• • • :e • • • • • • • • • • • • • • • :e • • • • . • •• • • 1: • • • • • =-• • • •
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`PAGE _ _
`
`..._N=-=O;..:....: ...... 19'----\ _
`
`Entered By : J ...\-:'. -'~ .
`~~
`
`Da\e
`:S /1~lo~
`
`ALCON 2018
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`PAGE _ _
`
`..._N=-=O;..:....: ...... 19'----\ _
`
`Entered By : J ...\-:'. -'~ .
`~~
`
`Da\e
`:S /1~lo~
`
`ALCON 2018
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
`
`Alcari
`R&DL/MS
`
`•
`
`Report Date:
`
`Lot Report
`25-MAR-2004 09:23 AM
`Page 1of1
`
`Lot Number: 04-36171-1
`Formulation ID: 106737 V . 1 AL6221 0.004% Oph Sol (Isotonic Sorbitol, Pres. Free)
`
`Lot Purpose: Exploratory
`Mfg Lot Number:
`
`Lot Description: PET
`
`Target pH: 6.0
`
`Project: 106464
`
`Reference Num: LN 11 068:20 H
`
`Dosage Form: Solution
`
`Batch Made by: Wayne Schneider
`
`Expiration Date:23-MAR-2005
`
`Retest Period: 1 year
`
`Storage Cond.: 2-25C
`
`FORMULATION
`Description
`AI06221, NOC
`Polyoxyl 40 Hydrogenated Castor Oil, NF,EUR,JPE
`Boric Acid, NF
`Sorbitol, NF
`Zinc Chloride, USP
`Sodiooi Hydroxide, NF
`Hydrochloric Acid, NF
`Purified Water. USP
`
`Concentration
`0.004"/o
`0.5%
`1%
`3.8%
`0.0025%
`adjust pH
`adjust pH
`Q.S . 100%
`
`Units
`WN %
`WN 'Yo
`WN %
`WN %
`WN %
`WN %
`WN %
`WN %
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Tonicity Agent
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`•
`
`Fonnulatlon Comments:
`
`Batch Comments:
`
`Lot Comments:
`
`PACKAGING
`Oescr: RESEARCH BOM 30,NONSPECIFIC PACKAGING TBD BY THE FORMULATOR
`Package BOM #: 549
`Lot Filled by: WAYNE SCHNEIDER
`Lot Fill Date:24-MAR-2004
`Num Units Filled 1
`Fill Volume: 90ml
`
`Fiii Location: R&D Fort Worth
`
`
`
`Approved by: ___ ~P'---~~-~-----·------- Date: ~,,.~
`
`~/]~>B~
`ADJUNQ:IVE D~TA TO._, ~fi I
`BOOK /!Pp%PAGE _21_J
`
`•
`
`Database: LIMSAR
`
`Batch-Lot#: 04-36171-1
`
`FB_Lot_Rep.02.LIMS041 .0.012004.P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DLIMS
`
`•
`
`to1so·.otq-3
`Lot Report
`2>MAR·2004 09:41 AM
`Page 1of1
`
`Report Date:
`
`Lot Number: 04-36172-1
`Formulation ID: 106738 V.
`
`Lot Purpose: Exploratory
`Mfg Lot Number:
`Reference Num: LN 11068:20 I
`
`AL6221 0.004% Oph Sol (Isotonic Glycine, Pres. Free)
`
`Lot Description: PET
`
`Dosage Fonn: Solution
`
`Batch Made by: Wayr.e Schneider
`
`Target pH: 6.0
`
`Project: 106404
`
`Expiration Date:23-MAR-2005
`
`Retest Period: 1 year
`
`Storage Cond.: 2-25C
`
`FORMULATION
`Description
`AI06221, NOC
`Polyoxyl 40 Hydrogenated Castor Oil, NF.EUR,JPE
`Boric Acid, NF
`Sorbitol, NF
`Glycine, USP
`Zinc Chloride, USP
`Sodium Hydroxide, NF
`Hydrochloric Acid, NF
`Purified Water, USP
`
`Concentration
`0.004%
`0.5%
`1%
`1%
`0.65%
`0.0025%
`adjust pH
`adjust pH
`q.s. 100%
`
`Units
`WN%
`WN%
`WN %
`WN%
`WN%
`WN%
`WN%
`WN %
`WN%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Tonicity Agent
`Tonicity Agent
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`•
`
`Formulation Comments:
`
`Batch Comments:
`
`Lot Comments:
`
`PACKAGING
`Package BOM #: 549
`Doser: RESEARCH BOM 30,NONSPECIFIC PACKAGING TBD BY THE FORMULA TOR
`Fiii Location: R&O Fort Worth
`Lot Filled by: WAYNE SCHNEIDER
`Lot Fill Date:24-MAR-2004
`Fill Volume: 90ml
`Num Units Filled 1
`
`,_..__~~,,-u;-~
`ADJUNCTIVE DATA TO':! .,
`BOOK (L~_AG_E__.e:-L---~.
`
`Database: LIMSAR
`
`Batch-Lot#: 04-36172-1
`
`FB_lot_Rep.02.LIMS041 .0.012004.P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`-
`
`----- - - - -
`
`•
`
`AJcari
`R&DLIMS
`
`Lot Number: 04-36173-1
`Formulation ID: 106755 V.
`
`Lot Purpose: Exploratory
`Mfg Lot Number:
`
`\01 so-. o lC\ -'1
`Lot Report
`25-MAR-2004 09:47 AM
`Page 1of1
`
`Report Date:
`
`AL6221 0.004% Oph Sol (Isotonic Propylene Glycol)
`
`Lot Description: PET
`
`Target pH: 6.0
`
`Project: 106464
`
`Reference Num: LN 11068:20 L
`
`Dosage Form: Solution
`
`Batch Made by: Wayne Schneider
`
`Expiration Date:23·MAR-2005
`
`Retest Period: 1 year
`
`Storage Cond.: 2-25C
`
`FORMULATION
`Description
`AI06221, NOC
`Polyoxyt 40 Hydrogenated Castor Oil, NF,EUR,JPE
`Boric Acid, NF
`Sorbitol. NF
`Propylene Glycol, USP
`Zinc Chloride, USP
`Sodium Hydroxide, NF
`Hydrochloric Acid, NF
`Purified Water, USP
`
`Concentration
`0.004%
`0.5%
`1%
`1%
`0.6%
`0.0025%
`adjust pH
`adjust pH
`q .s. 100%
`
`Units
`WNo/o
`WN%
`WN%
`WNo/o
`WN%
`WN%
`WN%
`WN %
`WN%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Tonicity Agent
`Tonicity Agent
`Exclpient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`Formulation Comments:
`
`Batch Comments:
`
`Lot Comments:
`
`PACKAGING
`. Descr: RESEARCH BOM 30,NONSPECIFIC PACKAGING TBD BY THE FORMULATOR
`Package BOM #:549
`Lot Filled by: WAYNE SCHNEIDER
`Lot Fill Oate: 24-MAR-2004
`Fiii Location: R&O Fort Worth
`Fill Volume: 90ml
`Num Units Fiiied 1
`
`•
`
`Date:
`
`ADJUNCTIVE DATA TO. , A i
`BOOK/f.Qk'~_PA_~/
`
`•
`
`Database; LIMSAR
`
`Batch-Lot#: 04-36173-1
`
`FB_Lot_Rep.02.LIMS041.0.012004.P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`-- - - - - - - - -
`
`Notebook 10750
`
`Page 019-5
`
`PRESERVATIVE RAW DATA
`
`Product:
`Sample Timepoint:
`On Test:
`04/06/2004
`
`Controls
`
`Initial
`
`Lot number:
`
`Date of Sample: - - - - --- --
`04/06/2004
`
`Organism Counts at Dilutions
`
`Test Organism
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`10-1
`
`\
`
`/
`•
`I
`\
`\
`I
`
`j
`
`I
`I
`\
`\
`(
`
`10-2
`
`I
`
`10-l
`
`(
`
`\
`
`\
`\
`\
`J
`
`I
`•
`1
`\
`
`)
`
`\
`
`\
`\
`\
`)
`
`I
`\
`)
`
`104
`
`\~4
`
`\ "\ <b
`
`\~\
`
`\ '). 3
`
`lCOO
`
`\"13
`
`lSl
`
`\ \0
`
`\~TC.
`
`\N\C..
`
`10-s
`
`tO
`
`\ '-\
`\i
`
`l~
`
`\~
`
`2()
`
`t3
`
`ti
`
`\0
`
`\ \
`
`Plate Count
`Average
`
`Initials
`-Date
`~ . .il.
`~ 4\qlo~
`\ .'5 x \0
`
`t.~.
`L\lq\04
`~ - JJ.
`iq~[o~
`
`~- .Jl.
`1'\'tloLt
`t . .tl.
`4 lctlo'-I
`
`lt
`\ • :2. X \O
`
`"
`\.u>c\O
`
`(0
`\.toX\0
`
`r.
`\.\ x \O
`
`••
`
`MEDIA:
`
`Peptone Lot (tubes):
`
`N/A
`
`Saline Lot (tubes): c~t\014 Polysallne Lot (tubes): 0 e.ou\
`Saline Lot (bulk): ot.\ e,o 1 o Polysallne Lot(bulk): O<\GO~Y
`Peptone Lot (bulk):
`N/A
`MCTA Lot: O"'\\?>C '! \ Waterbath Asset No.: 4;t.2.(hoO~hl Waterbath Temp(°C):
`'"\ «5, ~
`Other: --~N_l_A _____________ _
`OL.\ ~O~K
`
`Letheen Lot:
`
`ORGANISMS:
`
`\() 3\i: 6'-tlo· ls( ~1111 o0
`A. nlger Preparation Reference: \03t&'. ()'\\-\5 [ '-'l slo~ Transfer Log Reference:
`Analyst: --~ ~ Date: _4---'\-~,_\ O"'---~-'---------
`J{// ~Ii] __
`Ver!l!ed By:µ_l):T~ Date:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10750
`
`Page 019- lo
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL-6221 0.004%
`
`Lot number: 04-36171-1
`
`Sample Timepoint:
`On Test:
`04/06/2004
`
`Day 1
`
`Date of Sample: - - - - - - - -04/13/2004
`Organism Counts at Dilutions
`
`
`
`10"'
`
`Test Organism
`
`10-'
`
`10-2
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`£ . coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`I
`
`I I I
`
`r
`
`,
`
`10·3
`
`\C\1
`
`INTC.
`
`i'NTl
`
`11\li l-
`
`"t"NTC...
`
`200
`
`-rNTC.
`
`~2.
`
`l""N T C.
`
`ll ~
`
`3
`
`l "2.
`
`T/11-t-c_
`
`\"._,TC.
`
`.2.0:l.
`
`TNT<-
`
`'TN t'l.
`
`:2.\9
`
`INT"C.
`
`1"N'TC.
`
`""t'NTC.
`
`'1"NTC..
`
`.,.-1\JT(,
`
`\ N\l.
`
`l\ \
`
`4'-\
`--
`
`L\
`
`\0
`
`0
`
`\
`
`10-4
`
`I (o
`
`2.3
`
`0
`
`2..
`
`.1 l
`
`2.2
`
`1lD
`i5
`
`0
`
`0
`
`/
`v
`v
`v
`v
`v
`v
`/
`v
`v
`
`Plate Count
`Average
`
`s
`2.o x \O
`
`!>
`«g,\ l£ I 0
`
`Initials
`-Date
`c . ..tl.
`~ \1"lo~
`t. • .l!.
`3 4\111lo~
`C\ .~ )( \6
`t . ~.
`s 4\u.lo'{
`2..\)(10
`t.~.
`"\ \,o\ o~
`~ . ll.
`"l l~l o4
`
`2.
`'·\.Sx 10
`
`Peptone Lot (tubes):
`
`NIA
`
`Saline Lot (tubes): CL\~011.\ Polysaline Lot (tubes): Oj SO 4i o
`
`N/A
`Peptone Lot (bulk):
`NIA
`Saline lot (bulk) :
`N/A
`Polysaline Lot (bulk):
`Lt~. O
`MCTA Lot: ~~o'-\\ Waterbath Asset No.: ~~(A09gi) Waterbath Temp(°C):
`Letheen Lot: O~ ~ C:'t1
`Other: ---~N_\1\-~------------
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`- --- --- - -
`Analyst: ~~~
`Verified By: L{tQ 'iL==--~ :Q'JJ ~~
`
`Date:
`
`Date:
`
`Transfer Log Reference: NIA
`- -
`
`- - - -
`
`M40.02
`Rev. 10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10750
`
`Page 019-1
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL-6221 0.004%
`
`Lot number: 04-36172-1
`
`Sample Timepoint:
`04/06/2004
`On Test:
`
`Day 7
`
`04/13/2004
`Date of Sample: - -- - - - - -
`Organism Counts at Dilutions
`
`Test Organism
`
`10·1
`
`10·2
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`"T NT(
`
`1' N "t" (.
`
`\ 0 \
`
`\:,\
`
`IN'TC.
`-r l\)"\C,.
`
`,-, .. rtl
`
`"t"N\(..
`
`.,-NTC.
`
`\"NT(.
`
`45
`
`L\ 9
`
`"t"NTC..
`
`"'t'NTC.
`
`10-)
`
`I.\
`
`(J)
`
`~~
`'55
`
`\
`3
`'\'NT(.
`
`"fNTC..
`
`"t"rJ°T(.
`
`'i""1TC..
`
`\'NT(
`
`INT(.
`
`\ '-\
`
`2.5
`
`0
`
`\
`.
`
`10·4
`
`0
`
`2
`
`?,
`
`t{
`
`0
`
`I
`\ 3*6
`
`\~ 3
`
`D
`
`0
`
`10·5
`
`v
`v
`v
`v
`v
`v
`v
`I/
`v
`v
`
`Plate Count
`Average
`
`4
`\ 1.)Cl0
`
`Initials
`-Date
`c. Ji.
`4 \1tt \oct
`e . ..tl.
`~ '°'ht.\ o~
`54x\O
`t . .i.
`~ ~lu,(oq
`L\., x \0
`
`u
`\ .'-\x\O
`
`3
`l.0" \0
`
`t .l}.
`'i 120\0~
`~ . .d .
`'\\~o \ Ol\
`
`- - --
`
`Polysallne Lot {tubes):
`
`N/A
`
`Peptone Lot (bulk):
`
`N/A
`
`MCTALot: _ _ __ _
`
`Letheen Lot: -
`
`-
`
`-
`
`- - --
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`- - - - - - --
`Analyst: ~~- Date:
`VerlfiedBy:~ j2~>~ Date:
`
`Transfer Log Reference: NIA
`-- -- - -
`
`M40.02
`Rev. 10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10750
`
`Page 019· g
`
`PRESERVATIVE RAW DAT A
`
`•
`
`
`
`----------------- Lot number: 04·36173-1 Product: AL-6221 0.004%
`Sam p I e Timepoint:
`Day 7
`On Test:
`04/06/2004
`
`Date of Sample: - -- - -- - -04/13/2004
`
`
`
`Organism Counts at Dilutions
`
`Test Organism
`
`10·'
`
`10·2
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E.coli
`ATCC8739
`
`C a/bicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`~NT(.
`
`11
`
`l"NTC..
`
`\C>1
`
`£oS
`
`1\
`
`2.
`
`lo\
`
`TNT'<.
`
`"'fNTl.
`
`,-NTC.
`
`\NTC.
`
`.,. "'1"(.
`
`TNT<..
`
`i'"NTC.
`
`-t'fl)T(...
`
`1'"tJ Tl.
`.,..")'f'( ...
`\ 'l
`
`J.~
`
`10"3
`
`l\
`i
`
`0
`
`C>
`
`2-t
`
`3lo
`
`\tJTC.
`
`_,..,_,T<:.
`
`0
`
`l
`
`10-4
`
`0
`
`\
`
`0
`
`0
`
`:i.
`
`~
`
`.., \
`13
`
`0
`
`0
`
`•
`
`MEDIA:
`
`I/
`
`10-'
`
`/
`/
`/
`/
`
`/
`I/
`/
`/
`v
`
`-
`
`.
`
`Plate Count
`Average
`
`3
`~ . 2.X 10
`
`Initials
`-Date
`t.ll.
`4lii.\(ll.\
`
`.4
`<...'6 )( 10
`
`"\
`3.~ x \()
`. I
`
`s
`, • .2. )(, \0
`
`s
`2 . 2 x \0
`
`c.J!.
`4\uolo'{
`t . .l!.
`4 l \l1l o&l
`t . .ll.
`4 \;lo lot\
`c . ..tl.
`'t\~0\04
`
`Peptone Lot (bulk):
`
`N/A
`
`N/A
`
`MCTA Lot: -- - - - Waterbath Asset No.: - - -- -
`
`Letheen Lot: _ _____ _
`
`Other: _______ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`- --------
`Analyst: ~~ Date:
`Verified By:~JC'U~~~V>...___ Date:
`
`Transfer Log Reference: N/A
`- -- - --
`~ \ :lO l Qt{._ ___
`~
`
`_
`
`M40.02
`Rev. 10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10750
`
`Page 019· C\
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL-6221 0.004%
`
`Lot number: 04·36171-1
`
`Sample Timepoint:
`On Test:
`04/06/2004
`
`Day 14
`Date of Sample: -
`Organism Counts at Dilutions
`
`04/20/2004
`- - --
`- - -
`
`Test Organism
`
`10-1
`
`10-2
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`"T tJ \C.
`
`-r 1\1 TC.
`
`TtJ "tl.
`
`"T'NTL
`
`~
`
`Lt
`
`0
`
`0
`
`\NTL.
`
`--r t\J"t'C.
`
`lNTC-
`
`"f">.ITC..
`
`""t /VI(
`
`l~"t(
`
`"HJi"(.., TNIC..
`
`l ~
`
`23
`
`.2.
`
`~
`
`10-4
`
`10-s
`
`~5
`
`11
`
`Plate Count
`Average
`
`~
`1 . ~ ')( \0
`
`\
`5.5 X lO
`
`"i
`t..1 x \0
`
`5
`u:l X lO
`
`:2
`:2.\ x \0
`
`Initials
`-Date
`t...t:L
`4 b~\ol\
`t. ~.
`L\\:>.~\o~
`t . .li.
`L\ b_3 \ol.{
`L-tf.
`4 l:i.., loti
`t . .il.
`U.1~-i lol\
`
`/
`/
`I/ v
`/
`/
`/
`i/ v v
`/
`/
`v v
`/
`/
`v
`/
`I/ v
`
`lff3
`
`1'"i
`
`~u
`
`u"'
`11
`
`,.~TC
`
`\/\)\('.,
`
`/
`
`/
`
`Peptone Lot (tubes):
`
`NIA
`
`Saline Lot (tubes): O'i·· 3il'i25· I Polysallne Lot (tubes): 0"\·3<oL\ 5H
`
`Peptone Lot (bulk):
`
`Saline Lot (bulk):
`
`Polysaline Lot (bulk):
`
`NIA
`NIA
`NIA
`I..\ S. t
`MCTA Lot: o~ Bo1~ Waterbath Asset No.: •.;;i,. (Aooi3J Waterbath Temp(°C):
`<::>~ - 3, ~ 4 .2.Lt - \
`Other: ___ N~)A ______________ _
`
`Letheen Lot:
`
`ORGANISMS:
`
`A . niger Preparation Reference: N/A
`
`Transfer Log Reference: NIA
`
`-~~~~~---
`
`--~~~~
`
`Analyst:
`
`tHi~ .. ~~...
`""'"'c-b- - - --
`Verified By:
`
`-
`
`Date:
`
`Date:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10750
`
`Page 019· I 0
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL-6221 0.004%
`
`Lot number: 04-36172-1
`
`----------------~
`
`Sample Timepoint:
`On Test:
`04/06/2004
`
`Day 14
`Date of Sample:
`
`04/20/2004
`- - - --
`- - -
`
`Organism Counts at Dilutions
`
`10·2
`
`10·3
`
`10-4
`
`10·S
`
`0
`
`0
`
`?,C\
`
`L\ l
`
`0
`
`0
`
`~tt
`
`\"l 1
`
`10·•
`
`0
`
`0
`
`TNiC.
`
`\Nil
`
`\
`
`0
`
`IN\C.
`
`Test Organism
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`'TNTL TNT(.
`
`TIV'T(
`
`INTC..
`
`l~
`
`3~
`
`v /
`/
`v
`I/
`/
`v
`/
`v v
`~
`s
`v v
`/
`/ v v
`/
`v
`TNT( TN'l'(
`'",..\'-
`v v
`/
`/ v I/
`
`Plate Count
`Average
`
`Initials
`-Date
`
`~\O
`
`"'\0
`
`t. • .rl,
`iJ.\~l\o~
`t..11.
`3 4b~\O'i
`4. 0 x \0
`t.J:i.
`'·l\ ?.1\0~
`e. JJ.
`~ L\l~··do~
`', 2. x. lO
`t . ..tl.
`~l').'1 \ot.\
`
`3
`2 . ~x \O
`
`Peptone Lot (tu
`
`Peptone Lot (bulk):
`
`N/A
`
`Polysallne Lot (tubes):
`
`- - -
`N/A
`
`- - - -
`N/A
`
`Letheen Lot: - - -- --
`
`-
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`--- --- ---
`Analyst: -~ ~ Date:
`
`Transfer Log Reference: N/A
`-- - -- -
`
`---=--=-~~~-------~
`Date:
`
`Verified By:
`
`M40.02
`Rev. 10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10750
`
`Page 019- ll
`
`e Product: AL-6221 0.004%
`
`PRESERVATIVE RAW DATA
`
`Lot number: 04-36173-1
`
`Sample Timepoint:
`On Test:
`04/06/2004
`
`Day 14
`
`Date of Sample:
`
`04/20/2004
`
`~--~----
`
`Test Organism
`
`10·'
`
`Organism Counts at Dilutions
`
`10·2
`
`10-J
`
`10-4
`
`io-s
`
`5
`I
`
`0
`
`0
`
`/
`/
`
`0
`
`0
`
`/
`
`/
`
`/
`/
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`Peptone Lot (bulk):
`
`"'TN"\<_
`
`~5
`
`\NTL
`
`~l
`
`0
`
`0
`
`"\NTC..
`
`\N\l
`
`INTC.
`
`,. "'T (.
`
`\ tJ\(.
`
`\' NTC.
`
`/
`
`\
`i..\
`
`/
`
`Saline Lot (tubes):
`
`ao
`3\
`
`-----=---
`
`Plate Count
`Average
`
`'
`iJ.O r. \0
`
`.l \0
`
`Initials
`-Date
`~· J:J.
`l.\/~3,ott
`~.1L
`l.\}~3\0~
`t-.il.
`3 4 \~3\0~
`:l. u )( \0
`C: . ..t\.
`4 J ;n l ot.t
`t . .V.
`~ '-21 lo~
`
`/
`/
`/ v
`/
`/
`/
`/
`/
`/
`/
`/
`/
`u5
`/
`LDC\
`/
`/
`I/ v
`---- Polysaline Lot (tubes):
`
`5
`t.t.1 )! LO
`
`:J.
`5.\ x \0
`
`..
`
`N/A
`- - - -
`
`Polysaline Lot (bulk):
`
`N/A
`
`MCTALot: -
`- - - -
`Letheen Lot: _____ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`- - - - -- ---
`Analyst: -~ ,ti,~~---- Date:
`Verified By:
`Date:
`
`Transfer Log Reference: N/A
`-----~
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10750
`
`Page 019- \ 2..
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL-6221 0.004%
`
`Lot number: 04-36171-1
`
`Sample Timepoint:
`On Test:
`04/06/2004
`
`Day 28
`
`Date of Sample:
`
`05/04/2004
`
`~------~
`
`Organism Counts at Dilutions
`
`Test Organism
`
`10·'
`
`10·2
`
`10·l
`
`10·4
`
`10-s
`
`v
`/
`/ v
`v v v v
`/ v
`v v
`v v
`/ v
`"~ v
`/
`/ v v
`v I/
`[/
`
`Plate Count
`Average
`
`Initials
`-Date
`
`c.JJ.
`I Sl1 \o~
`5.5 )( \0
`e_.jJ,
`sl;\C>~
`
`<\O
`
`'
`\ . 0)(\0
`
`5
`3 o~ \o
`
`I
`t.S x. \O
`
`t.J:l.
`5 h \ott
`c.J:L
`'5/\l\01.\
`
`t.1L
`~/u \ o~
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`5
`
`(9
`
`0
`
`C>
`
`\
`
`\
`
`'IN'IC.
`
`"f N,.C-
`
`0
`
`3
`
`0
`
`0
`
`0
`
`(')
`
`0
`
`C>
`
`0
`
`0
`
`-rflJI(...
`
`T NTC.
`
`\Ni(;
`
`"11\lTC..
`
`3\
`
`0
`
`0
`
`Peptone Lot (tubes):
`
`N/A
`
`Saline Lot (tubes): Olt· 3[,_Slq· I Polysaline Lot (tubes): O't· a,t.58 q. 1
`
`Peptone Lot (bulk):
`
`MCTA Lot: L\ Ot'\\'-' \ C\
`
`N/A
`N/A
`Saline Lot (bulk):
`Polysallne Lo t (bulk):
`Waterbath Asset No.: ~:i.(AooS3) Waterbath Temp(°C):
`Letheen Lot: 0 4 · ~Lo 5 C\O ... \
`Other : _ _
`
`.....:;tJ"-'-'-,__ _ __ __ __ __ __ __ _
`
`N/A
`'-\ '.). ~
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`- - - - - -- --
`
`Transfer Log Reference: N/A
`
`-~~~~-
`
`Date:
`
`Date:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10750
`
`Page 019· l 3
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL-6221 0.004%
`- --- ------ -------
`Sam p I e Timepoint:
`· Day 28
`On Test:
`04/06/2004
`
`Date of Sample:
`
`Lot number: 04-36172-1
`
`05/04/2004
`
`Organism Counts at Dilutions
`
`-------~
`
`Test Organism
`
`10·'
`
`Plate Count
`Average
`
`Initials
`-Date
`
`<.. \ 0
`
`L \0
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC8739
`
`C. albicans
`ATCC 1023 1
`
`A. niger
`ATCC 16404
`
`0
`
`0
`
`0
`
`"
`
`~ ·,
`
`\
`
`Saline Lot (tubes):
`
`Polysallne Lot (tubes):
`
`Peptone Lot (bulk):
`
`MCTA Lot: _ ___ _
`
`Letheen Lot: - - - - - - -
`
`ORGANISMS:
`
`N/A - - --
`
`Polysaline Lot (bulk):
`
`N/A
`
`Transfer Log Reference: N/A
`---- - -
`
`A. niger Preparation Reference: N/A
`- --------
`Analyst: ~~
`Verified By: ~dJ,~.> lJ, '~
`
`Date:
`
`Date:
`
`M40.02
`Rev. 10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`·9 Product: AL-6221 0.004%
`
`Notebook 10750
`
`Page 019- I"{
`
`PRESERVATIVE RAW DATA
`
`Lot number. 04-36173-1
`
`~----~---------~
`
`Sample Timepoint:
`On Test:
`04/06/2004
`
`Day 28
`
`Date of Sample:
`
`05/04/2004
`
`---~----
`
`Test Organism
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`Organism Counts at Dilutions
`
`10-•
`
`0
`
`0
`
`0
`
`0
`
`(!)
`
`"
`
`""T"N\c_
`
`\'N\C...
`5
`
`~
`--
`
`/
`/
`
`10-2
`
`/
`
`/
`
`0
`
`0
`
`10-3
`
`/
`/
`/
`
`/
`/
`/
`
`-\tJ\C..
`
`'\"1'J"'f(_
`
`'TN\C..
`
`-f !VIC..
`
`/
`
`\
`\
`
`/
`
`10 ...
`
`/
`/
`/
`/
`I/ /
`/
`I/
`/
`/
`/
`
`.25
`
`3~
`
`/
`
`I/
`
`lo-'
`/
`/
`/
`/
`/
`
`Plate Count
`Average
`
`~ \()
`
`.l. \0
`
`L \0
`
`Initials
`-Date
`~j.
`~ \1 \ o~
`t . .lJ.
`Sh\ol\
`t.l.
`is h \o~
`
`t.iL
`5 ~ \i\\c 4
`.3.0 X \O
`t..iJ.
`5\u\04
`
`\
`S. S >c \ o
`
`Peptone Lot (bulk):
`
`MCTA Lot: - - - --
`
`Saline Lot (tubes):
`
`- - - -
`N/A
`- -- -
`
`Polysallne Lot (tubes):
`
`Polysaline Lot (bulk):
`
`- - - -
`N/A
`
`Letheen Lot: - --
`
`-
`
`- - -
`
`ORGANISMS:
`
`A . niger Preparation Reference: N/A
`- - - -- - - - -
`Analyst: _ tru't>\imd.=<-3.J\ ..... lll£...,..,.· ~~...,,c.----.,.----- Date:
`Verified By: ~~1l:iifM
`
`Date:
`
`Trarisfer Log Reference: N/A
`--- - - -
`
`M40.02
`Rev. 10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`Notebook 10750
`
`Page 019.::..15
`
`-
`
`Product: AL-6221 0.004o/o
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`Procedure No.:
`
`Unpreserved
`
`Date Assayed :
`
`04/06/2004
`
`04-36171-1
`Initial
`250ml
`
`·~---------~-
`
`Batch No.:
`
`FIDNo.:
`
`Project No.:
`
`~
`PROC-0001131 (V-2.0)
`LIMS No.:
`DUI. ""'~
`SUMMARY OF RESULTS
`
`Organism Counts (CFU/mL or CFU/g)
`
`106737
`225202
`
`200191978
`
`Test Organisms
`
`Initial
`
`7 Day
`
`14Day
`
`28Day
`
`•
`
`S. aureus
`ATCC6538
`
`P. aemginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`I. 5 )( \0 t.
`
`~
`~ . 0 X lO
`
`.2.. 0 )( \0 ~
`
`I
`5. '5 X lO
`
`l. 1 X \O"'
`
`3
`'1. ix \0
`
`\
`5 . 5 )( \0
`
`~\O
`
`(I
`\ , tgx\O
`
`5
`l . \ )( \0
`
`(.o .1 x \0 t.\
`
`I
`\. 0 x \0
`
`\.le x\o"
`
`s
`<t, \ )(. \0
`
`'5
`~-l )( \0
`
`cs
`.3..0 .)c \O
`
`(,,
`
`\. \ x \0
`
`.2.
`'4.~)l \0
`
`1..
`.l.\ Y.. \0
`
`\
`\.5:x \0
`
`Not Done (ND)
`
`Limits of Detection Established 0 _ _ ___ _____ _ _ __ _
`Limits of Detection Not Established Q--'°
`
`D Pass USP Requirements 13"'°Fail USP _S_a..._Jr-=E,,....c...._ _ _ _ _ _
`D Pass JP Requirements B"Fail JP
`-=So.=d...=r-=E."-"c"---- - --
`-
`
`Analyst: -~~ Date
`s/11loY
`Verifled By:~--- Date _.f?/g_j1_y,___ _ __ _
`
`•
`
`M40.03
`Rev. 6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook J 07jQ_ Page 019· 1/o
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`•
`
`Product: AL-6221 0.004%
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`Procedure No.:
`
`Unpreserved
`
`Date Assayed:
`
`04/06/2004
`
`04-36172·1
`Initial
`
`Batch No.:
`
`FID No.:
`
`250ml
`PROC-000113t ~-2.0)
`LIMS No.:
`(.gjt . SI 1a.l•'4
`SUMMARY OF RESULTS
`
`Project No.:
`
`On~anism Counts (CFU/mL or CFU/g)
`
`106738
`225202
`
`200191979
`
`Test Organisms
`
`Initial
`
`7 Day
`
`14Day
`
`28Day
`
`•
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`l.5'll.\Of#
`
`'t
`\. 1 )I. \0
`
`J.. \ 0
`
`L. \0
`
`\.'-l<\0
`
`"
`
`4
`5 .l\x\O
`
`'3
`L\. O ~ lO
`
`~\O
`
`1. {R
`
`(Q
`)c \0
`
`~
`t;.1 ,. \0
`
`"' l 0
`
`L. \0
`
`~
`\.<.o )( \0
`
`I#
`\.'-\ x \0
`
`l.f
`l . .1. x to
`
`s
`1 . q ~ \0
`
`\ . \ )t \ 0
`
`ii>
`
`3
`!2.0)<\0
`
`?
`.2 . lo~\O
`
`2.
`1 . ~ x \0
`
`Not Done (ND)
`
`Limits of Detection Established D
`Limits of Detection Not Established G:r
`
`0 Pass USP Requirements ~Fail USP f>o..
`0 Pass JP Requirements ~Fail JP
`g.t:A. · - -- - - -
`
`~-------
`
`Analyst:
`
`5/19. loc.t
`Verified By: ~-"'-~"'--'°"~'----=-'------ Date _§/__f/!f-___ _
`
`Date
`
`•
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`Notebook 10750
`
`Page 019· \1
`
`•
`
`Product: AL-6221 0.004%
`
`Preservative:
`
`Lot Number:
`
`Unpreserved
`- - - - - - - -- - - -
`04-36173 -1
`
`~--~--~-----
`
`Stability Data:
`
`Package:
`Procedure No.:
`
`1 nit i a I
`250ml
`
`...
`LIMS No.:
`PROC-000113~ \V·2.0)
`0 c:
`.9b1.(t'\
`-
`SUMMARY OF RESULTS
`
`Date Assayed:
`
`04/06/2004
`
`Batch No.:
`FID No.:
`
`Project No.:
`
`106755
`225202
`200191980
`
`Organism Counts (CFU/mL or CFU/S?)
`
`Test Organisms
`
`Initial
`
`7 Day
`
`14Day
`
`28Day
`
`•
`
`S. aureus
`ATCC6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`\ c;x \o4
`
`~
`9.1 x. \0
`
`I
`u .O x lo
`
`4\o
`
`\. 2. x \()
`
`~
`
`1.
`
`'" 'x \0
`
`J,. \0
`
`L. \0
`
`It
`\. u x \0
`
`4
`3.2.X\0
`
`12. u )< l0
`
`3
`
`L\0
`
`l.~X\O 11
`
`$
`1 . .1 X. lO
`
`5
`Lt.I )l lO
`
`5
`3 0 x \0
`
`\. \ x \0
`
`-
`
`;
`2 . 1 )( '0
`
`2.
`3 l X lO
`
`I
`
`5.5 x \0
`
`Not Done (ND)
`
`Limits of Detection Established 0 __________ _
`limits of Detection Not Established 13"
`
`D Pass USP Requirements G"Fail USP 't.t.
`0 Pass JP Requirements G'Fail JP
`......::e=-c.=--- - - -- - -
`
`~~-------
`
`•
`
`Analyst:
`
`Verified By:
`
`""'"'l.l.:~.L.....,.;;;,,,,_~~~~6------- Date
`s /, ,,_ f o 4 ____ _
`~~..r.e:.:::::::::(..,.,.c&?'J ...._~--- Date _!!!( tj_Af __ _
`
`M40.03
`Rev. 6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`AJPetResults.04.122002
`
`Database: LIMSAR
`
`I -~
`0 -.0
`
`0
`dl
`..J
`0
`
`Report Approved by: Kathleen Alford on 09..JUN-2004 01 :40pm
`
`Limits of Detection: Not Established
`
`Fail USP & JP (Sa, Ee)
`
`1.5E1
`3.0E5
`1.0E1
`<10
`5.5E1
`
`2.1E2
`6.7E5
`6.7E4
`5.5E1
`2.6E4
`
`4.3E2
`8.1E5
`2.1E5
`9.8E3
`2.0E5
`
`1.1E6
`1.6E6
`1.6E6
`1.2E6
`1.5E6
`
`28DAY
`
`14DAY
`
`7 DAY
`
`INIT
`
`Comments:
`Result Summary:
`
`USP: FAIL
`JP: FAIL
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`300910392 ,300910394
`
`Ref#:
`Project No.: 225202
`Preservative: Unpreserved
`Task IDs:
`
`10750:019
`
`samples)
`
`Package: 250 ml Filter Unit/ 90 ml (Use 10 ml
`Stability Data Initial
`Product: AL6221 0.004% OPH SOL (ISOTONIC S
`Submission ID: 100074264
`
`Method:
`Date Assayed: 06-APR-2004
`Series No.:
`User Sample ID: Lot 04-36171-1 (Use 10 ml samples)
`Sample ID:
`
`200191978
`
`PET, USP
`
`106737
`
`Page 1 of 1
`
`Report Date: 15-JUN-2004 01 :08 PM
`
`• USP Preservative Evaluation &mary
`
`(MTP PROC-0001136 (V-2.0))
`
`• Alcari
`
`R&DLIMS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`AIPetResults.04.122002
`
`Database: LIMSAR
`
`0 . ,
`(/\
`..J
`
`-0
`
`
`
`I -
`0 -,,D
`
`Report Approved by: Kathleen Alford on 09..JUN-2004 01 :40pm
`
`Limits of Detection: Not Established
`
`Fail USP & JP (Pa}
`
`2.6E2
`7.8E5
`<10
`<10
`<10
`
`2.6E3
`1.2E6
`<10
`4.0E3
`<10
`
`2.0E3
`1.4E6
`4.7E3
`5.4E4
`1.2E4
`
`1.1E6
`1.6E6
`1.6E6
`1.2E6
`1.5E6
`
`28DAY
`
`14DAY
`
`7DAY
`
`INIT
`
`Comments:
`Result Summary:
`
`USP: FAIL
`JP: FAIL
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`300910376 ,300910378
`
`Ref#:
`Project No.: 225202
`Preservative: Unpreservd
`Task IDs:
`
`10750:019
`
`samples)
`
`Package: 250 ml Filter Unit / 90 ml (Use 1 O ml
`Stability Data Initial
`Product: AL6221 0.004% OPH SOL (ISOTONIC G
`Submission ID: 100074264
`
`Method:
`Date Assayed: 06-APR-2004
`Series No.:
`User Sample ID: Lot 04-36172-1 (Use 10 ml samples}
`Sample ID:
`
`PET, USP
`
`106738
`
`200191979
`
`Page 1of1
`
`• USP Preservative Evaluation 6mary
`
`(MTP PROC-0001136 (V-2.0))
`
`Report Date: 15-JUN-2004 01:09 PM
`
`• Alcari
`
`R&DL/MS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`AIPetResults .04 .122002
`
`Database: LIMSAR
`
`
`-0
` ~
`
`0 -.
`ell
`
`0
`~
`I
`
`0 -rO
`
`Report Approved by: Kathleen Alford on 09-JUN-2004 01 :40pm
`
`Limits of Detection: Not Established
`
`Fail USP & JP (Ee}
`
`5.5E1
`3.0E5
`<10
`<10
`<10
`
`3.1E2
`6.7E5
`2.6E3
`<10
`6.0E1
`
`2.2E3
`7.2E5
`3.2E4
`6.8E2
`9.2E3
`
`1.1E6
`1.6E6
`1.6E6
`1.2E6
`1.5E6
`
`280AY
`
`14DAY
`
`7DAY
`
`INJT
`
`Comments:
`Result Summary:
`
`USP: FAIL
`JP: FAIL
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`300910380 ,300910382
`
`Ref#:
`Project No.: 225202
`Preservative: Unpreserved
`Task IDs:
`
`10750:019
`
`samples)
`
`Package: 250 ml Filter Unit/ 90 ml (Use 10 ml
`Stability Data Initial
`Product: AL6221 0.004% OPH SOL (ISOTONIC P
`Submission ID: 100074264
`
`Page 1 of 1
`
`Report Date: 15-JU N-2004 01 :09 PM
`
`• USP Preservative Evaluation .mary
`
`(MTP PROC-0001136 (V-2.0))
`
`Method:
`Date Assayed: 06-APR-2004
`Serles No.:
`User Sample ID: Lot 04-36173-1 (Use 10 ml samples)
`Sample ID:
`
`PET, USP
`
`106755
`
`200191980
`
`. ----------
`
`•
`
`R&DL/MS
`Alcori
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DLIMS
`
`,01so:o\q-2.\
`Intermediate Sample Results Report
`Report Date: 15-JUN-2004 01 :07 PM
`
`Page 1of1
`
`LIMS Submission ID: 100074264
`: L. Wayne Schneider
`Requester
`Customer Oatagroup
`: RESEARCH SUPPORT FORMU
`Logged By
`: SCHNEIDER
`
`225202
`Project Number
`Mail Code
`R1-36
`Telephone Extension: 8037
`
`•
`
`Sample Information
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Sup\/.
`Specific Location
`Date Logged
`
`:200191978
`: Lot 04-36171-1 (Use 10 ml samples)
`: 106737 AL6221 0.004"/o OPH SOL (ISOTONIC S
`:SOLUTION
`: A NEW MATERIAL TYPE
`: MICROBIOLOGY
`:PET LAB
`: 03/25/2004
`
`AGE
`DATE NEEDED
`FORMULATION ID
`LABORATORY
`NUMBER OF UNITS
`PKG/FILL VOL
`PURPOSE
`STORAGE CONDITION
`
`: Initial
`: 04-30-04
`: 106737
`: MICROBIOLOGY
`: 1
`: 250 ml Filter Unit I 90 ml
`: MICROBIOLOGY STUDY
`: RT,AMBIENT
`
`Result Information
`Task ID
`Component
`300910392 USP
`'
`300910392
`JP
`300910392 RESULT SUMMARY
`300910392 LIMITS OF DETECTION
`
`•
`
`Task Information
`
`Task ID
`
`Method
`
`300910392 PET.USP
`REFERF:NCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DA TE RECEIVED
`DATE ON TEST
`PRESERVATIVE
`
`: 10750:019
`: GUTIERREZC
`: PROC.0001136 (V-2.0)
`: 26-MAR-04
`: 06-APR--04
`: UnpreseNed
`
`(Use 10 ml samples)
`
`Result Value
`FAIL
`FAIL
`Fail USP & JP (Sa, Ee)
`Not Established
`
`Units
`
`Rep
`1
`1
`
`Procedure
`
`PET, USP
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Kathleen Alford on .09..JUN-2004 01 :40pm
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DL/MS
`
`\O"tSo : Ol<\- 2.'2..
`Intermediate Sample Results Report
`Report Date: 15-JUN-2004 0 1:08 PM
`
`Page 1 of 1
`
`LIMS Submission ID : 100074264
`Requester
`: L. Wayne Schneider
`Customer Datagroup
`: RESEARCH SUPPORT FORMU
`logged By
`: SCHNEIDER
`
`Project Number
`225202
`Mall Code
`R1 -36
`Telephone Extension : 8037
`
`•
`
`Sample Information
`:200191979
`: Lot 04-36172-1 (Use 10 ml samples)
`: 106738 AL6221 0.004% OPH SOL (ISOTONIC G
`: SOLUTION
`: A NEW MATERIAL TYPE
`: MICROBIOLOGY
`: PET LAB
`: 03/25/2004
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`AGE
`DATE NEEDED
`FORMULATION ID
`LABORATORY
`NUMBER OF UNITS
`PKG/FILL VOL
`PURPOSE
`STORAGE CONDITION
`
`: Initial
`: 04-30-04
`: 106738
`: MICROBIOLOGY
`: 1
`: 250 ml Filter Unit/ 90 ml
`: MICROBIOLOGY STUDY
`: RT.AMBIENT
`
`Result Information
`Task ID
`Component
`300910376 USP
`300910376
`JP
`300910376 RESULT SUMMARY
`LIMITS OF DETECTION
`300910376
`
`•
`
`(Use 10 ml samples)
`
`Result Value
`FAIL
`FAIL
`Fail USP & JP (Pa)
`Not Established
`
`Units
`
`Rep
`
`Task Information
`
`Task ID
`
`Method
`
`300910376 PET.USP
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DA TE RECEIVED
`DA TE ON TEST
`PRESERVATIVE
`
`: 10750:019
`: GUTIERREZC
`: PROC-0001136 (V·2.0)
`: Z6-MAR-04
`: 06-APR-04
`: Unpreservd
`
`Procedure
`
`Method
`Datagroup
`
`Condition
`
`PET, USP
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Kathleen Alford on 09.JUN-2004 01 :40pm
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DL/MS
`
`l 0 1So: o l C\ - :2 3
`Intermediate Sample Results Report
`Report Date: 15-JUN-2004 01 :08 PM
`
`Page 1of1
`
`LIMS Submission ID: 100074264
`: L. Wayne Schneider
`Requester
`Customer Datagroup
`: RESEARCH SUPPORT FORMU
`Logged By
`: SCHNEIDER
`
`225202
`Project Number
`R1-36
`Mall Code
`Telephone Extension : 8037
`
`•
`
`Sample Information
`:200191980
`: Lot 04-36173-1 (Use 10 ml samples)
`: 106755 AL6221 0.004% OPH SOL (ISOTONIC P
`: SOLUTION
`: A NEW MATERIAL TYPE
`: MICROBIOLOGY
`: PET LAB
`: 03/25/2004
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`AGE
`DATE NEEDED
`FORMULATION ID
`LABORATORY
`NUMBER OF UNITS
`PKG/FILL VOL
`PURPOSE
`STORAGE CONDITION
`
`: Initial
`: 04-30·04
`: 106755
`: MICROBIOLOGY
`: 1
`: 250 ml Filter Unit I 90 ml
`: MICROBIOLOGY STUDY
`: RT,AMBIENT
`
`Result Information
`Task ID
`Component
`300910380 USP
`JP
`300910380
`300910380 RESULT SUMMARY
`300910380 LIMITS OF DETECTION
`
`•
`
`Task Information
`
`Task ID
`
`Method
`
`300910380 PET. USP
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DATE RECEIVED
`DATE ON TEST
`PRESERVATIVE
`
`: 10750:019
`: GUTIERREZC
`: PROC·0001131J (V·2.0)
`: 26-MAR-04
`: 06-APR-04
`: Unpreserved
`
`(Use 10 ml samples}
`
`Result Value
`FAIL
`FAIL
`Fail USP & JP (Ee)
`Not Established
`
`Units
`
`Rep
`1
`1
`1
`
`Procedure
`
`PET, USP
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`'--~~~~~~R_e_p_o_rt_A_p_p_r_o_ve_d~by_:~K_at_h_lee_n~A_lf_o_rd~o_n_0_9_~~U_N_-2_0_0_4_0_1_:4_0_p_m~~~~~~
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
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