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`NO: 81-1
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`NO: 10750
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`Date
`Entered By :
`~!ems-~
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`ALCON 2011
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
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`t9 • • • •
`
`

`

`Alcari
`R&DLIMS
`
`Formulation Report
`Page 1of1
`04-MAY-200510:39 AM
`
`Report Date:
`
`Vers. 1
`Formulation ID: 109032
`Description: TRA VAT AN BAC Free, 0.004% - pH 5.5
`Units: WN %
`Target pH: 5.5
`
`Dosage Form: SOLUTION
`
`Component
`Al06221
`Polyoxyl 40 Hydrogenated Castor Oil
`Boric Acid
`Sorbitol
`Propylene Glycol
`Zinc Chloride
`Sodium Hydroxide
`Hydrochloric Acid
`Purified Water
`
`Concentration
`0.004%
`0.5%
`1%
`0.25%
`0.75%
`0.0025%
`adjust pH
`adjust pH
`q.s. 100%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Excipient
`Excipient
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`• Database: LIMSAR
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`FB_FormRep_Short.03.LIMS037.1.022005.P0002250
`
`

`

`Alcari
`R&DLIMS
`
`101'50: 0&\- 3
`
`Formulation Report
`Page 1of1
`04-MAY-200510:39 AM
`
`Report Date:
`
`Vers. 1
`Formulation ID: 109033
`Description: TRA VAT AN BAC Free, 0.004% - pH 6.5
`Target pH: 6.5
`Units: WN %
`
`Dosage Form: SOLUTION
`
`Component
`Al06221
`Polyoxyl 40 Hydrogenated Castor Oil
`Boric Acid
`Sorbitol
`Propylene Glycol
`Zinc Chloride
`Sodium Hydroxide
`Hydrochloric Acid
`Purified Water
`
`Concentration
`0.004%
`0.5%
`1%
`0.25%
`0.75%
`0.0025%
`adjust pH
`adjust pH
`q.s. 100%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Excipient
`Excipient
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`Database: LIMSAR
`
`FB_FormRep_Short.03.LIMS037 .1.022005.P0002250
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Alcari
`R&DLIMS
`
`Io 1 '50: o ~ l -
`
`lf
`
`Formulation Report
`Page 1of1
`04-MAY-200510:40 AM
`
`Report Date:
`
`Vers. 1
`Formulation ID: 109034
`Description: TRA VAT AN BAC Free, 0.004% -pH 5.5 w/ 85% of zinc, boric acid
`Target pH: 5.5
`Dosage Form: SOLUTION
`Units: WN %
`
`Component
`Al06221
`Polyoxyl 40 Hydrogenated Castor Oil
`Boric Acid
`Sorbitol
`Propylene Glycol
`Zinc Chloride
`Sodium Hydroxide
`Hydrochloric Acid
`Purified Water
`
`Concentration
`0.004%
`0.5%
`0.85%
`0.25%
`0.75%
`0.002125%
`adjust pH
`adjust pH
`q.s. 100%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Excipient
`Excipient
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`Database: LIMSAR
`
`FB _FormRep_Short.03.LIMS037 .1.022005.P0002250
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081-5
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product:
`
`Controls
`
`Lot number:
`
`Sample Timepoint: ---------~~~~-~!I _________ _
`05/05/2005
`5/5/2005
`On Test:
`Date of Sample: - - - - - - - -
`Or anism Counts at Dilutions
`
`10·5
`
`Plate Count
`Avera e
`
`°I
`
`I
`
`I
`
`~
`
`14?
`
`Initials
`-Date
`0 .-JJ.
`~ -9-o5
`t _Jj_
`s-'l-os
`
`5
`,q ~ \0
`
`5
`1.2x \C>
`
`s c. . J;t .
`c::s-ct-os
`e. '.J;I.
`'5- q -C>5
`
`i .I x \ 0
`
`s
`.ix \C
`
`Test Or anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`t. J;J •
`/.o s-q-os
`\.'3x\O
`
`~
`
`Peptone Lot (tubes):
`
`N/A ____ Saline Lot (tubes): oc:>-t\C~C>i- \ Polysaline Lot (tubes): c?-1..\~'-l 2~- \
`
`N/A
`Peptone Lot (bulk):
`Saline Lot (bulk): oS-L\.o<:>lu- \ Polysaline Lot (bulk): cl\. 3~q 11- 2
`- - - -
`MCTA Lot: ~ \O \?.I o Waterbath Asset No.:""° ul&oo~3) Waterbath Temp(°C):
`L\~ ,\
`Other: _·,j_l~A~-----------------
`o"S__-___1-j C>'3 l \ - l
`
`Letheen Lot:
`
`ORGANISMS:
`
`A. niger Preparation Reference: \\ul 3: Dc"J -\C\ (5/il0.;J Transfer Log Reference: \\lol3: OOl.P-\ill'5lc0
`I\.: ..... ·~
`~:~~::= B~~------ ---;--- --·--·-·-------------- :::::
`-=-~-----~------------
`---·--
`-------------------·
`
`____ 2~J~_Q5 _______________________ _
`
`___ CS_'.:_~_.::_~_'§ ___________________________ _
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081-
`
`(o
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: Travatan BAC Free, 0.004%
`Sample Timepoint: --------------~~-~? ____________ _
`On Test:
`5/5/2005
`
`Orn.anism Counts at Dilutions
`
`Date of Sample: - - - - - - - -05/12/2005
`
`Lot number: 05-40452-1
`
`Test Orn:anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A_ niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`10-1
`
`10·2
`
`10·3
`
`10-4
`
`'2.3
`
`l{ U>
`
`0
`
`()
`
`~C\
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`l.\ \
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`
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`0
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`0
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`0
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`0
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`0
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`0
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`D
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`:5 l.Q
`
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`
`0
`
`0
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`/
`/
`/
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`10·5
`
`/
`
`/
`
`/
`
`3
`
`~
`
`0
`
`0
`
`Plate Count
`Averae:e
`
`Initials
`-Date
`t.j.
`~ "5- H.J. - C> 5
`'-1.0 y.. \()
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`L.. \ ()
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`
`Peptone Lot (tubes):
`
`N/A
`- - - -
`NIA
`N/A
`Saline Lot (bulk):
`Polysaline Lot (bulk):
`Peptone Lot (bulk):
`- - - -
`- - - -
`MCTA Lot: ':SI o I "l I~ Waterbath Asset No.: ~'2.1.(Aoocgi) Waterbath Temp(°C):
`
`Saline Lot (tubes): o'S·l\Dl\ ci-\ Polysaline Lot (tubes): o'S. y c'{ 1l.D- I
`
`N/A
`
`'-\I.ii. <5
`
`Letheen Lot: _Q___')___:_'-\04C>1- L_ Other: _r;)~j~A.~----------------
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`- - - - - - - - -
`Analyst:~~------ Date:
`Verified By: ----------~------------- Date:
`
`Transfer Log Reference: NIA
`- - - - - -
`
`_____ ';)- \~_:Q~----------------------
`
`__ _5.-'~lQ5 __________ _
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081- 1
`
`• Product: TRAVATAN BAC Free, 0.004%
`
`PRESERVATIVE RAW DATA
`
`Lot number: 05-40453-1
`
`Sample Timepoint: _________ _!?_~~--~-------------
`On Test:
`5/5/2005
`
`Ornanism Counts at Dilutions
`
`Date of Sample: - - - - - - - -05/12/2005
`
`Test Omanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E. coli
`ATCC 8739
`
`10·1
`
`:;). I
`
`31
`
`Cl
`
`(l)
`
`;;i I
`
`L\~
`
`10-2
`
`I
`
`:i.
`
`("';
`
`0J
`
`:5
`...,
`
`10-J
`
`0
`
`I
`
`~
`
`0
`c
`
`D
`
`10·4
`
`,,.,
`
`0
`
`0
`
`0
`
`0
`
`CJ
`
`C. albicans
`ATCC 10231
`
`• A. niger
`
`ATCC 16404
`
`MEDIA:
`
`Tl\Y\C
`
`"TI\ '"t-r
`
`'Tf\J\r
`
`C."J
`
`"'\ f\YTr
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`10·5
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`/
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`/
`
`/
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`/
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`/
`/
`
`~
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`1
`
`0
`
`2-
`
`Plate Count
`AveraE?:e
`
`Initials
`-Date
`tj_
`
`'2..
`')( 10
`
`=1.9
`
`"S- IUi • o:S
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`t.J:L
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`c. .1''
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`5
`5.l\ 'x lO
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`c.. ~.
`.3 5- l C) • oS
`3.:2.x IC
`
`Peptone Lot (bulk):
`
`NIA
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.: _____ _
`
`Letheen Lot: ____________ _ Other:
`
`ORGANISMS:
`
`A. niger Preparation Reference: NIA
`- - - - - - - - -
`
`Transfer Log Reference: NIA
`- - - - - -
`
`M40.02
`
`•
`
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081- 8
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: Travatan BAC Free, 0.004%
`Sample Timepoint: ________ !:?~_t! _____ _
`05/12/2005
`On Test:
`5/5/2005
`Date of Sample: - - - - - - - -
`Ornanism Counts at Dilutions
`
`Lot number: 05-40454-1
`
`Test Or11:anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`10·!
`
`~\
`
`;-;,?-
`
`(')
`
`0
`
`1-ii
`
`\'1C\
`
`~6
`
`~
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`I Ni(
`
`..,.. f\)'i(
`
`\"r-.nc
`
`T IVTC.
`
`!~TC..
`
`...,- rVic
`
`i'rVT(
`
`T/VTr
`
`TIV'lC.
`
`Tl\/'ir
`
`p,
`
`9
`
`10·3
`
`10-4
`
`10·2
`
`("")
`
`I
`
`(')
`
`()
`
`\ 'b
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`C>
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`0
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`0
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`()
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`'.l
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`/
`/
`/
`
`lffs
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`/
`
`/
`
`/
`
`...,
`
`13
`
`0
`
`0
`
`Plate Count
`Avera11:e
`
`2
`.2.1 'lt \C
`
`~\O
`
`Initials
`-Date
`t. j).
`
`"S- llo-05
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`~ . .tJ.
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`"5-IL.a-C5
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`e_ • .tl ,
`3 Si- IUi- 05
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`tj-
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`c..11 .
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`~.'5 )( 10
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`0
`
`0
`
`(')
`
`0
`
`('")
`
`0
`
`5'5
`
`'5~
`
`0
`
`'3
`
`Peptone Lot (bulk):
`
`- - - -
`
`Saline Lot (tubes):
`
`- - - -
`N/A
`- - - -
`
`Polysaline Lot (tubes):
`
`Polysaline Lot (bulk):
`
`- - - -
`NIA
`
`MCTA Lot: ____ _
`
`------'"""-::::--- Waterbath Temp(°C):
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`- - - - - - - - -
`~--~-----------Date:
`~--~-----------Date:
`
`Analyst:
`
`Verified By:
`
`Transfer Log Reference: N/A
`- - - - - -
`
`5 - l C\- o_5 _________ _
`___ 5-3_tl)5 ________ _
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Sample Timepoint: --------~~~-~-~-·-----·--
`On Test:
`5/5/2005
`
`Omanism Counts at Dilutions
`w-3
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`• A. niger
`
`ATCC 16404
`
`MEDIA:
`
`10·!
`
`10-2
`
`10-4
`
`10-5
`
`v v
`/
`/
`I/ v v v
`v /
`v /
`v
`I/ v
`/
`v
`/
`/
`/
`0 v v I/ v
`/
`v
`v v v
`v v v
`
`Notebook 10750
`
`Page 081- '1
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: Travatan BAC Free, 0.004%
`
`Lot number: 05-40452-1
`
`Date of Sample: - - - - - - - -05/19/2005
`
`0
`
`0
`
`0
`
`0
`
`0
`
`'"il\)\C
`
`INT(
`
`T~Tr
`
`I t-YTC.
`
`I 1\..)\-c.
`
`11\JTC.
`
`~c:;
`
`L\L\
`
`llVTc
`
`I rJiC.
`
`9.
`
`\?-
`
`Plate Count
`Averal!e
`
`4
`
`\t:l
`
`~\0
`
`~\0
`
`5
`l.\.0)( lO
`
`3
`\,\x\D
`
`Initials
`-Date
`t. . J:l .
`
`~-)~-OS
`
`t.B.
`'S-d?- os
`
`t.~-
`'S- ;}3- c6
`t .ll.
`5-;i~-05
`t.;;J_
`5. ~lo- o5
`
`N/A
`
`L\lo.5
`
`Peptone Lot (tubes):
`
`Saline Lot (tubes): o'5·lfo~~U>-\ Polysaline Lot (tubes): o ".5. 40'-i'N ·I
`
`N/A
`- - - -
`N/A
`NIA
`- - - -
`- - - -
`MCTALot: 5,e9013 WaterbathAssetNo.: ~nlAoo~=3.J WaterbathTemp(°C):
`
`Peptone Lot (bulk):
`
`Saline Lot (bulk):
`
`Polysaline Lot (bulk):
`
`Letheen Lot:
`
`0"5-~Cl\ °t. '5- L_ Other: --~---"-I A ________________ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Transfer Log Reference: N/A
`
`Analyst' . ~-~~---------Date:
`Verified By: -~~----------- Date:
`
`5 -~l.o- cs
`
`==5--31_~=-=-~
`
`M40.02
`
`•
`
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081- IO
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: Travatan BAC Free, 0.004%
`Sample Timepoint: ------~~r_~-~---------
`On Test:
`5/5/2005
`Date of Sample:
`
`Lot number: 05-40453-1
`
`05/19/2005
`
`-------~
`
`Or anism Counts at Dilutions
`
`Plate Count
`Avera e
`
`Initials
`-Date
`
`L\0
`
`"?-J3-cS
`
`5
`)( \0
`
`0
`
`0
`
`11\)T
`
`'Tf\)IC.
`
`Test Or anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`Saline Lot (tubes):
`---==-----~
`
`Peptone Lot (bulk):
`
`MCTA Lot: _____ Waterbath Asset No.:
`
`Polysaline Lot (tubes):
`---~
`N/A
`- - - -
`
`Polysaline Lot (bulk):
`
`- - - -
`N/A
`
`ORGANISMS:
`
`A. niger Preparation Reference: NIA
`
`~ (>Ol~- 101-so:o~l-C\
`
`Transfer Log Reference: NIA
`- - - - - -
`
`M40.02
`
`•
`
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081- \ \
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: Travatan BAC Free, 0.004%
`
`Lot number: 05-40454-1
`
`Sample Timepoint: _______ D_~J~~----------
`On Test:
`5/5/2005
`Date of Sample: __ 05_/_19_/2_0_0_5 __
`
`Or anism Counts at Dilutions
`
`Test Or anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`· · .
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`Peptone Lot (bulk):
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.: _____ _
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`Plate Count
`Avera e
`
`Initials
`-Date
`
`~\O
`
`t.~.
`
`'5 -~c.,- oS
`
`N/A
`
`A. niger Preparation Reference: N/A
`- - - - - - - - -
`Analyst: ~-J ...\- -_
`_ . ___ Date:
`< ~~
`~----------------
`Verified By:
`·
`Date:
`- - -
`
`Transfer Log Reference: N/A
`- - - - - -
`
`5- d /..Q - 0 5
`
`----·--
`
`_5_0_t:9~-------
`
`M40.02
`
`•
`
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081- 12
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: Travatan BAC Free, 0.004%
`
`Lot number: 05-40452-1
`
`Sample Timepoint: _________ D~-~-~~------------
`On Test:
`5/5/2005
`Date of Sample:
`
`06/02/2005
`
`~-------
`
`Or anism Counts at Dilutions
`
`Test Or anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`Plate Count
`Avera e
`
`Initials
`-Date
`
`t .JJ.
`
`4 0
`
`u- tt -oS
`
`Lo-9-0~
`
`Peptone Lot (tubes):
`
`N/A
`
`- - - -
`
`Saline Lot (tubes): o5-~0lo4lo· l Polysaline Lot (tubes): 05 _ 4olo~ \-\
`NIA
`N/A
`N/A
`Peptone Lot (bulk):
`Saline Lot (bulk):
`Polysaline Lot (bulk):
`- - - -
`- - - -
`MCTA Lot: 'O 11 Lo &iPL> Waterbath Asset No.: °"i'12-LAooi~ Waterbath Temp(°C):
`
`'=\U. I
`
`Letheen Lot: 05 - ~IJI i .. \
`
`Other: -~,;)~l~Pr~---------
`
`ORGANISMS:
`
`A. niger Preparation Reference: NIA
`
`Transfer Log Reference: NIA
`
`~- tt-DS
`-----·- --·-·-·----·-·-·-·-······--·-·-----···-·--····--·····-··-···-··--····---------··-
`
`·--&-=-q~as:.. _______________________ _
`
`
`
`Analyst: -·------~-_-____ ······-~--·
`
`__ •
`
`_ ·-···· • ........ ··-··········-·-··--·---······························- Date:
`Date:
`
`Verified By:
`
`·-
`
`l/l A .11V"\
`- ~l.ll_!_. __ f______
`
`M40.02
`
`•
`
`Rev.10
`
`--
`
`-
`
`---··-----------------------·-----------------·
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081- \3
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: Travatan BAC Free, 0.004%
`
`Lot number: 05-40453-1
`
`Sample Timepoint: ---------~~~-~~----------
`On Test:
`5/5/2005
`Date of Sample:
`
`06/02/2005
`- - - - - - - -
`
`OrQanism Counts at Dilutions
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`10-•
`
`0
`
`0
`
`0
`
`0
`
`(')
`
`0
`
`10·3
`
`10-4
`
`10·2
`
`/
`
`/
`/
`/
`/
`/
`/
`/
`/
`/
`/
`v v v
`/
`v
`/
`/
`/ v
`/
`/
`
`10·5
`
`/
`
`/
`
`/
`
`/
`
`Plate Count
`AveraQe
`
`Initials
`-Date
`
`c. ~-
`lR ·ti!- os
`tj,
`(g -1.i! ~o~
`
`~\O
`
`L.( 0
`
`LtO
`
`t.jj.
`u · lP-0~
`t . .tl.
`q Le-'\-05
`~.~ )(' 16
`e. . .tl .
`l.o-q-os
`
`:;
`.t~)(\0
`
`C. albicans
`ATCC 10231
`
`• A. niger
`
`ATCC 16404
`
`MEDIA:
`
`-r JIJT[
`
`-fJ1 .. YtC.
`
`3!..\
`
`4
`
`\l\.lTC.
`
`-rl\.)\C
`
`"\" (\)\(
`
`~o
`
`'i' N"f(..-
`
`~5
`
`L\
`
`3"1
`
`/
`/
`v v
`
`/
`
`/
`
`Pieptomrl=c:'1.Ull.b!l!e~s~):~~N~/~A~- Saline Lot (tubes):
`
`- - - -
`
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`MCTA Lot: _____ Waterbath Asset No.:
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`- - - -
`NIA
`
`A. niger Preparation Reference: NIA
`- - - - - - - - -
`
`Transfer Log Reference: N/A
`- - - - - -
`
`lD- q - o"5
`----------·----------------·------- ----------------------··--
`--~9-_::o.5:_ _____________ _
`
`M40.02
`
`•
`
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook 10750
`
`Page 081- \<..\
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: Travatan BAC Free, 0.004%
`
`Lot number: 05-40454-1
`
`Sample Timepoint: -------~ay -~~------------
`On Test:
`5/5/2005
`Date of Sample:
`
`06/02/2005
`- - - - - - - -
`
`OrQ:anism Counts at Dilutions
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`10-l
`
`("')
`
`e
`0
`
`()
`v
`0
`
`/
`
`10-2
`
`10-3
`
`/
`/
`/
`/
`/
`/
`v I/ /
`/
`/
`/
`/
`/
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`-r (\)\[
`
`\(\.}IC
`
`C\ \
`
`\NT(
`
`""fN'TC
`
`'"rl'\J'"fC
`
`°1'1\)\(,
`
`\t.\
`
`11
`
`/
`
`C\4
`
`/
`
`/
`
`10-4
`
`10-5
`
`Plate Count
`Average
`
`/
`/
`I/
`/ (/
`/
`/
`/
`/
`
`<-10
`
`L. t6
`
`C:::lO
`
`4
`C\.?x \O
`
`~
`\.lo 'le' \0
`
`\
`q
`
`/
`/
`v /
`/
`
`Initials
`-Date
`
`t . .H.
`u- ~ ·05
`
`t .):),
`
`lo -IQ -OS
`c.,...ti.
`
`lo-Ill-OS
`c_j.
`u -9 -05
`t. li.
`U.-'f-C>5
`
`- - - - -
`N/A
`
`----==-----
`Peptone Lot (bulk):
`
`- - - -
`MCTA Lot: _____ Waterbath Asset No.: -----==-=-Waterbath Temp(°C):
`
`Po I y s a Ii n e Lot (bulk):
`
`Saline Lot (tubes):
`
`- - - - -
`
`Polysaline Lot (tubes):
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: NIA
`- - - - - - - - -
`Analyst: ~~-----·-·-------·- Date:
`Verified By: ~~--------------- Date:
`
`Transfer Log Reference: NIA
`- - - - - -
`
`----~---~, e>S ----·---------
`__ _k_Cf.115:_ ______________ _
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Notebook tOJ_~{L_ Page ]1;1_1.:___ 15
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`•
`
`Product: Travatan BAC Free, 0.004%
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`Date Assayed:
`
`NONE
`- - - - - - - - - - - -
`05-40452 -1
`Batch No.:
`____________________ 1"-iti~L ____________________ FID No.:
`Project No.:
`200ML Bulk
`
`Procedure No.:
`
`PROC-0001136 (V-3.0)
`LIMS No.:
`SUMMARY OF RESULTS
`Organism Counts (CFU/mL or CFU/g)
`
`5/5/2005
`
`109032
`
`225719
`
`200213082
`
`Test Organisms
`
`Initial
`
`7Day
`
`14Day
`
`28 Day
`
`•
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`5
`~.qx\O
`
`2..
`L\.0)(\0
`
`~\C
`
`<:. \0
`
`5
`"1. ,, )( \0
`
`.L. \ c
`
`~lD
`
`Ll0
`
`5
`i ·1x16
`
`~
`'3.'Sx \O
`
`L\O
`
`L-lO
`
`s
`
`"1. i Y \O
`
`s
`
`!.9.lD )l \ 0
`
`5
`'-\.(.'.) )( \0
`
`l\
`t:\.Lcx\c
`
`~
`'· 3x 10
`
`3
`:l.~X\C
`
`.3
`\. ' x \{)
`
`2.
`l.'?x \O
`
`Not Done (ND)
`
`Limits of Detection Established 0 ______________ _
`Limits of Detection Not Established ~
`
`.~::~:~,B~; ~--- ~::::--&~#~;~~~--- -
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`USP PRESERVATIVE EVALUATION SUMMARY
`Product: Travatan BAC Free, 0.004%
`
`•
`
`Notebook _1_gz§j)____ Page _Q.!1_1.:__14>
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`Procedure No.:
`
`NONE
`
`Date Assayed:
`
`5/5/2005
`
`- - - - - - - - - -
`
`. 05-40453-1
`
`Initial
`
`200ML Bulk
`
`Batch No.:
`
`FID No.:
`
`Project No.:
`
`-..
`
`-
`
`-- -·------------
`
`109033
`225719
`- - - - - - - - -
`200213084
`
`PRO C -0001136 (V-3.0)
`LIMS No.:
`SUMMARY OF RESULTS
`Organism Counts (CFU/mL or CFU/g)
`
`•
`
`Test Organisms
`
`Initial
`
`7Day
`
`l4Day
`
`28 Day
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`s
`/.f.q )( \0
`
`s
`I. 2 lC ID
`
`~
`
`:i." 'X. IC>
`
`L.. \.D
`
`L\O
`
`.L \ D
`
`Ll'b
`
`L\O
`
`'8.1 )( l 6
`
`s
`
`1.
`'3. :2. x. \ 0
`
`L\0
`
`L.. \D
`
`s
`\ 0
`
`:>
`\ C>
`
`c::;, '-\ )<
`
`'l. i
`
`)<.
`
`5
`3.l\"\0
`
`l\
`~ . lo )C \0
`
`(I?
`
`I. ~ )< \0
`
`~
`3. 'lX \0
`
`~
`3. -:l.X \ D
`
`3
`~-:, x \0
`
`Not Done (ND)
`
`Limits of Detection Established 0 ______________ _
`Limits of Detection Not Established [}"
`
`8-Pass USP Requirements D Fail USP - - - - - - - - -
`CY Pass JP Requirements D Fail JP
`
`e:::::=B; ~ --- ~::: --w;;~~::---
`
`~ ~L
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`USP PRESERVATIVE EVALUATION SUMMARY
`
`•
`
`Product: Travatan BAC Free, 0.004%
`
`Notebook _1Q_I~O___ Page _Q_IU.:_J 1
`
`Preservative:
`
`Date Assayed:
`
`NONE
`- - - - - - - - - - - -
`Batch No.:
`05-40454-1
`Lot Number:
`Stability Data: _________ l!!m~L ____________ FID No.:
`Package:
`200ML Bulk
`Project No.:
`Procedure No.:
`
`PROC-0001136 (V-3.0)
`
`LIMS No.:
`
`5/5/2005
`
`109034
`- - - - - · - · - - - - - - - - - -
`225719
`
`200213085
`
`•
`
`SUMMARY OF RESULTS
`Organism Counts (CFU/mL or CFU/g)
`
`Test Organisms
`
`Initial
`
`7Day
`
`l4Day
`
`28 Day
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`s
`l.R _q )l \0
`
`2.
`:Z.t)(l0
`
`~\O
`
`.!. \ 6
`
`s
`1. !2. )l \0
`
`L
`
`\ (')
`
`L\O
`
`L\O
`
`5
`~-l x \()
`
`3
`\.C\~ \0
`
`..:'.'..,(0
`
`L\.0
`
`'5
`., • <6 x \C>
`
`5
`c::;,1 )< \0
`
`L\. \ 'j._
`
`5
`\ <::>
`
`l\
`C\.~x \D
`
`~
`I.~ x \6
`
`3
`s.cs x \0
`
`3
`\ t>
`
`;
`\.Lo x \0
`
`Q.C\
`
`)C.
`
`Not Done (ND)
`
`Limits of Detection Established D ______________ _
`Limits of Detection Not Established
`[;}'
`
`rr-Pass USP Requirements D Fail USP _______ _
`crPass JP Requirements D Fail JP
`
`.:~:;,-~---~ ~::::-~~~;,
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`AIPetResults.05.LIMS 126.0.072004
`
`Database: LIMSAR
`
`cA
`
`0 "°
`
`-0
`
`
`
`0
`<II
`..-1
`
`Report Approved by: Kathleen Alford on 13-JUN-2005 04:55pm
`
`Limits of Detection: Not Established
`
`Pass USP & JP
`
`2.3E2
`9.6E4
`<10
`<10
`<10
`
`1.1E3
`4.0E5
`<10
`<10
`<10
`
`2.5E3
`6.6E5
`3.5E2
`<10
`4.0E2
`
`1.3E6
`7.8E5
`8.7E5
`7.2E5
`6.9E5
`
`28 DAY
`
`14DAY
`
`7 DAY
`
`INIT
`
`Comments:
`Result Summary:
`
`USP: PASS
`JP: PASS
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`301083132 ,301083134
`
`10750:081
`
`Ref#:
`Project No.: 225719
`Preservative: NONE
`Task IDs:
`
`Package: Millipore Filter Unit/ 200 ml
`Stability Data Initial
`Product: TRAVATAN BAG FREE, 0.004% -PH 5.
`Submission ID: 100082058
`
`Method:
`Date Assayed: 05-MAY-2005
`Series No.:
`User Sample ID: Lot 05-40452-1
`Sample ID:
`
`200213082
`
`PET, USP
`
`Page 1of1
`
`• USP Preservative Evaluation &mary
`
`(MTP PROC-0001136 (V-3.0))
`
`Report Date: 28-JUN-2005 03:40 PM
`
`• Alcari
`
`R&DLIMS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`AIPetResults.05. LIMS126.0.072004
`
`Database: LIMSAR
`
`...D
`
`oO
`0
`
`0
`ell
`.J
`0
`
`Report Approved by: Kathleen Alford on 13-JUN-2005 04:56pm
`
`Limits of Detection: Not Established
`
`Pass USP &JP
`
`2.3E3
`3.6E4
`<10
`<:10
`<10
`
`3.2E3
`3.4E5
`<10
`<:10
`<10
`
`3.2E3
`5.4E5
`3.2E2
`<10
`2.9E2
`
`1.3E6
`7.8E5
`8.7E5
`7.2E5
`6.9E5
`
`28 DAY
`
`14 DAY
`
`7 DAY
`
`INIT
`
`Comments:
`Result Summary:
`
`USP: PASS
`JP: PASS
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`301083128 ,301083130
`
`10750:081
`
`Ref#:
`Project No.: 225719
`Preservative: NONE
`Task IDs:
`
`Package: Millipore Filter Unit/ 200 ml
`Stability Data Initial
`Product: TRAVATAN BAG FREE, 0.004% -PH 6.
`Submission ID: 100082058
`
`Method:
`Date Assayed: 05-MAY-2005
`Series No.:
`User Sample ID: Lot 05-40453-1
`Sample ID:
`
`200213084
`
`PET, USP
`
`Page 1of1
`
`• USP Preservative Evaluation &mary
`
`(MTP PROC-0001136 (V-3.0))
`
`Report Date: 28-JUN-2005 03:41 PM
`
`• Alcari
`
`R&DLIMS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`AIPetResu Its. 05 .LI MS 126. 0. 072004
`
`Database: LIMSAR
`
`' "" G
`
`00
`0
`0 ..
`Ul
`.....1
`0
`
`Report Approved by: Kathleen Alford on 13-JUN-2005 04:56pm
`
`Limits of Detection: Not Established
`
`Pass USP & JP
`
`1.6E3
`9.3E4
`<10
`<10
`<10
`
`2.9E3
`4.1E5
`<10
`<10
`<10
`
`8.5E3
`5.7E5
`1.9E3
`<10
`2.7E2
`
`1.3E6
`7.8E5
`8.7E5
`7.2E5
`6.9E5
`
`28 DAY
`
`14DAY
`
`7DAY
`
`INIT
`
`Comments:
`Result Summary:
`
`USP: PASS
`JP: PASS
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`301083136 ,301083138
`
`10750:081
`
`Ref#:
`Project No.: 225719
`Preservative: NONE
`Task IDs:
`
`Package: Millipore Filter Unit/ 200 ml
`Stability Data Initial
`Product: TRAVATAN BAG FREE, 0.004% -PH 5.5
`Submission ID: 100082058
`
`Method:
`Date Assayed: 05-MAY-2005
`Series No.:
`User Sample ID: Lot 05-40454-1
`Sample ID:
`
`PET, USP
`
`200213085
`
`Page 1of1
`
`• USP Preservative Evaluation &mary
`
`(MTP PROC-0001136 (V-3.0))
`
`Report Date: 28-JUN-2005 03:41 PM
`
`• Alcari
`
`R&DLIMS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Alcari
`R&DL/MS
`
`~C1Sci ~O~l -d- \.
`Intermediate Sample Results Report
`Report Date: 28-JUN-2005 03:39 PM
`
`Page 1 of 1
`
`LIMS Submission ID: 100082058
`Requester
`: Bhagwati Kabra
`Customer Datagroup
`: FORMULATION DEVELOPMEN
`Logged By
`: SAUCEDA
`
`Project Number
`Mail Code
`Telephone Extension :
`CC: Reports To
`
`225719
`R1-36
`4489
`KABRA
`
`Sample Information
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`=200213082
`: Lot 05-40452-1
`: 109032 TRAVATAN BAC FREE, 0.004% - PH 5.
`:SOLUTION·
`:A NEW MATERIAL TYPE
`: MICROBIOLOGY
`:PET LAB
`: 05/04/2005
`
`AGE
`DATE NEEDED
`LABORATORY
`NUMBER OF UNITS
`PKG/FILL VOL
`PURPOSE
`STORAGE CONDITION
`
`: Initial
`: 06-01-05
`: MICROBIOLOGY
`: 1
`: Millipore Filter Unit I 200 ml
`: MICROBIOLOGY STUDY
`: RT,AMBIENT
`
`Result Information
`Component
`Task ID
`301083132 USP
`301083132
`JP
`301083132 RESULT SUMMARY
`301083132 LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`301083132 PET, USP
`
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DA TE RECEIVED
`DATE ON TEST
`PRESERVATIVE
`
`10750:081
`. GUTIERREZC
`PROC-0001136 (V-3.0)
`. 04-MAY-05
`. 05-MAY-05
`NONE
`
`Result Value
`PASS
`PASS
`Pass USP & JP
`Not Established
`
`Procedure
`
`PET, USP
`
`Units
`
`Rep
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Kathleen Alford on 13-JUN-2005 04:55pm
`
`Database: LIMSAR
`
`AISampleResults.07.LIMS110.1.012004.P0002241
`
`•
`
`•
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Alcari
`R&DLIMS
`
`I o "'"1 SC : c ~ l
`- d-;;)...
`Intermediate Sample Results Report
`Report Date: 28-JUN-2005 03:40 PM
`
`Page 1 of 1
`
`LIMS Submission ID: 100082058
`Requester
`: Bhagwati Kabra
`Customer Datagroup
`: FORMULATION DEVELOPMEN
`Logged By
`: SAUCEDA
`
`225719
`Project Number
`R 1-36
`Mail Code
`Telephone Extension : 4489
`CC: Reports To
`KABRA
`
`Sample Information
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`:200213084
`: Lot 05-40453-1
`: 109033 TRAVATAN BAC FREE, 0.004% - PH 6.
`:SOLUTION
`:A NEW MATERIAL TYPE
`: MICROBIOLOGY
`:PET LAB
`: 05/04/2005
`
`AGE
`DATE NEEDED
`LABORATORY
`NUMBER OF UNITS
`PKG/FILL VOL
`PURPOSE
`STORAGE CONDITION
`
`: Initial
`: 06-01-05
`: MICROBIOLOGY
`: 1
`: Millipore Filter Unit/ 200 ml
`: MICROBIOLOGY STUDY
`: RT,AMBIENT
`
`Result Information
`Task ID
`Component
`301083128 USP
`301083128
`JP
`301083128 RESULT SUMMARY
`301083128
`LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`301083128 PET, USP
`
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DA TE RECEIVED
`DATE ON TEST
`PRESERVATIVE
`
`10750:081
`. GUTIERREZC
`. PROC-0001136 (V-3.0)
`. 04-MAY-05
`. 05-MAY-05
`NONE
`
`Result Value
`PASS
`PASS
`Pass USP & JP
`Not Established
`
`Procedure
`
`PET, USP
`
`Units
`
`Rep
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Kathleen Alford on 13-JUN-2005 04:56pm
`
`Database: LIMSAR
`
`AISampleResults.07.LIMS110.1.012004.P0002241
`
`•
`
`•
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Alcori
`R&DL/MS
`
`\01 '50: oi I ~ d '3
`Intermediate Sample Results Report
`Report Date: 28-JUN-2005 03:40 PM
`
`Page 1 of 1
`
`LIMS Submission ID: 100082058
`: Bhagwati Kabra
`Requester
`Customer Datagroup
`: FORMULATION DEVELOPMEN
`Logged By
`: SAUCEDA
`
`225719
`Project Number
`R 1-36
`Mail Code
`Telephone Extension : 4489
`CC: Reports To
`KABRA
`
`Sample Information
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`:200213085
`: Lot 05-40454-1
`: 109034 TRAVATAN BAC FREE, 0.004% -PH 5.5
`:SOLUTION
`:A NEW MATERIAL TYPE
`: MICROBIOLOGY
`:PET LAB
`: 05/04/2005
`
`AGE
`DATE NEEDED
`LABORATORY
`NUMBER OF UNITS
`PKG/FILL VOL
`PURPOSE
`STORAGE CONDITION
`
`: Initial
`: 06-01-05
`: MICROBIOLOGY
`: 1
`: Millipore Filter Unit f 200 ml
`: MICROBIOLOGY STUDY
`: RT.AMBIENT
`
`Result Information
`Component
`Task ID
`301083136 USP
`301083136
`JP
`301083136 RESULT SUMMARY
`301083136 LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`301083136 PET, USP
`
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DA TE RECEIVED
`DATE ON TEST
`PRESE.RVA TIVE
`
`10750:081
`GUTIERRE.ZC
`PROC-0001136 (V-3. 0)
`04-MAY-05
`05-MAY-05
`NONE
`
`Result Value
`PASS
`PASS
`Pass USP & JP
`Not Established
`
`Procedure
`
`PET, USP
`
`Units
`
`Rep
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Kathleen Alford on 13-JUN-2005 04:56pm
`
`Database: LIMSAR
`
`AISampleResults.07.LIMS110.1.012004.P0002241
`
`•
`
`•
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`