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`I 0545 -"Ql/I ~:;, 3 1 </ 1
`:05lf5·.0~1-"-5 •
`r·os~J::··~··~·1·I:·0·,--1•·,··8I·-···,··-·········--··~-.-··-~-----·
`lQ5l(§': Q\L{ I::'] 1J01 L:L .. 1." .................... c ..... ..
`
`'
`
`I
`
`·
`
`•
`
`i
`
`A, '"'"'"°"' .,
`
`A"~M_,;.,,
`
`:
`
`.
`.
`"';0<Am•A··' ~-'~'~A,_'.A''·'~'~"~'=L~.,, .. ,
`.
`.
`.
`.
`.... '·············'·······<·-
`
`.
`.
`.
`.
`.
`.
`. ........... ., ......... ·········-····· .. ···· ..................... ; ................. ; ... .
`j
`L......
`.
`,
`.L,~,M .,~--~,,--~~~J~~~~,,~~-,~~--L., .. , ... L,~,
`
`i
`.
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`~
`~
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`:
`'"'" .. ''-"' "'"' ;vvNL"'""" ,. ~' ""'"""..:., ,,.,,, v;,l.,,,.,..,.,.,{vv~yy~""J ,.,,_,.,,., .. L,.,.
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`Date
`~ 5(11(@'('
`
`ALCON 2019
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
`
`'"""'''='
`
`"~""
`
`'"~''~"
`
`I 0545 -"Ql/I ~:;, 3 1 </ 1
`:05lf5·.0~1-"-5 •
`r·os~J::··~··~·1·I:·0·,--1•·,··8I·-···,··-·········--··~-.-··-~-----·
`lQ5l(§': Q\L{ I::'] 1J01 L:L .. 1." .................... c ..... ..
`
`'
`
`I
`
`·
`
`•
`
`i
`
`A, '"'"'"°"' .,
`
`A"~M_,;.,,
`
`:
`
`.
`.
`"';0<Am•A··' ~-'~'~A,_'.A''·'~'~"~'=L~.,, .. ,
`.
`.
`.
`.
`.... '·············'·······<·-
`
`.
`.
`.
`.
`.
`.
`. ........... ., ......... ·········-····· .. ···· ..................... ; ................. ; ... .
`j
`L......
`.
`,
`.L,~,M .,~--~,,--~~~J~~~~,,~~-,~~--L., .. , ... L,~,
`
`i
`.
`i
`~
`~
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`'"'" .. ''-"' "'"' ;vvNL"'""" ,. ~' ""'"""..:., ,,.,,, v;,l.,,,.,..,.,.,{vv~yy~""J ,.,,_,.,,., .. L,.,.
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`Date
`~ 5(11(@'('
`
`ALCON 2019
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
`
`Alcari
`R&DLIMS
`
`//)5i/5: ftJl/ I - Z..
`
`Report Date:
`
`Lot Report
`25-MAR-2004 09:50 AM
`Page 1of1
`
`•
`
`Lot Number: 04-36174-1
`Formulation ID: 106756 V. 1 AL6221 0.004% Oph Sol (Isotonic Sodium Chloride)
`
`Lot Purpose: Exploratory
`
`Mfg Lot Number:
`
`Lot Description: PET
`
`Reference Num: LN 11068:20 M
`
`Dosage Form: Solution
`
`Expiration Date:23-MAR-2005
`
`Retest Period: 1 year
`
`Target pH: 6.0
`
`Project: 106464
`
`Batch Made by: Wayne Schneider
`Storage Cond.: 2-25C
`
`FORMULATION
`Description
`AI06221, NOC
`Polyoxyl 40 Hydrogenated Castor Oil, NF,EUR,JPE
`Boric Acid, NF
`Sorbitol, NF
`Sodium Chloride, USP,PH.EUR,JP
`Zinc Chloride, USP
`Sodium Hydroxide, NF
`Hydrochloric Acid, NF
`Purified Water, USP
`
`Concentration
`0.004%
`0.5%
`1%
`1%
`0.26%
`0.0025%
`adjust pH
`adjust pH
`q.s. 100%
`
`Units
`WN"lo
`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
`Descr: RESEARCH BOM 30,NONSPECIFIC PACKAGING TBD BY THE FORMULATOR
`Package BOM #:549
`Lot Filled by: WAYNE SCHNEIDER
`Lot Fill Date:24-MAR-2004
`Fill Location:R&D Fort Worth
`Num Units Filled 1
`Fill Volume: 90ml
`
`•
`
`Approved by: __ _
`
`Date:
`
`r-bC---"'4-----=---3_
`
`... -u:-~
`AD. JUN~TIVE DATA TO. 1 .,~
`BOOK//_!Z_6lPAGE Y}_ .
`
`•
`
`Database: LIMSAR
`
`Batch-Lot#: 04-36174-1
`
`FB_Lot_Rep.02.LIMS041.0.012004.P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DLIMS
`
`1.
`
`/tJSl5:rJ'll, 3
`Lot Report
`25-MAR-2004 09:55 AM
`Page 1of1
`
`Report Date:
`
`Lot Number: 04-36176-1
`Formulation ID: 106757 V.
`
`AL6221 0.004% Oph Sol (Hypotonic; 1/2 Boric/Sorbitol)
`
`Lot Purpose: Exploratory
`
`Lot Description: PET
`
`Mfg Lot Number:
`
`Target pH: 6.0
`
`Project: 106464
`
`Reference Num: LN 11068:20 N
`
`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
`Sodium Hydroxide, NF
`Hydrochloric Acid, NF
`Purified Water, USP
`
`Concentration
`0.004%
`0.5%
`0.5%
`3.2%
`0.0025%
`adjust pH
`adjust pH
`q.s. 100%
`
`Units
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Tonicity Agent
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`Formulation Comments:
`
`Batch Comments:
`
`Lot Comments:
`
`PACKAGING
`Package BOM #:549
`Descr: RESEARCH BOM 30,NONSPECIFIC PACKAGING TBD BY THE FORMULATOR
`Lot Filled by: WAYNE SCHNEIDER
`Lot Fill Date:24-MAR-2004
`Fill Location:R&D Fort Worth
`Num Units Filled 1
`Fill Volume: 90ml
`
`Database: LIMSAR
`
`Batch-Lot#: 04-36176-1
`
`FB_Lot_Rep.02.LIMS041.0.012004.P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DLIMS
`
`/OSl/S-.-o 1/1-Y,
`Lot Report
`25-MAR-2004 09:58 AM
`Page 1of1
`
`Report Date:
`
`Lot Number: 04-36177-1
`Formulation ID: 106758 V.
`
`AL6221 0.004% Oph Sol (Ethanol/ No Zinc)
`
`Lot Purpose: Exploratory
`
`Lot Description: PET
`
`Mfg Lot Number:
`Reference Num: LN 11068:20 0.
`
`Dosage Form: Solution
`
`Batch Made by: Wayne Schneider
`
`Target pH: 6.0
`
`Project: 106464
`
`Expiration Date:23-MAR-2005
`
`Retest Period: 1 year
`
`Storage Cond.: 2-25C
`
`FORMULATION
`Description
`Al06221, NOC
`Polyoxyl 40 Hydrogenated Castor Oil, NF,EUR,JPE
`Boric Acid, NF
`Sorbitol, NF
`Dehydrated Alcohol (Ethyl Alcohol}, USP
`Sodium Hydroxide, NF
`Hydrochloric Acid, NF
`Purified Water, USP
`
`Concentration
`0.004%
`0.5%
`1%
`3.5%
`0.1%
`adjust pH
`adjust pH
`q.s. 100%
`
`Units
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Tonicity Agent
`Vehicle
`Ph Adjust
`Ph Adjust
`Vehicle
`
`•
`
`Formulation Comments:
`
`Batch Comments:
`
`Lot Comments:
`
`PACKAGING
`Descr: RESEARCH SOM 30,NONSPECIFIC PACKAGING TBD BY THE FORMULATOR
`Package BOM #:549
`Lot Filled by: WAYNE SCHNEIDER
`Lot Fill Date:24-MAR-2004
`Fill Location:R&D Fort Worth
`Num Units Filled 1
`Fill Volume: 90ml
`
`Approved by: __
`
`Date:}:_~~
`
`Database: LIMSAR
`
`Batch-Lot#: 04-36177-1
`
`FB_Lot_Rep.02.LIMS041.D.012004.P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- !i
`
`PRESERVATIVE RAW DATA
`
`Product:
`Sample Timepoint:
`On Test:
`4/6/2004
`
`Controls
`
`Initial
`
`Lot number:
`
`bate of Sample: __ 0_4/_0_6/_2_00_4 __
`
`Ornanism Counts at Dilutions
`
`{L
`S""
`<?3110 4-/q/o(
`5
`
`I
`
`<t.?. X/0
`
`Plate Count
`Avera!!e
`
`Initials
`-Date
`
`10-S
`{
`
`1
`9
`i
`0
`7
`5'1
`~ /DX /0
`/0
`10
`
`73 XI0
`
`5
`
`~
`
`h
`tJJx ro
`
`\ v
`
`Test Omanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`10-l
`
`10-2
`
`\
`
`\
`
`\
`
`I
`
`10-3
`
`I
`
`I
`
`I\
`I
`v
`/\
`v
`J
`\
`
`I
`
`I
`
`I
`
`\
`
`\
`
`\
`
`\
`
`10-4
`
`9<f
`~I
`70
`'l~
`~o
`'1)
`q5
`I 07
`TW/v
`
`771)1&
`
`•
`
`MEDIA:
`
`Saline Lot (tubes): {)__L//3 Q]j_ Polysaline Lot (tubes): {)___£/.60y 7
`Peptone Lot (tubes):
`N/A
`· - -
`Peptone Lot (bulk): ---~~':-_____ Saline Lot (bulk): D113JJ2/f__ Polysaline Lot (bulk): ()lf f3tJ ~ £/:
`MCTA Lot:O_<f/3.0 'i I __ Waterbath Asset No.: Aoat;~ Waterbath Temp(°C): _.t.j__t:,.5_
`Letheen Lot: Q t//O 0 Li$
`Other: ________________ _
`
`ORGANISMS:
`
`A. niger Pre~paration R~~=~;rj/sj'f: Transfer Log Reference: L(13/9 :o_</6-15'
`.:__ '?)!lttD.___ ___ m -
`y' hfa'f
`Verified By: ~ l
`---=5--1/'--'-1_0_,_/=o--1i_f-------
`
`Date:
`
`Date:
`
`Analyst:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- (o
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL 6221 0.004% (Isotonic NaCl)
`-··-------- --------------------------------------------------------------------·-·------------------···-----
`Sam pie Timepoint:
`Day 7 - - - - -
`On Test:
`4/6/2004
`Date of Sample: - - - - - - -
`04/13/2004
`Ornanism Counts at Dilutions
`
`Lot number: 04-36174-1
`
`Test Organism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`10·1
`
`10·2
`
`10·3
`
`10-4
`
`l/N/C
`-;r/10
`
`Tfl/ll-
`'TrJR
`
`d.J-1
`:J. 07
`~)]
`_30
`
`·n}IC....-
`
`--rrJTc
`
`3
`I~
`3
`~o
`8
`0
`d--
`0
`:J.1
`0
`,;s;,;l.,
`lf-
`'7YflC-
`IN\v
`Tflt/c Tll)IC- Tf'fK... I(
`·10
`1JtJ~ m'E-· ()1) TL-
`;;,
`I I
`r!JTC-
`l.3
`-rrJ /G.-
`0
`
`'
`
`0
`
`10·5
`0
`
`()
`
`0
`a
`0
`()
`4-
`'f
`v
`0
`
`•
`
`Plate Count
`Avera11:e
`
`Initials
`-Date
`'{ ~
`~.J- )( 10
`1/;ftJ/otf
`
`3
`~-q x 10
`
`4-
`3.0 >< ro
`
`\ v
`.- ~
`~
`'7.1x10
`lf fzof ot-
`
`1-J..x ro
`
`.3 t
`
`MEDIA:
`Peptone Lot (tubes): -----~JA _________ Saline Lot (tubes): ()_t.fi!'JJ_J_j __ Polysaline Lot (tubes): 0~~ o_:J_f?-_
`
`Peptone Lot (bulk): ----~!~------- Saline Lot (bulk): ~-
`MCTA Lot:. Ol/.6 0 <I/ Waterbath Asset No.: A-0 {JC/ (o
`Letheen Lot: 0</-t3011
`
`Polysaline Lot (bulk):
`
`Waterbath Temp(°C):
`
`N/A
`.¢5_ 8'
`
`Other: ________________ _
`
`ORGANISMS:
`
`Transfer Log Reference: N/A
`- - -
`- - ·
`
`,.
`
`I
`
`M40.02
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`· Notebook 10545
`
`Page 041- 7
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL 6221 0.004% (Hypotonic)
`----·-·---·-·--·------·-··----------------·--·-·-·---------·--·----·--·-·------·-·------·-·----·----------
`Sam pie Timepoint:
`Day 7
`On Test:
`4/6/2004
`
`
`
`Date of Sample: __ 0_4_/1--3 __ /2--0--=-0--=-4_
`
`Lot number: 04-36176-1
`
`On•anism Counts at Dilutions
`
`10-2
`
`-r?Jlu
`
`-H{TC. WIC
`
`Test Orn:anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. a/bicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`10-l
`
`TtVTL--
`{1\.)(0
`<j
`q
`-n\JTc...-
`
`11\1\(/
`
`(11)Te---
`1-rrtrc
`T(V·rc,,
`
`10-3
`10-4
`(
`(o(o
`INTc:..
`4-
`/NIV &;d-..
`I
`(
`rJ
`3
`0
`f)
`5
`)Sb
`11\)Tc:.-
`to
`I o·z_
`171)TL 15
`~;;L
`(l\J/v /fl/JC-
`~~ -5
`0
`d--
`0
`~o
`~ (054--S".D'f-{-<.o
`aline Lot (tubes):
`
`10-5
`
`0
`
`0
`
`I }
`
`{) -
`~
`o')X:tMOt
`0
`4
`·7
`I
`0
`
`Plate Count
`Avera1>e
`
`i
`(o.'-f 'f.. 10
`
`Initials
`-Date
`IA-
`4/1~/o.J
`
`I
`t{,5 ')( (0
`
`·~
`qy 'f.. 10
`\\/
`'7. 1x 1! fA__
`1(~/o~
`3 ~
`
`J., I K 10
`
`Polysaline Lot (tubes):
`
`- - - -
`
`N/A
`
`Peptone Lot (tubes):
`
`11
`
`"
`
`" - -
`
`Peptone Lot (bulk):
`
`N/A
`
`MCTA Lot: ______ Waterbath Asset No.: ____ _
`
`Letheen Lot: ______ _ Other: _________________ _
`
`Transfer Log Reference: N/A
`
`t(/;lt)jo r
`Date: 6/ ID {Q(-
`
`Date:
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`~:~~:::By:~-~~-=---
`•
`
`M40.02
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- <:;?
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL 6221 0.004% (Ethanol/No Zinc)
`- - - - - -
`---------·---------------------
`Sample Timepoint:
`Day 7
`On Test:
`4/6/2004
`
`Lot number: 04-36177-1
`
`Date of Sample: _ ____.c.0--=-4/'-"1--=-:3/=2'-=-00-=--4_::_
`
`Test Organism
`
`S aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. a/bicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`Orn:anism Counts at Dilutions
`
`10·1
`
`10·2
`
`10·3
`
`10·4
`d-.1
`11'\/IZ-
`Tl"'Tc... (7'iTc...
`-rf\1\C- 3"
`--rrJ--rc,.,.
`IN'lc...-
`--fNTc.. ~1
`~
`1(1/y-c.,
`TM&
`-rrl\<--- ~4
`I
`!Nie- TNTC-
`Tf'JTC -~q
`-,.rvro
`45'
`Jh}TV INTv
`7lf 7L
`'{O
`/ff TL
`1Jl/JC
`-;J1!7C-- S3
`(lVlU 7flrz/
`3q
`I
`(::>
`(
`33 ~
`I
`
`0
`
`Plate Count
`Average
`5
`J.'I x 10
`
`Initials
`-Date
`tfi._
`411 ~/0'-)
`
`10·5
`
`_))
`_,....-
`
`b
`0
`
`+
`~ ,q ,>c.10
`
`5
`4.'J..;1..rO
`
`0
`I
`'V
`(o
`I
`5 ~
`5 41tf0
`'11~/0</
`?-" J
`0
`D
`
`l3.({)j((0
`
`Peptone Lot (bulk):
`
`N/A
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.: ___ _
`
`Letheen Lot: ______ _ Other: _________________ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Transfer Log Reference: N/A
`
`sr::~-O-+---,-</=----~-=
`
`~::::=By: /!f!f-~~~.-. '-(_g__--.. --- - - ~:::
`
`
`•
`
`M40.02
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- q
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL 6221 0.004% (Isotonic NaCl)
`···-·-·-·---·-·-----·-·---·--·----·-·---------··--·-----------------·--·-·------
`Sample Timepoint:
`Day 14
`4/6/2004
`On Test:
`
`Lot number: 04-36174-1
`
`Date of Sample: __ 0_4/_2_:_0/=-2-'-0--=---04-"-----
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`10-'
`\ v.;1
`l (o5
`~?:>
`;)~
`IAJfG-
`
`Or1tanism Counts at Dilutions
`
`10-2
`
`10-3
`
`10-4
`
`10-5
`
`\C\
`\q
`(Q
`0
`L\'L\
`({'~
`)101"(,.
`{) <l
`IN~ llJ\C 11JR-
`Tf\J1C j~JlL )f\Jl(_,,. 00
`~3 5
`\q
`(0
`
`i
`I
`0
`()
`
`[
`
`\
`
`Plate Count
`Average
`
`Initials
`-Date
`
`I ,7 J<IO ~ Sm
`'-{-J3~0y
`ffY1
`c9.?>x.JD;r
`'-{--d-3-0~
`5(o )<J03 un
`U--;J3-0Li
`3;1J<J~ 8r
`lf-Jl--ot1
`d, (o 'f.lt:l tfY1
`l.1-J7-0l/
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`Peptone Lot (tubes): --~-/A __ Saline Lot (tubes):{)./_ 8 foV;& \ Polysaline Lot (tubes):()</ 8£R.O
`
`N/A
`Peptone Lot (bulk): ------~~~-- Saline Lot (bulk): ~/A ____ Polysaline Lot (bulk):
`Waterbath Asset No_: A OO°J(o
`Waterbath Temp(°C): 4b.O
`MCTA Lot:O<f.807 5"
`Letheen Lot: o~--3Wd-0- I
`
`Other: - - - - - - - - - - - - - - - - -
`
`ORGANISMS:
`A: niger Preparation Reference: NIA
`- - - - - - - -
`
`Transfer Log Reference: N/A
`- - - - - - - - - -
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- I 0
`
`PRESERVATIVE RAW DATA
`Product: A~-~22_!_~---~~-~!o C'"!~~tonicL ________________ _ Lot number: 04-36176-1
`
`•
`
`Sample Timepoint:
`On Test:
`4/6/2004
`
`Day 14
`
`Date of Sample:
`
`04/20/2004
`- - - - - - - -
`
`Onrnnism Counts at Dilutions
`
`10-l
`
`10·2
`
`\f'JTG YY
`-,u-rc !.-\lo
`0
`0
`I
`lb
`1--\10\(, Co1
`(o
`INTG
`(o \
`IAJTG lrNTL 1NR 89
`'J/0Tl- f).3
`1101L, ]f\)T(__,
`c-OS
`\
`I
`\~
`
`10-4
`
`~
`
`10·3
`(o
`3
`
`\
`
`10·5
`
`Plate Count
`Avera!!e
`
`LI ,'JXID'
`
`L\O
`
`~,4~10:?
`
`~.~~Db
`
`1/1 tCIOJ-
`
`Initials
`-Date
`(jY)
`Y-o."-ott
`5(1
`L/-d-1-oY
`Cf<)
`4-;}~
`cfY1
`Ui--a-7-6<-1
`f;fYl
`Lj-J-7-0L{
`
`Test Organism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`Peptone Lot (tubes):
`
`Peptone Lot (bulk):
`
`NIA
`
`1 oS ct S '. 0 lf I ~ q
`C . ,,
`alin~bes):
`
`Polysaline Lot (tubes):
`
`Polysaline Lot (bulk):
`
`NIA
`
`MCTA Lot:
`
`___ Waterbath Asset No.: ____ _
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Transfer Log Reference:· N/A
`
`Analyst: _ __:~~:::;::~,--J'-7'1:7~~-------- Date:
`Verified By:
`Date:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- I l
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL 6221 0.004% (Ethanol/No Zinc)
`
`Lot number: 04-36177-1
`
`Sample Timepoint:
`On Test:
`4/6/2004
`
`Day 14
`
`Date of Sample:
`
`04/20/2004
`- - - - - - - -
`
`Onrnnism Counts at Dilutions
`
`10·!
`
`10·2
`
`10·3
`
`w4
`
`10·5
`
`--mT(_, tg~ ~
`lo0
`\C)
`}tJ1"L,
`0
`d
`I~
`7)
`IS
`fr
`\<-10\
`-r~ST~ )101"(,
`)N\t--- -r~ \~q
`j~TL,, Jf\rr(__ ~}L/
`/)8
`11'.STL- --rf\Jc B:;Jo c97
`;:)
`::Ho
`l
`l~
`
`Plate Count
`Avera1?e
`
`Initials
`-Date
`
`7.lrtll? ZfYJ
`Lt--a3-otf
`I \lX /D d- 8Yl
`Lt-a.3-CH
`\1Yt<ID~ ijY)
`:J.'Jr-lcf an
`l-f--J7-0Y
`J.d-)<lO'O- if()
`u]-Jt-0'1
`
`~ ...-J. ?>--Ot-1
`
`Test Or!!anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`• A. niger
`
`ATCC 16404
`
`MEDIA:
`
`Peptone Lot (bulk):
`
`N/A
`
`Saline Lot (bulk):
`
`MCTA Lot: _____ Waterbath Asset No.: ____ _
`
`Letheen Lot: ______ _ Other: _________________ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Transfer Log Reference: N/A
`
`M40.02
`
`Date:
`
`Analyst: __ 1 ___ ~<--+--7'~--
`.,__· -~_,__,..~'~~----- Date:
`Verified By: 7, .. bfii-~-tiijd-vf.
`Rev.10 •
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- / ?J
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: AL 6221 0.004% (Isotonic NaCl)
`------------·-·---·-···--------------·-------------------------------·-----------------------
`Sample Timepoint:
`Day 28
`On Test:
`4/6/2004
`
`Lot number: 04-36174-1
`
`Date of Sample: __ 0_5/_;_0_4/_2__;_00_:_4~_
`
`Plate Count
`Average
`
`Initials
`-Date
`
`..c_ I 0
`
`..c:-..J 0
`
`&.--
`5/1for
`lJ-
`r{/7/<f
`~10 ~t:To</
`5
`/,q x 10
`
`'
`
`{ti_
`_, ( {( (cJ.f
`~
`I ~
`q.o y..rtJ
`£//1f (J_I
`
`.
`
`Test Organism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`OrP"anism Counts at Dilutions
`
`10-2
`
`10-3
`
`10-'
`\
`\
`f)
`l
`J
`0
`\
`0
`~
`"'
`0
`)
`0
`I
`\
`0
`0
`7f\)f. Tllf /{,,
`/~c/
`(10\c WIG- 141
`)
`?
`')
`)
`~
`/0
`
`10-4
`
`10-5
`
`"-
`'\
`)
`)
`I
`I
`(
`~
`')
`')
`1 7
`;5
`\
`I
`rJO
`\
`')
`7
`(
`
`'
`
`MEDIA:
`
`Peptone Lot (tubes):
`
`N/A
`
`Saline Lot (tubes):{Jt/-30/~j_ Poiysaline Lot (tubes): _j/jg
`
`Peptone Lot (bulk):
`·Saline Lot (bulk):
`N/A
`N/A
`MCTA Lot: l/U1-l-J/j_!j_ __ Waterbath Asset No.: A QQq(Q
`Letheenlot: [)_<.(~365tj()-/
`
`Polysaline Lot (bulk):
`N/A
`- -
`Waterbath Temp(°C): % . ~
`Other: ________________ _
`
`- - - -
`
`ORGANISMS:
`
`· - - - - - - -
`
`Transfer Log Reference: N/A
`· - - -
`
`Analyst: -~~::.!C:~~~~~_::_,~----- Date:
`Verified By:
`Date:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- /3
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: ~~-~-~~-~~:~~~~-{!!~~~-~~~-~~)_~-----·-·------·· Lot number: 04-36176-1
`
`Sample Timepoint:
`On Test:
`4/6/2004
`
`D_ay_2_8 __ _
`Date of Sample:
`
`05/04/2004
`
`Plate Count
`Avera e
`
`Initials
`-Date
`
`Or anism Counts at Dilutions
`
`Test Or anism
`
`10-I
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`;A
`
`0
`0
`0
`()
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`~ iosv.-~·.o<+r-- (2/
`Peptone Lot (tu l>e!:t.---IN+.Q.._-...;._§Saline Lot (tubes):
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`N/A
`
`Polysaline Lot (bulk):
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.:
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Transfer Log Reference: N/A
`
`::::.::By:~~--- ~::: 1-~~~------u
`•
`
`M40.02
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 041- / ~
`
`PRESERVATIVE RAW DATA
`
`---------
`
`Lot number: 04-36177-1
`
`• Product: AL 6221 0.004% (Ethanol/No Zinc)
`
`----------·--·-----------------------------------
`Sample Timepoint:
`Day 28
`On Test:
`4/6/2004
`
`Date of Sample: - - - - - - - -
`05/04/2004
`Organism Counts at Dilutions
`
`10·1
`
`10·2
`
`10·3
`
`10-4
`
`10·5
`
`Plate Count
`Average
`
`Initials
`-Date
`
`Test Orn:anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`0
`f)
`
`()
`()
`11vTc..
`IWTG
`fY>'lc..
`T]l)T&
`3
`£
`
`\
`)"'"'
`\
`
`J
`
`0
`"" ~ -<- /O
`)
`0
`I
`I
`7
`(
`(
`\
`\
`)
`7
`</0
`(
`if-
`(
`!25
`tr//C- 15
`~
`Io
`I
`1.3
`8/
`T)'1/Tf-
`\
`)
`)
`)
`I
`\
`I
`~
`I
`. ~ (05tf-5:0tff- 12--
`
`)
`
`~
`5h!O<(
`~
`</7(~
`0~(41j
`(A_
`s/11/oy
`ti--
`<!JI!~
`
`'
`
`-<-tO
`
`Sly1c/
`
`t:t y tO<f
`
`1
`
`f.o X/0
`
`sanne Lot (tubes):
`
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`N/A
`
`Polysaline Lot (bulk):
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.: ----~--=..:::
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`A. niger Pre~//\__ -----·
`· ~e
`~-;.,~
`
`Analyst:
`
`·
`
`Verified By:
`
`Transfer Log Reference: N/A
`
`Date:
`
`Date:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`Notebook 10545
`
`_,,
`Page 041- f ~
`
`Preservative:
`
`NONE
`
`Date Assayed:
`
`4/6/2004
`
`• Product: AL 6221 0.004% (Isotonic NaCl)
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`04-36174-1
`Initial
`- - - - - - - - - - -
`Bulk
`- - - - - - - - - - - -
`Procedure No.:
`LIMS No.:
`PRO C -0001136. V-2.0
`- - - - - - - - - ' - - - - -
`SUMMARY OF RESULTS
`
`Batch No.:
`FID No.:
`
`Project No.:
`
`106756
`225202
`
`200191981
`
`Organism Counts (CFU/mL or CFU/g)
`
`Test Organisms
`
`Initial
`
`7Day
`
`14Day
`
`28Day
`
`•
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`5
`f.3 x!O
`
`5
`<j.;) x 10
`
`5
`1, ~ x 10
`
`b
`/.OxtO
`
`p
`/. 0 XIV
`
`'f
`~.;. x 10
`
`! ,lxJD~
`
`£
`
`)0
`
`3
`:;,.q x /tJ
`
`:;;. '~ K.J 0 g._
`
`L(O
`
`<-(0
`
`. .,.,.
`?
`/.C/x ro
`
`3. 0 x.101 5. lu~lt)~
`3.°1)(106
`5
`7. Ix 10
`.3 d .Ui ~)()d- q.o ~ 10
`/.AX /0
`
`I
`
`Not Done (ND)
`
`Limits of Detection Established 0 ________ .
`Limits of Detection Not Established ~
`
`D Pass USP Requirements u:a'Fail USP -~----=-IJ~£c.~---
`D Pass 'Jp Requirements ~ail JP
`~SA~-+-i ~[~C~----
`
`I
`
`'
`
`•
`
`Analyst: --/---J-l~~"'------1~"--I!---''----=------ Date: ~5~6,_t_,_/~/O~__,c/ __ _
`Date: ~J7.._,_-/,~1~-=;<--··_tJ_,_(/_1
`__ _
`,~,
`
`Verified By:
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`•
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`USP PRESERVATIVE EVALUATION SUMMARY
`Product: AL 6221 0.004% (Hypotonic)
`
`Notebook 10545
`
`NONE
`- - - - - - - - - - · - - - - - - - - - - - - - - - - - - - -
`04-36176-1
`- - - - - - - - - - -
`1 nit i a I
`- - - - - - - - - - -
`Bulk
`- - - - - - - - - - - - -
`PROC-0001136, V-2.0
`LIMS No.:
`Procedure No.:
`SUMMARY OF RESULTS
`Organism Counts (CFU/mL or CFU/g)
`
`Date Assayed:
`
`Batch No.:
`
`FID No.:
`
`Project No.:
`
`4/6/2004
`
`106757
`
`225202
`
`200191982
`
`•
`
`Test Organisms
`
`Initial
`
`7 Day
`
`14 Day
`
`28Day
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`5
`
`f.3 x.10
`s
`.
`<(. /)..f ID
`
`5
`7, g x 10
`
`~
`/.Ox.tD
`
`b
`/ 0 A ff)
`
`/p.f ;x 101 LLS>(/0~ 1·5 x <0
`
`I
`
`I LIO
`'J.5 )<JO
`
`q. 'f x: /Orf ~ .ctx/o3
`5 d.Cexl0°
`1. 9x10
`3 ) /1 )(/(Jd-
`cl-Ix JO
`
`L-(Q
`
`..<:({)
`
`f
`J.~y._/D
`
`I
`L/5x 10
`
`Not Done (ND)
`Limits of Detection Established 0 _____________ _
`Limits of Detection Not Established ~
`
`D Pass USP Requirements ~ail USP SA , '/2' G
`D Pass JP Requirements ~ Fail JP SQ; E(...
`
`Analyst: -~-J..A~~-----M-~~c,.----- Date: _,,,~"""-r/ll,__l_._WJ;--'-1£-=--().-1-.>iu __ _
`Date: ___ rj_~ _ _,_1~~-o~J __ _
`
`Verified By:
`
`•
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`Notebook 10545
`
`Page 041. l 7
`
`•
`
`Product: AL 6221 0.004% (Ethanol/No Zinc)
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`NONE
`··-·--------·----·----·-·--------·
`04-36177-1
`Initial
`
`Bulk
`
`Date Assayed:
`
`41612004
`
`Batch No.:
`
`FID No.:
`
`Project No.:
`
`106758
`
`225202
`- - -
`200191983
`
`Procedure No.:
`
`PROC-0001136, V-2.0
`
`LIMS No.:
`
`SUMMARY OF RESULTS
`On?;anism Counts (CFU/mL or CFU/g)
`
`Test Organisms
`
`Initial
`
`?Day
`
`14 Day
`
`28 Day
`
`•
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`Not Done (ND)
`
`b
`g.g f/()
`
`5
`J.qt!O 7i~YJ0 3
`
`.<..{ 0
`
`,.,..
`
`!J Ji.1 x rr! Llx10 g_
`~. ~ x. ttJ
`5
`1.~ x;fJ
`
`!J .... LL\ x:10S
`1.~x10
`
`~
`/.() X/0
`
`).;)>QO'?
`
`.L(D
`
`-
`3
`,!) . f K fQ
`
`'f
`f_f x10
`
`/.Ox!!J 3. (p 1£ 1()
`
`z,
`
`9. ~110).--
`
`(
`
`t-/.O J fD
`
`1-/7 x1f
`"
`
`Limits of Detection Established 0 _____________ _
`Limits of Detection Not Established CB"'
`
`D Pass USP Requirements l:ia'Fail USP ~ e(._,
`D Pass JP Requirements CErFail JP
`S1.1 J' Ev
`
`I.
`Analyst:~
`
`Verified By:
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`AIPetResults.04.122002 ~
`~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~_J~
`~
`~
`c.r:,
`~ ;{:..I
`..........
`
`Database: LIMSAR
`
`Report Approved by: Ronald Berry on 28-MAY-2004 04:21 pm
`
`Limits of Detection: NOT ESTABLISHED
`
`FAILS USP (Sa, Ee) and FAILS JP (Sa, Ee)
`
`9.0E1
`1.9E5
`<10
`<10
`<10
`
`2.6E2
`3.9E5
`5.6E3
`2.3E2
`1.7E3
`
`1.2E3
`7.1E5
`3.0E4
`2.9E3
`2.2E4
`
`1.0E6
`1.0E6
`7.8E5
`8.2E5
`8.3E5
`
`28 DAY
`
`14 DAY
`
`7 DAY
`
`INIT
`
`Comments:
`Result Summary:
`
`USP: FAIL
`JP: FAIL
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`300910384 ,300910386
`
`10545:041
`
`Ref#:
`Project No.: 225202
`Preservative: NONE
`Task IDs
`
`samples)
`
`Package: 250 ml Filter Unit I 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 04-36174-1 (Use 10 ml samples)
`Sample ID:
`
`200191981
`
`PET, USP
`
`106756
`
`Page 1 of 1
`
`• USP Preservative Evaluation ~mmary
`
`(MTP PROC-0001136, V-2.0)
`
`Report Date: 01-JUN-2004 01 :49 PM
`
`• Alcari
`
`R&DLIMS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`~
`I .......
`~ ........
`~I
`~
`~
`<::s
`
`AIPetResults.04.122002
`
`Database: LIMSAR
`
`Report Approved by: Ronald Berry on 28-MAY-2004 04:23pm
`
`Limits of Detection: NOT ESTABLISHED
`
`FAILS USP (Sa, Ee), AND FAILS JP (Sa, Ee)
`
`4.5E1
`3.2E4
`<10
`<10
`1.5E1
`
`1.9E2
`2.6E5
`6.4E3
`<10
`4.5E3
`
`2.1E3
`7.9E5
`9.4E4
`8.5E1
`6.4E4
`
`1.0E6
`1.0E6
`7.8E5
`8.2E5
`8.3E5
`
`28DAY
`
`14 DAY
`
`7DAY
`
`INIT
`
`Comments:
`Result Summary:
`
`USP: FAIL
`JP: FAIL
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`300910388 ,300910390
`
`10545:041
`
`Ref#:
`Project No.: 225202
`Preservative: NONE
`Task IDs
`
`samples)
`
`Package: 250 ml Filter Unit I 90 ml (Use 10 ml
`Stability Data Initial
`Product: AL6221 0.004% OPH SOL (HYPOTONIC;
`Submission ID: 100074264
`
`Method:
`Date Assayed:06-APR-2004
`Series No.:
`User Sample ID: Lot 04-36176-1 (Use 10 ml samples)
`Sample ID:
`
`200191982
`
`PET, USP
`
`106757
`
`Page 1 of 1
`
`Report Date: 01-JUN-2004 01 :49 PM
`
`(MTP PROC-0001136, V-2.0)
`
`USP Preservative Evaluation ~mmary
`
`•
`
`• Alcari
`
`R&DLIMS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Database: LIMSAR
`l_~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~A~l;,Pe:tR;.e:s:iul~ts~.0~4.~122:;;00;;2 ~
`~
`~ <-·\ ..
`
`~
`
`Report Approved by: Ronald Berry on 28-MAY-2004 04:26pm
`
`Limits of Detection: NOT ESTABLISHED
`
`FAILS USP (Sa, Ee), AND JP (Sa, Ee)
`
`4.0E1
`8.8E4
`5.1E3
`<10
`<10
`
`2.2E2
`2.2E5
`1.4E5
`1.7E2
`7.6E3
`
`3.6E2
`4.7E5
`4.2E5
`2.9E4
`2.9E5
`
`1.0E6
`1.0E6
`7.8E5
`8.2E5
`8.3E5
`
`28 CAY
`
`14DAY
`
`7CAY
`
`INIT
`
`Comments:
`Result Summary:
`
`USP: FAIL
`JP: FAIL
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`300910396 ,300910398
`
`10545:041
`
`Ref#:
`Project No.: 225202
`Preservative: NONE
`Task IDs
`
`samples)
`
`Package: 250 ml Filter Unit/ 90 ml (Use 10 ml
`Stability Data Initial
`Product: AL6221 0.004% OPH SOL (ETHANOL I
`Submission ID: 100074264
`
`Method:
`Cate Assayed: 06-APR-2004
`Series No.:
`User Sample ID: Lot 04-36177-1 (Use 10 ml samples)
`Sample ID:
`
`200191983
`
`PET, USP
`
`106758
`
`Page 1 of 1
`
`Report Date: 01-JUN-2004 01 :49 PM
`
`(MTP PROC-0001136, V-2.0)
`USP Preservative Evaluation .mmary
`
`•
`
`• Alcari
`
`R&DL/MS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DLIMS
`
`(tJS-'I); 0 '{f-;J-/
`Sample Results Report
`Report Date: 01-JUN-2004 01:52 PM
`
`Page 1 of 1
`
`LIMS Submission ID : 100074264
`: L. Wayne Schneider
`Requester
`Customer Datagrou
`: RESEARCH SUPPORT FORML
`Logged By
`: SCHNEIDER
`
`225202
`Project Number
`: R1-36
`Mail Code
`Telephone Extension: 8037
`
`Sample Information
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`:200191981
`: Lot 04-36174-1 (Use 10 ml samples)
`: 106756 AL6221 0.004% OPH SOL {ISOTONIC S
`:SOLUTION
`:A NEW MATERIAL TYPE
`: MICROBIOLOGY
`:PET LAB
`: 03/25/2004
`
`: Initial
`AGE
`: 04-30-04
`DATE NEEDED
`: 106756
`FORMULATION ID
`: MICROBIOLOGY
`LABORATORY
`: 1
`NUMBER OF UNITS
`: 250 ml Filter Unit/ 90 ml (Use 10 ml samples)
`PKG/FILL VOL
`: MICROBIOLOGY STUDY
`PURPOSE
`STORAGE CONDITIOI\ : RT,AMBIENT
`
`Result Information
`Task ID
`Component
`300910384 USP
`300910384
`JP
`300910384 RESULT SUMMARY
`
`300910384 LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`300910384 PET, USP
`
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DATE RECEIVED
`DATE ON TEST
`PRESERVA T/VE
`
`: 10545:041
`: ALFORD
`: PROC-0001136, V-2.0
`: 26-MAR-04
`: 06-APR-04
`: NONE
`
`Result Value
`FAIL
`FAIL
`FAILS USP (Sa, Ee) and FAILS JP
`(Sa, Ee)
`NOT ESTABLISHED
`
`Units
`
`Rep
`1
`1
`
`Procedure
`
`PET, USP
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Ronald Berry on 28-MAY-2004 04:21pm
`
`Database: LIMSAR
`
`AISampleResults.07.LIMS110.1.012004.P0002241
`
`•
`
`•
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DLIMS
`
`/(}571~ :or1t-d?(cid:173)
`Sample Results Report
`Report Date: 01-JUN-2004 01:53 PM
`
`Page 1 of 1
`
`LIMS Submission ID : 100074264
`: L. Wayne Schneider
`Requester
`Customer Datagrou
`: RESEARCH SUPPORT FORML
`Logged By
`: SCHNEIDER
`
`Project Number
`225202
`: R1-36
`Mail Code
`Telephone Extension: 8037
`
`Sample Information
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`:200191982
`: Lot 04-36176-1 (Use 10 ml samples)
`: 106757 AL6221 0.004% OPH SOL (HYPOTONIC;
`:SOLUTION
`:A NEW MATERIAL TYPE
`: MICROBIOLOGY
`:PET LAB
`: 03/25/2004
`
`: Initial
`AGE
`: 04-30-04
`DATE NEEDED
`: 106757
`FORMULATION ID
`: MICROBIOLOGY
`LABORATORY
`: 1
`NUMBER OF UNITS
`: 250 ml Filter Unit I 90 ml (Use 10 ml samples)
`PKG/FILL VOL
`: MICROBIOLOGY STUDY
`PURPOSE
`STORAGE CONDITIOI\ : RT,AMBIENT
`
`Result Information
`Component
`Task ID
`300910388 USP
`300910388
`JP
`300910388 RESULT SUMMARY
`
`300910388 LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`300910388 PET, USP
`
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DATE RECEIVED
`DATE ON TEST
`PRESERVATIVE
`
`: 10545:041
`: ALFORD
`: PROC-0001136, V-2.0
`: 26-MAR-04
`: 06-APR-04
`: NONE
`
`Units
`
`Result Value
`FAIL
`FAIL
`FAILS USP (Sa, Ee), AND FAILS JP
`(Sa, Ee)
`NOT ESTABLISHED
`
`Rep
`1
`1
`1
`
`Procedure
`
`PET, USP
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Ronald Berry on 28-MAY-2004 04:23pm
`
`Database: LIMSAR
`
`AISampleResults.07.LIMS110.1.012004.P0002241
`
`•
`
`•
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&DLIMS
`
`!OS-<1s··~<1l-:J-3
`Sample Results Report
`Report Date: 01-JUN-2004 01 :53 PM
`
`Page 1 of 1
`
`LIMS Submission ID : 100074264
`Requester
`: L. Wayne Schneider
`Customer Datagrou
`: RESEARCH SUPPORT FORML
`Logged By
`: SCHNEIDER
`
`Project Number
`225202
`: R1-36
`Mail Code
`Telephone Extension: 8037
`
`Sample Information
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`:200191983
`: Lot 04-36177-1 (Use 10 ml samples)
`: 106758 AL6221 0.004% OPH SOL (ETHANOL I
`: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 CONDITIOfl
`
`: Initial
`: 04-30-04
`: 106758
`: MICROBIOLOGY
`: 1
`: 250 ml Filter Unit I 90 ml {Use 1 O ml samples)
`: MICROBIOLOGY STUDY
`: RT.AMBIENT
`
`Result Information
`Task ID
`Component
`300910396 USP
`300910396
`JP
`300910396 RESULT SUMMARY
`
`300910396 LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`300910396 PET, USP
`
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DA TE RECEIVED
`DATE ON TEST
`PRESERVATIVE
`
`: 10545:041
`: ALFORD
`; PROC-0001136, V-2.0
`: 26-MAR-04
`: 06-APR-04
`; NONE
`
`Result Value
`FAIL
`FAIL
`FAILS USP (Sa, Ee), AND JP (Sa,
`Ee)
`NOT ESTABLISHED
`
`Units
`
`Rep
`1
`1
`1
`
`Procedure
`
`PET, USP
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Ronald Berry on 28-MAY-2004 04:26pm
`
`Database: LIMSAR
`
`AISampleResults.07.LIMS110.1.012004.POD02241
`
`•
`
`•
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
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