classifications of clean rooms

6
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ñPP HJ D&ODVV0 URRP KDVDSDUW LFOHO LP LW IRUSDUW LFOHVñP P RIP 7KLVLV VKRZLQ7DEOH 7DEOH) HGHUDO 6WDQGDUG( $LUERUQH3DUWLFXODWH&OHDQOLQHVV&ODVVHV &ODVVLILFDW LRQV2 I &OHDQ5RRP V KWW S ZZZ ILOWHUDLULQIRDUW LFOHVDUW LFOHFIP $UW LFOH ,' ( &$ $

Upload: rizwanul-fattah

Post on 11-Mar-2015

67 views

Category:

Documents


12 download

DESCRIPTION

Classifications of Clean Rooms for Pharmaceutical Industries.

TRANSCRIPT

/ RJLQ + R P H 5HS�/ RFDWRU &DWDORJ ,$4 � &DOFXODWRU / LWHUDWXUH�/ LEUDU\ 7HFKQLFDO�$ UWLFOHV

5HODWHG�,QIRUPDWLRQ) LOWHU�%OHHG�7KURXJK) LOWHU�6HOHFWLRQ+ ( 3 $ �8/ 3$�7HVWLQJ+LJK�7HPS�) LOWHUV

6LWH�) HDWXUHV

$LU�4XDOLW\

$QWKUD[

$YDLODEOH�/ LWHUDWXUH

&RQWDLQPHQW�6\ VWHPV

&XUUHQW�( YHQWV

& \ WRWR[LFLW\

) LEHU�6 L] H

+HDOWK�&DUH

,$4 � $QDO\ VLV

0 ( 5 9

0ROG

3KDUPDFHXWLFDO

6 $ 5 6

6FKRRO�,$4

&ODVVLILFDWLRQV�2 I�&OHDQ�5 RRP V

&OHDQ�URRPV�DUH�FODVVLILHG�E\ � WKH�FOHDQOLQHVV�RI�WKHLU�DLU�7 KH�PHWKRG�PRVW�HDVLO\ � X QGHUVWRRG�DQG�PRVWXQLYHUVDOO\ � DSSOLHG�LV�WKH�RQH�VXJJHVWHG�LQ�WKH�HDUOLHU�YHUVLRQV�$�WR�' � RI�) HGHUDO �WDQGDUG�RI�WKH�8 6 $�,QWKLV�ROG�VWDQGDUG�WKH�QXPEHU�RI�SDUWLFOHV�HTXDO�WR�DQG�JUHDWHU�WKDQ�P �P �LV�PHDVX UHG�LQ�RQH�FXELF�IRRW�RI�DLUDQG�WKLV�FRXQW�XVHG�WR�FODVVLI\ � WKH�URRP�7 KH�PRVW�UHFHQW�( � YHUVLRQ�KDV�DOVR�DFFH SWHG�D�PHWULFQRPHQFODWXUH�,Q�WKH�8 . � WKH�%ULWLVK�6 WDQGDUG�SXEOLVKHG�LQ�LV�DOVR�XVHG�W R�FODVVLI\ � FOHDQ�URRPV�7 KLVVWDQGDUG�LV�DERXW�WR�EH�VXSHUVHGHG�E\ � %6�( 1 � ,6 2

) HGHUDO�6WDQGDUG

7KLV�VWDQGDUG�ZDV�ILUVW�SXEOLVKHG�LQ�LQ�WKH�8 6 � DQG�WLWOHG�&OHDQ�5 RRP�DQG�: RUN� 6 WDWLRQ�5 HTXLUHPHQWV�&RQWUROOHG�( QYLURQPHQWV�,W�Z DV�UHYLVHG�LQ�$ � %�& � � DQG�( � ,W�LVDYDLODEOH�IURP�

,QVWLWXWH�RI�( QYLURQPHQWDO�6 FLHQFHV�DQG�7HFKQRORJ\� DVW�1 RUWKZHVW�+LJKZD\0 RXQW�3URVSHFW�,OOLQRLV�8 6 $7HO)D[H�PDLO LHVW# LHVW�RUJ

7KH�FOHDQ�URRP�FODVVLILFDWLRQV�JLYHQ�LQ�WKH�HDUOLHU�$ � WR�' � YHUVLRQV�DUH�VKRZQ�LQ�7DE OH

7DEOH�) HGHUDO�6WDQGDUG�' � &ODVV�/ LP LWV

,Q�WKH�QHZ�( � SXEOLVKHG�LQ�WKH�DLUERUQH�FRQFHQWUDWLRQV�LQ�WKH�URRP�DUH�JLYHQ� LQPHWULF�XQLWV�L�H�SHU�PDQG�WKH�FODVVLILFDWLRQV�RI�WKH�URRP�GHILQHG�DV�WKH�ORJDULWKP�RI�WKHDLUERUQH�FRQFHQWU DWLRQ�RI�SDUWLFOHV�ñ�P �PH�J�D�&ODVV�0 � URRP�KDV�D�SDUWLFOH�OLPLW�IRUSDUWLFOHV�ñ�P �P �RI�P �7 KLV�LV �VKRZ�LQ�7DEOH

7DEOH�) HGHUDO�6WDQGDUG�( � $LUERUQH�3 DUWLFXODWH�&OHDQOLQHVV�&ODVVHV

&ODVVLILFDWLRQV�2 I�&OHDQ�5RRP V KWWS�Z Z Z�ILOWHUDLU�LQIR�DUWLFOHV�DUWLFOH�FIP � $ UWLFOH,' � ( &$ � $

�� � �

%ULWLVK�6WDQGDUG

7KLV�VWDQGDUG�LV�DYDLODEOH�IURP�

%�6 � ,�6 WDQGDUGV����&KLV�+LJK�5 RDG/ RQGRQ�: � $ /7HO)D[H�PDLO LQIR# EVL�RUJ � XN

%HFDXVH�RI�WKH�LPPLQHQW�SXEOLFDWLRQ�RI�( 1 � ,6 2 � SDUWV�RI�WKLV�%ULWLVK�6 WDQGDUG �KDY�D�OLPLWHG�OLIH�3 DUWV�Z LOOEH�VXSHUVHGHG�E\ � WKH�,6 2 � VWDQGDUGV�DV�WKH\ � DSSHDU�DV�DQ�( 1 � VWDQGDUG�

7KH�%ULWLVK�6WDQGDUG�LV�LQ�ILYH�SDUWV�7KHVH�DUH�

3DUW�* HQHUDO�LQWURGXFWLRQ�DQG�WHUPV�DQG�GHILQLWLRQV�IRU�FOHDQ�URRPV�DQG�FOHDQ�DL U�GHYLFHV�SDJHV�

3DUW�6 SHFLILFDWLRQ�IRU�FOHDQ�URRPV�DQG�FOHDQ�DLU�GHYLFHV�SDJHV�

3DUW�0 HWKRG�IRU�VSHFLI\ LQJ�WKH�GHVLJQ�FRQVWUXFWLRQ�DQG�FRPPLVVLRQLQJ�RI�FOHDQ�U RRP�DQG�FOHDQ�DLU�GHYLFHV�����S�

3DUW�* XLGH�WR�RSHUDWLRQDO�SURFHGXUHV�DQG�GLVFLSOLQHV�DSSOLFDEOH�WR�FOHDQ�URRPV�D QG�FOHDQ�DLU�GHYLFHVSDJHV�

3DUW�6 SHFLILFDWLRQ�IRU�PRQLWRULQJ�FOHDQ�URRPV�DQG�FOHDQ�DLU�GHYLFHV�WR�SURYH�FRQ WLQXHG�FRPSOLDQFH�Z LWK�%6������

3DUW�RI�WKH�VWDQGDUG�FRQWDLQV�WHQ�FODVVHV�RI�HQYLURQPHQWDO�FOHDQOLQHVV�6 KRZ Q�LQ�7 DEOH�DUH�WKH�FODVVHV�JLYHQLQ�WKH�VWDQGDUG�$OO�FODVVHV�KDYH�SDUWLFOH�FRXQWV�VSHFLILHG�IRU�DW�OHDVW�WZR�SDUWLFO H�VL] H�UDQJHV�WR�SURYLGH�DGHTXDWHFRQILGHQFH�RYHU�WKH�UDQJH�RI�SDUWLFOH�VL]H�UHOHYDQW�WR�HDFK�FODVV�

7DEOH�%5 � ( QYLURQP HQWDO�&OHDQOLQHVV�&ODVVHV

&ODVVLILFDWLRQV�2 I�&OHDQ�5RRP V KWWS�Z Z Z�ILOWHUDLU�LQIR�DUWLFOHV�DUWLFOH�FIP � $ UWLFOH,' � ( &$ � $

�� � �

%6� ( 1 � ,62 � 6WDQGDUG

%HFDXVH�RI�WKH�ODUJH�QXPEHU�RI�FOHDQ�URRP�VWDQGDUGV�SURGXFHG�E\ � LQGLYLGXDO�FRXQWULHV �L�LV�YHU\ � GHVLUDEOH�WKDWRQH�Z RUOGZLGH�VWDQGDUG�RI�FOHDQ�URRP�FODVVLILFDWLRQ�LV�SURGXFHG�7 KH�ILUVW�,6 2 � VWDQG DUG�RQ�FOHDQ�URRPV�KDV�EHHQSXEOLVKHG�- XQH�DV�µ&ODVVLILFDWLRQ�RI�$LU�&OHDQOLQHVV¶�,W�LV�DERXW�WR �E�DGRSWHG�DV�D�( XURSHDQVWDQGDUG�DQG�KHQFH�D�VWDQGDUG�IRU�DOO�FRXQWULHV�LQ�WKH�( 8 � 7 KLV�VWDQGDUG�LV�DYDLODEO H�IURP�VWDQGDUG�RUJDQL] DWLRQVWKURXJKRXW�WKH�Z RUOG�DQG�LQ�WKH�8 . � LV�DYDLODEOH�IURP�WKH�%6 ,�6 KRZ Q�LQ�7DEOH�LV�WK H�FODVVLILFDWLRQ�WKDW�KDV�EHHQDGRSWHG�7DEOH�6 HOHFWHG�,62 � DLUERUQH�SDUWLFXODWH�FOHDQOLQHVV�FODVVHV�IRU�FOHD Q�URRPV�DQG�FOHDQ�] RQHV�

7KH�WDEOH�LV�GHULYHG�IURP�WKH�IROORZ LQJ�IRUPXOD�

ZKHUH�

&ODVVLILFDWLRQV�2 I�&OHDQ�5RRP V KWWS�Z Z Z�ILOWHUDLU�LQIR�DUWLFOHV�DUWLFOH�FIP � $ UWLFOH,' � ( &$ � $

�� � �

&Q�UHSUHVHQWV�WKH�PD[ LPXP�SHUPLWWHG�FRQFHQWUDWLRQ�LQ�SDUWLFOHV�P �RI�DLU�RI�DLUE RUQH�SDUWLFOHV�WKDW�DUH�HTXDO�WRRU�ODUJHU�WKDQ�WKH�FRQVLGHUHG�SDUWLFOH�VL]H�&Q�LV�URXQGHG�WR�WKH�QHDUHVW�Z KROH�QXPE HU�1 � LV�WKH�,6 2 � FODVVLILFDWLRQQXPEHU�ZKLFK�VKDOO�QRW�H[FHHG�WKH�YDOXH�RI�,QWHUPHGLDWH�,6 2 � FODVVLILFDWLRQ�QXPEH UV�PD\ � EH�VSHFLILHG�ZLWKWKH�VPDOOHVW�SHUPLWWHG�LQFUHPHQW�RI�1 � ' � LV�WKH�FRQVLGHUHG�SDUWLFOH�VL]H�LQ�P �P �L�D�FRQVWDQW�ZLWK�D�GLPHQVLRQRI�P �P �7DEOH�VKRZ V�D�FURVVRYHU�WR�WKH�ROG�) 6 � FODVVHV�H�J� ,6 2 � LV�HTXLYDOHQW �R�WKH�ROG�) 6 � &ODVV

7KH�RFFXSDQF\ � VWDWH�LV�GHILQHG�LQ�WKLV�VWDQGDUG�DV�IROORZV�

$V�EXLOW�WKH�FRQGLWLRQ�Z KHUH�WKH�LQVWDOODWLRQ�LV�FRPSOHWH�ZLWK�DOO�VHUYLFHV�FRQQHFW HG�DQG�IXQFWLRQLQJ�EXW�Z LWK�QRSURGXFWLRQ�HTXLSPHQW�PDWHULDOV�RU�SHUVRQQHO�SUHVHQW�

$W�UHVW� �7K�FRQGLWLRQ�ZKHUH�WKH�LQVWDOODWLRQ�LV�FRPSOHWH�ZLWK�HTXLSPHQW�LQVWDOOHG�DQG�RSHUD WLQJ�LQ�D�PDQQHUDJUHHG�EHWZ HHQ�WKH�FXVWRPHU�DQG�VXSSOLHU�EXW�ZLWK�QR�SHUVRQQHO�SUHVHQW�

2SHUDWLRQDO��7K�FRQGLWLRQ�Z KHUH�WKH�LQVWDOODWLRQ�LV�IXQFWLRQLQJ�LQ�WKH�VSHFLILHG�PDQQHU�Z LWK�W KH�VSHFLILHGQXPEHU�RI�SHUVRQQHO�SUHVHQW�DQG�ZRUNLQJ�LQ�WKH�PDQQHU�DJUHHG�XSRQ�7KH�VWDQGDUG�DOVR �LYHV�D�PHWKRG�E\ZKLFK�WKH�SHUIRUPDQFH�RI�D�FOHDQ�URRP�PD\ � EH�YHULILHG�L�H�VDPSOLQJ�ORFDWLRQV�VDPSO H�YROXPH�HWF�7 KHVH�DUHVLPLODU�WR�) 6 � ,W�DOVR�LQFOXGHV�D�PHWKRG�IRU�VSHFLI\ LQJ�D�URRP�XVLQJ�SDUWLFOHV�R XWVLGH�WKH�VL] H�UDQJH�JLYHQ�LQWKH�WDEOH�6 PDOOHU�SDUWLFOHV�XOWUDILQH�Z LOO�EH�RI�SDUWLFXODU�XVH�WR�WKH�VHPLFRQG XFWRU�LQGXVWU\ � DQG�WKH�ODUJH�ñ�PP �PDFUR�SDUWLFOHV�Z LOO�EH�RI�XVH�LQ�LQGXVWULHV�VXFK�DV�SDUWV�RI�WKH�PHGLFDO�GHYLFH� LQGXVWU\ �ZKHUH�VPDOO�SDUWLFOHVDUH�RI�QR�SUDFWLFDO�LPSRUWDQFH�) LEHUV�FDQ�DOVR�EH�XVHG�

7KH�PHWKRG�HPSOR\ HG�ZLWK�PDFUR�SDUWLFOHV�LV�WR�XVH�WKH�IRUPDW�

µ0 � D�E�F¶

ZKHUH

D�LV�WKH�PD[LPXP�SHUPLWWHG�FRQFHQWUDWLRQ�P �E�LV�WKH�HTXLYDOHQW�GLDPHWHU�F�LV�WKH�VSHFLILHG�PHDVXUHPHQW�PHWKRG�

$Q�H[ DPSOH�ZRXOG�EH�

µ0 � P �P �WR�P �P �FDVFDGH�LPSDFWRU�IROORZ HG�E\ � PLFURVFRSLF�VL]LQJ�DQGFRXQWLQJ¶�

3KDUPDFHXWLFDO�&OHDQ�5 RRP � &ODVVLILFDWLRQ

( 8 � * * 0 3

7KH�PRVW�UHFHQW�VHW�RI�VWDQGDUGV�IRU�XVH�LQ�( XURSH�FDPH�LQWR�RSHUDWLRQ�RQ�WKH�VW�RI �-DQXDU� 7 KLV�LVFRQWDLQHG�LQ�D�µ5 HYLVLRQ�RI�WKH�$QQH[ �WR�WKH�( 8 � * XLGH�WR�* RRG�0 DQXIDFWXULQJ�3 UDFWLFH �0DQXIDWXUH�RI�6 WHULOH0 HGLFLQDO�3 URGXFWV¶�7 KH�IROORZLQJ�LV�DQ�H[ WUDFW�RI�WKH�LQIRUPDWLRQ�LQ�WKH�VWDQGDUG� WKDW�LV�UHOHYDQW�WR�WKH�GHVLJQ�RIFOHDQ�URRPV�

)RU�WKH�PDQXIDFWXUH�RI�VWHULOH�PHGLFLQDO�SURGXFWV�IRXU�JUDGHV�DUH�JLYHQ�7 KH�DLUERUQ H�SDUWLFXODWH�FODVVLILFDWLRQ�IRUWKHVH�JUDGHV�LV�JLYHQ�LQ�WKH�IROORZLQJ�WDEOH�

1RWHV���,Q�RUGHU�WR�UHDFK�WKH�%�&�DQG�' � DLU�JUDGHV�WKH�QXPEHU�RI�DLU�FKDQJHV�VKRXOG�EH �UHODWH�WR�WKH�VL] H�RI�WKH�URRP � DQG�WKHHTXLSPHQW�DQG�SHUVRQQHO�SUHVHQW�LQ�WKH�URRP�7KH�DLU�V\ VWHP � VKRXOG�EH�SURYLGHG�ZLWK� DSSURSULDWH�ILOWHUV�VXFK�DV�+ ( 3$� IRUJUDGHV�$�%�DQG�&���7KH�JXLGDQFH�J LYHQ�IRU�WKH�PD[ LPXP � SHUPLWWHG�QXPEHU�RI�SDUWLFOHV�LQ�WKH�DW�UHVW ��FRQWLRQ�FRUUHVSRQGV�DSSUR[ LPDWHO\

&ODVVLILFDWLRQV�2 I�&OHDQ�5RRP V KWWS�Z Z Z�ILOWHUDLU�LQIR�DUWLFOHV�DUWLFOH�FIP � $ UWLFOH,' � ( &$ � $

�� � �

WR�WKH�86�) HGHUDO�6WDQGDUG�( � DQG�WKH�,62 � FODVVLILFDWLRQV�DV�IROORZ V�JUDGHV�$ � DQG ��FRUUHVSRQG�ZLWK�FODVV�0,62 � JUDGH�&�Z LWK�FODVV�0 � ,6 2 � DQG�JUDGH�' � Z LWK�FODVV�0 � � ,��7KH�UHTXLUHPHQW�DQG�OLP LW�IRU�WKLV�DUHD�ZLOO�GHSHQG�RQ�WKH�QDWXUH�RI�WKH�RSHUDWL RQV�FDUULHG�RXW�7KH�SDUWLFXODWH�FRQGLWLRQVJLYHQ�LQ�WKH�WDEOH�IRU�WKH�DW�UHVW�VWDWH�VKRXOG�EH�DFKLHYHG�LQ�WKH�XQPDQQHG�VWDWH� DIWHU�D�VKRUW�FOHDQ�XS�SHULRG�RIP LQXWHV�J XLGDQFH�YDOXH�DIWHU�FRPSOHWLRQ�RI�RSHUDWLRQV�7KH�SDUWLFXODWH�FRQGLWLRQV �IR�JUDGH�$�LQ�RSHUDWLRQ�JLYHQ�LQ�WKHWDEOH�VKRXOG�EH�P DLQWDLQHG�LQ�WKH�] RQH�LP PHGLDWHO\ � VXUURXQGLQJ�WKH�SURGXFW�ZKHQHYHU� WKH�SURGXFW�RU�RSHQ�FRQWDLQHU�LVH[SRVHG�WR�WKH�HQYLURQP HQW�,W�LV�DFFHSWHG�WKDW�LW�PD\ � QRW�DOZD\ V�EH�SRVVLEOH�WR�GHP RQVWUDWH�FRQIRUP LW\ � ZLWK�SDUWLFXODWHVWDQGDUGV�DW�WKH�SRLQW�RI�ILOO�Z KHQ�ILOOLQJ�LV�LQ�SURJUHVV�GXH�WR�WKH�JHQHUDWLRQ�RI �SDWLFOHV�RU�GURSOHWV�IURP�WKH�SURGXFW�LWVHOI�([DPSOHV�RI�RSHUDWLRQV�WR�EH�FDUULHG�RXW�LQ�WKH�YDULRXV�JUDGHV�DUH�JLYHQ�LQ�WKH�WDEO H�EHORZ�VHH�DOVR�SDU�DQG

$GGLWLRQDO�PLFURELRORJLFDO�PRQLWRULQJ�LV�DOVR�UHTXLUHG�RXWVLGH�SURGXFWLRQ�RSHUDWLRQV ��J�DIWHU�YDOLGDWLRQ�RIV\VWHPV�FOHDQLQJ�DQG�VDQLWL] DWLRQ�

1RWHV���7KHVH�DUH�DYHUDJ H�YDOXHV���,QGLYLGXDO�VHWWOH�SODWHV�PD\ � EH�H[ SRVHG�IRU�OHVV�WKDQ�KRXUV���$SSURSULDWH�DOHUW�DQG�DFWLRQ�OLP LWV�VKRXOG�EH�VHW�IRU�WKH�UHVXOWV�RI�SDUWLFXODWH �DQ�PLFURELRORJLFDO�PRQLWRULQJ�,I�WKHVHOLP LWV�DUH�H[ FHHGHG�RSHUDWLQJ�SURFHGXUHV�VKRXOG�SUHVFULEH�FRUUHFWLYH�DFWLRQ�

,VRODWRU�DQG�%ORZ � ) LOO�7HFKQRORJ\ � H[ WUDFW�RQO\ �

7KH�DLU�FODVVLILFDWLRQ�UHTXLUHG�IRU�WKH�EDFNJURXQG�HQYLURQPHQW�GHSHQGV�RQ�WKH�GHVLJQ �R�WKH�LVRODWRU�DQG�LWVDSSOLFDWLRQ�,W�VKRXOG�EH�FRQWUROOHG�DQG�IRU�DVHSWLF�SURFHVVLQJ�EH�DW�OHDVWJUDGH�' �

%ORZ�ILOO�VHDO�HTXLSPHQW�XVHG�IRU�DVHSWLF�SURGXFWLRQ�ZKLFK�LV�ILWWHG�ZLWK�DQ�HIIHFWL YH�JUDGH�$�DLU�VKRZHU�PD\ � EHLQVWDOOHG�LQ�DW�OHDVW�D�JUDGH�& �HQYLURQPHQW�SURYLGHG�WKDW�JUDGH�$�%�FORWKLQJ�LV�XVH G�7 KH�HQYLURQPHQW�VKRXOGFRPSO\ � ZLWK�WKH�YLDEOH�DQG�QRQ�YLDEOH�OLPLWV�DW�UHVW�DQG�WKH�YLDEOH�OLPLW�RQO\ � Z KHQ� LQ�RSHUDWLRQ�%ORZ�ILOO�VHDOHTXLSPHQW�XVHG�IRU�WKH�SURGXFWLRQ�RI�SURGXFWV�IRU�WHUPLQDO�VWHULOL]DWLRQ�VKRXOG�EH�L QVWDOOHG�LQ�DW�OHDVW�D�JUDGH�'HQYLURQPHQW�

* XLGHOLQH�RQ�6WHULOH�' UXJ�3URGXFWV�3 URGXFHG�E\ � $ VHSWLF�3URFHVVLQJ

7KLV�GRFXPHQW�LV�SURGXFHG�E\ � WKH�) ' $�LQ�WKH�8 6 $ � DQG�SXEOLVKHG�LQ�7ZR�DUHDV�DUH �GHILQH�7KH�µFULWLFDODUHD¶�LV�Z KHUH�WKH�VWHULOL] HG�GRVDJH�IRUP�FRQWDLQHUV�DQG�FORVXUHV�DUH�H[SRVHG�WR�W KH�HQYLURQPHQW�7 KHµFRQWUROOHG�DUHD¶�LV�ZKHUH�XQVWHULOL] HG�SURGXFW�LQ�SURFHVV�PDWHULDOV�DQG�FRQWDLQHU �ORVXUHV�DUH�SUHSDUHG�

&ODVVLILFDWLRQV�2 I�&OHDQ�5RRP V KWWS�Z Z Z�ILOWHUDLU�LQIR�DUWLFOHV�DUWLFOH�FIP � $ UWLFOH,' � ( &$ � $

�� � �

7KH�HQYLURQP HQWDO�UHTXLUHP HQWV�IRU�WKHVH�WZR�DUHDV�JLYHQ�LQ�WKH�* XLGH�DUH�DV�IROORZ V

&ULWLFDO�DUHDV�µ$ LU�LQ�WKH�LPPHGLDWH�SUR[ LPLW\ � RI�H[ SRVHG�VWHULOL]HG�FRQWDLQHUV�FORV XUHV�DQG�ILOOLQJ�FORVLQJRSHUDWLRQV�LV�RI�DFFHSWDEOH�SDUWLFXODWH�TXDOLW\ � ZKHQ�LW�KDV�D�SHU�FXELF�IRRW�SDUWLFO H�FRXQW�RI�QR�PRUH�WKDQ�LQ�DVL]H�UDQJH�RI�PLFURQ�DQG�ODUJHU�&ODVV�ZKHQ�PHDVXUHG�QRW�PRUH�WKDQ�RQH�IRRW �DZD� IURP�WKH�ZRUN�VLWH�DQG�XSVWUHDP�RI�WKH�DLU�IORZ�GXULQJ�ILOOLQJ�FORVLQJ�RSHUDWLRQV�7 KH�DJHQF\ � UHFRJQL] HV�WKDW�VRPH�SRZGHU�ILOOLQJRSHUDWLRQV�PD\ � JHQHUDWH�KLJK�OHYHOV�RI�SRZ GHU�SDUWLFXODWHV�ZKLFK�E\ � WKHLU�QDWXUH�GR �QW�SRVH�D�ULVN�RI�SURGXFWFRQWDPLQDWLRQ�,W�PD\ � QRW�LQ�WKHVH�FDVHV�EH�IHDVLEOH�WR�PHDVXUH�DLU�TXDOLW\ � Z LWKLQ �KH�RQH�IRRW�GLVWDQFH�DQG�VWLOOGLIIHUHQWLDWH�EDFNJURXQG�QRLVH�OHYHOV�RI�SRZ GHU�SDUWLFOHV�IURP�DLU�FRQWDPLQDQWV�Z KLFK�FDQ�LPSHDFK�SURGXFWTXDOLW\� ,Q�WKHVH�LQVWDQFHV�LW�LV�QRQHWKHOHVV�LPSRUWDQW�WR�VDPSOH�WKH�DLU�LQ�D�PDQQ HU�Z KLFK�WR�WKH�H[WHQW�SRVVLEOHFKDUDFWHUL]HV�WKH�WUXH�OHYHO�RI�H[ WULQVLF�SDUWLFXODWH�FRQWDPLQDWLRQ�WR�ZKLFK�WKH�SUR GXFW�LV�H[SRVHG�

$LU�LQ�FULWLFDO�DUHDV�VKRXOG�EH�VXSSOLHG�DW�WKH�SRLQW�RI�XVH�DV�+ ( 3 $�ILOWHUHG�ODPLQD U�IORZ � DLU�KDYLQJ�D�YHORFLW\VXIILFLHQW�WR�VZHHS�SDUWLFXODWH�PDWWHU�DZD\ � IURP�WKH�ILOOLQJ�FORVLQJ�DUHD�1 RUPDOO\ � ��YHORFLW\ � RI�IHHW�SHU�PLQXWH�SOXV�RU�PLQXV�LV�DGHTXDWH�DOWKRXJK�KLJKHU�YHORFLWLHV�PD\ � EH�QHHGHG�ZKHUH�WKH�R SHUDWLRQV�JHQHUDWH�KLJKOHYHOV�RI�SDUWLFXODWHV�RU�Z KHUH�HTXLSPHQW�FRQILJXUDWLRQ�GLVUXSWV�ODPLQDU�IORZ�

$LU�VKRXOG�DOVR�EH�RI�D�KLJK�PLFURELDO�TXDOLW\ � $ Q�LQFLGHQFH�RI�QR�PRUH�WKDQ�RQH�FRO RQ\IRUPLQJ�XQLW�SHU�FXELFIHHW�LV�FRQVLGHUHG�DV�DWWDLQDEOH�DQG�GHVLUDEOH�

&ULWLFDO�DUHDV�VKRXOG�KDYH�D�SRVLWLYH�SUHVVXUH�GLIIHUHQWLDO�UHODWLYH�WR�DGMDFHQW�OHV V�FOHDQ�DUHDV�D�SUHVVXUHGLIIHUHQWLDO�RI�LQFK�RI�ZDWHU�LV�DFFHSWDEOH¶�

&RQWUROOHG�DUHDV�µ$LU�LQ�FRQWUROOHG�DUHDV�LV�JHQHUDOO\ � RI�DFFHSWDEOH�SDUWLFXODWH�TXD OLW\ � LI�LW�KDV�D�SHU�FXELF�IRRWSDUWLFOH�FRXQW�RI�QRW�PRUH�WKDQ�LQ�D�VL] H�UDQJH�RI�PLFURQ�DQG�ODUJHU�&O DVV�Z KHQ�PHDVXUHGLQ�WKH�YLFLQLW\ � RI�WKH�H[ SRVHG�DUWLFOHV�GXULQJ�SHULRGV�RI�DFWLYLW\ � : LWK�UHJDUG�WR�P LFURELDO�TXDOLW\ �DQ�LQFLGHQFH�RI�QRPRUH�WKDQ�FRORQ\ � IRUPLQJ�XQLWV�SHU�FXELF�IHHW�LV�DFFHSWDEOH�

,Q�RUGHU�WR�PDLQWDLQ�DLU�TXDOLW\ � LQ�FRQWUROOHG�DUHDV�LW�LV�LPSRUWDQW�WR�DFKLHYH�D�V XIILFLHQW�DLUIORZ�DQG�D�SRVLWLYHSUHVVXUH�GLIIHUHQWLDO�UHODWLYH�WR�DGMDFHQW�XQFRQWUROOHG�DUHDV�,Q�WKLV�UHJDUG�DLUIO RZ�VXIILFLHQW�WR�DFKLHYH�DW�OHDVWDLU�FKDQJHV�SHU�KRXU�DQG�LQ�JHQHUDO�D�SUHVVXUH�GLIIHUHQWLDO�RI�DW�OHDVW�LQFK� RI�ZDWHU�Z LWK�DOO�GRRUV�FORVHGDUH�DFFHSWDEOH�: KHQ�GRRUV�DUH�RSHQ�RXWZDUG�DLUIORZ � VKRXOG�EH�VXIILFLHQW�WR�PLQLPL] H�LQJUHVV�RI�FRQWDPLQDWLRQ¶�

7KLV�LQIRUPDWLRQ�Z DV�FRP SLOHG�IURP�YDULRXV�VRXUFHV�LQFOXGLQJ�WKH�OLVWHG�DJHQFLHV�DQG �KH�KDQGERRN�µ&OHDQ�5 RRP7HFKQRORJ\¶�DV�ZULWWHQ�E\ � %LOO�: K\ WH�

? � &DPILO�) DUU�

&ODVVLILFDWLRQV�2 I�&OHDQ�5RRP V KWWS�Z Z Z�ILOWHUDLU�LQIR�DUWLFOHV�DUWLFOH�FIP � $ UWLFOH,' � ( &$ � $

�� � �