,700 10,200 3, ISO Class 6 1,000, , ,000 35,200 8, ISO Class 7 352,000 83,200 2,930 ISO Class 8 3,520, ,000 29,300 ISO Class 9 35,200,000 8,320, ,000 ISO :1999 Cells in Yellow Reflect the omitted values in :DIS 2010

10 Fig.1 The basic classification table proposed in ISO DIS :2010 ISO Classification Number (N) Maximum allowable concentrations (particles / m³) for particles equal to and greater than the considered sizes shown below a) ISO &- 2 Draft International Standards 0.1µm 0.2µm 0.3µm 0.5µm 1.0µm 5.0µm ISO Class 1 10 b d d d d e ISO Class b d d e ISO Class 3 1, b d e ISO Class 4 10,000 2,370 1, b e ISO Class 5 100,000 23,700 10,200 3, e ISO Class 6 1,000, , ,000 35,200 8, ISO Class 7 c c c 352,000 83,200 2,930 ISO Class 8 c c c 3,520, ,000 29,300 ISO Class 9 c c c 35,200,000 8,320, ,000 a All concentrations in the table are cumulative, e.g. for ISO Class 5, the particles shown at 0,3 µm include all particles equal to and greater than this size. b These concentrations will lead to large air sample volumes for classification. Sequential sampling procedure may be applied; see Annex D. c Concentration limits are not applicable in this region of the table due to very high particle concentration. d Sampling and statistical limitations for particles in low concentrations make classification inappropriate. e Sample collection limitations for both particles in low concentrations and sizes greater than 1 μm make classification inappropriate, due to potential particle losses in the sampling system.

ISO 14644-1 Draft International Standard The current standard had a simple

number of sample locations has been based on a more rational basis intended to

11 ISO Draft International Standard The current standard had a simple calculation for the minimum number of sample points: In DIS: The selection of number of sample locations has been based on a more rational basis intended to confirm with 95% confidence that 90% of the cleanroom will meet the intended classification.

12 Area of cleanroom (m²)) less than or equal to ISO &- 2 Draft International Standards Minimum number of sample Locations to be tested (N L ) The selection of number of sample locations has been based on a more 32 8 rational basis intended 36 to confirm with 95% confidence that 990% of the cleanroom will meet 52 the intended classification NOTE 1 The number of sample locations are based on area units of 1, 2, and m², to achieve 95 % confidence that at least 90 % of the total area does not exceed the class limit

13 Area of cleanroom (m²)) less than or equal to ISO &- 2 Draft International Standards The selection of number of sample locations has been based on a more rational basis 36 intended to confirm with 95% 9 confidence that 90% of 6 the cleanroom will 52 meet the intended classification. 10 Comparison DIS verse DIS 1 1 CURRENT CURRENT

14 ISO Draft International Standard A semi-random sampling technique is proposed based on a "hypergeometric" distribution, which is the statistical model for sampling without replacement. This is a significant change from current practice, and means that each time a zone is classified, the sample locations may be different. If a firm has determined through a risk assessment, that certain locations need to be examined specifically, then these should be designated in addition to the randomly selected locations

ISO 14644-1 Draft International Standard What about 5.0µm in Grade A and B?

0 micron class limit for ISO 5 has been removed in the revised standard, parties

15 ISO Draft International Standard What about 5.0µm in Grade A and B? Recognizing that the <=5.0 micron class limit for ISO 5 has been removed in the revised standard, parties wishing to use the standard for classifying the environments EU GMP Grade A, and B "at rest" will have to use the macroparticle descriptor retained in the standard.

16 ISO International Standard Particle Counter Calibration Normative reference The following normative document contains provisions, which, through reference in this text, constitute provisions of this part of ISO Subsequent amendments to or revisions of this publication do not apply. However, parties to agreements based on this part of ISO are encouraged to investigate the possibility of applying the most recent editions of the normative document indicated below. ISO :2007, Determination of particle size distribution Single particle light interaction methods Part 4: Light scattering airborne particle counter for clean spaces

17 ISO Draft International Standard Title Change: Old: 2000 Cleanrooms and associated controlled environments Part 2: Testing and monitoring to prove continued compliance with ISO New: 2010 Cleanrooms and associated controlled environments Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO

18 ISO Draft International Standard Frequency intervals removed 4.2 Monitoring and periodic testing plan Requires a documented monitoring and periodic testing plan Plan to be based upon an assessment of risks

19 ISO &- 2 Draft International Standards Recertification: Table One Removed Classification Maximum time interval Test method ISO Class 5 6 months Annex B ISO :1999 > ISO Class 5 12 months Annex B ISO :1999 NOTE: Particle Count tests will normally be performed in the operational state, but may also be performed in the at-rest state in accordance with the designated ISO classification Every Year Now for ALL Classes Table 1 --Schedule of testing to demonstrate compliance with particle concentration limits.

20 It s a Draft, Baby, only a Draft If you really care and want to comment:

21 TC Cleanrooms and associated controlled environments Participating countries: 22 Observing countries: 19 Participating Countries: 22 Secretariat: USA (ANSI) Australia (SA) Kenya (KEBS) Belgium (NBN) South Korea (KAT) Brazil (ABNT) Netherlands (NEN) China (SAC) Norway (SN) Denmark (DS) Philippines (BPS) Finland (SFS) Portugal (IPQ) France (AFNOR) Russian Federation (GOST R) Germany (DIN) Sweden (SIS) Ireland (NSAI) Switzerland (SNV) Italy (UNI) United Kingdom (BSI) Japan (JISC) Observing Countries: 19 Argentina (IRAM) Bosnia and Herzegovina (BAS) Bulgaria (BDS) Cuba (NC) Czech Republic (UNMZ) Egypt (EOS) Hungary (MSZT) India (BIS) Iran (ISIRI) Jamaica (BSJ) Malaysia (DSM) Poland (PKN) Romania (ASRO) Saudi Arabia (SASO) Serbia (ISS) South Africa (SABS) Thailand (TISI) Turkey (TSE) Ukraine (DSSU)

BP Statistical Review of World Energy June 2017

BP Statistical Review of World Energy June 217 Primary energy 8 Consumption 8 Consumption by fuel 9 66 th edition Primary energy Consumption* Growth rate per annum Million tonnes oil equivalent 26 27 28