Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
6-/- 5!.#( '( )$ '("&)&7+ ()#.!#89&"! 1 "-+ (%
-:;(#&<- '( ,-.#!%("(. )$) "!5!"&'!'()
"-/(."&!%() 1 '( )(.<&"&- #8"+&"- (+ =8>&"-? @(##( 6-/5!"#&+9 '&- ! "-+-"(. A$( '()'(
(% /() '( B$+&-? )$) !"#&<&'!'() '( +(9-"&- (+ #(..&#-.&- /(>&"!+- )(.C+ /!+(;!'!)
D% 5.&/(. "-+#!"#- "-+ @(##( 6-/5!"#&+9 =8>&"- )(.C (% &+9(+&(.- E+'.8) F!."G!?
'&.("#-. 9(+(.!%? ! A$&(+ %! /!1-.G! '( %-) "%&(+#() "-+-"(+ 1 !5.("&!+H D% &+9(+&(.-
F!."G! "$(+#! "-+ %-) "-+-"&/&(+#-) 1 %! (>5(.&(+"&! +("()!.&! 5!.! !'("$!. )$)
'$.!+#( %-) I%#&/-) !J-) ()#!:%("&7 (+ (% /(."!'- /(>&"!+-H E% "-+#!. "-+ $+ (A$&5-
'( !%#! (>5(.&(+"&! "-/(."&!% 1 #8"+&"!H 6-+ (% (A$&5- '( #.!:!;- "-/5$()#- 5-. (%
&+9(+&(.- K!&. D)5&+-)!? B-)8 K$&) L!.!+;-? 6!.%-) =-+.-1 1 M(9-J! 0$C.(2? #-'-) (%%-)
%&'(.(!'-) 5-. (% &+9(+&(.- F!."G! )( '!.C "-+#&+$&'!' ! A$( %!) #!.(!) A$( )( <(+G!+
.(!%&2!+'- #!+#- (+ (% C.(! "-/(."&!% "-/- (+ (% )(.<&"&- #8"+&"-? %- A$( "-+)&'(.!/-)
!$#-.&2!"&7+ '( %! @--' N O.$9 E'/&+&)#.!#&-+ P@OEQ '( D)#!'-) 3+&'-)? 5!.!
"-/(."&!%&2!. (% 0&)#(/! 3%#.!04!5( 5!.! %! .('$""&7+ +- &+<!)&<! '( %! "&."$+,(.(+"&!
!:'-/&+!% ! #.!<8) '( %! '()#.$""&7+ '( %!) "8%$%!) !'&5-)!)H D% 0&)#(/! 3%#.!04!5( ()
(% 5.&/(. 1 I+&"- #.!#!/&(+#- '( .(/-'(%!"&7+ "-.5-.!% +- &+<!)&<- A$( $#&%&2! 5$%)-)
'( (+(.9G! '( $%#.!)-+&'- (+,-"!'-) A$( !5$+#!+ '( /!+(.! 5.("&)! ! %! !'&5-)&'!'
)$:"$#C+(!? ! %! <(2 /!+#&(+( &+#!"#-) ! %-) #(;&'-)? <!)-) )!+9$G+(-)? +(.<&-) 1
3%#.!04!5( $)! $+ (,("#- /("C+&"- 5$.- 5!.! '()#.$&. %!) "8%$%!) !'&5-)!)? )&+ 5.-<-"!.
'!J- #8./&"-? %- "$!% :.&+'! $+ #.!#!/&(+#- )(9$.- 1 "-+,-.#!:%(H
&/5-.#!+#( &+<(.)&7+ (+ (% '()!..-%%- '( 5.-'$"#-) +- &+<!)&<-) 5!.! %! .(/-'(%!"&7+
"-.5-.!% +-) "-%-"! (+ $+! 5-)&"&7+ (>"%$)&<! 5!.! %&'(.!. (% /(."!'- "-+ %! #("+-%-9G!
'( '()#.$""&7+ /("C+&"! '( %! !'&5-)&'!' A$( 5.()(+#! 3%#.!04!5( 1 "-+ +$()#.!
&+&9$!%!:%( #("+-%-9G! #8./&"! R(%!04!5( SSS? !/:!) !5.-:!'!) 5-. %! @OETH D% 0&)#(/!
3%#.!04!5( -:#$<- %! /!."! 6D (+ UVVW 1 )( "-/(."&!%&2! (+ D$.-5!? 6!+!'C 1
0#!. =8'&"! .(!%&27 %! !5(.#$.! '( )$) +$()#.!) &+)#!%!"&-+()? 0#!. =8'&"! X&5? $+
()5("&!%&'!' 5('&C#.&"! ! +&<(% +!"&-+!%? "-+ )(.<&"&-) '( I%#&/! 9(+(.!"&7+? #("+-%-9G!
'( 5$+#! 1 /-'(.+!) &+)#!%!"&-+()H
"-+)-%&'!+'- ! %! "-/5!JG! "-/- %! "!'(+! '( 4-)5&#!%() 5.&<!'-) '( /!1-.
(/5%(-) '&.("#-) 1 Y?WVV &+'&.("#-)? %- "$!% .(,.(+'! (% "-/5.-/&)- '(% F.$5- "-+ %!
)-"&('!' /(>&"!+!H D+ 5!%!:.!) '( E%(;!+'.- =!.#G+ '(% 6!/5- 0()"-))(? 5.()&'(+#(
?5#(6($#5 X-)5&#!% S+,!+#&%
Z.&<!'- 0#!. =8'&"! XSZ X&5 "$(+#! "-+ /C) '( [V !J-) '( (>5(.&(+"&! (+ %! !#(+"&7+? '-"(+"&! ( &+<()#&9!"&7+
(+ 5('&!#.G! 1 +(-+!#-%-9G!? %- A$( +-) 5(./&#( -,.("(. )-%$"&-+() /8'&"!) &+#(9.!%()H
! %-) 5(A$(J-)? /&)/! A$( +- )( (+"-+#.!.C (+ -#.- 4-)5&#!% 5.&<!'- ()5("&!%&2!'- (+
5('&C#.&"-) (+ '&<(.)!) .!/!) '( %! /('&"&+!? #!%() "-/- \(.!5&! S+#(+)&<! 1 L(-+!#!%?
X(/-'&+!/&!? 6!.'&-%-9G!? 6&.$9G! K!5!.-)"75&"! =G+&/! S+<!)&<!? L($.-"&.$9G!?
].#-5('&! 1 \.!$/!#-%-9G!? \.!)5%!+#()? ]+"-%-9G! 1 3.9(+"&!)? (+#.( -#.-) )(.<&"&-)H
6!:( /(+"&-+!. A$( 5!.! UVY[? 0#!. =8'&"! %%(<!.C ! "!:- %! !5(.#$.! '( )$) +$(<!)
$+&'!'() 4-)5&#!%!.&!) (+ %-) ()#!'-) '( R(.!".$2 1 64&4$!4$!^ 1 (+ UVYW? &+&"&!.C %!)
-5(.!"&-+() '( $+! )(9$+'! $+&'!' 4-)5&#!%!.&! (+ %! "&$'!' '( =-.(%&!? =&"4-!"C+?
0#!. =8'&"! K!) E/8.&"!)? 4("4- A$( .-:$)#("(.C )$ "-/5.-/&)- 5-. :.&+'!. (% /C)
!%#- +&<(% '( "-+,-.# 1 !#(+"&7+ '( )!%$' 5.&<!'!H
!"##$%& ()*+#,-.
METODOLOGÍA DE ANÁLISIS DE RIESGO DE PROCESOS Y OPERACIONES FARMACÉUTICOS (ARPO) PARTE II
EN EL ARTÍCULO ANTERIOR COMENTAMOS LAS BASES GENERALES DEL ANÁLISIS DE RIESGO DE PROCESOS
Y OPERACIONES FARMACÉUTICOS (ARPO).
/- 0)"1"&*" 2)*+#,-. )"2-$32)4 ,&2 5"1#)$0#$%& 6," $&*"&*2 "70-$#2) 2
@
@
@
DR. EN C. ANA CECILIA GONZÁLEZ VILLEGAS
OPKO MEXICO
/& "1*" 0,&*.9 -2 B.);2 D"7$#2&2 $&5$#2 -2 &"#"1$525 5"- "1*2>-"#@
$;$"&*. 5" ,&2 !"#$%$&$'() +," -") .")&/0)%) %" !)1".) "2"3#/4) 5).)
.")&/0). &) 6"-#/71 %" 8/"-'$ %" 9)&/%)%: @
/21 9,$5"-$&"9,$5"-$&" :;2
/31 9,$5"-$&":<=2
!"##$%& ()*+#,-.
3" #0-#,-. 3" 5).))2*". . 4"3$#$%& &. 52)247*)$#2 3" -2 5).121$-$323
=
!"##$%& ()*+#,-.
"# %&'()*+ ,-(.+/ 012)')3()45 !$/*"01 2" 01&,31#*,)1 1#*,1- 4," "/
*1- #,1- /" )"1-$51&6 7"). #.& -1/ -$0$*1#$.&"/ 2"- 71/12. 8 -./ #109$./
=
?CA D,$2"-$&"D,$2"-$&" EF;
INTEGRACIÓN DE ESTRATEGIAS PARA I YD EN LA INDUSTRIA FARMACÉUTICA
EL SECTOR FARMACÉUTICO CONSTITUYE UN SECTOR ESTRATÉGICO EN LA ECONOMÍA DE MÉXICO, SE ESTIMA
QUE EN 2013 GENERÓ CERCA DE 100 MIL EMPLEOS DIRECTOS, LO QUE DEMUESTRA QUE LA INDUSTRIA
MEXICANA ES UNA DE LAS DE MAYOR TAMAÑO Y PRODUCTIVIDAD EN AMÉRICA LATINA.
RAÚL SORIA DIRECTOR INOSAN BIOPHARMA, S.A.
!$& "/01)2.3 -14 "/5)"414 *)1&4&1#$.&1-"4 6./$&1& "- /")#16. &17
#$.&1-3 6"0$6. 5)$&#$51-/"&*" 1 -.4 "-"816.4 #.4*.4 6" -1 $&8"4*$21#$%&
9 6"41)).--. :;9<=3 5).6,##$%& 9 #./")#$1-$>1#$%& 6" /"6$#1/"&*.4?
@.) 61) ,& "A"/5-. 6" -.4 2)1&6"4 #.4*.43 4" "4*$/1 B," "- 6"41)).--.
6" ,& &,"8. /"6$#1/"&*. )"B,$")" ,&1 $&8")4$%& 6" CDD 1 EDD /$-7
-.&"4 6" 6%-1)"4 9 6" FD 1 FC 1G.4 6" $&8"4*$21#$%&3 5).#"4. B," 4%-.
5.#.4 -10.)1*.)$.4 5,"6"& 5121)? @.) .*)1 51)*"3 -1 #.&#"&*)1#$%& 6"
-1 #151#$616 6" 5).6,##$%&3 "- $/5,-4. 6" /"6$#1/"&*.4 2"&H)$#.4
$&*")#1/0$10-"43 -1 0$.*"#&.-.2+1 9 -1 $&#$5$"&*" /"6$#$&1 2"&%/$#1
I1& 2"&")16. ,& "&*.)&. 5-1216. 6" )"*.4?
J& "4*" 4"&*$6. -14 "/5)"414 K1)/1#H,*$#14 6" /"&.) *1/1G. /,"4*)1&
,&1 /"&.) #151#$616 6" #./5"*"&#$1 "& "4*" "&*.)&.3 4$& "/01)2. I1&
7
*)1*H2$#1 "& -1 .5")1#$%& 6" -1 "/5)"41? L./. ,&1 K,&#$%& 6" &"2.#$.43
&M/"). 9 *$5.4 6" #./5"*$6.)"43 -.4 181&#"4 "& -14 *"#&.-.2+143 -.4
#1/0$.4 )"2,-1*.)$.43 "&*)" .*).4 K1#*.)"4?
8"&*1A14 4.0)" -14 5.4$0-"4 .5.)*,&$616"4 B," 4" 5)"4"&*"&3 "4 5.) "4*1
-.4 "-"/"&*.4 B," #.&4*$*,9"& -1 ;9< "& -1 1#*,1-$616?
#$%&'()*+,$ .& #/0 &$ 1) &2%(3*%3()
.& 142 1)54()%4(+42 6)(7)*83%+*42
J& -1 N$2,)1 F 4" /,"4*)1 "- 5).#"4. 2"&")1- 51)1 -1 $&*"2)1#$%& 6" ;9<
7
"4*),#*,)1 6" ;9< 9 14+ 5.*"&#$1) 4,4 5).5$14 #151#$616"4?
N$2,)1 F? J4*)1*"2$1 2"&H)$#1 6" $&*"2)1#$%& 6" ;9< #.& -1 "4*),#*,)1
2"&")1- 6" -1 .)21&$>1#$%&?
N,"&*"O PQ$44 $& R1&2$&2 P"#I&.-.2$#1- ;&&.81*$.&3 S.&2/1&3 S.&6.&3
FTUV3 5? WX?
#$%&%'()* ,% $- %*(.-(%/0- ,% 123
/& -0 1$2,)0 3 4" 5)"4"&*0 ,& 6$02)070 6" -.4 "-"7"&*.4 8," $&*"2)0& -0 "4*)0*"2$0 6" 9:;<
1$2,)0 3= /-"7"&*.4 50)0 ,&0 $&*"2)0#$%& 6" -0 "4*)0*"2$0 6" 9:;=
1,"&*"< >=?=@= @.)&0*AB: 0&6 C= 1-"$4#D") $& E).#"44"4 .F @"#D&.-.2$#0- 9&&.G0*$.&H ;= I= J"0-*D 0&6 I.= >"K$&2*.&H LMMN= E OP=
456%(07)* ,% '%/)80) ,% $- )./-'09-80:'; >0 "4*)0*"2$0 2"&")0- 6" 9:; 6"Q"& "4*0) 0-$&"0604 #.& -.4 .QR"*$G.4 2"&")0-"4 : 50)*$#,-0)"4 6"
-0 .)20&$A0#$%&=
3%80*0)'%* %*(.-(=/08-* ,% 123; T
2$04 6" 04$7$-0#$%&H $75-"7"&*0#$%& : 05-$#0#$%& 6" *"#&.-.2+04 "& 5).6,#*.4=
T
#$%&'%()*'$ ,-$*.'$ /'&' 0' 123
!" /0& #0)0#*")$102. 2.3 *$4.3 2" "3*)0*"5$03 2" 6789 -03 2":"&3$;03 7
-03 .:"&3$;03< =0 "3*)0*"5$0 2":"&3$;0 "3 0>,"--0 >," 4)"*"&2" ?0&*"&")
-0 4.3$#$%& *"#&.-%5$#0 2" -0 .)50&$10#$%& "& "- ?")#02.9 ?$"&*)03 >,"
-0 .:"&3$;0 "3 -0 >," *$"&" ,& "&:.>," 4).0#*$;. 0 -0 *"#&.-.5+0 7 0-
?"@.)0?$"&*. 2" -.3 4).2,#*.3 7 4).#"3.3< A& -0 B0C-0 D9 3" 4)"3"&*0&
-.3 "-"?"&*.3 2" #020 "3*)0*"5$09 "& *E)?$&.3 2" #0)0#*")+3*$#03 7
?"#0&$3?.3 2" .4")0#$%&<
B0C-0 D< F.?40)0#$%& 2" "3*)0*"5$03 .:"&3$;0 7 2":"&3$;0 7 3, $?40#*.
0&2 !*)0*"579 G..27"0) H,C-$3/$&5 F.< !*0 I.&$#09 F(J<
A3 $?4.)*0&*" ;$3,0-$10) >," 4.) -03 #0)0#*")+3*$#03 2" -0 $&2,3*)$0
:0)?0#E,*$#09 -0 ?07.)+0 2" -03 "?4)"303 "?4-"0& 0?C03 "3*)0*"K
4.3$#$.&0?$"&*. "& "- ?")#02. 7 -03 #040#$202"3 2" -0 .)50&$10#$%&<
@,"50 -0 678 "& -0 $&2,3*)$0 :0)?0#E,*$#0 7 -03 ;"&*0@03 #.?4"*$*$;03
>," 4).4.)#$.&09 4.) -. >," "3 &"#"30)$. >," "- 2$3"L. 7 -0 .4")0#$%&
3"0 0 -0 ?"2$20 7 3" "&#,"&*)" 0-$&"020 0 -0 "3*)0*"5$0 7 .C@"*$;.3 2"
-0 .)50&$10#$%&<
4(5(&(6.*'$7
& I0&5$&5 B"#/&.-.5$#0- 6&&.;0*$.&9 =.&5?0&9 =.&2.&9 MNOP9
4DQ<
K
K
!"##$%& ()*+#,-.
/& 0$1 $&$#$.1 "& -2 1,3")4$1$%& 5" -2 02&,62#*,)2 62)02#7,*$#28 0" *.#%
"&6)"&*2) "- )"*. 5" &.)02-$92) ,& 3).#"1. 5" "&42125. 5" 3.-4.1 32)2
$&:"##$%&8 ;," 2 3"12) 5" -21 -$0$*2#$.&"1 5" #232#$525 5" -2 0<;,$&2
--"&25.)28 $03-$#2=2 *"&") =2>. #.&*).- "- "&*.)&. 0$#).=$.-%?$#. 5"- 3).@
#"1.8 &. 1%-. "& *7)0$&.1 5" 5"1$&6"##$%&8 0"&.) *$"03. 5" "A3.1$#$%&
5" "1*" 2)*+#,-.8 1$&. "& *7)0$&.1 5" 3).5,#*$4$525B
E)2#$21 2- #.&.#$0$"&*. 5" -2 #232#$525 5" -2 0<;,$&2 --"&25.)2 : -21
#2)2#*")+1*$#2 ?)2&,-.07*)$#21 5" -2 02*")$2 3)$028 -.?)20.1 .3*$0$92)
5" 1,3")4$12) 5$#K.1 3).#"1.18 #.&1$5")7 )"13.&12=-" #.03$-2) -2
$&6.)02#$%& ;," 0" 1$)4$% : ;," .=*,4" 3)$&#$32-0"&*" !"#$"% 5" -2
3.).1$5258 5"&1$525 4")525")2 : 5"&1$525 232)"&*"H
@
5,#$5. )"13"#*. 2- 3-2&. K.)$9.&*2- #,2&5. 1" -" 5">2 #2") -$=)"0"&*"
<&?,-. 5" )"3.1. "1*<*$#.QB
!$ ,& 3$03. 35*")$5- 0" "B53$&5 6.) -.0 4.0 0$0*"350 5&*")$.)"0@
-. 310 0"2,). "0 :," "- 1&2,-. 4"))5354. 4C 3,#A. 35D.) :," "-
*535E. 4" 65)*+#,-5 4"- 35*")$5-F
/& *C)3$&.0 2"&")5-"0@ "- 1&2,-. 4" )"6.0. 0" ,*$-$G5 65)5 "85-,5)
2)5&,-54.0 =8C50" *5<-5 H?I
"0 4" "06")5)0" :," -.0 2)5&,-54.0 7.)354.0 6.) 65)*+#,-50 -$050 .
"07C)$#50 6)"0"&*"& 1&2,-.0 4" )"6.0. 3,D 56-5&54.0 D 8$#"8")05J
!$ 0" *.35 "- *535E. $&4"6"&4$"&*" 4" -5 7.)35 D 4"&0$454 4"
-5 65)*+#,-5@ 0" 6,"4" "06")5) :," -50 65)*+#,-50 #.& *535E.0 $&7")$.)"0
K*).0 3"#5&$03.0 :," 0" 6,"4"& ,*$-$G5) 65)5 4$03$&,$) -50 7,")G50
4" #.A"0$%& 0.&I
!"##$%& ()*+#,-.
4$6,$"&*"4 2"#/&$42.478
B& )"C,$4$*. >,&1/2"&*/- "4 C," "- -,3)$#/&*" 1"3" *"&") ,& */2/D.
:& "4*" *$0. 1" /&5-$4$4 4" *.2/& GFH 6 1" 2,"4*)/ = 4" 1"I/ 0/4/)
1" "20/C,"*/2$"&*.8
!"##$%& ()*+#,-.
!" EDICIÓN ESPECIAL 2014
:- 3.-,0"& 626)"&*" >?@,-AB $&#-,C" -.1 "126#$.1 D," "E$1*"& "&*)"
!" 2,"7"& .@1")36) 7.1 0I*.7.1 D," 1" 7$5")"&#$6& "& -.1 "D,$2.1
,*$-$G67.1=
!" 2616 MNN; 7"- 2.-3. 2.) ,&6 06--6 OM< >MNNNPQB 26)6
2),"@6 *")0$&6 #,6&7. &. 1" )"7,G#6 041 "- 3.-,0"& 6 2"16) 7" --"36)
:E$1*"& 7.1 0I*.7.1 2.) -.1 #,6-"1 1" 2,"7" --"36) 6 #6@. -6 2),"@6
:- 2.)#"&*6H" 7" #.02)"1$@$-$767 $&7$)"#*60"&*" 1,0$&$1*)6 ,&6 $7"6
(-;,&.1 6,*.)"1 1.1*$"&"& D," "&*)" 06C.) 1"6 -6 7"&1$767 626)"&*"9
X
!"##$%& ()*+#,-.
!" !"#$#%& !()!$#*+ ,-./
/01-0 23 !$4*"50 6" #0)0#*")$70#$%& 6" -.4 8.-9.4 4":;& 4,4 8).8$"< 223
=>$4*" .*)0 ">8)"4$%& ?," "4 -0 8).8.)#$%& 6" @0,4&") ?," "4 "-
A0*"5B*$#05"&*" 4" ">8)"40 #.5.C
< D).8.)#$%& 6" @0,4&") E DF(
G0 6"&4$606 9")606")0 5$6" )"0-5"&*" -0 #0&*$606 6" 50*")$0- .#,806.
8.) *.604 -04 80)*+#,-04 4$& *"&") "& #,"&*0 -.4 "480#$.4 90#+.4 H9.-,<
5"& 080)"&*"I 0;& "& -04 80)*+#,-04 5B4 8.).4043 =4*0 6"&4$606 4"
8,"6" .1*"&") #.& ,& 8$#&%5"*). 6" :04 H@"-$.I J "4 ,& 80)B5"*).
#0)0#*")+4*$#. 80)0 #060 *$8. 6" 50*")$0-K 5$"&*)04 ?," -0 6"&4$606 6"
9.-,5"& "4 ,& 80)B5"*). ?," 6"8"&6")B 6" -04 #.&6$#$.&"4 "& -04
#,0-"4 4" "L"#,*" "- 5M*.6. 6" 5"6$602N3
G0 6"&4$606 080)"&*" 6"8"&6" O,")*"5"&*" 6" -04 #0)0#*")+4*$#04 6"
"580?,"*05$"&*.3
=- 90-.) 6" 6"&4$606 080)"&*" 6"- 8.-9. 6"8"&6" 6" -0 6"&4$606
*050P.K 6$4*)$1,#$%& J O.)50 6" -0 80)*+#,-03
G.4 8.-9.4 #.& 10L0 6"&4$606 080)"&*" J 6" 9.-,5"& 080)"&*" 0-*.
4" #0*0-.:0& #.5. 8.-9.4 -$:").4K J 9$#"9")403
#$%&%' %$ )*+,-$.&/&0&%'%
6*-*.&%'%
G0 8.).4$606 6" -.4 :)B&,-.4 6"8"&6" 6" -0 O.)50 J 6$4*)$1,#$%& 6"-
*050P. J -0 O.)50 6" 80)*+#,-04K *051$M& 6" -0 ),:.4$606 6" -04 4,<
D.) "4*0 )07%& -0 8.).4$606 80)0 ,&0 5$450 4,4*0&#$0 6"8"&6" 6"-
:)06. 6" 5.-$"&60K *05$70L" . #.580#*0#$%& 6"- :)0&,-06.3
!$ ,& :)0&,-06. "4*B O.)506. 8.) 80)*+#,-04 5,J )+:$604K &. Q01)B 1,"&
--"&0)+0& 1$"& -04 50*)$#"4 6" -0 *01-"*"06.)0 6,)0&*" -0 #.58)"4$%&K
6"1$6. 0 4, 0-*0 #.Q"4$%& J :)0& O)$##$%& "&*)" -04 80)*+#,-043
=& *M)5$&.4 :"&")0-"4K *.6. *$8. 6" :)0&,-06. "4*B O.)506. 8.)
80)*+#,-04 0&$4.*)%8$#04 6.&6" -04 80)*+#,-04 8"?,"P04 *$"&6"& 0 --"&0)
!" 6"*")5$&0 "& O.)50 4$5$-0) 0- B&:,-. 6" )"8.4.K 8"). "& "4*" #04.
"& ,&0 "48B*,-0 8-0&0 #.& #$")*0 $&#-$&0#$%&3
D,"6" 4") 0- $:,0- . &. 0- B&:,-. 6" )"8.4. "4*B*$#.3
D).8.)#$.&0 ,&0 5"6$60 $&6$)"#*0 6" -0 O.)50K "- *050P.K #.Q"4$9$606
J 8.).4$606 6"- :)0&,-06.N3
T3 D.U6")4 0&6 :)B&,-"43883 2TV3
N3 !U0)1)$#WK X05"43 2YYV3 =&#J#-.8"6$0 .O 8Q0)50#",*$#0- /"#Q&.-.:J3 Z.J-0&K X05"43
A0)#"- 6"WW") [\]3 \"U ^.)W3 _.-3 `[[3 88 2ab<2a23/.5. T
R3 Q**8CFF#-04438QJ4384,3"6,F8SaVF">8")$5"&*4F:)0&,-0)c50**")386O
S3 [(!d3 D"4#Q-3 A"04,)"5"&* 0&6 "90-,0*$.& .O 5"#Q0&$#0- 8).8")*$"4 .O 8.U6")4K
8.U6") Q0&6-$&: 0&6 8).#"44$&:3 2 2YeY \.3 N 2Ra<2S2
0 5$#).&$7"6 #.58.&"&*3 HNbb2I88 23 Sf #"&*)0- =,).8"0& 4J58.4$,5 .O 8Q0)50#",*$#0-
*"#Q&.-.:JK !"8*"51") NR<NaK 9$"&&03
=5:3 2b2 H SI Ve<Yb L,& 2YYS3
V3 D(ggh/K =,:"&"3 DQ0)50#",*$#0- *"#Q&.-.:J3 i,&605"&*0- DQ0)50#",*$#43 Z,):"44
8,1-$4Q$&: #.580&J3 =6$*3 R)03 A$&&"08.-$43 j!(3 2YV23883 22<2S
*"#Q&.-.:J3 h#*.1")3 Nbbb3 UUU38Q0)58.)*0-3#.5
1,-W "&:3 2b HTI 2V<Ne H2YYTI
2b3 (5")$#0& 4.#$"*J O.) *"4*$&: 0&6 50*")$0-43 !*0&60)6 4Q"0) *"4* 5"*Q.6 O.) 1,-W 4.-$64
#Q0)0#*")$70*$.& 1J ]0))k4 $&6$#"43 (!/A 4*0&60)6 lTRYR<YY 2YYY
223 !U0)1)$#WK X05"43 2YYV3 =&#J#-.8"6$0 .O 8Q0)50#",*$#0- /"#Q&.-.:J3 Z.J-0&K X05"43
A0)#"- 6"WW") [\]3 \"U ^.)W3 _.-3 `[[3 882Ta3/.5. T3
50*")$0-4C 0 )"9$"U .O 5"*Q.643 DQ0)503 i.),53 Na HRI eNYe<eRba 2YYY3
2R3 @"-50&K X.4"3 i0)50#.*"#&$0 /".)+0 J 8)B#*$#03 2YeN3 "63 ].&*$&"&*0-3 A">$#.3 2)0
"63 2Yeb3 883/.5. [[ 8832TNa<2TNe3
2S3 _.$:QK g,6.-O3 2YeN3 /)0*06. 6" *"#&.-.:+0 i0)50#M,*$#03 =6$*.)$0- (#)$1$03 d0)0:.703
R)03 =6$#$%&3 d0)0:.703 D83 2bY<22b3
!"##$%& ()*+#,-.
#$%& () (* +,+-+.
/- .0.&. 1234 "5 ,&6 7.)86 *)$6*%8$#6 965".56 :"- .;+9"&.< /5 #)"6:.
&6*,)6-8"&*" "& -6 6*8%57")6 =.) $))6:$6#$%& ,-*)6>$.-"*6 1?@A &84
:" .;+9"&. 12B4< (,&C," "- .0.&. "5 ?3 >"#"5 8D5 5.-,E-" C," -6
8.-F#,-6 2BG 5$9," 5$"&:. #.&5$:")6:. "5#6568"&*" 5.-,E-"<
/- .0.&. "5 ";*)"86:68"&*" $&"5*6E-" 6 =)"5$.&"5 H *"8=")6*,)65 6*I
8.57F)$#65G 5$& "8E6)9. 5, 9)6& =.*"&#$6- J)":.;K -. L6#" "- 8D5 =.*"&*"
69"&*" .;$:6&*" ,56:. "& 5$5*"865 :" 56&$*$06#$%& 76)86#F,*$#6< /5
8D5 =.*"&*" C," .*).5 69"&*"5 .;$:6&*"5 56&$*$06&*"5 #.8")#$6-8"&*"
:$5=.&$E-"5G *6-"5 #.8. "- #-.). . "- =")%;$:. :" L$:)%9"&.< /- =.*"&#$6-
J)":.;K :" "5*.5 56&$*$06&*"5 5")+6M
20.&.M NB<OP "Q 1/-"#*).&>.-*$.4
R-.).M N?<3S "Q
T")%;$:. :" U$:).9"&.M N?<PP"Q
/- .0.&. 5" :"5#.8=.&" 7D#$-8"&*" 6 8.-F#,-6 $&.#,6 :" 2BG #.8.
56&$*$06#$%&<
/5 $8=)D#*$#. *)6*6) :" 6-86#"&6) .0.&. =6)6 ,5.5 5,E5"#,"&*"5 :"E$:.
6 5, &6*,)6-"06 $&"5*6E-" 1=,":" 5") ";=-.5$>. "& >.-V8"&"5 W 6 ?OX
:"- >Y> "& "- 6$)"4 )"6#*$>$:6: 69)"5$>6 H >$:6 8":$6 #.)*6<
/- .0.&. "5 ,5,6-8"&*" 9"&")6:. "& E6Z65 #.&#"&*)6#$.&"5 =6)6 6##$%&
$&8":$6*6G )"-6*$>68"&*" #")#6 :"- -,96) :" 6=-$#6#$%&< [.5 8F*.:.5
#.8")#$6-"5 8D5 #.8,&"5 =6)6 -6 86&,76#*,)6 :" .0.&. 5.& #.& E65"
"& -6 9"&")6#$%& :" ,&6 #.).&6 "-F#*)$#6 :" :"5#6)96 "& -6 =)"5"&#$6
:" .;+9"&. H =.) "-"#*).-$5$5 :" 69,6<
\"="&:$"&:. :" -6 #.&#"&*)6#$%& :" .0.&. H "- *$"8=. :" #.&*6#*.G 5,
6##$%& 5.E)" #.8=,"5*.5 .)9D&$#.5 "& "- 69,6 =,":" 9"&")6) ="C,"]65
#6&*$:6:"5 :" :$%;$:. :" #6)E.&.G #.8. -6 =.)#$%& :" #6)E.&. :"-
#.8=,"5*. .)9D&$#. "5 .;$:6:6<
^+=$#68"&*"G -.5 #.8=,"5*.5 .)9D&$#.5 .;$:6:.5 =.) "- .0.&. 5.& 5%-.
=6)#$6-8"&*" :"9)6:6:.5 "& D#$:.5 . 7.)865 :" 5,5*6&#$65 .)9D&$#65
8D5 ="C,"]65 #6)E.;+-$#.5< [6 9"&")6#$%& :" "5*.5 =).:,#*.5 :"
:"9)6:6#$%& $.&$06:.5 6 &$>"-"5 :" =6)*"5 =.) E$--%& 1==E4 #.& "-
*$"8=. =,":" *"&") ,& $8=6#*. :"*"#*6E-" "& "- =U H -6 #.&:,#*$>$:6:
:" )"7)"5#. &,">6<
=)$&#$=6-8"&*" .;+9"&. 5" 7.)86)D #,6&:. "- .0.&. 5" :"5#.8=.&"<
[6 7.)86#$%& :" )6:$#6-"5 -$E)"5 "5 $&L")"&*" H 7,&:68"&*6- =6)6 "-
=).#"5. :" :"5$&7"##$%& :"- .0.&.< _& )6:$#6- -$E)" "5 ,&6 8.-F#,-6
#.& ,& "-"#*)%& &. 6=6)"6:. H "5 6-*68"&*" )"6#*$>.<
!!!"#$"%&#
"#$#%&'($
!"#$%& ()*+
!"#$%&'( *+%&(,+- *. /01 22341 5#6&%( 78 933: 2;04 1;11
'()*+,(-.' .0,+,.-1.'
!" EDICIÓN ESPECIAL 2014
/.0 1$2).3$-.0 45678 )92$#9-"0 -$:)"0 0" ;.)<9& #,9&2. "- .=.&. 0"
2">)929? ( @"09) 2" A," -.0 )92$#9-"0 -$:)"0 *$"&"& ,&9 B$29 <,C #.)*9
40%-. 2,)9 ,& &9&. 9 <$-$D0">,&2.8E *$"&"& ,& @.*"&#$9- )"2.3 4FEGH "I8E
$&#-,0. <J0 9-*. A," "- .=.&. 4FEHK "I8? /9 #9@9#$292 2" .3$29#$%&
#.<:$&92. 2" -.0 )92$#9-"0 -$:)"0 1$2).3$-.0 C 0,0 <.-L#,-90 2" .=.&.
@92)" 0.& )"0@.&09:-"0 2" -9 2"0$&;"##$%& 9-*9<"&*" 9>)"0$B9 C ";"#*$B9
2" -.0 *)9*9<$"&*.0 #.& .=.&.?
/.0 )92$#9-"0 -$:)"0 A," 0" ;.)<9& 2,)9&*" "- ,0. 2"- .=.&. #.&*)$:,C"&
0,0*9&#$9-<"&*" 9 -9 2"0$&;"##$%& C "- #.&*).- <$#).:$.-%>$#.?
M,9&2. 0" @).2,#"& )"9##$.&"0 2" *")<$&9#$%&E "- )92$#9- -$:)" 0" #.&D
0,<" 4. 0" "3*$&>,"8 "& ,& "&-9#" #.B9-"&*" "& -,>9) 2" @).@9>9)0"?
N0*" @).#"0. 2" $&9#*$B9#$%& 2" )92$#9-"0 -$:)" *$"&2" 9 2.<$&9)E -.
A," )"0,-*9 "& "- *)9&0$*.)$. 4@"). 9-*9<"&*" )"9#*$B.8E @)"0"&#$9 2"
)92$#9-"0 -$:)"0?
N0*.0 )92$#9-"0 -$:)"0 0" 2$0$@9& <,C )J@$29<"&*" 4@.) "O"<@-.E "-
.=.&.8 0" "-$<$&9 . 0" 2">)929E -.0 )92$#9-"0 -$:)"0 )"0$2,9-"0 *9<:$L&
0" 2$0$@9& 2" ;.)<9 #90$ $&0*9&*J&"9E @.) -. *9&*.E &. #.&0*$*,C"& ,&9
@)".#,@9#$%& #.& )"0@"#*. 9 -9 #9-$292 2"- 9>,9?
#$%&'()*+ - .+%+ /$ &0&12$ /$3 +4+'+
/.0 ";"#*.0 .3$29&*"0 2"- .=.&.E C -.0 9P& <J0 9>)"0$B.0 1$2).3$-.0
)92$#9-"0 -$:)"0 -$:")92.0 @.) 2"0#.<@.0$#$%& 2"- .=.&. 9- .3+>"&.E
9-*")9& -90 "0*),#*,)90 <.-"#,-9)"0 #.& -90 A," $&*")9#*P9& C #9<:$9&
0,0 @).@$"292"0?
M,9&2. "0*90 "0*),#*,)90 <.-"#,-9)"0E #,")@.0 ;,&#$.&9-"0 2" <$#)..)D
>9&$0<.0E 0" 9-*")9& 2" ;.)<9 @")<9&"&*"E -90 ;,&#$.&"0 <"*9:%-$#90E
90+ #.<. -9 "0*),#*,)9 #"-,-9) "0"&#$9-E A," 9;"#*9 -9 #9@9#$292 2" -.0
<$#)..)>9&$0<.0 @9)9 0.:)"B$B$) . @).-$;")9)? M,9&2. -9 @9)"2 #"-,-9)
C -9 <"<:)9&9 #"-,-9) 2" -90 :9#*")$90 0" B"& 9;"#*92.0E -9 #L-,-9
@$")2" 0, $&*">)$292 #.&*)9 "- 9<:$"&*" "3*")&. @).B.#9&2. "- 9@9>92.
<"*9:%-$#.E @.0$:-" -$0$0 C -9 <,")*" #"-,-9)?
Q,#190 2" -90 "0*),#*,)90 A,+<$#90 "& -90 <9#).<.-L#,-90 :$.-%>$#90
0.& 0,0#"@*$:-"0 9 "0*.0 ";"#*.0 ;,")*"<"&*" .3$29&*"0E A," $&#-,C"&
9<$&90E 9<$290 C >),@.0 0,-;1$2)$-.? N- .=.&. *9<:$L& @,"2" 9*9#9)
*9&*. 09*,)92.0 #.<. $&09*,)92.0 "&-9#"0 2" #9):.&. 2.:-"0 A,"
@,"2"& 0") @9)*" 2" -9 R#.-,<&9 B")*":)9-S 2" -90 <.-L#,-90?
#$5+6&) $' 3+) /()$7+) /$ 3+) )()0$*&) /$ &82& .&6*&%920(%&
9 *)9BL0 2" <"O.)90 "& -.0 2$0"T.0E .@")9#$%& C <9&*"&$<$"&*.? N09
2"- .=.&.?
N0*90 <"O.)90 "& 9->,&.0 2$0"T.0 0" 19& 0$2. 9@-$#9290 9 *)9BL0 2"U
:; VL#&$#90 2" 0.-292,)9?
:::; V"#&.-.>+90 2" $&0@"##$%&?
<; W$0"T. $&*">)92. 2" BJ-B,-90 @,&*. 2" ,0.?
<:; W$0"T.0 <"O.)92.0 2" <"=#-90 2" .=.&.?
<::; (,*.<9*$=9#$%&?
!"##$%& ()*+#,-.
!" EDICIÓN ESPECIAL 2014
#$% '() %*%+%, -(+./0/$ 1 '($-(+./0/$
/0)0 1"#$1$) . &. "- ,2. 1"- .3.&. "& 2$2*"402 1" 05,06 70 2"0 "& ,&
2$2*"40 &,"8. 79. "& ,&. ":$2*"&*" #.& .*). *$;. 1" 20&$*$30#$%&6 "-
1$2"<01.) 79. ;).;$"*0)$. *$"&" =," 0&0-$30) #-0)04"&*" -02 8"&*0>02
7 1"28"&*0>02?
;)"8$04"&*" $&2*0-01. 2$& @:$*. "& "- #.&*).- 4$#).A$0&. ,*$-$30 .*). *$;.
2$2*"402 20&$*$30A-" "& #0-$"&*"6 02+ =," -0 1$B")"&#$0 "& #.2*. ;,"1"
--"50) 0 2") 4,7 #.&2$1")0A-"?
2(+./0/$3
45 6)./ 78%'9:.;-;'/'< C- ,2. 1"- .3.&. ;,"1" .B)"#") #$#-.2 1" !0&$*$D
.;")0#$.&"2 1" ;).1,##$%&? /.) ">"4;-.6 -0 20&$*$30#$%& "& ,& -..; 1"
1$2*)$A,#$%& ;,"1" 2") #.4;-"*010 "& ,&0 E.)0 ,20&1. F3.&$30#$%&?
G.&1" 20&$*$30#$%& =,+4$#0 . #0-$"&*" ;,"1" *.40) E.)02 HIJ E.)02K?
!$2*"402 1" 05,0 #.& .3.&.6
*+;$#04"&*" .3.&0& 0- *0&=," #.&*$&,04"&*"6 "2*. *$"&" #.4. )"2,-*01.
,& #.&*).- 2.2*"&$1. 4$#).A$0- 7 )"1,#" -02 #.&#"&*)0#$.&"2 1" LFM
#.&2$1")0A-"4"&*"? N0 B0#$-$101 1" -.2 )"-0*$804"&*" ;")$.1.2 #.)*.2 1"
20&$*$30#$%&6 ;")4$*"& #$#-.2 1" 20&$*$30#$%& 4O2 B)"#,"&*"2?
!5 6=%88% '( :/>;./)< (-5,&02 $&2*0-0#$.&"2 ;,"1"& &. *"&") -0 01"D
#,010 #0;0#$101 4+&$40 &"#"20)$0 1" 80;.) $&1,2*)$0- =," )"=,$")"&
-.2 2$2*"402 1" 05,0 #.& 20&$*$30#$%& "& #0-$"&*" 1" ,& 2$2*"40 &,"8.?
C- ,2. 1" .3.&. ;,"1" "8$*0) -0 $&2*0-0#$%& 1" ,&0 &,"80 #0-1")0 7 1"
,& &,"8. ME$--") 2$ 2" )"=,$")" 1" "&B)$04$"&*.6 ;.) -. *0&*. 2" "8$*0
"- 502*. 1" -.2 "=,$;.2 7 2, $&2*0-0#$%& #.4. 2.& "- 0$2-04$"&*. 7 -.2
#,01).2 1" #.&*).- 1" 80;.)?
?5 @(A98;'/'< C- ,2. 1" .3.&. ;,"1" B0#$-$*0) -02 #.&1$#$.&"2 1" 2"D
5,)$101 1" -.2 .;")0)$.2 7 ;")2.&0- 1" 40&*"&$4$"&*. "-$4$&0&1. -.2
)$"25.2 02.#$01.2 #.& -0 .;")0#$%& 1" 2$2*"402 #0-$"&*"2?
B5 6=%88% (+ :%$.%$ '( (+(8AC/< M.4;0)01. #.& -.2 2$2*"40 1" 05,0
20&$*$30A-" #.& 05,0 #0-$"&*"6 "- .3.&. ,*$-$30 4,#E. 4"&.2 "&")5+0
;.) &. )"=,")$) -0 .;")0#$%& 1" ,&0 #0-1")0 $&1,2*)$0- 7 *.1.2 2,2 ;")D
$B@)$#.26 2%-. )"=,$")" 1" -0 4+&$40 "&")5+0 =," #.&2,4" "- 5"&")01.)
7 1"2*),#*.) 1" .3.&. #,0&1. "2*O& "& .;")0#$%&?
M.4;0)01. #.& -0 407.)+0
1" -.2 ;).#"2.2 1" 20&$*$30#$%& =,+4$#06 "- .3.&. ;,"1" 2") )"4.8$1.
2$& #.&2,4.2 ":#"2$8.2 1" 05,0 1" "&>,05,"? N.2 ;).#"2.2 =," ,*$-$30&
=,+4$#.2 1"A"& 2") ;,)501.2 7 1)"&01.2 #.& 5)0&1"2 #0&*$101"2
1" #.2*.20 05,0 *)0*010? (-5,&.2 20&$*$30&*"2 =,+4$#.2 )"=,$")"&
1" #.2*.2 01$#$.&0-"2 ;0)0 2, &",*)0-$30#$%& 0&*"2 1" 2") 1"2"#E010
0 -.2 1)"&0>"2? C& -,50)"2 1.&1" "- 1"2"#E. 1" =,+4$#.2 0- 1)"&0>"
"2*O )"2*)$&5$1. 79. ;).E$A$1.6 -0 ,*$-$30#$%& 1" .3.&. "2 0-*04"&*"
)"#.4"&10A-"?
"&>,05,"2 ;.) ,2.2 1" =,+4$#.26 ,& #$#-. 1" 20&$*$30#$%& ;.) .3.&.
;,"1" 2") ">"#,*01. "& ;")$.1.2 4,7 #.)*.2 7 02+ 2" .A*$"&"P
/5 Q0#$-$101 1" ,2. B)"#,"&*"? N.2 ;0).2 #.)*.2 1" F.;")0#$%& 1" -.2
!"##$%& ()*+#,-.
!" !"#$#%& !()!$#*+ ,-./
#$%&$'()*)%+
,- /.0*.0 1.) "- "2,$1. 3" 4"&")5#$%& 3" .6.&.7 8,"3"& "9$0*$)
5-4,&.0 #.0*.0 )"-5*$:.0 1.) -5 ;,"&*" 3" .9+4"&. < 0$ "- =>*.3. 3"
4"&")5#$%& 3" .6.&. )"2,$")" 3" ,&5 ;,"&*" 3" .9+4"&.?7
.- /.0*.0 1.) "2,$1. 15)5 3"0*),##$%& 3" .6.&.7 @0 &"#"05)$. -5 $&*"A
4)5#$%& 3" "2,$1.0 <BC? #.&"#*5350 "& -+&"5D 50+ #.=. <0$ -. )"2,$")"?
!- /.0*.0 1.) "2,$1. 3" =.&$*.)".7 E.0 0"&0.)"0 3" .6.&. 0.& &"#A
"05)$.0 15)5 ="3$) -5 #.&#"&*)5#$%& F -5 )"=.#$%& <3"0*),##$%&? 3"-
-50 #.&#"&*)5#$.&"0 FG. 5,0"&#$50 3"- =$0=.7
0- /5-$353 3" 54,57 E5 #.&3,#*$:$353 3"- 54,5 1,"3" 4)53,5-="&*"
5,="&*5) "& 0$0*"=50 ,05&3. ,&5 ;,"&*" #.).&5 3" 3"0#5)45 #.& H5I5
1,)"65 3" .9+4"&. F 2," *"&45 1.#. FG. &. ,0. 3" 54,5 1.) 1")$.3.0
-5)4.07
1-
54,5 #5-$"&*"7 @- ,0. ;)"#,"&*" 3"- .6.&. <3$5)$. FG. 0"=5&5-="&*"?
)"2,")$3.0 5-*.0 &$:"-"0 3" .6.&. . 5-4K& .*). 1).#"0. 3" 05&$*$65#$%&
2- /.=15*$H$-$353 3" =5*")$5-"07 !%-. =5*")$5-"0 #.=15*$H-"0 F )"0$0*A
"&*"0 5- .6.&. 3"H")J& 0") ,053.0D 4"&")5-="&*" "- 5#"). $&.9$35H-"
LMNE *$"&" ,&5 :$35 $-$=$*535 #.& "- .6.&.O 0$& "=H5)4.D 5-4,&.0 "=A
152,"0 FG. "-50*%=").0 1,"3"& *"&") ,&5 )"0$0*"&#$5 #.)*57
8.) -. *5&*.D #$")*.0 #.0*.0 3" 15)*"0 3" )""=1-56. 3"H"& 0") #.&0$3A
")53.07 P5*")$5-"0 $&#.=15*$H-"0 #.& "- .6.&. . 52,"--.0 3"I53.0 "&
0"):$#$. 1.) -5)4. *$"=1. 0" 1,"3"& 3"4)535) F ;5--5)D . 1".) 5K& 0"
1,"3"& 3$0.-:") "& "- 54,57
1,"3"& 3$0.-:") "& "- 54,57
XXX70$$;057#.=7=9
!" EDICIÓN ESPECIAL 2014
#$ "$ &$
LOS SISTEMAS SINGLE-USE (MAL LLAMADOS O MAL TRADUCIDOS, DESDE MI PUNTO DE VISTA, DESECHABLE.
PREFIERO UTILIZAR EL TÉRMINO SISTEMAS DE UN SOLO-USO), ESTÁN SIENDO CONSIDERADOS E
IMPLEMENTADOS EN MUCHOS PROCESOS BIOFARMACÉUTICOS PORQUE DICHAS COMPAÑÍAS HAN IDENTIFICADO
VENTAJAS IMPORTANTES QUE ESTOS SISTEMAS OFRECEN COMPARADOS CON LOS SISTEMAS TRADICIONALES
REUTILIZABLES (ESPECÍFICAMENTE LOS SISTEMAS DE ACERO INOXIDABLE).
QFB, CPIM N. SAÚL ESTRADA ILLESCAS
#$ "$ &$ !$ '$
!"##$%& ()*+#,-.
/
INTRODUCCIÓN A LA FABRICACIÓN DE FORMAS FARMACÉUTICAS SÓLIDAS
LA FORMA FARMACÉUTICA DE UN MEDICAMENTO, ES LA ESTRUCTURA A LA QUE SE ADAPTAN LOS PRINCIPIOS
:
3.0$#$%& $&4$;$4,6-$<646 6 =," 0" 6463*6& -.0 3)$&#$3$.0 6#*$;.0 >
?60 5.)260 56)26#7,*$#60 .)6-"0 3.) ;+6 0%-$46 280 @6A$*,6-"0 0.&
3).*"/$460 3.) ,&6 #,A$")*6 &.)26-2"&*" 4" /"-6*$&6 . A$"& 4" /"-6*$&6
:
.)+6 6 A60" 4" /"-6*$&6 > 06#6).06 >9 /"&")6-2"&*"9 0" ,*$-$<6& 36)6
?.0 /)6&,-64.09 0.& 2,> 0$2$-6)"0 6 -.0 3.-;.09 3"). 0" 4$5")"&#$6&
"& =," -.0 #.&0*$*,>"&*"09 @6& 0$4. 0.2"*$4.0 6 ,& 3).#"0. =," -.0
B-*$2.9 -60 #.&.#$460 #.2. *6A-"*60 )"#,A$")*609 0.& 5.)260 .A*"&$460
2"4$6&*" "- )"#,A)$2$"&*. 4" &B#-".09 @6A$*,6-2"&*" #.23)$2$4.09
?6 "-6A.)6#$%& 4" -60 5.)260 56)26#7,*$#609 "0 4" 0,26 $23.)*6&#$6
36)6 /6)6&*$<6) ,&6 ,*$-$<6#$%& )6#$.&6- 4" -.0 3)$&#$3$.0 6#*$;.09
6463*8&4.-.0 6 -6 ;+6 4" 642$&$0*)6#$%& 64"#,6469 *$"&" 64"280
.*).0 .A1"*$;.0 $23.)*6&*"0 *6-"0 #.2.C 56;.)"#") -6 #.&0");6#$%&
4" -.0 3)$&#$3$.0 6#*$;.0 > 3).*"/")-.0 #.&*)6 56#*.)"0 4" 6-*")6#$%&9
?6 ;+6 .)6- A)$&46 ;"&*6160 #.2.9 58#$- > #%2.46 642$&$0*)6#$%&9
6-*")6#$%& 4" 3)$&#$3$.0 6#*$;.0 3.) 36)*" 4" -60 0"#)"#$.&"0 4"- *,A.
4$/"0*$;.9 -6 3.0$A$-$464 4" $))$*6#$%& 4"- *)6#*. /60*).$&*"0*$&6- D06-$#$-6:
?6 26>.)+6 4" -.0 2"4$#62"&*.0 ,064.0 @.> "& 4+6 0" "&#,"&*)6&
"& 5.)26 0%-$469 3.) -. =," "0 #.2B& -6 3)8#*$#6 4" *)$*,)6) *6A-"*60 >
2"<#-6)-60 #.& 6-$2"&*.0 6&*"0 4" 642$&$0*)6)-609 "03"#$6-2"&*" "&
:
!"##$%& ()*+#,-.
)"0,$")" #.&3$2")/#$.&"3 2" -/3 #/)/#*")+3*$#/3 8+3$#/37 0,+4$#/3 ;
<$.-%5$#/3 2" *.2. "- 8=)4/#. ; -.3 $&5)"2$"&*"3 8/)4/#>,*$#.3 ,3/2.3
"& -/ 8/<)$#/#$%& 2"- 1).2,#*.7 /2"4=37 2" 1).1.)#$.&/) "- 4"#/&$34.
1/)/ -/ 3"5,)$2/2 ; -/ -$<")/#$%& /2"#,/2/ 2" -/ 2.3$3 )"0,")$2/7 -/3
/2$#$.&/-"3?
4"2$#/4"&*.37 3" 2$3,"-6"& </B. -/ -"&5,/ . "&*)" -/3 "&#+/3 ; -/
!$ "3*/3 1)"1/)/#$.&"3 3.& 2"5-,*$2/37 )"3,-*/& $&"8"#*$6/3 . 4"&.3
#,<$")*/ "&*>)$#/ "6$*/& -/ $))$*/#$%& "3*.4/#/-7 1)"6$"&"& -/ 2"3*),##$%&
2"- 1)$&#$1$. /#*$6. 1.) -.3 =#$2.3 2"- "3*%4/5. ;7 )"*/)2/& "- $&$#$. 2"
"& "- "3*%4/5. #.& -/ 1.3$<$-$2/2 2" $))$*/) -/ 4,#.3/ "3*.4/#/-7 .
#$%&'()%* &2 -.,2$1(.5/ 26)2/&.&1 % *%*)2/.&1
@
; )"#,<)$>&2.-. #.& 4C-*$1-"3 #/1/37 #.&8.)4" "- 4"2$#/4"&*. 1/3/ /
*)/6>3 2"- *)/#*. 5/3*).$&*"3*$&/-7 -/3 #/1/3 4=3 "9*")&/3 2" -/ */<-"*/
.*)/37 "- 1)$&#$1$. /#*$6. 3" #.-.#/ "& ,&/ 4/*)$D $&")*" "31"#$/- 0,"
0," *$"&"& 4C-*$1-"3 #/1/3 -/3 #,/-"3 3" 2$3,"-6"& -"&*/4"&*" #.&
@
@
#/#$%& 2" 8.)4/3 8/)4/#>,*$#/3 3%-$2/3 3.&?
!"##$%&
#$% '()*+,(% -. /0(*+ -. 1,%$ (23+,*%$4(% 3%,% 5% ($-6)*,(% 7%,2%4/68
*(4%9 %5(2.$*%,(% : 5%) ($-6)*,(%) ;6<2(4%)= > 3%,% 5% ?(-% -. 264'%)
3.,)+$%)
()*) #)+,$)*- #.&/"+.0 1) 2$0/.*$) 3" 4&) +)&"*) 3$5"*"&/"6 7& "&"*.
3" "0/" )8.- "1 9.&3. 3" 1)0 :)#$.&"0 ;&$3)0 <)*) 1) =&5)&#$)- ;:=>79
$&5.*+% 3" ?4" 1) <.1$.+$"1$/$0 2) 0$3. "**)3$#)3) <.* #.+<1"/. "& 1)
=&3$) @*)#$)0 ) 4&) #)+<)8) 3" A)#4&)#$%& 0$& <*"#"3"&/"06 B5@)&$0/C&
D :$@"*$) 0"*E)& 1.0 0$@4$"&/"0- )&4&#$%6 >)+,$. 3" "0#"&)F 7& 4& A$8"3.
"& 1) *"@$%& 3"1 ()1)/$&)3. 3" B1"+)&$)- 1)0 <.1$11)0 +)#2. 3" 1) A$3 ,40#)&
3"0"0<"*)3)+"&/" ) 1)0 2"+,*)0 *"#"</$A)06 ("*. 0%1. ""&/*)& )+G
<.11"/)0 ?4" #.&/$"&"& 5"*.+.&)0 H)/*)D"&/"0 0"I4)1"0 3" 1) +4J"*K- <.* 1.
70/)0 0.& 2$0/.*$)0 3" 1) A$3) #./$3$)&)6 !.& )#"*#) 3" LI$/.0- @*)&3"0 D
<"?4"8.06 M$5"*"&/"0 D /)& 0"<)*)3.0 "& "1 "0<)#$.- #.+. <4"3"& 0"*-
&$&@4&. 3" "11.0 0"*E) #.&#",$,1" 0$& 4&) $&&.A)#$%& /"#&.1%@$#)6 70/.
"0 )0E <.*?4" #)3) 4&. 3" "0/.0 1E?4$3.0 . <)0/.0.0 <*.34#/.0 /$"&"&
?4" 11"@)* ) 04 3"0/$&.F >)1#4/)- N),41- )1 A$8"3. )1"+C& . )1 2.0<$/)1 "&
),0.14/)+"&/" "0/L*$1"06
"& 4&) 5"#2) /"+<*)&) 54" O"*2)*3 P)&0"& 3"
#4*0. 3" "1"#/*$#$0/) D .,/4A. 4& /E/41. "& $&@"&$"*E)
)"*.&C4/$#)6 7&/.&#"0- )1 $@4)1 ?4" +4#2.0 +$"+G
,*.0 3" 04 @"&"*)#$%&- A$. 04 #)**"*) 3.1.*.0)+"&/"
D ),*4</)+"&/" $&/"**4+<$3) <.* 1) !"@4&3) O4"**)
Q4&3$)16 !40 "I<"*$"&#$)0 54"*.& $&404)1"0 "& "1
2"#2. 3" ?4" "& 3.0 .#)0$.&"0 1.@*% "0#)<)* 3"1
#)4/$A"*$. R40.6
G
,+22.5%1@
"& B)*)46 70. 54" 2)#" #$"&/) )8.06 P.D ,+22.5%1 @ "0 4& +$"+,*.
3" 1) +)*#) A+**.53%4B @ =
("*.- S?4L 2) 2"#2. "0/) /"#&.1.@E) /)& /*"+"&3)+"&/" "I$/.0) "& 1.0
?4" 0$@4" 0$"&3. 5L*/$16
70 4&) #4"0/$%& 3" /*"0 <)0.06 T.3)0 1)0 +C?4$&)0A+**.53%4B @ 54&#$.&)&
#*")& #.&/"&"3.*"0 3" @*C&41.0 /"*+.<1C0/$#.0 H,1.UK- 11"&)& 1.0 <*.34#/.0
1.0 +L/.3.0 3" "+,)1)J" #.&A"&#$.&)1"0F 1.0 <*.34#/.0 &. #.&/$"&"&
#.&0"*A)3.*"0 . #.&/)+$&)&/"0V "1 <*.#"0. "0 /./)1+"&/" )4/.+C/$#.-
#.& 1. ?4" )2.**) /$"+<.- "0<)#$. D +)&. 3" .,*)V 1.0 #.&/"&"3.*"0 "0/C&
0"11)3.0- 0.& $**.+<$,1"0 D <1"@),1"0- D 1) +CI$+) 0"@4*$3)3 3"1 <*.34#/.
"0/C )0"@4*)3) "& /.3. +.+"&/. H1.0 #.&/"&"3.*"0 0.& )0L</$#.0 D )
<*4",) 3" +)&$<41)#$%&K6
TRES EN UNO A LA PERFECCIÓN. HACE CINCUENTA AÑOS, ROMMELAG® REVOLUCIONÓ LA TECNOLOGÍA DE
EMPAQUE PLÁSTICO
"7"268(1 +" 6-"," 2"&#$(&*. "8 ."#$"&/"2"&/" ,"+*..(88*,( +$+/"2* ,"
"26*9-" *+06/$#( 5(": #$%%&'()*+ , ;*<.$#*. "&)*+"+ ," 8"#="1 *#"$/" )">"/*81 .";."+#(+1 #(+20/$#(+1 ,"/".?
"8 0&;*+$+ "& /(,( "8 2-&,( +" "&#-"&/.* "& 8(+ 6.(,-#/(+ ;*.2*#0-/$#(+@
239-$&*+ 5(": #$%%&'()*+ , 6-"," ;*<.$#*. #(&/"&",(."+ 2-8/$?#*6* #(&
#*6*+ ," <*..".*+ "+6"#$*8"+ 6*.* "8 "26*9-" ," 6.(,-#/(+ *8/*2"&/"
+"&+$<8"+4 B& 8* #(?":/.-+$%& ,$;"."&/"+ 2*/".$*8"+ 683+/$#(+ +(& ":/.-$,(+
"& #(&7-&/( "& ;(.2* ," /-<(+ 2-8/$?#*6* 6*.* 8(>.*. #(2<$&*#$(&"+
."9-$"."& -&* *>-7* +"6*.*,* 6*.* ":/.*". "8 #(&/"&",(.1 A *26(88"/*+ ,"
8(+ (C,(+ #(& #32*.*+ ,$+6"&+*,(.*+ $&/">.*,*+ 9-" "8$2$&*& 8* &"#"+$,*,
," #(&+".)*,(."+4 D*."#" &( =*<". 8C2$/" * 8*+ ;-&#$(&"+ 9-" +" ,"+*..(88"&
"& "+/."#=* #(8*<(.*#$%& #(& 8(+ #8$"&/"+4
+">-.$,*,@ 6*.* "8 6.(#"+( A 6*.* "8 6.(,-#/( "& +C4 E"<" =*<". *<+(8-/*
"+/".$8$,*, ,-.*&/" "8 6.(#"+( ," 88"&*,( *+06/$#( A -& +"88*,( 6".;"#/*?
=-2*&* "+ 8* 6.$&#$6*8 6."(#-6*#$%&4 F(,*+ 8*+ 6".+(&*+ "&.$//&')0 ,
"+/3& #(&+#$"&/"+ ," "+/* ."+6(&+*<$8$,*, ":$+/"&#$*84
#$%& ," #(&/"&",(."+1 8*+ 239-$&*+#$%%&'()*+ , 6-","& "+/*. "9-$6*,*+
#(& -&* *268$* >*2* ," +">-.$,*,1 8* >*.*&/C* ," #*8$,*, A 2%,-8(+ ,"
2*&".*1 /*2<$0& #-268"& #(& 8*+ &(.2*+ >-<".&*2"&/*8"+1 #(2( 8(+ ,"
8* G,2$&$+/.*#$%& ," E.(>*+ A G8$2"&/(+ ," B+/*,(+ H&$,(+ IJEG1 6(. +-+
8(+ 6.(,-#/(+4
8(+ $&+6"##$(&*& 6*.* <-+#*. #(&/*2$&*#$%& 6(. 6*./C#-8*+ A ":6-8+*.
*-/(23/$#*2"&/" 8(+ "8"2"&/(+ ,";"#/-(+(+4 G,"23+1 =*A ,$+6(+$/$)(+
6*.* 6.(<*. *26(88"/*+ ,-.*&/" 8* 6.(,-##$%&1 2(&$/(."( ," *$." "& #-*./(+
," ;(.2* $&,$)$,-*84 B+/."#=(+ #(&/*#/(+ #(& 8(+ #8$"&/"+ +(& +$& ,-,* -&*
+$+/"2*+ ," ,$*>&%+/$#( ."2(/(1 "&/."&*2$"&/( ,"8 #8$"&/" "& "8 5"&/.(
," 5*6*#$/*#$%& #$%%&'()*+ , A ,"+68$">-" ," 6".+(&*8 ," 2*&/"&$2$"&/(
"+6"#$*82"&/" "&/."&*,( "& /(,( "8 2-&,(4 L.*#$*+ "& >.*& 6*./" * 8*
+-<#(&/.*/*#$%& ," +-+ #(26*MC*+ =".2*&*+ N(8(6*#O "& G8"2*&$* A
$//&')0 , 6.(,-#/(+ A +".)$#$(+ 6*.* "8 "&)*+*,( ," 8C9-$,(+1 $-A"&,( 8*+ )*#-&*+4
D.(6(.#$(&* *6(A( * +-+ #8$"&/"+ "& "8 6.(#"+( ," ;*<.$#*#$%& ," 6.-"<*+1
P * N(8(6*#O
B8 23+ $268*#*<8" #(26"/$,(. 6-"," +". &(2<.*,( "& -&* +(8* 6*8*<.*@ )$,?
.$(4 G8>-&*+ /.*,$#$(&"+ /$"&"& -& 6".+$+/"&#$* 9-" ,"+*;C* /(,* ":68$#*#$%&
.*#$(&*84 B8 )$,.$( 6-"," /"&". -&* */.*##$%& &(+/38>$#*1 #(& 6.(;-&,*+
.*C#"+ "& 8* =$+/(.$* ," 8* 2",$#$&*1 6".( "+ (<+(8"/* #(2( "&)*+" 6.$2*.$(
"& 2-#=*+ *68$#*#$(&"+4 D*.* ,*. -& "7"268( /C6$#(1 8*+ ."#(2"&,*#$(&"+
," 8* KQ! 6*.* $&(#-8*#$%& *,)$"./"& ":68C#$/*2"&/" #(&/.* 8(+ ."+/(+ ,"
"&)*+"+ ," )$,.$( .(/(4 R*,* 6(,.C* +". 23+ ;3#$8 9-" ,"+#*./*. "+/" .$"+>(
2",$*&/" #(&/"&",(."+ ," 683+/$#( A #$".."+ 9-" &( 6-",*& .(26".+"4
+$& .$"+>( ," 9-" +" .(26*&1 A +(& ;3#$82"&/" ,"+2(&/*<8"+ 6*.* 9-" 8*
)"&/$8*#$%& &( +"* &"#"+*.$*4 !(& 9-C2$#*2"&/" $&"./"+1 8$<."+ ," *,$/$)(+
+">-.*1 &( +%8( "& 8(+ =(+6$/*8"+ +$&( /*2<$0& "& (6".*#$(&"+ 2%)$8"+4
#$%%&'()*+ , )$"&"& "& *-2"&/(
9-" )$)"& "& 6*C+"+ ,(&," "8 +$+/"2* ,"8 #-$,*,( ," 8* +*8-, +" "&#-"&/.*
/(,*)C* "& ;*+" ," ,"+*..(88(4 R( "+ ," ":/.*M*. 9-"1 5=$&* " S&,$* +" =*&
#(&)"./$,( "& $26(./*&/"+ 2".#*,(+ 6*.* .$//&')0 , 4
G8 2$+2( /$"26( 8(+ "&)*+"+ ," 683+/$#( +(& *2*<8"+ #(& "8 2",$( *2?
#$%%&'()*+ , *,$/$)(+ *#/$)(+ *,$#$(&*8"+4
D(. 8( /*&/(1 .$//&')0 , /$"&" 2-#=*+ #(+*+ 9-" ,"#$.8" *8 2-&,(4 !%8(
6(,"2(+ ,"+"*. 9-" 8( 8(>."4 E"+6-0+ ," /(,(1 8( 9-" "+/3 "& 7-">( "+
"8 *#/$)( 23+ )*8$(+( 6*.* 8*+ 6".+(&*+@ +- +*8-,4
!
(Departamento de Diseño)
Cada cliente tiene sus muy especiales requerimientos. Es por eso que nosotros
en OPTIMA fabricamos líneas de llenado que son diseñadas a las necesidades
particulares de nuestros clientes mientras ofrecemos los beneficios de una
línea completa e integrada: El paquete completo de la máquina incluye
funcionalidades de alta precisión, respaldadas por documentación consistente y
apoyadas por una solución de software optimizado y adaptado – además de un
punto central de contacto que es un apasionado en todas sus inquietudes…
Somos expertos en soluciones especiales, después de todo.
Visítenos en EXPO PACK Mexico | 17 - 20 Junio 2014 | # 1924
OPTIMA packaging machines S.A. de C.V | Mexico | D.F. 04600 | www.optima-mex.com
OPTIMA pharma GmbH | 74523 Schwaebisch Hall | www.optima-pharma.com
Member of
$2 /3$'C" %$ $//"/ D+?&*" 0 -"*.&?3*&-3E* &'"-3&%&F G2
'3'.$?& %$ 22$*&%" B$/3'.H2.3-" IJK6 $23?3*& 2"' -"'."' 0
2"' /3$'C"' %$ 2&' L"?L&' #"2+?A./3-&' %$ 22$*&%"F
M& IJK6 $' +* '3'.$?& %$ 22$*&%" %$ '"L/$?$'& N+$ '$
+.323@& $* %$B&/.&?$*."' %$ 3*#$'.3C&-3E* 0 %$'&//"22"
,&/?&-A+.3-"' %+/&*.$ 2&' ,&'$' %$ $*'&0" -2O*3-"P " $*
$?B/$'&' %$ ,&L/3-&-3E* '+L-"*./&.&%& B&/& &+?$*.&/ 2&
G2 .&B"*&%" B&/& .&B"*$' $*./$ 7; ?? 0 96 ?? *" *$-$'3.&
B3$@&' %$ ,"/?&." &%3-3"*&2$'F
,2+3%" -"?" 2"' ,/&'-"' 22$*"' N+$%&* -"?B2$.&?$*.$
$*-$//&%"'F
&%&B.&%&' & 2&' $U3C$*-3&' %$ 2&' 3*%+'./3&' &23?$*.&/3& 0
G* /$'+?$*5 $'.& '$/3$ %$ #H2#+2&' /$X*$ ."%&' 2&'
-&/&-.$/O'.3-&' &-.+&2$' *$-$'&/3&' $* -+&*." & 2& -&23%&%
Y+*.&' %$ 2&/C& #3%& X.32P -+$/B" /"L+'."P ?&.$/3&2$' %$ &2.&
-&23%&%P %3'$Z" 3*.$23C$*.$5 C/&-3&' & ."%" $22" 2&' #H2#+2&'
23?B3&/F G2 &--3"*&?3$*." %$ 2& #H2#+2& '3* ?&*.$*3?3$*."
0 -"?B2$.&?$*.$ '"2%&%" $'.H %3'$Z&%" B&/& '"B"/.&/
7F666F666 %$ -3-2"' %$ -"*?+.&-3E*F
C&/&*.O& %$ -&23%&% $U-$B-3"*&2$'F Q$B/$'$*.&* 2& '"2+-3E*
'&L$/ -+H*%" $' '$C+/" 3*3-3&/ $2 B/"-$'"P '3 2&' B/+$L&'
$'.H* &-.+&23@&%&' " '3 2& L&2&*@& $'.H *3#$2&%& 0 ,+*-3"*&
-"//$-.&?$*.$F
L&2&*@&' [SG ",/$-$* 3*-"*.&L2$' "B-3"*$' B&/& %3,$/$*.$'
4& $*#"2#$%"/& &+."56.3-& 17) 89:; %3'$<&%& =&/& 2">/&/ &2.&' #$2"-3%&%$' %$ $5=&-&%"
0 =/3*-3=&25$*.$ =&/& 2& 3*%+'./3& -"'5?.3-&; $' &=/$-3&%& ="/ '+ >/&* =/$-3'3@* %$ $*#"2.+/&;
$*#+$2."' '$ &235$*.&* ="/ 5$%3" %$ +*& A&*%& ./&*'="/.&%"/&; &-.3#&*%" +*& ,"."-?2+2& %$
B$ >&/&*.3C& +*& $*#"2.+/& -"*'3%$/&A2$5$*.$ &=/$.&%& -"* =$2D-+2& %$ &2.& .$*'3@* ="/
'"'.3$*$ $2 =/"%+-." $* '+ 2+>&/ %+/&*.$ 2& $2$#&-3@* 0 $2 %3'$<" %$ 2& +*3%&% =/"="/-3"*&
+*& $*#"2.+/& =/$-3'& 0 ./&*',$/$*-3& ="/ 5"#353$*." "'-32&."/3" $* '3*-/"*3C&-3@* -"* 2& .&'&
%$ &235$*.&-3@* %$ +* '"2" =&E+$.$F
$*./$ 2& A&//& %$ '$22&%" " $2 =+*." 0 $2 =/"%+-." $' 5&0"/ E+$ $* 2& 56E+3*& %$ 5"#353$*."
G2 '$22&%" ./&*'#$/'&2 '$ =+$%$ 22$#&/ & -&A" $* 2& -&/& 3*,$/3"/ %$2 =/"%+-." " 3*-2+'" & 2"'
56E+3*& $* ,+*-3"*&53$*."; .&*." $2 -"/.$ %$ 2& =$2D-+2& 0 =&/& $2 -$*./&%" %$ 2& =$2D-+2& $*
& ./&#?' %$ 2& =/"%+--3@*; =&/& =/"="/-3"*&/ %3'-"*.3*+3%&%$' %35$*'3"*&2$' $#$*.+&2$' $*
=/"%+-."' & '$/ $5=&-&%"'F
G2 89: .&5A3?* =+$%$ &%$-+&/'$ -"* 2"' '3>+3$*.$' %3'="'3.3#"' "=-3"*&2$'H '3'.$5& %$
-&5A3" /6=3%" %$ ,"/5&."; &=23-&-3@* %$ -3*.& %$ '$22&%" I=&/& +*& &=$/.+/& %$ =&E+$.$ 56'
,6-32J; 35=/$'"/& =&/& %&."' %$ =/"%+--3@* #&/3&A2$'; %3'="'3.3#" =&/& %3#3%3%" &+."56.3-" %$
5&.$/3&2 =&/& $5=&-&%" 0 %$'#3&-3@* =&/& 2& ./&*'="/.&-3@* &2.$/*&.3#& %$ =/"%+-."' E+$
*" '$/6* $*#+$2."'F
-"5" '$3' 5<=+3*&' '$*-322&'> %"' $*-&/."*&%"/&': +*&
$.3=+$.&%"/& 6&/& #3&2$': +*& 5<=+3*& %$ 22$*&%" %$ .+;"'
-"* &235$*.&%"/ ?";"#3'3"* 0 %"' 22$*&%"/&' %$ 28=+3%"'@
A* .".&2: "*-$ '"2+-3"*$' %$ $56&-&%" =+$ 6/"6"/-3"*&*
D&/&*.3E&/ +*& 6$/,$-.& 0 '$D+/& &--$'3;323%&% & ."%&'
2&' E"*&' -/8.3-&' =+$ +'&* D+&*.$': +*& D$'.39* 5<' ,<-32
%$ 2&' 63$E&' %$ /$6+$'." 0 5&*.$*353$*.": &'8 -"5" 2&
"6.353E&-39* 6&/& 2& 3*'.&2&-39* %$ '3'.$5&' %$ -"*.$*-39*
?FGC: &3'2&*.$' " $'-+%"' %$ 6/".$--39* 0 $2 *+$#"
5"*";2"=+$ %$ 22$*&%" 0 .&6"*$&%" )4HIJ: $=+36&%"
-"* IJ -&;$E&' %$ 22$*&%" 0 %"' ."//$' %$ .&6"*$&%" 6&/&
,&/5&-B+.3-&: 0 2& *+$#& O*3-&: +*& 28*$& /";".3E&%& 6&/&
6/",+*%" 0 $2 $56&=+$ $* -&/.9*@
A* $2 6"%3" %$ 2&' '"2+-3"*$' %$ $56&=+$ 5<' 3**"#&%"/&'
6&/& $56&-&%" %$ ;23'.$/' P*.$D/& QRM: +* -"*-$*./&%"
'3'.$5&' %$ -"*./"2: $2 *+$#" '3'.$5& %$ /$-"2$--39* 0
&6$/.+/& =+$ 6$/53.$ 6/"%+-3/ QRM ;23'.$/' 0 S&'.& RHM
-&/."*$' 6"/ 53*+."@
T&5;3B* '$ 5"'./9 2& 2 8*$& /";".3E&%& 6&/& ;23'.$/' )GUHM:
+*& %$ 2&' 28*$&' 6&/& ;23'.$/' 5<' /<63%& %$ 2& -"56&78&:
6"/ )&/-S$'3*3 =+$ /$#"2+-3"*9 $2 5$/-&%" ,&/5&-B+.3-"
$* 2"' V2.35"' %3$E &7"' 0 2& $*-&/."*&%"/& %$ 5"#353$*."
-"*.3*+" S"/3E"*.&2 )FQNR : &6.& 6&/& $56&-&%" $* -&/.9*
%$ &2.& #$2"-3%&% 6&/& -+&2=+3$/ 6/"%+-."@
+*& 5<=+3*& $.3=+$.&%"/& 0 2& )1JRM: +*& 3**"#&%"/&
5&*$/& '3D*3,3-&.3#& $2 %$'$56$7" $* .B/53*"' %$
%$ )&/-S$'3*3 '$ 6+$%$* "/D&*3E&/ %$ &-+$/%" -"* $2
6/"0$-." 0 -"* 2&' *$-$'3%&%$' %$ 2"' -23$*.$': &'8 -"5"
2& 2$D3'2&-39* #3D$*.$@
3*-2+0$*%" +* *+$#" %$.$-."/ %$ 5$.&2$': '3'.$5&' %$
4"5& 0 /$'+$2#$ 6/";2$5&' %$ /&'./$&;323%&% %$2 +'+&/3" -"*
+*& *+$#& ;3.<-"/& %$ &--$'" ;&'<*%"'$ $* 1K?RI L&/.$
II 0 &25&-$*&*%" S&'.& NMM $#$*."'@ T&5;3B* '"2+-3"*&
%$/3#&-3"*$' %$ 2& ;";3*& 6/3*-36&2 0 ,&2'"' /$-S&E"'
%$ 6/"%+-."' 6"/ #&/3&-3"*$' '+.32$' $* .$56$/&.+/&
&.5"',B/3-& 0 -&/&-.$/8'.3-&' %$ 2"' 6/"%+-."'@ F%$5<': '+
'3'.$5& 3*.$23D$*.$ %$ #&23%&-39* %$ 6/"%+-."' 5$5"/3E& 2"'
6/<-.3-& %$2 53*"/3'.& 3*%3#3%+&2@
4"' *+$#"' '3'.$5&' C6&-$C&#$/ [N "-+6&* 5$*"' $'6&-3"
0 -+$*.&* -"* 2& .$-*"2"D8& FFT %$ 3*'6$--39* 6"/ /&0"'
[: %$ V2.35& D$*$/&-39*: 5$%3&*.$ 2& -+&2 2"D/&* %$.$-.&/
-"*.&53*&*.$' 5$.<23-"' 0 *" 5$.<23-"' %$ 5&*$/& 5<'
%3'$7&%"' $'6$-3&25$*.$ 6&/& 6/$#$*3/ 2& /$-"2$--39* %$
23563&/ =+$ '"2+-3"*& 6/";2$5&' 6".$*-3&2$' %$ $'.&;323%&%
-&+'&%"' 6"/ $*."/*"' %$ 6/"-$'&53$*." /+3%"'"'@ A'
-&6&E %$ 3*'6$--3"*&/ QM:MMM .&;2$.&' 6"/ 53*+." 0 $'
$* $2 5$/-&%"@
T$2@> NN\ NNHN\UUMM
&%5$'3#"8
,)1","4 15#
D) ;7*@ +*& ,&6323& %$ A/"%+-."' A&/& -/"6&."C/&,9&
,'6"+)1"6 #$%&' BRS J??T)
6&6('%"6 +' +'6%&#'1"!&$".&7# &#('01"! ,"1" "08" ,81&3&."+" A$/63.3/: F+$ +'.$% -+6A2& -"* 2"' /$F+$/363$*."' $'.&E2$-3%"' $* -"*%+-.3#3%&% ] N8JI
4 >*./$?& %$ ;&@+$.$' %$
'$/ ";$/&%&' %$ :&*$/& 3*%$;$*%3$*.$9 B& 3*?$*3$/C& 0 2"' %3'$D"' %$ 2&' :3':&' '"*
%$;$*%3$*%" %$ 2& &;23-&-38*E '$?+/3%&% 0 ;/$'+;+$'."'9 >* F<1F $'.&:"' -"*#$*-3%"'
3*'.&2&-3"*$'9
4$'" &5"/& $' 4"'362$ $* 3*'.&2&-3"*$' $* %"*%$ 2&' 2373.&-3"*$' %$ $'4&-3" &*.$' $/&*
3*'.&2&/ +*& 6='-+2& 5&6/>& '3%" 374$*'&62$9 ?+ %3'$<" 73*37&23'.&@ 53A" 4"'362$ B+$ & ./&#C'
%$ 3**"#&-3"*$' .C-*3-&'@ '$& /$#"2+-3"*&/3"9
%$ DE 0 FE 8/&7"' -"* +*& 2$836323%&% %$ 5&'.& DE 73-/"8/&7"'9 1"* &2."' >*%3-$' %$
&-.+&23A&-3;* 0 ./&*',$/$*-3& %3/$-.& %$ %&."'@ '"* 3%$&2$' 4&/& &423-&-3"*$' %$ .3$74" -/>.3-"9
&5"//&/ $'4&-3"9
%$ 4/"%+-."' -"'."'"'9 G* &7423" /&*8"
%$ &--$'"/3"'@ .&2$' -"7" &-"42$' %$
./&*'4"/.&%"/ -"* /"%322"'@ 4$/73.$ +*& ,=-32
-"* 2"' /$B+$/373$*."' %$ 3*8$*3$/>& %$
42&*.& 0 '"* 3%$&2$' 4&/& $2 -"*./"2 %$
4/"-$'" %$ 22$*&%" &+."7=.3-" 0 %3'4$*'&%"
%$ 4/"%+-."' ,&/7&-C+.3-"'9
4/$-3'3;* 4&/& &423-&-3"*$' &+."7&.3A&%&'@
.&2$' -"7" %3'./36+-3;*@ 22$*&%" 0 /$#3'3;*
%$ 4$'"9
#3'3.$ *+$'./& 4=83*&L
5/"-$'" %$ 22$*&%" '"* &2G&-$*&%"' $* 2& G$G"/3&
%$2 '3'.$G&: H2 +'+&/3" 5+$%$ -/$&/ *+$#"' 5/"I/&G&' %$
22$*&%" %$ ,"/G& /J53%& 0 '$*-322&:
&2.+/& '"F/$ $2 #3&2K '$IL* '$& "F.+/&%"/ 5&/& 3*0$-.&F2$ "
5"/ #&-M":
-/3G5&%" *$+GJ.3-"K -"* $2 -+&2 '$ -"*'3I+$ 2& GM*3G&
I$*$/&-3O* %$ 5&/.M-+2&' %+/&*.$ $2 5/"-$'" %$ -$//&%":
9"%"' 2"' -3$//$' %$ +'" -"//3$*.$ 5+$%$* '$/ ./&.&%"' '3*
5/"F2$G&'K .&2$' -"G"8
R&/& 5/"%+-."' P+$ '$ %$F&* 2 3", 3 2 3Q&/K $73'.$ 2&
5"'3F323%&% %$ %3#3%3/ $* %"' GJP+3*&' 3*%$5$*%3$*.$'
2"' 5/"-$'"' %$8
N& GJP+3*& P+$ 2$ 5/$'$*.&G"' $' +*& -"GF3*&-3O*
#3&2$' -32M*%/3-"' $* #3%/3"K 52J'.3-" " F3$* G$.&2K 5&/&
$2 &-"*%3-3"*&%" &+."GJ.3-" %$ ."%" .35" %$ 5/"%+-."'
2MP+3%"'K '$G3B2MP+3%"' " $* 5"2#"K $* Q"*& $'.6/32 " '&2&
R&/& 5/"%+--3"*$' %$ S&'.& C:DDD +5S:
1"* 2& +.323Q&-3O* %$ +* &3'2&%"/K 2& Q"*& $'.6/32 '$ 23G3.&
$'.J*%&/$' %$ 2& 3*%+'./3& ,&/G&-6+.3-&:
N& GJP+3*& $' &%$-+&%& .&*." 5&/& 2".$' %$ $*'&0"' -2M*3-"'
-"G" 5&/& $7.$*'"' 2".$' %$ 5/"%+--3O*:
X*.$'
/"44$2&5 2& 467+3*& &'89.3-& -"492$.&4$*.$ $28-./3-&
:;<) 9&/& 2& 3*'9$--3=* %$ #3&2$' >?)@ -"*./"2&/ $2 9/"-$'"
-"492$.&4$*.$ &+."46.3-" %$ A2"7+$' %$ &49"22$.&' BCD
0 -"*.$*$%"/$' BCDE
9&/& 2& 3*'9$--3=* $* 9/"-$'" %$ A2"7+$' %$ &49"22$.&' BCDE
-"4" ,+$/G&' %$ ."/'3=*@ 9$'" %$ 22$*&%"@ 5/"'"' %$ 9&/$%$'
0 4&/-&' 3*%3#3%+&2$' %$ 2&' &49"22$.&' +'&*%" 3*'9$--3=*
9"/ -64&/&' H1I J/$-"*"-343$*." %$ -&/&-.$/$' =9.3-"'K
9+$%$ &2-&*G&/ L&'.& MNO &49"22$.&' 9"/ L"/&E
P2 $*,"7+$ %$ /"44$2&5 9&/& 2& 3*'9$--3=* #3'+&2
&+."4&.3G&%& %$ 9&/.Q-+2&' '$ A&'& $* 2& 32+43*&-3=*
'$ /$&23G& +*& '$/3$ %$ ,"."5/&,Q&'E
F&' 467+3*&' %$ 3*'9$--3=* %$ 9&/.Q-+2&' %$ /"44$2&5
.$*$/ $* -+$*.& 2&' /$'9$-.3#&' 3*.$/&--3"*$' %$2 4&.$/3&2
0 %$.$-.&* %$,$-."' -"'48.3-"'@ &'Q -"4" "./"' %&R"'
$'.8.3-"' J4&*-L&' *$5/&' " 4&2,"/4&-3"*$'KE S+$%$*
+.323G&/'$ 9&/& ."%"' 2"' .&4&R"' %$ -"*.$*$%"/$' 0 A2"7+$'
23A/$ %$ -"*.&-." 0 *" %$'./+-.3#"E P2 /$*%343$*." %$ 2&'
467+3*&' $' $'-&2&A2$ L&'.& 46' %$ ;M 432 -"*.$*$%"/$'
3*%3#3%+&2$' 9"/ L"/&E
T'34 3'4" $ /"44$2&5 0 -"*.$*$%"/$' BD 9&/& 3*'9$--3=* %$ -+$/9" -"492$."
$*-"*./&*%" .&4&R"' %$ ,+5&' %$ L&'.& N U4 " 3*-2+'"
4$*"/$'E P2 $7+39" $' 4+0 $'-&2&A2$ 9&/& %3,$/$*.$'
&923-&-3"*$'E
3"#3&+
!"/4&' :T &-$9.&%"' 9&/& $2 +'" '&*3.&/3" $ 3*%+'./3&2@
S&/& &'$5+/&/ 2& -&23%&% %$ 2&' *"/4&' $' 3*%3'9$*'&A2$ 2&
-"4A3*&-3=* %$ 2& $W9$/3$*-3& -"* 2& .$-*"2"5Q& 4"%$/*&Z
9+*."' 7+$ *" 9+$%$* '$9&/&/'$ -+&*%" '$ %$'$& "A.$*$/
5&4& %$ %3,$/$*.$' .39"' " 4"%$2"' -+A/3$*%" -&9&-3%&%$'
L&'.& [O@OOO 2.'E
)!"#$% &'(')'*'+'@ )%,-.++./@ S&.0)'@ \%++.1,@ )!+#('@
VVVE5/+9"-39'&E-"4
2$-L$ -"*%$*'&%&@ -/$4&@ 0"5+/.@ '+$/"@
$.-8.$/&E
%$ &:+& 7"/ 2" 9+$ *" /$9+3$/$ %$ -"*$;3<* & +*& ."4&6 2"
9+$ 2& =&-$ 45' #$/'5.32 0 .".&24$*.$ 7"/.5.32>
*" =&0& 22$:&%" & -$/">
#$%$ '( )$*$
.(#(+/(0#(1 (1#2+-&(1 *+$3&(045 6$$1#(+ !0. *+$3&(04 0*7
+,-./,01',2
$2 7/"%+-."> H32./&%"' 0 22$*&%"' $'.B/32$'6 $* +* &4I3$*.$
&'B7.3-" 12&'$ J -&%& 7&9+$.$ $'.5 $4I".$22&%" $* %"I2$
I"2'& 7&/& +*& ,5-32 $*./&%& $* '+ &4I3$*.$ &'B7.3-"> K'."'
7/"%+-."' .3$*$* +* $;.$*'" 7&9+$.$ %$ %"-+4$*.&-3<* 7&/&
'"7"/.$ %$2 $9+37" %$ L$/#3-3"' MB-*3-"' %$ LMKANL 7&/&
&'3'.$*-3& 7$/'"*&23?&%& %$ &723-&-3<* 0 #&23%&-3<*>
E&/& 4&' 3*,"/4&-3<*C
)3456# #$%$ '( )$*$
)1/1+.(/72.8+12
1"*.3$*$ '+/,&-.&*.$' 0 7$/<;3%"
&4723" $'7$-./" %$ '+-3$%&%$'>
-"* #&/3"' '+I'./&."'>
-&23%&%>
7/"-$'"' %$ 23473$?&>
+(1*-+!.$+ *"+-8-%!.$+ ('!
[EUEA6 7"/ '+' '3:2&' $* 3*:2B'@> U2 ",/$-$/ & 2"' +'+&/3"'
+* ,&-."/ %$ 7/".$--3<* &'3:*&%" %$ \RRR 0 +* '3'.$4& %$
18999: ;& 3**"#&%"/& 42&.&,"/6& -+</$ +* /&*=" %$ >&'.&
2"' $A+34"'5 &'B -"6" /$%+-3/ $2 -"'." .".&2 %$ 4/"43$%&%:
C2 4"/.&,"23" %3*D63-" %$ 18999 3*-2+0$ $2 18E89 -"* +*&
4&*.&22& .D-.32 %$ FE 4+2=&%&' 0 -&4&-3%&% %$ &26&-$*&63$*."
-"* +*& &6423& =&6& %$ ,+*-3"*$' "4-3"*&2$' %$ '",.G&/$
4/"%+--3H*:
4/"4"/-3"*& 4/".$--3H* -"*./& 2&' #3</&-3"*$' -&+'&%&'
4"/ "./&' 2B*$&' %$ 4/"%+--3H* 6&A+3*&/3& 0 ",/$-$ +*
6&0"/ 4/$-3'3H*: C2 %3'$I" 6"%+2&/ %$2 '3'.$6& 4$/63.$ +*&
$2$=3/ $*./$ +*& =&6& %$ -"6<3*&-3"*$' "4-3"*&2$' %$
.$-*"2"=B& %$ 3*'4$--3H* %$ 4/"%+-." -"6" %$.$--3H* %$
6$.&2 J6"%$2" 1)K5 3*'4$--3H* %$ /&0"'LM J6"%$2" 1NK "
3*'4$--3H* #3'+&2 J6"%$2" 1OK:
6$.&2$' 4$/63.$ A+$ 2&' 2B*$&' %$ 4/"-$'&63$*." "4$/$*
& #$2"-3%&%$' H4.36&'5 3*'4$--3"*&%" +*& #&/3$%&% %$
4/"%+-."' & *3#$2$' -"//$-."' %$ ,/$-+$*-3& 4&/& =&/&*.3P&/
%$ %$.$--3H* %$ 6$.&2 3*-"/4"/&* %"' /&*="' %$ ,/$-+$*-3&
3*.$/,&P >"6</$L6DA+3*& -"*./"2& $2 4$'" 0 2& .$-*"2"=B&
%$ %$.$--3H* %$ 6$.&2$' QCC5 /$%+-3$*%" .3$64" %$
4/"=/&6&-3H* 0 $2 /3$'=" %$ $//"/ %$ ,+*-3"*&63$*.": ;"'
'3'.$6&' .&6<3?* 3*.$=/&* 2& .$-*"2"=B& %$ =$'.3H* %$
'"</$ -&6<3"' %$ 4/"%+-." 0 $2 /$->&P" %$ 2"' 4/"%+-."'
%$,$-.+"'"':
2& 2B*$& %$ 4/"%+--3H* 0 #3</&-3"*$': R*& P"*& %$ ./&*'3-3H*
"4.363P&%& $*./$ 2"' /"%322"' %$ %3D6$./" 6D' 4$A+$I" %$ 2&'
%$ $'.& 6&*$/& 3*-/$6$*.&* +*& 6&0"/ 4/$-3'3H* %$ 2&
4$'&%&5 0 4"/ 2" .&*." +* 6&0"/ /$*%363$*.":
<&'$ .+<+2&/ 0 +
"-/(."&!%() 1 '( )(.<&"&- #8"+&"- (+ =8>&"-? @(##( 6-/5!"#&+9 '&- ! "-+-"(. A$( '()'(
(% /() '( B$+&-? )$) !"#&<&'!'() '( +(9-"&- (+ #(..&#-.&- /(>&"!+- )(.C+ /!+(;!'!)
D% 5.&/(. "-+#!"#- "-+ @(##( 6-/5!"#&+9 =8>&"- )(.C (% &+9(+&(.- E+'.8) F!."G!?
'&.("#-. 9(+(.!%? ! A$&(+ %! /!1-.G! '( %-) "%&(+#() "-+-"(+ 1 !5.("&!+H D% &+9(+&(.-
F!."G! "$(+#! "-+ %-) "-+-"&/&(+#-) 1 %! (>5(.&(+"&! +("()!.&! 5!.! !'("$!. )$)
'$.!+#( %-) I%#&/-) !J-) ()#!:%("&7 (+ (% /(."!'- /(>&"!+-H E% "-+#!. "-+ $+ (A$&5-
'( !%#! (>5(.&(+"&! "-/(."&!% 1 #8"+&"!H 6-+ (% (A$&5- '( #.!:!;- "-/5$()#- 5-. (%
&+9(+&(.- K!&. D)5&+-)!? B-)8 K$&) L!.!+;-? 6!.%-) =-+.-1 1 M(9-J! 0$C.(2? #-'-) (%%-)
%&'(.(!'-) 5-. (% &+9(+&(.- F!."G! )( '!.C "-+#&+$&'!' ! A$( %!) #!.(!) A$( )( <(+G!+
.(!%&2!+'- #!+#- (+ (% C.(! "-/(."&!% "-/- (+ (% )(.<&"&- #8"+&"-? %- A$( "-+)&'(.!/-)
!$#-.&2!"&7+ '( %! @--' N O.$9 E'/&+&)#.!#&-+ P@OEQ '( D)#!'-) 3+&'-)? 5!.!
"-/(."&!%&2!. (% 0&)#(/! 3%#.!04!5( 5!.! %! .('$""&7+ +- &+<!)&<! '( %! "&."$+,(.(+"&!
!:'-/&+!% ! #.!<8) '( %! '()#.$""&7+ '( %!) "8%$%!) !'&5-)!)H D% 0&)#(/! 3%#.!04!5( ()
(% 5.&/(. 1 I+&"- #.!#!/&(+#- '( .(/-'(%!"&7+ "-.5-.!% +- &+<!)&<- A$( $#&%&2! 5$%)-)
'( (+(.9G! '( $%#.!)-+&'- (+,-"!'-) A$( !5$+#!+ '( /!+(.! 5.("&)! ! %! !'&5-)&'!'
)$:"$#C+(!? ! %! <(2 /!+#&(+( &+#!"#-) ! %-) #(;&'-)? <!)-) )!+9$G+(-)? +(.<&-) 1
3%#.!04!5( $)! $+ (,("#- /("C+&"- 5$.- 5!.! '()#.$&. %!) "8%$%!) !'&5-)!)? )&+ 5.-<-"!.
'!J- #8./&"-? %- "$!% :.&+'! $+ #.!#!/&(+#- )(9$.- 1 "-+,-.#!:%(H
&/5-.#!+#( &+<(.)&7+ (+ (% '()!..-%%- '( 5.-'$"#-) +- &+<!)&<-) 5!.! %! .(/-'(%!"&7+
"-.5-.!% +-) "-%-"! (+ $+! 5-)&"&7+ (>"%$)&<! 5!.! %&'(.!. (% /(."!'- "-+ %! #("+-%-9G!
'( '()#.$""&7+ /("C+&"! '( %! !'&5-)&'!' A$( 5.()(+#! 3%#.!04!5( 1 "-+ +$()#.!
&+&9$!%!:%( #("+-%-9G! #8./&"! R(%!04!5( SSS? !/:!) !5.-:!'!) 5-. %! @OETH D% 0&)#(/!
3%#.!04!5( -:#$<- %! /!."! 6D (+ UVVW 1 )( "-/(."&!%&2! (+ D$.-5!? 6!+!'C 1
0#!. =8'&"! .(!%&27 %! !5(.#$.! '( )$) +$()#.!) &+)#!%!"&-+()? 0#!. =8'&"! X&5? $+
()5("&!%&'!' 5('&C#.&"! ! +&<(% +!"&-+!%? "-+ )(.<&"&-) '( I%#&/! 9(+(.!"&7+? #("+-%-9G!
'( 5$+#! 1 /-'(.+!) &+)#!%!"&-+()H
"-+)-%&'!+'- ! %! "-/5!JG! "-/- %! "!'(+! '( 4-)5&#!%() 5.&<!'-) '( /!1-.
(/5%(-) '&.("#-) 1 Y?WVV &+'&.("#-)? %- "$!% .(,.(+'! (% "-/5.-/&)- '(% F.$5- "-+ %!
)-"&('!' /(>&"!+!H D+ 5!%!:.!) '( E%(;!+'.- =!.#G+ '(% 6!/5- 0()"-))(? 5.()&'(+#(
?5#(6($#5 X-)5&#!% S+,!+#&%
Z.&<!'- 0#!. =8'&"! XSZ X&5 "$(+#! "-+ /C) '( [V !J-) '( (>5(.&(+"&! (+ %! !#(+"&7+? '-"(+"&! ( &+<()#&9!"&7+
(+ 5('&!#.G! 1 +(-+!#-%-9G!? %- A$( +-) 5(./&#( -,.("(. )-%$"&-+() /8'&"!) &+#(9.!%()H
! %-) 5(A$(J-)? /&)/! A$( +- )( (+"-+#.!.C (+ -#.- 4-)5&#!% 5.&<!'- ()5("&!%&2!'- (+
5('&C#.&"-) (+ '&<(.)!) .!/!) '( %! /('&"&+!? #!%() "-/- \(.!5&! S+#(+)&<! 1 L(-+!#!%?
X(/-'&+!/&!? 6!.'&-%-9G!? 6&.$9G! K!5!.-)"75&"! =G+&/! S+<!)&<!? L($.-"&.$9G!?
].#-5('&! 1 \.!$/!#-%-9G!? \.!)5%!+#()? ]+"-%-9G! 1 3.9(+"&!)? (+#.( -#.-) )(.<&"&-)H
6!:( /(+"&-+!. A$( 5!.! UVY[? 0#!. =8'&"! %%(<!.C ! "!:- %! !5(.#$.! '( )$) +$(<!)
$+&'!'() 4-)5&#!%!.&!) (+ %-) ()#!'-) '( R(.!".$2 1 64&4$!4$!^ 1 (+ UVYW? &+&"&!.C %!)
-5(.!"&-+() '( $+! )(9$+'! $+&'!' 4-)5&#!%!.&! (+ %! "&$'!' '( =-.(%&!? =&"4-!"C+?
0#!. =8'&"! K!) E/8.&"!)? 4("4- A$( .-:$)#("(.C )$ "-/5.-/&)- 5-. :.&+'!. (% /C)
!%#- +&<(% '( "-+,-.# 1 !#(+"&7+ '( )!%$' 5.&<!'!H
!"##$%& ()*+#,-.
METODOLOGÍA DE ANÁLISIS DE RIESGO DE PROCESOS Y OPERACIONES FARMACÉUTICOS (ARPO) PARTE II
EN EL ARTÍCULO ANTERIOR COMENTAMOS LAS BASES GENERALES DEL ANÁLISIS DE RIESGO DE PROCESOS
Y OPERACIONES FARMACÉUTICOS (ARPO).
/- 0)"1"&*" 2)*+#,-. )"2-$32)4 ,&2 5"1#)$0#$%& 6," $&*"&*2 "70-$#2) 2
@
@
@
DR. EN C. ANA CECILIA GONZÁLEZ VILLEGAS
OPKO MEXICO
/& "1*" 0,&*.9 -2 B.);2 D"7$#2&2 $&5$#2 -2 &"#"1$525 5"- "1*2>-"#@
$;$"&*. 5" ,&2 !"#$%$&$'() +," -") .")&/0)%) %" !)1".) "2"3#/4) 5).)
.")&/0). &) 6"-#/71 %" 8/"-'$ %" 9)&/%)%: @
/21 9,$5"-$&"9,$5"-$&" :;2
/31 9,$5"-$&":<=2
!"##$%& ()*+#,-.
3" #0-#,-. 3" 5).))2*". . 4"3$#$%& &. 52)247*)$#2 3" -2 5).121$-$323
=
!"##$%& ()*+#,-.
"# %&'()*+ ,-(.+/ 012)')3()45 !$/*"01 2" 01&,31#*,)1 1#*,1- 4," "/
*1- #,1- /" )"1-$51&6 7"). #.& -1/ -$0$*1#$.&"/ 2"- 71/12. 8 -./ #109$./
=
?CA D,$2"-$&"D,$2"-$&" EF;
INTEGRACIÓN DE ESTRATEGIAS PARA I YD EN LA INDUSTRIA FARMACÉUTICA
EL SECTOR FARMACÉUTICO CONSTITUYE UN SECTOR ESTRATÉGICO EN LA ECONOMÍA DE MÉXICO, SE ESTIMA
QUE EN 2013 GENERÓ CERCA DE 100 MIL EMPLEOS DIRECTOS, LO QUE DEMUESTRA QUE LA INDUSTRIA
MEXICANA ES UNA DE LAS DE MAYOR TAMAÑO Y PRODUCTIVIDAD EN AMÉRICA LATINA.
RAÚL SORIA DIRECTOR INOSAN BIOPHARMA, S.A.
!$& "/01)2.3 -14 "/5)"414 *)1&4&1#$.&1-"4 6./$&1& "- /")#16. &17
#$.&1-3 6"0$6. 5)$&#$51-/"&*" 1 -.4 "-"816.4 #.4*.4 6" -1 $&8"4*$21#$%&
9 6"41)).--. :;9<=3 5).6,##$%& 9 #./")#$1-$>1#$%& 6" /"6$#1/"&*.4?
@.) 61) ,& "A"/5-. 6" -.4 2)1&6"4 #.4*.43 4" "4*$/1 B," "- 6"41)).--.
6" ,& &,"8. /"6$#1/"&*. )"B,$")" ,&1 $&8")4$%& 6" CDD 1 EDD /$-7
-.&"4 6" 6%-1)"4 9 6" FD 1 FC 1G.4 6" $&8"4*$21#$%&3 5).#"4. B," 4%-.
5.#.4 -10.)1*.)$.4 5,"6"& 5121)? @.) .*)1 51)*"3 -1 #.&#"&*)1#$%& 6"
-1 #151#$616 6" 5).6,##$%&3 "- $/5,-4. 6" /"6$#1/"&*.4 2"&H)$#.4
$&*")#1/0$10-"43 -1 0$.*"#&.-.2+1 9 -1 $&#$5$"&*" /"6$#$&1 2"&%/$#1
I1& 2"&")16. ,& "&*.)&. 5-1216. 6" )"*.4?
J& "4*" 4"&*$6. -14 "/5)"414 K1)/1#H,*$#14 6" /"&.) *1/1G. /,"4*)1&
,&1 /"&.) #151#$616 6" #./5"*"&#$1 "& "4*" "&*.)&.3 4$& "/01)2. I1&
7
*)1*H2$#1 "& -1 .5")1#$%& 6" -1 "/5)"41? L./. ,&1 K,&#$%& 6" &"2.#$.43
&M/"). 9 *$5.4 6" #./5"*$6.)"43 -.4 181&#"4 "& -14 *"#&.-.2+143 -.4
#1/0$.4 )"2,-1*.)$.43 "&*)" .*).4 K1#*.)"4?
8"&*1A14 4.0)" -14 5.4$0-"4 .5.)*,&$616"4 B," 4" 5)"4"&*"&3 "4 5.) "4*1
-.4 "-"/"&*.4 B," #.&4*$*,9"& -1 ;9< "& -1 1#*,1-$616?
#$%&'()*+,$ .& #/0 &$ 1) &2%(3*%3()
.& 142 1)54()%4(+42 6)(7)*83%+*42
J& -1 N$2,)1 F 4" /,"4*)1 "- 5).#"4. 2"&")1- 51)1 -1 $&*"2)1#$%& 6" ;9<
7
"4*),#*,)1 6" ;9< 9 14+ 5.*"&#$1) 4,4 5).5$14 #151#$616"4?
N$2,)1 F? J4*)1*"2$1 2"&H)$#1 6" $&*"2)1#$%& 6" ;9< #.& -1 "4*),#*,)1
2"&")1- 6" -1 .)21&$>1#$%&?
N,"&*"O PQ$44 $& R1&2$&2 P"#I&.-.2$#1- ;&&.81*$.&3 S.&2/1&3 S.&6.&3
FTUV3 5? WX?
#$%&%'()* ,% $- %*(.-(%/0- ,% 123
/& -0 1$2,)0 3 4" 5)"4"&*0 ,& 6$02)070 6" -.4 "-"7"&*.4 8," $&*"2)0& -0 "4*)0*"2$0 6" 9:;<
1$2,)0 3= /-"7"&*.4 50)0 ,&0 $&*"2)0#$%& 6" -0 "4*)0*"2$0 6" 9:;=
1,"&*"< >=?=@= @.)&0*AB: 0&6 C= 1-"$4#D") $& E).#"44"4 .F @"#D&.-.2$#0- 9&&.G0*$.&H ;= I= J"0-*D 0&6 I.= >"K$&2*.&H LMMN= E OP=
456%(07)* ,% '%/)80) ,% $- )./-'09-80:'; >0 "4*)0*"2$0 2"&")0- 6" 9:; 6"Q"& "4*0) 0-$&"0604 #.& -.4 .QR"*$G.4 2"&")0-"4 : 50)*$#,-0)"4 6"
-0 .)20&$A0#$%&=
3%80*0)'%* %*(.-(=/08-* ,% 123; T
2$04 6" 04$7$-0#$%&H $75-"7"&*0#$%& : 05-$#0#$%& 6" *"#&.-.2+04 "& 5).6,#*.4=
T
#$%&'%()*'$ ,-$*.'$ /'&' 0' 123
!" /0& #0)0#*")$102. 2.3 *$4.3 2" "3*)0*"5$03 2" 6789 -03 2":"&3$;03 7
-03 .:"&3$;03< =0 "3*)0*"5$0 2":"&3$;0 "3 0>,"--0 >," 4)"*"&2" ?0&*"&")
-0 4.3$#$%& *"#&.-%5$#0 2" -0 .)50&$10#$%& "& "- ?")#02.9 ?$"&*)03 >,"
-0 .:"&3$;0 "3 -0 >," *$"&" ,& "&:.>," 4).0#*$;. 0 -0 *"#&.-.5+0 7 0-
?"@.)0?$"&*. 2" -.3 4).2,#*.3 7 4).#"3.3< A& -0 B0C-0 D9 3" 4)"3"&*0&
-.3 "-"?"&*.3 2" #020 "3*)0*"5$09 "& *E)?$&.3 2" #0)0#*")+3*$#03 7
?"#0&$3?.3 2" .4")0#$%&<
B0C-0 D< F.?40)0#$%& 2" "3*)0*"5$03 .:"&3$;0 7 2":"&3$;0 7 3, $?40#*.
0&2 !*)0*"579 G..27"0) H,C-$3/$&5 F.< !*0 I.&$#09 F(J<
A3 $?4.)*0&*" ;$3,0-$10) >," 4.) -03 #0)0#*")+3*$#03 2" -0 $&2,3*)$0
:0)?0#E,*$#09 -0 ?07.)+0 2" -03 "?4)"303 "?4-"0& 0?C03 "3*)0*"K
4.3$#$.&0?$"&*. "& "- ?")#02. 7 -03 #040#$202"3 2" -0 .)50&$10#$%&<
@,"50 -0 678 "& -0 $&2,3*)$0 :0)?0#E,*$#0 7 -03 ;"&*0@03 #.?4"*$*$;03
>," 4).4.)#$.&09 4.) -. >," "3 &"#"30)$. >," "- 2$3"L. 7 -0 .4")0#$%&
3"0 0 -0 ?"2$20 7 3" "&#,"&*)" 0-$&"020 0 -0 "3*)0*"5$0 7 .C@"*$;.3 2"
-0 .)50&$10#$%&<
4(5(&(6.*'$7
& I0&5$&5 B"#/&.-.5$#0- 6&&.;0*$.&9 =.&5?0&9 =.&2.&9 MNOP9
4DQ<
K
K
!"##$%& ()*+#,-.
/& 0$1 $&$#$.1 "& -2 1,3")4$1$%& 5" -2 02&,62#*,)2 62)02#7,*$#28 0" *.#%
"&6)"&*2) "- )"*. 5" &.)02-$92) ,& 3).#"1. 5" "&42125. 5" 3.-4.1 32)2
$&:"##$%&8 ;," 2 3"12) 5" -21 -$0$*2#$.&"1 5" #232#$525 5" -2 0<;,$&2
--"&25.)28 $03-$#2=2 *"&") =2>. #.&*).- "- "&*.)&. 0$#).=$.-%?$#. 5"- 3).@
#"1.8 &. 1%-. "& *7)0$&.1 5" 5"1$&6"##$%&8 0"&.) *$"03. 5" "A3.1$#$%&
5" "1*" 2)*+#,-.8 1$&. "& *7)0$&.1 5" 3).5,#*$4$525B
E)2#$21 2- #.&.#$0$"&*. 5" -2 #232#$525 5" -2 0<;,$&2 --"&25.)2 : -21
#2)2#*")+1*$#2 ?)2&,-.07*)$#21 5" -2 02*")$2 3)$028 -.?)20.1 .3*$0$92)
5" 1,3")4$12) 5$#K.1 3).#"1.18 #.&1$5")7 )"13.&12=-" #.03$-2) -2
$&6.)02#$%& ;," 0" 1$)4$% : ;," .=*,4" 3)$&#$32-0"&*" !"#$"% 5" -2
3.).1$5258 5"&1$525 4")525")2 : 5"&1$525 232)"&*"H
@
5,#$5. )"13"#*. 2- 3-2&. K.)$9.&*2- #,2&5. 1" -" 5">2 #2") -$=)"0"&*"
<&?,-. 5" )"3.1. "1*<*$#.QB
!$ ,& 3$03. 35*")$5- 0" "B53$&5 6.) -.0 4.0 0$0*"350 5&*")$.)"0@
-. 310 0"2,). "0 :," "- 1&2,-. 4"))5354. 4C 3,#A. 35D.) :," "-
*535E. 4" 65)*+#,-5 4"- 35*")$5-F
/& *C)3$&.0 2"&")5-"0@ "- 1&2,-. 4" )"6.0. 0" ,*$-$G5 65)5 "85-,5)
2)5&,-54.0 =8C50" *5<-5 H?I
"0 4" "06")5)0" :," -.0 2)5&,-54.0 7.)354.0 6.) 65)*+#,-50 -$050 .
"07C)$#50 6)"0"&*"& 1&2,-.0 4" )"6.0. 3,D 56-5&54.0 D 8$#"8")05J
!$ 0" *.35 "- *535E. $&4"6"&4$"&*" 4" -5 7.)35 D 4"&0$454 4"
-5 65)*+#,-5@ 0" 6,"4" "06")5) :," -50 65)*+#,-50 #.& *535E.0 $&7")$.)"0
K*).0 3"#5&$03.0 :," 0" 6,"4"& ,*$-$G5) 65)5 4$03$&,$) -50 7,")G50
4" #.A"0$%& 0.&I
!"##$%& ()*+#,-.
4$6,$"&*"4 2"#/&$42.478
B& )"C,$4$*. >,&1/2"&*/- "4 C," "- -,3)$#/&*" 1"3" *"&") ,& */2/D.
:& "4*" *$0. 1" /&5-$4$4 4" *.2/& GFH 6 1" 2,"4*)/ = 4" 1"I/ 0/4/)
1" "20/C,"*/2$"&*.8
!"##$%& ()*+#,-.
!" EDICIÓN ESPECIAL 2014
:- 3.-,0"& 626)"&*" >?@,-AB $&#-,C" -.1 "126#$.1 D," "E$1*"& "&*)"
!" 2,"7"& .@1")36) 7.1 0I*.7.1 D," 1" 7$5")"&#$6& "& -.1 "D,$2.1
,*$-$G67.1=
!" 2616 MNN; 7"- 2.-3. 2.) ,&6 06--6 OM< >MNNNPQB 26)6
2),"@6 *")0$&6 #,6&7. &. 1" )"7,G#6 041 "- 3.-,0"& 6 2"16) 7" --"36)
:E$1*"& 7.1 0I*.7.1 2.) -.1 #,6-"1 1" 2,"7" --"36) 6 #6@. -6 2),"@6
:- 2.)#"&*6H" 7" #.02)"1$@$-$767 $&7$)"#*60"&*" 1,0$&$1*)6 ,&6 $7"6
(-;,&.1 6,*.)"1 1.1*$"&"& D," "&*)" 06C.) 1"6 -6 7"&1$767 626)"&*"9
X
!"##$%& ()*+#,-.
!" !"#$#%& !()!$#*+ ,-./
/01-0 23 !$4*"50 6" #0)0#*")$70#$%& 6" -.4 8.-9.4 4":;& 4,4 8).8$"< 223
=>$4*" .*)0 ">8)"4$%& ?," "4 -0 8).8.)#$%& 6" @0,4&") ?," "4 "-
A0*"5B*$#05"&*" 4" ">8)"40 #.5.C
< D).8.)#$%& 6" @0,4&") E DF(
G0 6"&4$606 9")606")0 5$6" )"0-5"&*" -0 #0&*$606 6" 50*")$0- .#,806.
8.) *.604 -04 80)*+#,-04 4$& *"&") "& #,"&*0 -.4 "480#$.4 90#+.4 H9.-,<
5"& 080)"&*"I 0;& "& -04 80)*+#,-04 5B4 8.).4043 =4*0 6"&4$606 4"
8,"6" .1*"&") #.& ,& 8$#&%5"*). 6" :04 H@"-$.I J "4 ,& 80)B5"*).
#0)0#*")+4*$#. 80)0 #060 *$8. 6" 50*")$0-K 5$"&*)04 ?," -0 6"&4$606 6"
9.-,5"& "4 ,& 80)B5"*). ?," 6"8"&6")B 6" -04 #.&6$#$.&"4 "& -04
#,0-"4 4" "L"#,*" "- 5M*.6. 6" 5"6$602N3
G0 6"&4$606 080)"&*" 6"8"&6" O,")*"5"&*" 6" -04 #0)0#*")+4*$#04 6"
"580?,"*05$"&*.3
=- 90-.) 6" 6"&4$606 080)"&*" 6"- 8.-9. 6"8"&6" 6" -0 6"&4$606
*050P.K 6$4*)$1,#$%& J O.)50 6" -0 80)*+#,-03
G.4 8.-9.4 #.& 10L0 6"&4$606 080)"&*" J 6" 9.-,5"& 080)"&*" 0-*.
4" #0*0-.:0& #.5. 8.-9.4 -$:").4K J 9$#"9")403
#$%&%' %$ )*+,-$.&/&0&%'%
6*-*.&%'%
G0 8.).4$606 6" -.4 :)B&,-.4 6"8"&6" 6" -0 O.)50 J 6$4*)$1,#$%& 6"-
*050P. J -0 O.)50 6" 80)*+#,-04K *051$M& 6" -0 ),:.4$606 6" -04 4,<
D.) "4*0 )07%& -0 8.).4$606 80)0 ,&0 5$450 4,4*0&#$0 6"8"&6" 6"-
:)06. 6" 5.-$"&60K *05$70L" . #.580#*0#$%& 6"- :)0&,-06.3
!$ ,& :)0&,-06. "4*B O.)506. 8.) 80)*+#,-04 5,J )+:$604K &. Q01)B 1,"&
--"&0)+0& 1$"& -04 50*)$#"4 6" -0 *01-"*"06.)0 6,)0&*" -0 #.58)"4$%&K
6"1$6. 0 4, 0-*0 #.Q"4$%& J :)0& O)$##$%& "&*)" -04 80)*+#,-043
=& *M)5$&.4 :"&")0-"4K *.6. *$8. 6" :)0&,-06. "4*B O.)506. 8.)
80)*+#,-04 0&$4.*)%8$#04 6.&6" -04 80)*+#,-04 8"?,"P04 *$"&6"& 0 --"&0)
!" 6"*")5$&0 "& O.)50 4$5$-0) 0- B&:,-. 6" )"8.4.K 8"). "& "4*" #04.
"& ,&0 "48B*,-0 8-0&0 #.& #$")*0 $&#-$&0#$%&3
D,"6" 4") 0- $:,0- . &. 0- B&:,-. 6" )"8.4. "4*B*$#.3
D).8.)#$.&0 ,&0 5"6$60 $&6$)"#*0 6" -0 O.)50K "- *050P.K #.Q"4$9$606
J 8.).4$606 6"- :)0&,-06.N3
T3 D.U6")4 0&6 :)B&,-"43883 2TV3
N3 !U0)1)$#WK X05"43 2YYV3 =&#J#-.8"6$0 .O 8Q0)50#",*$#0- /"#Q&.-.:J3 Z.J-0&K X05"43
A0)#"- 6"WW") [\]3 \"U ^.)W3 _.-3 `[[3 88 2ab<2a23/.5. T
R3 Q**8CFF#-04438QJ4384,3"6,F8SaVF">8")$5"&*4F:)0&,-0)c50**")386O
S3 [(!d3 D"4#Q-3 A"04,)"5"&* 0&6 "90-,0*$.& .O 5"#Q0&$#0- 8).8")*$"4 .O 8.U6")4K
8.U6") Q0&6-$&: 0&6 8).#"44$&:3 2 2YeY \.3 N 2Ra<2S2
0 5$#).&$7"6 #.58.&"&*3 HNbb2I88 23 Sf #"&*)0- =,).8"0& 4J58.4$,5 .O 8Q0)50#",*$#0-
*"#Q&.-.:JK !"8*"51") NR<NaK 9$"&&03
=5:3 2b2 H SI Ve<Yb L,& 2YYS3
V3 D(ggh/K =,:"&"3 DQ0)50#",*$#0- *"#Q&.-.:J3 i,&605"&*0- DQ0)50#",*$#43 Z,):"44
8,1-$4Q$&: #.580&J3 =6$*3 R)03 A$&&"08.-$43 j!(3 2YV23883 22<2S
*"#Q&.-.:J3 h#*.1")3 Nbbb3 UUU38Q0)58.)*0-3#.5
1,-W "&:3 2b HTI 2V<Ne H2YYTI
2b3 (5")$#0& 4.#$"*J O.) *"4*$&: 0&6 50*")$0-43 !*0&60)6 4Q"0) *"4* 5"*Q.6 O.) 1,-W 4.-$64
#Q0)0#*")$70*$.& 1J ]0))k4 $&6$#"43 (!/A 4*0&60)6 lTRYR<YY 2YYY
223 !U0)1)$#WK X05"43 2YYV3 =&#J#-.8"6$0 .O 8Q0)50#",*$#0- /"#Q&.-.:J3 Z.J-0&K X05"43
A0)#"- 6"WW") [\]3 \"U ^.)W3 _.-3 `[[3 882Ta3/.5. T3
50*")$0-4C 0 )"9$"U .O 5"*Q.643 DQ0)503 i.),53 Na HRI eNYe<eRba 2YYY3
2R3 @"-50&K X.4"3 i0)50#.*"#&$0 /".)+0 J 8)B#*$#03 2YeN3 "63 ].&*$&"&*0-3 A">$#.3 2)0
"63 2Yeb3 883/.5. [[ 8832TNa<2TNe3
2S3 _.$:QK g,6.-O3 2YeN3 /)0*06. 6" *"#&.-.:+0 i0)50#M,*$#03 =6$*.)$0- (#)$1$03 d0)0:.703
R)03 =6$#$%&3 d0)0:.703 D83 2bY<22b3
!"##$%& ()*+#,-.
#$%& () (* +,+-+.
/- .0.&. 1234 "5 ,&6 7.)86 *)$6*%8$#6 965".56 :"- .;+9"&.< /5 #)"6:.
&6*,)6-8"&*" "& -6 6*8%57")6 =.) $))6:$6#$%& ,-*)6>$.-"*6 1?@A &84
:" .;+9"&. 12B4< (,&C," "- .0.&. "5 ?3 >"#"5 8D5 5.-,E-" C," -6
8.-F#,-6 2BG 5$9," 5$"&:. #.&5$:")6:. "5#6568"&*" 5.-,E-"<
/- .0.&. "5 ";*)"86:68"&*" $&"5*6E-" 6 =)"5$.&"5 H *"8=")6*,)65 6*I
8.57F)$#65G 5$& "8E6)9. 5, 9)6& =.*"&#$6- J)":.;K -. L6#" "- 8D5 =.*"&*"
69"&*" .;$:6&*" ,56:. "& 5$5*"865 :" 56&$*$06#$%& 76)86#F,*$#6< /5
8D5 =.*"&*" C," .*).5 69"&*"5 .;$:6&*"5 56&$*$06&*"5 #.8")#$6-8"&*"
:$5=.&$E-"5G *6-"5 #.8. "- #-.). . "- =")%;$:. :" L$:)%9"&.< /- =.*"&#$6-
J)":.;K :" "5*.5 56&$*$06&*"5 5")+6M
20.&.M NB<OP "Q 1/-"#*).&>.-*$.4
R-.).M N?<3S "Q
T")%;$:. :" U$:).9"&.M N?<PP"Q
/- .0.&. 5" :"5#.8=.&" 7D#$-8"&*" 6 8.-F#,-6 $&.#,6 :" 2BG #.8.
56&$*$06#$%&<
/5 $8=)D#*$#. *)6*6) :" 6-86#"&6) .0.&. =6)6 ,5.5 5,E5"#,"&*"5 :"E$:.
6 5, &6*,)6-"06 $&"5*6E-" 1=,":" 5") ";=-.5$>. "& >.-V8"&"5 W 6 ?OX
:"- >Y> "& "- 6$)"4 )"6#*$>$:6: 69)"5$>6 H >$:6 8":$6 #.)*6<
/- .0.&. "5 ,5,6-8"&*" 9"&")6:. "& E6Z65 #.&#"&*)6#$.&"5 =6)6 6##$%&
$&8":$6*6G )"-6*$>68"&*" #")#6 :"- -,96) :" 6=-$#6#$%&< [.5 8F*.:.5
#.8")#$6-"5 8D5 #.8,&"5 =6)6 -6 86&,76#*,)6 :" .0.&. 5.& #.& E65"
"& -6 9"&")6#$%& :" ,&6 #.).&6 "-F#*)$#6 :" :"5#6)96 "& -6 =)"5"&#$6
:" .;+9"&. H =.) "-"#*).-$5$5 :" 69,6<
\"="&:$"&:. :" -6 #.&#"&*)6#$%& :" .0.&. H "- *$"8=. :" #.&*6#*.G 5,
6##$%& 5.E)" #.8=,"5*.5 .)9D&$#.5 "& "- 69,6 =,":" 9"&")6) ="C,"]65
#6&*$:6:"5 :" :$%;$:. :" #6)E.&.G #.8. -6 =.)#$%& :" #6)E.&. :"-
#.8=,"5*. .)9D&$#. "5 .;$:6:6<
^+=$#68"&*"G -.5 #.8=,"5*.5 .)9D&$#.5 .;$:6:.5 =.) "- .0.&. 5.& 5%-.
=6)#$6-8"&*" :"9)6:6:.5 "& D#$:.5 . 7.)865 :" 5,5*6&#$65 .)9D&$#65
8D5 ="C,"]65 #6)E.;+-$#.5< [6 9"&")6#$%& :" "5*.5 =).:,#*.5 :"
:"9)6:6#$%& $.&$06:.5 6 &$>"-"5 :" =6)*"5 =.) E$--%& 1==E4 #.& "-
*$"8=. =,":" *"&") ,& $8=6#*. :"*"#*6E-" "& "- =U H -6 #.&:,#*$>$:6:
:" )"7)"5#. &,">6<
=)$&#$=6-8"&*" .;+9"&. 5" 7.)86)D #,6&:. "- .0.&. 5" :"5#.8=.&"<
[6 7.)86#$%& :" )6:$#6-"5 -$E)"5 "5 $&L")"&*" H 7,&:68"&*6- =6)6 "-
=).#"5. :" :"5$&7"##$%& :"- .0.&.< _& )6:$#6- -$E)" "5 ,&6 8.-F#,-6
#.& ,& "-"#*)%& &. 6=6)"6:. H "5 6-*68"&*" )"6#*$>.<
!!!"#$"%&#
"#$#%&'($
!"#$%& ()*+
!"#$%&'( *+%&(,+- *. /01 22341 5#6&%( 78 933: 2;04 1;11
'()*+,(-.' .0,+,.-1.'
!" EDICIÓN ESPECIAL 2014
/.0 1$2).3$-.0 45678 )92$#9-"0 -$:)"0 0" ;.)<9& #,9&2. "- .=.&. 0"
2">)929? ( @"09) 2" A," -.0 )92$#9-"0 -$:)"0 *$"&"& ,&9 B$29 <,C #.)*9
40%-. 2,)9 ,& &9&. 9 <$-$D0">,&2.8E *$"&"& ,& @.*"&#$9- )"2.3 4FEGH "I8E
$&#-,0. <J0 9-*. A," "- .=.&. 4FEHK "I8? /9 #9@9#$292 2" .3$29#$%&
#.<:$&92. 2" -.0 )92$#9-"0 -$:)"0 1$2).3$-.0 C 0,0 <.-L#,-90 2" .=.&.
@92)" 0.& )"0@.&09:-"0 2" -9 2"0$&;"##$%& 9-*9<"&*" 9>)"0$B9 C ";"#*$B9
2" -.0 *)9*9<$"&*.0 #.& .=.&.?
/.0 )92$#9-"0 -$:)"0 A," 0" ;.)<9& 2,)9&*" "- ,0. 2"- .=.&. #.&*)$:,C"&
0,0*9&#$9-<"&*" 9 -9 2"0$&;"##$%& C "- #.&*).- <$#).:$.-%>$#.?
M,9&2. 0" @).2,#"& )"9##$.&"0 2" *")<$&9#$%&E "- )92$#9- -$:)" 0" #.&D
0,<" 4. 0" "3*$&>,"8 "& ,& "&-9#" #.B9-"&*" "& -,>9) 2" @).@9>9)0"?
N0*" @).#"0. 2" $&9#*$B9#$%& 2" )92$#9-"0 -$:)" *$"&2" 9 2.<$&9)E -.
A," )"0,-*9 "& "- *)9&0$*.)$. 4@"). 9-*9<"&*" )"9#*$B.8E @)"0"&#$9 2"
)92$#9-"0 -$:)"0?
N0*.0 )92$#9-"0 -$:)"0 0" 2$0$@9& <,C )J@$29<"&*" 4@.) "O"<@-.E "-
.=.&.8 0" "-$<$&9 . 0" 2">)929E -.0 )92$#9-"0 -$:)"0 )"0$2,9-"0 *9<:$L&
0" 2$0$@9& 2" ;.)<9 #90$ $&0*9&*J&"9E @.) -. *9&*.E &. #.&0*$*,C"& ,&9
@)".#,@9#$%& #.& )"0@"#*. 9 -9 #9-$292 2"- 9>,9?
#$%&'()*+ - .+%+ /$ &0&12$ /$3 +4+'+
/.0 ";"#*.0 .3$29&*"0 2"- .=.&.E C -.0 9P& <J0 9>)"0$B.0 1$2).3$-.0
)92$#9-"0 -$:)"0 -$:")92.0 @.) 2"0#.<@.0$#$%& 2"- .=.&. 9- .3+>"&.E
9-*")9& -90 "0*),#*,)90 <.-"#,-9)"0 #.& -90 A," $&*")9#*P9& C #9<:$9&
0,0 @).@$"292"0?
M,9&2. "0*90 "0*),#*,)90 <.-"#,-9)"0E #,")@.0 ;,&#$.&9-"0 2" <$#)..)D
>9&$0<.0E 0" 9-*")9& 2" ;.)<9 @")<9&"&*"E -90 ;,&#$.&"0 <"*9:%-$#90E
90+ #.<. -9 "0*),#*,)9 #"-,-9) "0"&#$9-E A," 9;"#*9 -9 #9@9#$292 2" -.0
<$#)..)>9&$0<.0 @9)9 0.:)"B$B$) . @).-$;")9)? M,9&2. -9 @9)"2 #"-,-9)
C -9 <"<:)9&9 #"-,-9) 2" -90 :9#*")$90 0" B"& 9;"#*92.0E -9 #L-,-9
@$")2" 0, $&*">)$292 #.&*)9 "- 9<:$"&*" "3*")&. @).B.#9&2. "- 9@9>92.
<"*9:%-$#.E @.0$:-" -$0$0 C -9 <,")*" #"-,-9)?
Q,#190 2" -90 "0*),#*,)90 A,+<$#90 "& -90 <9#).<.-L#,-90 :$.-%>$#90
0.& 0,0#"@*$:-"0 9 "0*.0 ";"#*.0 ;,")*"<"&*" .3$29&*"0E A," $&#-,C"&
9<$&90E 9<$290 C >),@.0 0,-;1$2)$-.? N- .=.&. *9<:$L& @,"2" 9*9#9)
*9&*. 09*,)92.0 #.<. $&09*,)92.0 "&-9#"0 2" #9):.&. 2.:-"0 A,"
@,"2"& 0") @9)*" 2" -9 R#.-,<&9 B")*":)9-S 2" -90 <.-L#,-90?
#$5+6&) $' 3+) /()$7+) /$ 3+) )()0$*&) /$ &82& .&6*&%920(%&
9 *)9BL0 2" <"O.)90 "& -.0 2$0"T.0E .@")9#$%& C <9&*"&$<$"&*.? N09
2"- .=.&.?
N0*90 <"O.)90 "& 9->,&.0 2$0"T.0 0" 19& 0$2. 9@-$#9290 9 *)9BL0 2"U
:; VL#&$#90 2" 0.-292,)9?
:::; V"#&.-.>+90 2" $&0@"##$%&?
<; W$0"T. $&*">)92. 2" BJ-B,-90 @,&*. 2" ,0.?
<:; W$0"T.0 <"O.)92.0 2" <"=#-90 2" .=.&.?
<::; (,*.<9*$=9#$%&?
!"##$%& ()*+#,-.
!" EDICIÓN ESPECIAL 2014
#$% '() %*%+%, -(+./0/$ 1 '($-(+./0/$
/0)0 1"#$1$) . &. "- ,2. 1"- .3.&. "& 2$2*"402 1" 05,06 70 2"0 "& ,&
2$2*"40 &,"8. 79. "& ,&. ":$2*"&*" #.& .*). *$;. 1" 20&$*$30#$%&6 "-
1$2"<01.) 79. ;).;$"*0)$. *$"&" =," 0&0-$30) #-0)04"&*" -02 8"&*0>02
7 1"28"&*0>02?
;)"8$04"&*" $&2*0-01. 2$& @:$*. "& "- #.&*).- 4$#).A$0&. ,*$-$30 .*). *$;.
2$2*"402 20&$*$30A-" "& #0-$"&*"6 02+ =," -0 1$B")"&#$0 "& #.2*. ;,"1"
--"50) 0 2") 4,7 #.&2$1")0A-"?
2(+./0/$3
45 6)./ 78%'9:.;-;'/'< C- ,2. 1"- .3.&. ;,"1" .B)"#") #$#-.2 1" !0&$*$D
.;")0#$.&"2 1" ;).1,##$%&? /.) ">"4;-.6 -0 20&$*$30#$%& "& ,& -..; 1"
1$2*)$A,#$%& ;,"1" 2") #.4;-"*010 "& ,&0 E.)0 ,20&1. F3.&$30#$%&?
G.&1" 20&$*$30#$%& =,+4$#0 . #0-$"&*" ;,"1" *.40) E.)02 HIJ E.)02K?
!$2*"402 1" 05,0 #.& .3.&.6
*+;$#04"&*" .3.&0& 0- *0&=," #.&*$&,04"&*"6 "2*. *$"&" #.4. )"2,-*01.
,& #.&*).- 2.2*"&$1. 4$#).A$0- 7 )"1,#" -02 #.&#"&*)0#$.&"2 1" LFM
#.&2$1")0A-"4"&*"? N0 B0#$-$101 1" -.2 )"-0*$804"&*" ;")$.1.2 #.)*.2 1"
20&$*$30#$%&6 ;")4$*"& #$#-.2 1" 20&$*$30#$%& 4O2 B)"#,"&*"2?
!5 6=%88% '( :/>;./)< (-5,&02 $&2*0-0#$.&"2 ;,"1"& &. *"&") -0 01"D
#,010 #0;0#$101 4+&$40 &"#"20)$0 1" 80;.) $&1,2*)$0- =," )"=,$")"&
-.2 2$2*"402 1" 05,0 #.& 20&$*$30#$%& "& #0-$"&*" 1" ,& 2$2*"40 &,"8.?
C- ,2. 1" .3.&. ;,"1" "8$*0) -0 $&2*0-0#$%& 1" ,&0 &,"80 #0-1")0 7 1"
,& &,"8. ME$--") 2$ 2" )"=,$")" 1" "&B)$04$"&*.6 ;.) -. *0&*. 2" "8$*0
"- 502*. 1" -.2 "=,$;.2 7 2, $&2*0-0#$%& #.4. 2.& "- 0$2-04$"&*. 7 -.2
#,01).2 1" #.&*).- 1" 80;.)?
?5 @(A98;'/'< C- ,2. 1" .3.&. ;,"1" B0#$-$*0) -02 #.&1$#$.&"2 1" 2"D
5,)$101 1" -.2 .;")0)$.2 7 ;")2.&0- 1" 40&*"&$4$"&*. "-$4$&0&1. -.2
)$"25.2 02.#$01.2 #.& -0 .;")0#$%& 1" 2$2*"402 #0-$"&*"2?
B5 6=%88% (+ :%$.%$ '( (+(8AC/< M.4;0)01. #.& -.2 2$2*"40 1" 05,0
20&$*$30A-" #.& 05,0 #0-$"&*"6 "- .3.&. ,*$-$30 4,#E. 4"&.2 "&")5+0
;.) &. )"=,")$) -0 .;")0#$%& 1" ,&0 #0-1")0 $&1,2*)$0- 7 *.1.2 2,2 ;")D
$B@)$#.26 2%-. )"=,$")" 1" -0 4+&$40 "&")5+0 =," #.&2,4" "- 5"&")01.)
7 1"2*),#*.) 1" .3.&. #,0&1. "2*O& "& .;")0#$%&?
M.4;0)01. #.& -0 407.)+0
1" -.2 ;).#"2.2 1" 20&$*$30#$%& =,+4$#06 "- .3.&. ;,"1" 2") )"4.8$1.
2$& #.&2,4.2 ":#"2$8.2 1" 05,0 1" "&>,05,"? N.2 ;).#"2.2 =," ,*$-$30&
=,+4$#.2 1"A"& 2") ;,)501.2 7 1)"&01.2 #.& 5)0&1"2 #0&*$101"2
1" #.2*.20 05,0 *)0*010? (-5,&.2 20&$*$30&*"2 =,+4$#.2 )"=,$")"&
1" #.2*.2 01$#$.&0-"2 ;0)0 2, &",*)0-$30#$%& 0&*"2 1" 2") 1"2"#E010
0 -.2 1)"&0>"2? C& -,50)"2 1.&1" "- 1"2"#E. 1" =,+4$#.2 0- 1)"&0>"
"2*O )"2*)$&5$1. 79. ;).E$A$1.6 -0 ,*$-$30#$%& 1" .3.&. "2 0-*04"&*"
)"#.4"&10A-"?
"&>,05,"2 ;.) ,2.2 1" =,+4$#.26 ,& #$#-. 1" 20&$*$30#$%& ;.) .3.&.
;,"1" 2") ">"#,*01. "& ;")$.1.2 4,7 #.)*.2 7 02+ 2" .A*$"&"P
/5 Q0#$-$101 1" ,2. B)"#,"&*"? N.2 ;0).2 #.)*.2 1" F.;")0#$%& 1" -.2
!"##$%& ()*+#,-.
!" !"#$#%& !()!$#*+ ,-./
#$%&$'()*)%+
,- /.0*.0 1.) "- "2,$1. 3" 4"&")5#$%& 3" .6.&.7 8,"3"& "9$0*$)
5-4,&.0 #.0*.0 )"-5*$:.0 1.) -5 ;,"&*" 3" .9+4"&. < 0$ "- =>*.3. 3"
4"&")5#$%& 3" .6.&. )"2,$")" 3" ,&5 ;,"&*" 3" .9+4"&.?7
.- /.0*.0 1.) "2,$1. 15)5 3"0*),##$%& 3" .6.&.7 @0 &"#"05)$. -5 $&*"A
4)5#$%& 3" "2,$1.0 <BC? #.&"#*5350 "& -+&"5D 50+ #.=. <0$ -. )"2,$")"?
!- /.0*.0 1.) "2,$1. 3" =.&$*.)".7 E.0 0"&0.)"0 3" .6.&. 0.& &"#A
"05)$.0 15)5 ="3$) -5 #.&#"&*)5#$%& F -5 )"=.#$%& <3"0*),##$%&? 3"-
-50 #.&#"&*)5#$.&"0 FG. 5,0"&#$50 3"- =$0=.7
0- /5-$353 3" 54,57 E5 #.&3,#*$:$353 3"- 54,5 1,"3" 4)53,5-="&*"
5,="&*5) "& 0$0*"=50 ,05&3. ,&5 ;,"&*" #.).&5 3" 3"0#5)45 #.& H5I5
1,)"65 3" .9+4"&. F 2," *"&45 1.#. FG. &. ,0. 3" 54,5 1.) 1")$.3.0
-5)4.07
1-
54,5 #5-$"&*"7 @- ,0. ;)"#,"&*" 3"- .6.&. <3$5)$. FG. 0"=5&5-="&*"?
)"2,")$3.0 5-*.0 &$:"-"0 3" .6.&. . 5-4K& .*). 1).#"0. 3" 05&$*$65#$%&
2- /.=15*$H$-$353 3" =5*")$5-"07 !%-. =5*")$5-"0 #.=15*$H-"0 F )"0$0*A
"&*"0 5- .6.&. 3"H")J& 0") ,053.0D 4"&")5-="&*" "- 5#"). $&.9$35H-"
LMNE *$"&" ,&5 :$35 $-$=$*535 #.& "- .6.&.O 0$& "=H5)4.D 5-4,&.0 "=A
152,"0 FG. "-50*%=").0 1,"3"& *"&") ,&5 )"0$0*"&#$5 #.)*57
8.) -. *5&*.D #$")*.0 #.0*.0 3" 15)*"0 3" )""=1-56. 3"H"& 0") #.&0$3A
")53.07 P5*")$5-"0 $&#.=15*$H-"0 #.& "- .6.&. . 52,"--.0 3"I53.0 "&
0"):$#$. 1.) -5)4. *$"=1. 0" 1,"3"& 3"4)535) F ;5--5)D . 1".) 5K& 0"
1,"3"& 3$0.-:") "& "- 54,57
1,"3"& 3$0.-:") "& "- 54,57
XXX70$$;057#.=7=9
!" EDICIÓN ESPECIAL 2014
#$ "$ &$
LOS SISTEMAS SINGLE-USE (MAL LLAMADOS O MAL TRADUCIDOS, DESDE MI PUNTO DE VISTA, DESECHABLE.
PREFIERO UTILIZAR EL TÉRMINO SISTEMAS DE UN SOLO-USO), ESTÁN SIENDO CONSIDERADOS E
IMPLEMENTADOS EN MUCHOS PROCESOS BIOFARMACÉUTICOS PORQUE DICHAS COMPAÑÍAS HAN IDENTIFICADO
VENTAJAS IMPORTANTES QUE ESTOS SISTEMAS OFRECEN COMPARADOS CON LOS SISTEMAS TRADICIONALES
REUTILIZABLES (ESPECÍFICAMENTE LOS SISTEMAS DE ACERO INOXIDABLE).
QFB, CPIM N. SAÚL ESTRADA ILLESCAS
#$ "$ &$ !$ '$
!"##$%& ()*+#,-.
/
INTRODUCCIÓN A LA FABRICACIÓN DE FORMAS FARMACÉUTICAS SÓLIDAS
LA FORMA FARMACÉUTICA DE UN MEDICAMENTO, ES LA ESTRUCTURA A LA QUE SE ADAPTAN LOS PRINCIPIOS
:
3.0$#$%& $&4$;$4,6-$<646 6 =," 0" 6463*6& -.0 3)$&#$3$.0 6#*$;.0 >
?60 5.)260 56)26#7,*$#60 .)6-"0 3.) ;+6 0%-$46 280 @6A$*,6-"0 0.&
3).*"/$460 3.) ,&6 #,A$")*6 &.)26-2"&*" 4" /"-6*$&6 . A$"& 4" /"-6*$&6
:
.)+6 6 A60" 4" /"-6*$&6 > 06#6).06 >9 /"&")6-2"&*"9 0" ,*$-$<6& 36)6
?.0 /)6&,-64.09 0.& 2,> 0$2$-6)"0 6 -.0 3.-;.09 3"). 0" 4$5")"&#$6&
"& =," -.0 #.&0*$*,>"&*"09 @6& 0$4. 0.2"*$4.0 6 ,& 3).#"0. =," -.0
B-*$2.9 -60 #.&.#$460 #.2. *6A-"*60 )"#,A$")*609 0.& 5.)260 .A*"&$460
2"4$6&*" "- )"#,A)$2$"&*. 4" &B#-".09 @6A$*,6-2"&*" #.23)$2$4.09
?6 "-6A.)6#$%& 4" -60 5.)260 56)26#7,*$#609 "0 4" 0,26 $23.)*6&#$6
36)6 /6)6&*$<6) ,&6 ,*$-$<6#$%& )6#$.&6- 4" -.0 3)$&#$3$.0 6#*$;.09
6463*8&4.-.0 6 -6 ;+6 4" 642$&$0*)6#$%& 64"#,6469 *$"&" 64"280
.*).0 .A1"*$;.0 $23.)*6&*"0 *6-"0 #.2.C 56;.)"#") -6 #.&0");6#$%&
4" -.0 3)$&#$3$.0 6#*$;.0 > 3).*"/")-.0 #.&*)6 56#*.)"0 4" 6-*")6#$%&9
?6 ;+6 .)6- A)$&46 ;"&*6160 #.2.9 58#$- > #%2.46 642$&$0*)6#$%&9
6-*")6#$%& 4" 3)$&#$3$.0 6#*$;.0 3.) 36)*" 4" -60 0"#)"#$.&"0 4"- *,A.
4$/"0*$;.9 -6 3.0$A$-$464 4" $))$*6#$%& 4"- *)6#*. /60*).$&*"0*$&6- D06-$#$-6:
?6 26>.)+6 4" -.0 2"4$#62"&*.0 ,064.0 @.> "& 4+6 0" "&#,"&*)6&
"& 5.)26 0%-$469 3.) -. =," "0 #.2B& -6 3)8#*$#6 4" *)$*,)6) *6A-"*60 >
2"<#-6)-60 #.& 6-$2"&*.0 6&*"0 4" 642$&$0*)6)-609 "03"#$6-2"&*" "&
:
!"##$%& ()*+#,-.
)"0,$")" #.&3$2")/#$.&"3 2" -/3 #/)/#*")+3*$#/3 8+3$#/37 0,+4$#/3 ;
<$.-%5$#/3 2" *.2. "- 8=)4/#. ; -.3 $&5)"2$"&*"3 8/)4/#>,*$#.3 ,3/2.3
"& -/ 8/<)$#/#$%& 2"- 1).2,#*.7 /2"4=37 2" 1).1.)#$.&/) "- 4"#/&$34.
1/)/ -/ 3"5,)$2/2 ; -/ -$<")/#$%& /2"#,/2/ 2" -/ 2.3$3 )"0,")$2/7 -/3
/2$#$.&/-"3?
4"2$#/4"&*.37 3" 2$3,"-6"& </B. -/ -"&5,/ . "&*)" -/3 "&#+/3 ; -/
!$ "3*/3 1)"1/)/#$.&"3 3.& 2"5-,*$2/37 )"3,-*/& $&"8"#*$6/3 . 4"&.3
#,<$")*/ "&*>)$#/ "6$*/& -/ $))$*/#$%& "3*.4/#/-7 1)"6$"&"& -/ 2"3*),##$%&
2"- 1)$&#$1$. /#*$6. 1.) -.3 =#$2.3 2"- "3*%4/5. ;7 )"*/)2/& "- $&$#$. 2"
"& "- "3*%4/5. #.& -/ 1.3$<$-$2/2 2" $))$*/) -/ 4,#.3/ "3*.4/#/-7 .
#$%&'()%* &2 -.,2$1(.5/ 26)2/&.&1 % *%*)2/.&1
@
; )"#,<)$>&2.-. #.& 4C-*$1-"3 #/1/37 #.&8.)4" "- 4"2$#/4"&*. 1/3/ /
*)/6>3 2"- *)/#*. 5/3*).$&*"3*$&/-7 -/3 #/1/3 4=3 "9*")&/3 2" -/ */<-"*/
.*)/37 "- 1)$&#$1$. /#*$6. 3" #.-.#/ "& ,&/ 4/*)$D $&")*" "31"#$/- 0,"
0," *$"&"& 4C-*$1-"3 #/1/3 -/3 #,/-"3 3" 2$3,"-6"& -"&*/4"&*" #.&
@
@
#/#$%& 2" 8.)4/3 8/)4/#>,*$#/3 3%-$2/3 3.&?
!"##$%&
#$% '()*+,(% -. /0(*+ -. 1,%$ (23+,*%$4(% 3%,% 5% ($-6)*,(% 7%,2%4/68
*(4%9 %5(2.$*%,(% : 5%) ($-6)*,(%) ;6<2(4%)= > 3%,% 5% ?(-% -. 264'%)
3.,)+$%)
()*) #)+,$)*- #.&/"+.0 1) 2$0/.*$) 3" 4&) +)&"*) 3$5"*"&/"6 7& "&"*.
3" "0/" )8.- "1 9.&3. 3" 1)0 :)#$.&"0 ;&$3)0 <)*) 1) =&5)&#$)- ;:=>79
$&5.*+% 3" ?4" 1) <.1$.+$"1$/$0 2) 0$3. "**)3$#)3) <.* #.+<1"/. "& 1)
=&3$) @*)#$)0 ) 4&) #)+<)8) 3" A)#4&)#$%& 0$& <*"#"3"&/"06 B5@)&$0/C&
D :$@"*$) 0"*E)& 1.0 0$@4$"&/"0- )&4&#$%6 >)+,$. 3" "0#"&)F 7& 4& A$8"3.
"& 1) *"@$%& 3"1 ()1)/$&)3. 3" B1"+)&$)- 1)0 <.1$11)0 +)#2. 3" 1) A$3 ,40#)&
3"0"0<"*)3)+"&/" ) 1)0 2"+,*)0 *"#"</$A)06 ("*. 0%1. ""&/*)& )+G
<.11"/)0 ?4" #.&/$"&"& 5"*.+.&)0 H)/*)D"&/"0 0"I4)1"0 3" 1) +4J"*K- <.* 1.
70/)0 0.& 2$0/.*$)0 3" 1) A$3) #./$3$)&)6 !.& )#"*#) 3" LI$/.0- @*)&3"0 D
<"?4"8.06 M$5"*"&/"0 D /)& 0"<)*)3.0 "& "1 "0<)#$.- #.+. <4"3"& 0"*-
&$&@4&. 3" "11.0 0"*E) #.&#",$,1" 0$& 4&) $&&.A)#$%& /"#&.1%@$#)6 70/.
"0 )0E <.*?4" #)3) 4&. 3" "0/.0 1E?4$3.0 . <)0/.0.0 <*.34#/.0 /$"&"&
?4" 11"@)* ) 04 3"0/$&.F >)1#4/)- N),41- )1 A$8"3. )1"+C& . )1 2.0<$/)1 "&
),0.14/)+"&/" "0/L*$1"06
"& 4&) 5"#2) /"+<*)&) 54" O"*2)*3 P)&0"& 3"
#4*0. 3" "1"#/*$#$0/) D .,/4A. 4& /E/41. "& $&@"&$"*E)
)"*.&C4/$#)6 7&/.&#"0- )1 $@4)1 ?4" +4#2.0 +$"+G
,*.0 3" 04 @"&"*)#$%&- A$. 04 #)**"*) 3.1.*.0)+"&/"
D ),*4</)+"&/" $&/"**4+<$3) <.* 1) !"@4&3) O4"**)
Q4&3$)16 !40 "I<"*$"&#$)0 54"*.& $&404)1"0 "& "1
2"#2. 3" ?4" "& 3.0 .#)0$.&"0 1.@*% "0#)<)* 3"1
#)4/$A"*$. R40.6
G
,+22.5%1@
"& B)*)46 70. 54" 2)#" #$"&/) )8.06 P.D ,+22.5%1 @ "0 4& +$"+,*.
3" 1) +)*#) A+**.53%4B @ =
("*.- S?4L 2) 2"#2. "0/) /"#&.1.@E) /)& /*"+"&3)+"&/" "I$/.0) "& 1.0
?4" 0$@4" 0$"&3. 5L*/$16
70 4&) #4"0/$%& 3" /*"0 <)0.06 T.3)0 1)0 +C?4$&)0A+**.53%4B @ 54&#$.&)&
#*")& #.&/"&"3.*"0 3" @*C&41.0 /"*+.<1C0/$#.0 H,1.UK- 11"&)& 1.0 <*.34#/.0
1.0 +L/.3.0 3" "+,)1)J" #.&A"&#$.&)1"0F 1.0 <*.34#/.0 &. #.&/$"&"&
#.&0"*A)3.*"0 . #.&/)+$&)&/"0V "1 <*.#"0. "0 /./)1+"&/" )4/.+C/$#.-
#.& 1. ?4" )2.**) /$"+<.- "0<)#$. D +)&. 3" .,*)V 1.0 #.&/"&"3.*"0 "0/C&
0"11)3.0- 0.& $**.+<$,1"0 D <1"@),1"0- D 1) +CI$+) 0"@4*$3)3 3"1 <*.34#/.
"0/C )0"@4*)3) "& /.3. +.+"&/. H1.0 #.&/"&"3.*"0 0.& )0L</$#.0 D )
<*4",) 3" +)&$<41)#$%&K6
TRES EN UNO A LA PERFECCIÓN. HACE CINCUENTA AÑOS, ROMMELAG® REVOLUCIONÓ LA TECNOLOGÍA DE
EMPAQUE PLÁSTICO
"7"268(1 +" 6-"," 2"&#$(&*. "8 ."#$"&/"2"&/" ,"+*..(88*,( +$+/"2* ,"
"26*9-" *+06/$#( 5(": #$%%&'()*+ , ;*<.$#*. "&)*+"+ ," 8"#="1 *#"$/" )">"/*81 .";."+#(+1 #(+20/$#(+1 ,"/".?
"8 0&;*+$+ "& /(,( "8 2-&,( +" "&#-"&/.* "& 8(+ 6.(,-#/(+ ;*.2*#0-/$#(+@
239-$&*+ 5(": #$%%&'()*+ , 6-"," ;*<.$#*. #(&/"&",(."+ 2-8/$?#*6* #(&
#*6*+ ," <*..".*+ "+6"#$*8"+ 6*.* "8 "26*9-" ," 6.(,-#/(+ *8/*2"&/"
+"&+$<8"+4 B& 8* #(?":/.-+$%& ,$;"."&/"+ 2*/".$*8"+ 683+/$#(+ +(& ":/.-$,(+
"& #(&7-&/( "& ;(.2* ," /-<(+ 2-8/$?#*6* 6*.* 8(>.*. #(2<$&*#$(&"+
."9-$"."& -&* *>-7* +"6*.*,* 6*.* ":/.*". "8 #(&/"&",(.1 A *26(88"/*+ ,"
8(+ (C,(+ #(& #32*.*+ ,$+6"&+*,(.*+ $&/">.*,*+ 9-" "8$2$&*& 8* &"#"+$,*,
," #(&+".)*,(."+4 D*."#" &( =*<". 8C2$/" * 8*+ ;-&#$(&"+ 9-" +" ,"+*..(88"&
"& "+/."#=* #(8*<(.*#$%& #(& 8(+ #8$"&/"+4
+">-.$,*,@ 6*.* "8 6.(#"+( A 6*.* "8 6.(,-#/( "& +C4 E"<" =*<". *<+(8-/*
"+/".$8$,*, ,-.*&/" "8 6.(#"+( ," 88"&*,( *+06/$#( A -& +"88*,( 6".;"#/*?
=-2*&* "+ 8* 6.$&#$6*8 6."(#-6*#$%&4 F(,*+ 8*+ 6".+(&*+ "&.$//&')0 ,
"+/3& #(&+#$"&/"+ ," "+/* ."+6(&+*<$8$,*, ":$+/"&#$*84
#$%& ," #(&/"&",(."+1 8*+ 239-$&*+#$%%&'()*+ , 6-","& "+/*. "9-$6*,*+
#(& -&* *268$* >*2* ," +">-.$,*,1 8* >*.*&/C* ," #*8$,*, A 2%,-8(+ ,"
2*&".*1 /*2<$0& #-268"& #(& 8*+ &(.2*+ >-<".&*2"&/*8"+1 #(2( 8(+ ,"
8* G,2$&$+/.*#$%& ," E.(>*+ A G8$2"&/(+ ," B+/*,(+ H&$,(+ IJEG1 6(. +-+
8(+ 6.(,-#/(+4
8(+ $&+6"##$(&*& 6*.* <-+#*. #(&/*2$&*#$%& 6(. 6*./C#-8*+ A ":6-8+*.
*-/(23/$#*2"&/" 8(+ "8"2"&/(+ ,";"#/-(+(+4 G,"23+1 =*A ,$+6(+$/$)(+
6*.* 6.(<*. *26(88"/*+ ,-.*&/" 8* 6.(,-##$%&1 2(&$/(."( ," *$." "& #-*./(+
," ;(.2* $&,$)$,-*84 B+/."#=(+ #(&/*#/(+ #(& 8(+ #8$"&/"+ +(& +$& ,-,* -&*
+$+/"2*+ ," ,$*>&%+/$#( ."2(/(1 "&/."&*2$"&/( ,"8 #8$"&/" "& "8 5"&/.(
," 5*6*#$/*#$%& #$%%&'()*+ , A ,"+68$">-" ," 6".+(&*8 ," 2*&/"&$2$"&/(
"+6"#$*82"&/" "&/."&*,( "& /(,( "8 2-&,(4 L.*#$*+ "& >.*& 6*./" * 8*
+-<#(&/.*/*#$%& ," +-+ #(26*MC*+ =".2*&*+ N(8(6*#O "& G8"2*&$* A
$//&')0 , 6.(,-#/(+ A +".)$#$(+ 6*.* "8 "&)*+*,( ," 8C9-$,(+1 $-A"&,( 8*+ )*#-&*+4
D.(6(.#$(&* *6(A( * +-+ #8$"&/"+ "& "8 6.(#"+( ," ;*<.$#*#$%& ," 6.-"<*+1
P * N(8(6*#O
B8 23+ $268*#*<8" #(26"/$,(. 6-"," +". &(2<.*,( "& -&* +(8* 6*8*<.*@ )$,?
.$(4 G8>-&*+ /.*,$#$(&"+ /$"&"& -& 6".+$+/"&#$* 9-" ,"+*;C* /(,* ":68$#*#$%&
.*#$(&*84 B8 )$,.$( 6-"," /"&". -&* */.*##$%& &(+/38>$#*1 #(& 6.(;-&,*+
.*C#"+ "& 8* =$+/(.$* ," 8* 2",$#$&*1 6".( "+ (<+(8"/* #(2( "&)*+" 6.$2*.$(
"& 2-#=*+ *68$#*#$(&"+4 D*.* ,*. -& "7"268( /C6$#(1 8*+ ."#(2"&,*#$(&"+
," 8* KQ! 6*.* $&(#-8*#$%& *,)$"./"& ":68C#$/*2"&/" #(&/.* 8(+ ."+/(+ ,"
"&)*+"+ ," )$,.$( .(/(4 R*,* 6(,.C* +". 23+ ;3#$8 9-" ,"+#*./*. "+/" .$"+>(
2",$*&/" #(&/"&",(."+ ," 683+/$#( A #$".."+ 9-" &( 6-",*& .(26".+"4
+$& .$"+>( ," 9-" +" .(26*&1 A +(& ;3#$82"&/" ,"+2(&/*<8"+ 6*.* 9-" 8*
)"&/$8*#$%& &( +"* &"#"+*.$*4 !(& 9-C2$#*2"&/" $&"./"+1 8$<."+ ," *,$/$)(+
+">-.*1 &( +%8( "& 8(+ =(+6$/*8"+ +$&( /*2<$0& "& (6".*#$(&"+ 2%)$8"+4
#$%%&'()*+ , )$"&"& "& *-2"&/(
9-" )$)"& "& 6*C+"+ ,(&," "8 +$+/"2* ,"8 #-$,*,( ," 8* +*8-, +" "&#-"&/.*
/(,*)C* "& ;*+" ," ,"+*..(88(4 R( "+ ," ":/.*M*. 9-"1 5=$&* " S&,$* +" =*&
#(&)"./$,( "& $26(./*&/"+ 2".#*,(+ 6*.* .$//&')0 , 4
G8 2$+2( /$"26( 8(+ "&)*+"+ ," 683+/$#( +(& *2*<8"+ #(& "8 2",$( *2?
#$%%&'()*+ , *,$/$)(+ *#/$)(+ *,$#$(&*8"+4
D(. 8( /*&/(1 .$//&')0 , /$"&" 2-#=*+ #(+*+ 9-" ,"#$.8" *8 2-&,(4 !%8(
6(,"2(+ ,"+"*. 9-" 8( 8(>."4 E"+6-0+ ," /(,(1 8( 9-" "+/3 "& 7-">( "+
"8 *#/$)( 23+ )*8$(+( 6*.* 8*+ 6".+(&*+@ +- +*8-,4
!
(Departamento de Diseño)
Cada cliente tiene sus muy especiales requerimientos. Es por eso que nosotros
en OPTIMA fabricamos líneas de llenado que son diseñadas a las necesidades
particulares de nuestros clientes mientras ofrecemos los beneficios de una
línea completa e integrada: El paquete completo de la máquina incluye
funcionalidades de alta precisión, respaldadas por documentación consistente y
apoyadas por una solución de software optimizado y adaptado – además de un
punto central de contacto que es un apasionado en todas sus inquietudes…
Somos expertos en soluciones especiales, después de todo.
Visítenos en EXPO PACK Mexico | 17 - 20 Junio 2014 | # 1924
OPTIMA packaging machines S.A. de C.V | Mexico | D.F. 04600 | www.optima-mex.com
OPTIMA pharma GmbH | 74523 Schwaebisch Hall | www.optima-pharma.com
Member of
$2 /3$'C" %$ $//"/ D+?&*" 0 -"*.&?3*&-3E* &'"-3&%&F G2
'3'.$?& %$ 22$*&%" B$/3'.H2.3-" IJK6 $23?3*& 2"' -"'."' 0
2"' /3$'C"' %$ 2&' L"?L&' #"2+?A./3-&' %$ 22$*&%"F
M& IJK6 $' +* '3'.$?& %$ 22$*&%" %$ '"L/$?$'& N+$ '$
+.323@& $* %$B&/.&?$*."' %$ 3*#$'.3C&-3E* 0 %$'&//"22"
,&/?&-A+.3-"' %+/&*.$ 2&' ,&'$' %$ $*'&0" -2O*3-"P " $*
$?B/$'&' %$ ,&L/3-&-3E* '+L-"*./&.&%& B&/& &+?$*.&/ 2&
G2 .&B"*&%" B&/& .&B"*$' $*./$ 7; ?? 0 96 ?? *" *$-$'3.&
B3$@&' %$ ,"/?&." &%3-3"*&2$'F
,2+3%" -"?" 2"' ,/&'-"' 22$*"' N+$%&* -"?B2$.&?$*.$
$*-$//&%"'F
&%&B.&%&' & 2&' $U3C$*-3&' %$ 2&' 3*%+'./3&' &23?$*.&/3& 0
G* /$'+?$*5 $'.& '$/3$ %$ #H2#+2&' /$X*$ ."%&' 2&'
-&/&-.$/O'.3-&' &-.+&2$' *$-$'&/3&' $* -+&*." & 2& -&23%&%
Y+*.&' %$ 2&/C& #3%& X.32P -+$/B" /"L+'."P ?&.$/3&2$' %$ &2.&
-&23%&%P %3'$Z" 3*.$23C$*.$5 C/&-3&' & ."%" $22" 2&' #H2#+2&'
23?B3&/F G2 &--3"*&?3$*." %$ 2& #H2#+2& '3* ?&*.$*3?3$*."
0 -"?B2$.&?$*.$ '"2%&%" $'.H %3'$Z&%" B&/& '"B"/.&/
7F666F666 %$ -3-2"' %$ -"*?+.&-3E*F
C&/&*.O& %$ -&23%&% $U-$B-3"*&2$'F Q$B/$'$*.&* 2& '"2+-3E*
'&L$/ -+H*%" $' '$C+/" 3*3-3&/ $2 B/"-$'"P '3 2&' B/+$L&'
$'.H* &-.+&23@&%&' " '3 2& L&2&*@& $'.H *3#$2&%& 0 ,+*-3"*&
-"//$-.&?$*.$F
L&2&*@&' [SG ",/$-$* 3*-"*.&L2$' "B-3"*$' B&/& %3,$/$*.$'
4& $*#"2#$%"/& &+."56.3-& 17) 89:; %3'$<&%& =&/& 2">/&/ &2.&' #$2"-3%&%$' %$ $5=&-&%"
0 =/3*-3=&25$*.$ =&/& 2& 3*%+'./3& -"'5?.3-&; $' &=/$-3&%& ="/ '+ >/&* =/$-3'3@* %$ $*#"2.+/&;
$*#+$2."' '$ &235$*.&* ="/ 5$%3" %$ +*& A&*%& ./&*'="/.&%"/&; &-.3#&*%" +*& ,"."-?2+2& %$
B$ >&/&*.3C& +*& $*#"2.+/& -"*'3%$/&A2$5$*.$ &=/$.&%& -"* =$2D-+2& %$ &2.& .$*'3@* ="/
'"'.3$*$ $2 =/"%+-." $* '+ 2+>&/ %+/&*.$ 2& $2$#&-3@* 0 $2 %3'$<" %$ 2& +*3%&% =/"="/-3"*&
+*& $*#"2.+/& =/$-3'& 0 ./&*',$/$*-3& ="/ 5"#353$*." "'-32&."/3" $* '3*-/"*3C&-3@* -"* 2& .&'&
%$ &235$*.&-3@* %$ +* '"2" =&E+$.$F
$*./$ 2& A&//& %$ '$22&%" " $2 =+*." 0 $2 =/"%+-." $' 5&0"/ E+$ $* 2& 56E+3*& %$ 5"#353$*."
G2 '$22&%" ./&*'#$/'&2 '$ =+$%$ 22$#&/ & -&A" $* 2& -&/& 3*,$/3"/ %$2 =/"%+-." " 3*-2+'" & 2"'
56E+3*& $* ,+*-3"*&53$*."; .&*." $2 -"/.$ %$ 2& =$2D-+2& 0 =&/& $2 -$*./&%" %$ 2& =$2D-+2& $*
& ./&#?' %$ 2& =/"%+--3@*; =&/& =/"="/-3"*&/ %3'-"*.3*+3%&%$' %35$*'3"*&2$' $#$*.+&2$' $*
=/"%+-."' & '$/ $5=&-&%"'F
G2 89: .&5A3?* =+$%$ &%$-+&/'$ -"* 2"' '3>+3$*.$' %3'="'3.3#"' "=-3"*&2$'H '3'.$5& %$
-&5A3" /6=3%" %$ ,"/5&."; &=23-&-3@* %$ -3*.& %$ '$22&%" I=&/& +*& &=$/.+/& %$ =&E+$.$ 56'
,6-32J; 35=/$'"/& =&/& %&."' %$ =/"%+--3@* #&/3&A2$'; %3'="'3.3#" =&/& %3#3%3%" &+."56.3-" %$
5&.$/3&2 =&/& $5=&-&%" 0 %$'#3&-3@* =&/& 2& ./&*'="/.&-3@* &2.$/*&.3#& %$ =/"%+-."' E+$
*" '$/6* $*#+$2."'F
-"5" '$3' 5<=+3*&' '$*-322&'> %"' $*-&/."*&%"/&': +*&
$.3=+$.&%"/& 6&/& #3&2$': +*& 5<=+3*& %$ 22$*&%" %$ .+;"'
-"* &235$*.&%"/ ?";"#3'3"* 0 %"' 22$*&%"/&' %$ 28=+3%"'@
A* .".&2: "*-$ '"2+-3"*$' %$ $56&-&%" =+$ 6/"6"/-3"*&*
D&/&*.3E&/ +*& 6$/,$-.& 0 '$D+/& &--$'3;323%&% & ."%&'
2&' E"*&' -/8.3-&' =+$ +'&* D+&*.$': +*& D$'.39* 5<' ,<-32
%$ 2&' 63$E&' %$ /$6+$'." 0 5&*.$*353$*.": &'8 -"5" 2&
"6.353E&-39* 6&/& 2& 3*'.&2&-39* %$ '3'.$5&' %$ -"*.$*-39*
?FGC: &3'2&*.$' " $'-+%"' %$ 6/".$--39* 0 $2 *+$#"
5"*";2"=+$ %$ 22$*&%" 0 .&6"*$&%" )4HIJ: $=+36&%"
-"* IJ -&;$E&' %$ 22$*&%" 0 %"' ."//$' %$ .&6"*$&%" 6&/&
,&/5&-B+.3-&: 0 2& *+$#& O*3-&: +*& 28*$& /";".3E&%& 6&/&
6/",+*%" 0 $2 $56&=+$ $* -&/.9*@
A* $2 6"%3" %$ 2&' '"2+-3"*$' %$ $56&=+$ 5<' 3**"#&%"/&'
6&/& $56&-&%" %$ ;23'.$/' P*.$D/& QRM: +* -"*-$*./&%"
'3'.$5&' %$ -"*./"2: $2 *+$#" '3'.$5& %$ /$-"2$--39* 0
&6$/.+/& =+$ 6$/53.$ 6/"%+-3/ QRM ;23'.$/' 0 S&'.& RHM
-&/."*$' 6"/ 53*+."@
T&5;3B* '$ 5"'./9 2& 2 8*$& /";".3E&%& 6&/& ;23'.$/' )GUHM:
+*& %$ 2&' 28*$&' 6&/& ;23'.$/' 5<' /<63%& %$ 2& -"56&78&:
6"/ )&/-S$'3*3 =+$ /$#"2+-3"*9 $2 5$/-&%" ,&/5&-B+.3-"
$* 2"' V2.35"' %3$E &7"' 0 2& $*-&/."*&%"/& %$ 5"#353$*."
-"*.3*+" S"/3E"*.&2 )FQNR : &6.& 6&/& $56&-&%" $* -&/.9*
%$ &2.& #$2"-3%&% 6&/& -+&2=+3$/ 6/"%+-."@
+*& 5<=+3*& $.3=+$.&%"/& 0 2& )1JRM: +*& 3**"#&%"/&
5&*$/& '3D*3,3-&.3#& $2 %$'$56$7" $* .B/53*"' %$
%$ )&/-S$'3*3 '$ 6+$%$* "/D&*3E&/ %$ &-+$/%" -"* $2
6/"0$-." 0 -"* 2&' *$-$'3%&%$' %$ 2"' -23$*.$': &'8 -"5"
2& 2$D3'2&-39* #3D$*.$@
3*-2+0$*%" +* *+$#" %$.$-."/ %$ 5$.&2$': '3'.$5&' %$
4"5& 0 /$'+$2#$ 6/";2$5&' %$ /&'./$&;323%&% %$2 +'+&/3" -"*
+*& *+$#& ;3.<-"/& %$ &--$'" ;&'<*%"'$ $* 1K?RI L&/.$
II 0 &25&-$*&*%" S&'.& NMM $#$*."'@ T&5;3B* '"2+-3"*&
%$/3#&-3"*$' %$ 2& ;";3*& 6/3*-36&2 0 ,&2'"' /$-S&E"'
%$ 6/"%+-."' 6"/ #&/3&-3"*$' '+.32$' $* .$56$/&.+/&
&.5"',B/3-& 0 -&/&-.$/8'.3-&' %$ 2"' 6/"%+-."'@ F%$5<': '+
'3'.$5& 3*.$23D$*.$ %$ #&23%&-39* %$ 6/"%+-."' 5$5"/3E& 2"'
6/<-.3-& %$2 53*"/3'.& 3*%3#3%+&2@
4"' *+$#"' '3'.$5&' C6&-$C&#$/ [N "-+6&* 5$*"' $'6&-3"
0 -+$*.&* -"* 2& .$-*"2"D8& FFT %$ 3*'6$--39* 6"/ /&0"'
[: %$ V2.35& D$*$/&-39*: 5$%3&*.$ 2& -+&2 2"D/&* %$.$-.&/
-"*.&53*&*.$' 5$.<23-"' 0 *" 5$.<23-"' %$ 5&*$/& 5<'
%3'$7&%"' $'6$-3&25$*.$ 6&/& 6/$#$*3/ 2& /$-"2$--39* %$
23563&/ =+$ '"2+-3"*& 6/";2$5&' 6".$*-3&2$' %$ $'.&;323%&%
-&+'&%"' 6"/ $*."/*"' %$ 6/"-$'&53$*." /+3%"'"'@ A'
-&6&E %$ 3*'6$--3"*&/ QM:MMM .&;2$.&' 6"/ 53*+." 0 $'
$* $2 5$/-&%"@
T$2@> NN\ NNHN\UUMM
&%5$'3#"8
,)1","4 15#
D) ;7*@ +*& ,&6323& %$ A/"%+-."' A&/& -/"6&."C/&,9&
,'6"+)1"6 #$%&' BRS J??T)
6&6('%"6 +' +'6%&#'1"!&$".&7# &#('01"! ,"1" "08" ,81&3&."+" A$/63.3/: F+$ +'.$% -+6A2& -"* 2"' /$F+$/363$*."' $'.&E2$-3%"' $* -"*%+-.3#3%&% ] N8JI
4 >*./$?& %$ ;&@+$.$' %$
'$/ ";$/&%&' %$ :&*$/& 3*%$;$*%3$*.$9 B& 3*?$*3$/C& 0 2"' %3'$D"' %$ 2&' :3':&' '"*
%$;$*%3$*%" %$ 2& &;23-&-38*E '$?+/3%&% 0 ;/$'+;+$'."'9 >* F<1F $'.&:"' -"*#$*-3%"'
3*'.&2&-3"*$'9
4$'" &5"/& $' 4"'362$ $* 3*'.&2&-3"*$' $* %"*%$ 2&' 2373.&-3"*$' %$ $'4&-3" &*.$' $/&*
3*'.&2&/ +*& 6='-+2& 5&6/>& '3%" 374$*'&62$9 ?+ %3'$<" 73*37&23'.&@ 53A" 4"'362$ B+$ & ./&#C'
%$ 3**"#&-3"*$' .C-*3-&'@ '$& /$#"2+-3"*&/3"9
%$ DE 0 FE 8/&7"' -"* +*& 2$836323%&% %$ 5&'.& DE 73-/"8/&7"'9 1"* &2."' >*%3-$' %$
&-.+&23A&-3;* 0 ./&*',$/$*-3& %3/$-.& %$ %&."'@ '"* 3%$&2$' 4&/& &423-&-3"*$' %$ .3$74" -/>.3-"9
&5"//&/ $'4&-3"9
%$ 4/"%+-."' -"'."'"'9 G* &7423" /&*8"
%$ &--$'"/3"'@ .&2$' -"7" &-"42$' %$
./&*'4"/.&%"/ -"* /"%322"'@ 4$/73.$ +*& ,=-32
-"* 2"' /$B+$/373$*."' %$ 3*8$*3$/>& %$
42&*.& 0 '"* 3%$&2$' 4&/& $2 -"*./"2 %$
4/"-$'" %$ 22$*&%" &+."7=.3-" 0 %3'4$*'&%"
%$ 4/"%+-."' ,&/7&-C+.3-"'9
4/$-3'3;* 4&/& &423-&-3"*$' &+."7&.3A&%&'@
.&2$' -"7" %3'./36+-3;*@ 22$*&%" 0 /$#3'3;*
%$ 4$'"9
#3'3.$ *+$'./& 4=83*&L
5/"-$'" %$ 22$*&%" '"* &2G&-$*&%"' $* 2& G$G"/3&
%$2 '3'.$G&: H2 +'+&/3" 5+$%$ -/$&/ *+$#"' 5/"I/&G&' %$
22$*&%" %$ ,"/G& /J53%& 0 '$*-322&:
&2.+/& '"F/$ $2 #3&2K '$IL* '$& "F.+/&%"/ 5&/& 3*0$-.&F2$ "
5"/ #&-M":
-/3G5&%" *$+GJ.3-"K -"* $2 -+&2 '$ -"*'3I+$ 2& GM*3G&
I$*$/&-3O* %$ 5&/.M-+2&' %+/&*.$ $2 5/"-$'" %$ -$//&%":
9"%"' 2"' -3$//$' %$ +'" -"//3$*.$ 5+$%$* '$/ ./&.&%"' '3*
5/"F2$G&'K .&2$' -"G"8
R&/& 5/"%+-."' P+$ '$ %$F&* 2 3", 3 2 3Q&/K $73'.$ 2&
5"'3F323%&% %$ %3#3%3/ $* %"' GJP+3*&' 3*%$5$*%3$*.$'
2"' 5/"-$'"' %$8
N& GJP+3*& P+$ 2$ 5/$'$*.&G"' $' +*& -"GF3*&-3O*
#3&2$' -32M*%/3-"' $* #3%/3"K 52J'.3-" " F3$* G$.&2K 5&/&
$2 &-"*%3-3"*&%" &+."GJ.3-" %$ ."%" .35" %$ 5/"%+-."'
2MP+3%"'K '$G3B2MP+3%"' " $* 5"2#"K $* Q"*& $'.6/32 " '&2&
R&/& 5/"%+--3"*$' %$ S&'.& C:DDD +5S:
1"* 2& +.323Q&-3O* %$ +* &3'2&%"/K 2& Q"*& $'.6/32 '$ 23G3.&
$'.J*%&/$' %$ 2& 3*%+'./3& ,&/G&-6+.3-&:
N& GJP+3*& $' &%$-+&%& .&*." 5&/& 2".$' %$ $*'&0"' -2M*3-"'
-"G" 5&/& $7.$*'"' 2".$' %$ 5/"%+--3O*:
X*.$'
/"44$2&5 2& 467+3*& &'89.3-& -"492$.&4$*.$ $28-./3-&
:;<) 9&/& 2& 3*'9$--3=* %$ #3&2$' >?)@ -"*./"2&/ $2 9/"-$'"
-"492$.&4$*.$ &+."46.3-" %$ A2"7+$' %$ &49"22$.&' BCD
0 -"*.$*$%"/$' BCDE
9&/& 2& 3*'9$--3=* $* 9/"-$'" %$ A2"7+$' %$ &49"22$.&' BCDE
-"4" ,+$/G&' %$ ."/'3=*@ 9$'" %$ 22$*&%"@ 5/"'"' %$ 9&/$%$'
0 4&/-&' 3*%3#3%+&2$' %$ 2&' &49"22$.&' +'&*%" 3*'9$--3=*
9"/ -64&/&' H1I J/$-"*"-343$*." %$ -&/&-.$/$' =9.3-"'K
9+$%$ &2-&*G&/ L&'.& MNO &49"22$.&' 9"/ L"/&E
P2 $*,"7+$ %$ /"44$2&5 9&/& 2& 3*'9$--3=* #3'+&2
&+."4&.3G&%& %$ 9&/.Q-+2&' '$ A&'& $* 2& 32+43*&-3=*
'$ /$&23G& +*& '$/3$ %$ ,"."5/&,Q&'E
F&' 467+3*&' %$ 3*'9$--3=* %$ 9&/.Q-+2&' %$ /"44$2&5
.$*$/ $* -+$*.& 2&' /$'9$-.3#&' 3*.$/&--3"*$' %$2 4&.$/3&2
0 %$.$-.&* %$,$-."' -"'48.3-"'@ &'Q -"4" "./"' %&R"'
$'.8.3-"' J4&*-L&' *$5/&' " 4&2,"/4&-3"*$'KE S+$%$*
+.323G&/'$ 9&/& ."%"' 2"' .&4&R"' %$ -"*.$*$%"/$' 0 A2"7+$'
23A/$ %$ -"*.&-." 0 *" %$'./+-.3#"E P2 /$*%343$*." %$ 2&'
467+3*&' $' $'-&2&A2$ L&'.& 46' %$ ;M 432 -"*.$*$%"/$'
3*%3#3%+&2$' 9"/ L"/&E
T'34 3'4" $ /"44$2&5 0 -"*.$*$%"/$' BD 9&/& 3*'9$--3=* %$ -+$/9" -"492$."
$*-"*./&*%" .&4&R"' %$ ,+5&' %$ L&'.& N U4 " 3*-2+'"
4$*"/$'E P2 $7+39" $' 4+0 $'-&2&A2$ 9&/& %3,$/$*.$'
&923-&-3"*$'E
3"#3&+
!"/4&' :T &-$9.&%"' 9&/& $2 +'" '&*3.&/3" $ 3*%+'./3&2@
S&/& &'$5+/&/ 2& -&23%&% %$ 2&' *"/4&' $' 3*%3'9$*'&A2$ 2&
-"4A3*&-3=* %$ 2& $W9$/3$*-3& -"* 2& .$-*"2"5Q& 4"%$/*&Z
9+*."' 7+$ *" 9+$%$* '$9&/&/'$ -+&*%" '$ %$'$& "A.$*$/
5&4& %$ %3,$/$*.$' .39"' " 4"%$2"' -+A/3$*%" -&9&-3%&%$'
L&'.& [O@OOO 2.'E
)!"#$% &'(')'*'+'@ )%,-.++./@ S&.0)'@ \%++.1,@ )!+#('@
VVVE5/+9"-39'&E-"4
2$-L$ -"*%$*'&%&@ -/$4&@ 0"5+/.@ '+$/"@
$.-8.$/&E
%$ &:+& 7"/ 2" 9+$ *" /$9+3$/$ %$ -"*$;3<* & +*& ."4&6 2"
9+$ 2& =&-$ 45' #$/'5.32 0 .".&24$*.$ 7"/.5.32>
*" =&0& 22$:&%" & -$/">
#$%$ '( )$*$
.(#(+/(0#(1 (1#2+-&(1 *+$3&(045 6$$1#(+ !0. *+$3&(04 0*7
+,-./,01',2
$2 7/"%+-."> H32./&%"' 0 22$*&%"' $'.B/32$'6 $* +* &4I3$*.$
&'B7.3-" 12&'$ J -&%& 7&9+$.$ $'.5 $4I".$22&%" $* %"I2$
I"2'& 7&/& +*& ,5-32 $*./&%& $* '+ &4I3$*.$ &'B7.3-"> K'."'
7/"%+-."' .3$*$* +* $;.$*'" 7&9+$.$ %$ %"-+4$*.&-3<* 7&/&
'"7"/.$ %$2 $9+37" %$ L$/#3-3"' MB-*3-"' %$ LMKANL 7&/&
&'3'.$*-3& 7$/'"*&23?&%& %$ &723-&-3<* 0 #&23%&-3<*>
E&/& 4&' 3*,"/4&-3<*C
)3456# #$%$ '( )$*$
)1/1+.(/72.8+12
1"*.3$*$ '+/,&-.&*.$' 0 7$/<;3%"
&4723" $'7$-./" %$ '+-3$%&%$'>
-"* #&/3"' '+I'./&."'>
-&23%&%>
7/"-$'"' %$ 23473$?&>
+(1*-+!.$+ *"+-8-%!.$+ ('!
[EUEA6 7"/ '+' '3:2&' $* 3*:2B'@> U2 ",/$-$/ & 2"' +'+&/3"'
+* ,&-."/ %$ 7/".$--3<* &'3:*&%" %$ \RRR 0 +* '3'.$4& %$
18999: ;& 3**"#&%"/& 42&.&,"/6& -+</$ +* /&*=" %$ >&'.&
2"' $A+34"'5 &'B -"6" /$%+-3/ $2 -"'." .".&2 %$ 4/"43$%&%:
C2 4"/.&,"23" %3*D63-" %$ 18999 3*-2+0$ $2 18E89 -"* +*&
4&*.&22& .D-.32 %$ FE 4+2=&%&' 0 -&4&-3%&% %$ &26&-$*&63$*."
-"* +*& &6423& =&6& %$ ,+*-3"*$' "4-3"*&2$' %$ '",.G&/$
4/"%+--3H*:
4/"4"/-3"*& 4/".$--3H* -"*./& 2&' #3</&-3"*$' -&+'&%&'
4"/ "./&' 2B*$&' %$ 4/"%+--3H* 6&A+3*&/3& 0 ",/$-$ +*
6&0"/ 4/$-3'3H*: C2 %3'$I" 6"%+2&/ %$2 '3'.$6& 4$/63.$ +*&
$2$=3/ $*./$ +*& =&6& %$ -"6<3*&-3"*$' "4-3"*&2$' %$
.$-*"2"=B& %$ 3*'4$--3H* %$ 4/"%+-." -"6" %$.$--3H* %$
6$.&2 J6"%$2" 1)K5 3*'4$--3H* %$ /&0"'LM J6"%$2" 1NK "
3*'4$--3H* #3'+&2 J6"%$2" 1OK:
6$.&2$' 4$/63.$ A+$ 2&' 2B*$&' %$ 4/"-$'&63$*." "4$/$*
& #$2"-3%&%$' H4.36&'5 3*'4$--3"*&%" +*& #&/3$%&% %$
4/"%+-."' & *3#$2$' -"//$-."' %$ ,/$-+$*-3& 4&/& =&/&*.3P&/
%$ %$.$--3H* %$ 6$.&2 3*-"/4"/&* %"' /&*="' %$ ,/$-+$*-3&
3*.$/,&P >"6</$L6DA+3*& -"*./"2& $2 4$'" 0 2& .$-*"2"=B&
%$ %$.$--3H* %$ 6$.&2$' QCC5 /$%+-3$*%" .3$64" %$
4/"=/&6&-3H* 0 $2 /3$'=" %$ $//"/ %$ ,+*-3"*&63$*.": ;"'
'3'.$6&' .&6<3?* 3*.$=/&* 2& .$-*"2"=B& %$ =$'.3H* %$
'"</$ -&6<3"' %$ 4/"%+-." 0 $2 /$->&P" %$ 2"' 4/"%+-."'
%$,$-.+"'"':
2& 2B*$& %$ 4/"%+--3H* 0 #3</&-3"*$': R*& P"*& %$ ./&*'3-3H*
"4.363P&%& $*./$ 2"' /"%322"' %$ %3D6$./" 6D' 4$A+$I" %$ 2&'
%$ $'.& 6&*$/& 3*-/$6$*.&* +*& 6&0"/ 4/$-3'3H* %$ 2&
4$'&%&5 0 4"/ 2" .&*." +* 6&0"/ /$*%363$*.":
<&'$ .+<+2&/ 0 +
Related Documents
