;
`
`;
`
`~~,,0,.~-~"'"'"-'" 0 '~ Y.~"'~'~,;~,~~
`
`Verified By:~/.~
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`ALCON 2010
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
`
`;
`
`~~,,0,.~-~"'"'"-'" 0 '~ Y.~"'~'~,;~,~~
`
`Verified By:~/.~
`
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`ALCON 2010
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
`
`•
`
`Alcari
`R&DL/MS
`
`(09/-S:OS' - '-(cid:173)
`Lot Detail Report
`Report Date:
`07-JUL-2004 01:39 PM
`Page 1of1
`
`Lot Number: 04-37150·1
`Formulation ID: 107337 V.
`
`Lot Status: SCHEDULED
`TRAVATAN BAC Free, 0.004%-no ZnCl2
`
`External Lot: N
`
`Lot Purpose: Microbiology
`Mfg Lot Number:
`
`Lot Description: 0.004% TRavatan BAC Free no Zinc chloride
`Target pH: 6.0
`Project: 225719
`
`Reference Num: LN 11246:008
`
`Dosage Form: Solution
`
`Batch Made by: Sandhya Rugwani
`
`Expiration Date:
`
`Retest Period:
`
`Storage Cond.: 2-25C
`
`FORMULATION
`Description
`AI06221,
`Polyoxyl 40 Hydrogenated Castor Oil,
`Boric Acid,
`Sorbitol,
`Propylene Glycol,
`Sodium Hydroxide,
`Hydrochloric Acid,
`Purified Water,
`
`Formulation Comments:
`
`Concentration
`0.004%
`0.5%
`1%
`0.25%
`0.75%
`adjust pH
`adjust pH
`q.s. 100%
`
`Units
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Excipient
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`Batch Comments:
`
`Lot Comments:
`
`PACKAGING
`Package BOM #: 94
`
`Descr: FORMULATION DEV BOM 19, BULK POLYSTYRENE PLASTIC CONTAINER
`
`Component Description
`
`Sterilization Package
`Method
`Lot No.
`
`Expiration
`Date
`
`Packaging
`Operation
`Performed/
`Witnessed by
`
`Perform &
`Witness
`Date
`
`Alcon
`
`Part# I-
`
`Lot Filled by: SANDHYA RUGWANI
`Fill Volume: 200mL
`
`Lot Fill Date: 07-Jul-2004
`Num Units Filled: 1
`
`Approved by:_~
`
`Fill Location: R&D Fort Worth
`
`Date: ~!~~--
`
`•
`
`Database: LIMSAR
`
`Batch-Lot#: 04-37150-1
`
`FB_Lot_Rep.03.LIMS042.1.032004. P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`)
`
`Alcon
`R&DL/MS
`
`/~S115-..- os1-3
`Lot Detail Report
`07-JUL-2004 01:41 PM
`Report Date:
`Page 1of1
`
`Lot Number: 04-37152-1
`Formulation ID: 107339 V.
`
`Lot Status: SCHEDULED
`TRAVATAN BAC Free, 0.004%-No Boric Acid
`
`External Lot: N
`
`Lot Purpose: Microbiology
`
`Mfg Lot Number:
`
`Lot Description: 0.004% TRavatan BAC Free, no Boric Acid
`Target pH: 6.0
`Project: 225719
`
`Reference Num: LN 11246:009
`
`Dosage Form: Solution
`
`Batch Made by: Sandhya Rugwani
`
`Expiration Date:
`
`Retest Period:
`
`Storage Cond.: 2-25C
`
`FORMULATION
`Description
`AI06221,
`Polyoxyl 40 Hydrogenated Castor Oil,
`Sorbitol,
`Propylene Glycol,
`Zinc Chloride,
`Sodium Hydroxide,
`Hydrochloric Acid,
`Purified Water,
`
`Formulation Comments:
`
`Concentration
`0.004%
`0.5%
`0.25%
`0.75%
`0.0025%
`adjust pH
`adjust pH
`q.s. 100%
`
`Units
`WN%
`WN%
`WN%
`WN%
`WN%
`WN o/o
`WNo/o
`WNo/o
`
`Purpose
`Active Ingredient
`Surfactant
`Excipient
`Excipient
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`Batch Comments:
`
`Lot Comments:
`
`PACKAGING
`Package BOM #: 94
`
`Descr: FORMULATION DEV BOM 19, BULK POLYSTYRENE PLASTIC CONTAINER
`
`Component Description
`
`Sterilization Package
`Method
`Lot No.
`
`Expiration
`Date
`
`Lot Filled by: SANDHYA RUGWANI
`Fill Volume: 200ml
`
`Lot Fill Date: 07-Jul-2004
`Num Units Filled: 1
`
`Alcon
`Part #
`
`Packaging
`Perform &
`Operation
`Witness
`Performed/
`Witnessed by Date
`L _.s~ _ _ , ..., 11 1o4-'
`L /,/IMll
`. 7-7<>'-f .
`I
`Fill Location: R&D Fort Worth
`
`Approved by:_~~
`
`Date: --:!/$'=1-
`
`Database: LIMSAR
`
`Batch-Lot#: 04-37152-1
`
`FB_Lot_Rep.03.LIMS042.1.032004.P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`)
`
`Alcari
`R&DL/MS
`
`/()54~:os1-1
`Lot Detail Report
`Report Date:
`07-JUL-2004 01 :44 PM
`Page 1of1
`
`Lot Number: 04-37156-1
`Formulation ID: 107341 V.
`
`Lot Status: SCHEDULED
`TRAVATAN BAC Free, 0.004%-85% ZnCl2 & Boric Acid
`
`External Lot: N
`
`Lot Purpose: Microbiology
`Mfg Lot Number:
`
`Lot Description: D.004% Travatan BAC Free,85% ZnCl2 & Boric Acid
`Target pH: 6.0
`Project: 225202
`
`Reference Num: LN 11246: 010
`
`Dosage Form: Solution
`
`Batch Made by: Sandhya Rugwani
`
`Expiration Date:
`
`Retest Period:
`
`Storage Cond.: 2-25C
`
`FORMULATION
`Description
`AI06221,
`Polyoxyl 40 Hydrogenated Castor Oil,
`Boric Acid,
`Sorbitol,
`Propylene Glycol,
`Zinc Chloride,
`Sodium Hydroxide,
`Hydrochloric Acid,
`Purified Water,
`
`Formulation Comments:
`
`Concentration
`0.004%
`0.5%
`0.85%
`0.25%
`0.75%
`0.002125%
`adjust pH
`adjust pH
`q.s. 100%
`
`Units
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`WN%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Excipient
`Excipient
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`Descr: FORMULATION DEV BOM 19, BULK POLYSTYRENE PLASTIC CONTAINER
`
`Sterilization Package
`Method
`Lot No.
`
`Expiration
`Date
`oo~o~ODI 0 I I 0 =I
`
`Alcon
`Part#
`
`Packaging
`Perform &
`Operation
`Witness
`Performed/
`Witnessed by Date
`'117/0
`i-7-c:J.1
`Fill Location: R&D Fort Worth
`
`Batch Comments:
`
`Lot Comments:
`
`PACKAGING
`Package BOM #: 94
`
`Component Description
`
`Lot Filled by: SANDHYA RUGWANI
`Fill Volume: 20Dml
`
`Lot Fill Date: 07-Jul-2004
`Num Units Filled: 1
`
`Approved by:-~~________ Date: ~-1-O_!:J_
`
`•
`
`Database: LIMSAR
`
`Batch-Lot#: 04-37156-1
`
`FB_Lot_Rep.03.LIMS042.1.032004.P0002254
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`R&D LIMS
`
`• Alcari
`
`Formulation ID: 107047
`Vers. 2
`Description: TRA VAT AN BAC Free, 0.004%
`Target pH: 6.0
`Units: W!V %
`
`Component
`Al06221
`Polyoxyl 40 Hydrogenated Castor Oil
`Boric Acid
`Sorbitol
`Propylene Glycol
`Zinc Chloride
`Sodium Hydroxide
`Hydrochloric Acid
`Purified Water
`
`-
`
`I tJ.5?.J): OS!-;'
`Formulation Report
`Page 1of1
`06-JUL-2004 02:35 PM
`
`Report Date:
`
`Dosage Form: SOLUTION
`
`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.02.LIMS037 .0. 012004.P0002250
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Alcari
`R&D LIMS
`
`/09/S-: 051 '-~
`Formulation Report
`Page 1of1
`09-JUL-2004 09:39 AM
`
`Report Date:
`
`Vers. 1
`Formulation ID: I 07340
`Descr:iption: TRA VATAN BAC Free, 0.004%-No Sorbitol or Propylene Glycol
`Units: WN %
`Target pH: 6.0
`Dosage Form: SOLUTION
`
`•
`
`Component
`Al06221
`Polyoxyl 40 Hydrogenated Castor Oil
`Boric Acid
`Zinc Chloride
`Sodium Hydroxide
`Hydrochloric Acid
`Purified Water
`
`Concentration
`0.004%
`0.5%
`1%
`0.0025%
`adjust pH
`adjust pH
`q.s. 100%
`
`Purpose
`Active Ingredient
`Surfactant
`Buffering Agent
`Excipient
`Ph Adjust
`Ph Adjust
`Vehicle
`
`Database: LIMSAR
`
`FB_FormRep_Short.02.LIMS037.0.012004.POOD2250
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`•
`
`Product:
`Sample Timepoint:
`On Test:
`7113/2004
`
`Test Onranism
`
`10-l
`
`Notebook 10545
`
`Page 051- 7
`
`PRESERVATIVE RAW DATA
`
`Controls
`
`Initial
`
`Lot number:
`
`Date of Sample: - - - - - - -
`07/13/2004
`Qrg-anism Counts at Dilutions
`
`10-2
`
`"\
`)
`I
`
`\
`
`\
`
`l
`I
`
`j
`
`I
`I
`\
`t
`
`10-3
`
`"
`l
`J
`I
`
`104
`q;
`C)O
`9;}
`10/o
`J /cf
`q)-
`\_
`~ 1'1
`I
`70
`-rrJT0
`1]\JrL-
`
`'
`
`10-5
`
`Initials
`Plate Count
`Avera!!e
`-Date
`LJ._
`~
`5'
`(/./'f. ro
`7/1~(of
`'7
`Ii-.
`1
`b
`'~ ~-1x10 ·7(t<p/Dtj
`10 /. 0 x /Oft;
`1/r 1of or
`/
`IS
`.,,.
`tp.._
`1
`?
`'(!5x10 1 (rip/of
`3
`(/A_
`9
`f.5 x tO 1( r0(of
`/0
`
`(>-.__
`
`.... ~
`~
`
`'
`
`I
`J
`
`I
`
`\
`\
`l
`
`\
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`Peptone Lot (tubes): ------~~~-------- Saline Lot (tubes):/y/_:_}}J_~t_L Polysaline Lot (tubes): Q't_.j__Z~_?!/- /
`-~!!-________ Saline Lot (bulk): {)i/--__3_f!!!_tk-L Polysaline Lot (bulk): 01:-2_~1[4?_'/-I
`Peptone Lot (bulk):
`MCTA Lot: 1;t/£859 Waterbath Asset No.: A ~StJt) Waterbath Temp(°C): -~5-~
`Letheen Lot: [)l/, 371 lf fl--/
`Other: _______________ _
`
`ORGANISMS:
`
`Reference: /f)3Jl_:O'f__Z-0J_~z/t,_fTransfer Log Reference: /__(}3_/tff ~pt/Cr~Cj
`
`Analyst: -'~...-44~~~"""->'E'-='-----fl-~'----=----- Date:
`Verified By:
`Date:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051- </
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, NO ZINC CHLORID Lot number: 04-37150-1
`
`Sample Timepoint: ___ D_ay 7 __ _
`On Test:
`7/13/2004
`07/20/2004
`Date of Sample: - - - - - -
`
`Test Or anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`Or anism Counts at Dilutions
`
`10-5
`
`10'4
`
`19
`5
`/3
`d.5
`
`Plate Count
`Avera e
`
`.
`s
`/. / x 10
`
`5
`/.8 x ({)
`
`5
`,OxtO
`
`5
`(o_J 'f /0
`
`Initials
`-Date
`(A_
`7(dot/-
`~
`1{i3(<J/
`~
`l(i,3{o
`
`~
`
`3
`.Oy!O
`
`fi.--
`7/i1/oq
`
`77V1V
`-rr/rc..
`{7YTV
`
`7J1/Tl,,,
`r/f/7'/
`
`nYil..-
`
`IL.-
`-rr/TC/
`·r111rc.
`
`f/V(</
`
`TZ-
`
`(711~
`
`•
`
`MEDIA:
`
`Peptone Lot (tubes):
`
`N/A
`
`Saline Lot (tubes):l.}/-37 J.01/ Polysaline Lot (tubes): Ocf-37,;J..OJJ- /
`
`Peptone Lot (bulk):
`
`N/A
`
`Saline Lot (bulk):
`
`N/A
`
`Polysaline Lot (bulk):
`
`N/A
`
`~·---------·---·-·---·--·----·-·--
`
`M CT A Lot: L/ ! 'i' ~g 59 Waterbath Asset No.: d~.;£ Waterbath Temp(°C): L/S: f'
`Letheen Lot: IJ <./' 3 7 C}.5 ;),.~ I Other: _________________ _
`
`ORGANISMS:
`
`Transfer Log Reference: N/A
`
`Analyst: -~<-<=-"'"?-"-----'---.---
`Verified By:
`
`/----"'----.-~----Date:
`Date:
`
`,£-\--=-=--"""''-'"'~~=----....-..~-'-'J-~'-'----"~---
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051-ct
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, NO BORIC ACID
`
`Lot number: 04-37152-1
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 7
`
`Date of Sample:
`
`07/20/2004
`- - - - - - - -
`
`Orn:anism Counts at Dilutions
`
`10-2
`0
`f)
`
`()
`n
`if)
`
`P'i
`-
`ll\/\L-
`
`11'\J"t,;
`
`10-l
`
`I
`0
`()
`0
`f)
`D
`TNIV
`
`fNIC...-
`
`IT1ViT
`
`Th'TV
`
`Test Orn:anism
`
`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):
`
`N/A
`
`lff5
`'""
`-.......
`I
`)
`(
`(
`\ ~ ..L (0
`I
`(
`era
`l
`)
`{)
`(
`3
`0
`?{
`IN IC-
`ITVTC
`12.
`TN'Tu
`TI\JTU IN~
`~ (OS<-fS .. ,051-1
`Saline Lot (tubes):
`Polysaline Lot (tubes):
`
`10-3
`
`10·4
`
`{)
`0
`0
`()
`
`If)
`
`0
`C)CJ,
`31
`17\JK:..
`
`Plate Count
`Average
`
`.L..._ ro
`
`t(
`di-1x 10
`
`(p
`/,ox ro
`
`Initials
`-Date
`({;._
`1(23(of
`
`~
`£()3/D'f
`
`(p.__
`
`-,( J.-5lof
`fL
`'1/J-7/ot/
`tL
`1/ i,7/ 0 '/
`
`-~
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.: _____ _
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Transfer Log Reference: N/A
`
`Date: 7/J7/ot
`Date: ~q/ot
`
`Analyst: ~;=~
`VerffledByb<~
`•
`
`M40.02
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051-/D
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC·FREE, 85% ZnCL&BA
`
`Lot number: 04-37156·1
`
`Sample Timepoint:
`On Test:
`7113/2004
`
`Day 7
`
`07/20/2004
`Date of Sample:
`- - - - - - -
`
`Ornanism Counts at Dilutions
`
`10-2
`
`10-3
`
`10-4
`
`10-5
`
`Plate Count
`Avera11:e
`
`Initials
`-Date
`
`-8 ~
`
`"') ~ ~ f{)xro I ~
`0
`I
`(
`)
`n
`7(23/o<f
`\
`')
`(
`'2. ~
`~
`"\ l-5x 10
`)
`~
`-;)_
`7(23(o'f
`\
`40
`(
`I?
`If&; x f 0 1/;,3ld/
`sd
`(
`I
`.;l \
`ti-
`=3q
`-mrr.. TNTC
`3
`4:3 xro S'
`fil/lC- 7Jl/70 41
`5
`1(2 7(o<{
`{fJITG-
`(!,_
`-rr/TG 3~ 3
`s
`(
`0
`l3.f ~ {0
`0
`7(-;> 7/d(-
`f7'//{_
`;;L(J
`0
`I f
`~ lOS'fS-'. Q.'S 1-<6
`
`10-'
`I)
`1
`oZo
`I O
`-TN~
`Tf'/TU
`
`-r/V1Z-
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`• A. niger
`
`ATCC 16404
`
`MEDIA·
`
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`N/A
`
`NIA
`
`MCTA Lot: _____ Waterbath Asset No.: ____ _
`
`Letheen Lot: ______ _ Other: _________________ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`~:~~:::By~----~::: 7~/(0!/ __________ _
`
`Transfer Log Reference: N/A
`
`M40.02
`
`•
`
`Rev.10
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051- /I
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, 0.004%
`
`Lot number: 04-37157-3
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 7 - - - -
`Date of Sample:
`
`--'------'-'=--:...c_=-=..c::_::_ __
`
`07/20/2004
`
`Orn:anism Counts at Dilutions
`
`10-2
`
`10·3
`
`10-4
`
`10·5
`
`Initials
`-Date
`(A_
`~ ~ ~ '-.......
`/
`) 15Xf0 7f 23foy
`)
`(
`I
`\
`)
`~
`\_
`(
`7123/o'f
`'
`tA-
`l{z,3/0~
`&_
`7/')..1/o</
`t1i_
`7f;;i.7(of
`
`Plate Count
`Averai>e
`
`I
`
`I
`3.0 Xt<!J
`
`/.t.f x 10 f
`
`S'
`4.5 >< ro
`
`5ox 1t?
`
`(
`
`""
`I
`)
`41
`42-
`)
`~
`
`'
`"\
`(
`\
`
`Test Onranism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`10-I
`
`-,
`Sl
`J
`Lf
`TTV\L
`
`TlV~
`
`fNTl,,,
`
`INTC
`(Jf rc,
`
`I~-;)..
`/Sb
`T!VTL.--
`TTVTI:...-- TN~ TN TC-
`)
`)
`
`I
`)
`(
`
`TJ1) TL--
`
`'C)')
`45'
`
`Peptone Lot (bulk):
`
`NIA
`
`MCTA Lot: ___ _
`
`Waterbath Asset No.:
`
`Polysaline Lot (tubes):
`
`N/A
`
`Letheen Lot: ______ _ Other: ________ ____.._ ________ _
`
`ORGANISMS:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051- /Y
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN SAC-FREE, No Sorbitol or Pro/ Lot number: 04-37160-1
`
`-------·--------------------------·------------------
`Sam pie Timepoint:
`_D_ay_7 __ _
`07/20/2004
`Date of Sample: - - - - - - - -
`On Test:
`7/13/2004
`Or11anism Counts at Dilutions
`
`Test Organism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`10-'
`{)
`()
`
`~
`
`f)
`n
`0
`0
`
`10-2
`
`10-3
`
`I)
`
`f)
`n
`-
`n
`n
`f)
`
`I)
`
`/')
`
`0
`()
`
`;:)
`
`f)
`
`I FV It"
`
`. 'YlllTG.-
`
`T/V/(_
`
`Plate Count
`Averal!e
`
`Initials
`-Date
`
`10-5
`
`()
`
`L/O
`
`<-ID
`
`L-{Q
`
`10-4
`0
`f)
`
`0
`0
`
`f )
`
`()
`91
`(o 7
`)
`)
`
`{f__
`--J( i3/o'f
`0
`~
`()
`7{i,3{otf
`0
`4-
`0
`7{~1{0~
`{)
`'\
`5 ~
`I
`71/(./(}
`7(-;;1/of
`-OVTV
`TIVTC-·
`T!VTT ~
`r;._
`\
`·mu_ T!V/C- 3lf
`-- tf
`'f
`Iv· X tO 7/21/ot/
`(
`.~ tf-
`nVTC-
`T!V~
`~ lOS4S-~V s I-~
`MEDIA:
`Peptone Lot (t~ub~e;s~):-tN°iitAA-~~:J:~ot (tubes):
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`N/A
`
`N/A
`
`MCTA Lot: ___ _
`
`Waterbath Asset No.: ____ _
`
`Letheen Lot: ______ _ Other: _________________ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: NIA
`
`Transfer Log Reference: N/A
`
`Analyst: -~1-~~~~~~~~W'----=~-- Date:
`Verified By:
`Date:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051- /3
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN SAC-FREE, NO ZINC CHLORID Lot number: 04-37150-1
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 14
`
`Date of Sample: ------"0_;_7=/2:..::_7/=2=0-=-04-=---
`
`Or""anism Counts at Dilutions
`
`10-3
`
`10-4
`
`10-5
`
`Plate Count
`Averave
`
`Initials
`-Date
`
`10-2
`110
`f b
`IC/If
`/gj
`
`~ \
`(}__
`1
`9.tx1cl
`7
`I
`1 (30(0'-{
`(o
`\
`(
`(5
`/. 9x101 ~
`\
`(
`7(3ti /of
`Old-
`/
`tlP---
`31
`IN\?_ (NV
`3,q x 1rf
`1 '30/0~
`(
`IN~ f fo
`TNv
`\
`-m/R: 60
`S' 6
`I 33x10 1 /3/o<{
`6_5
`(l'l/T'C-
`\
`,:;_
`)
`I
`<j.5 XIO 1&/o<f
`)
`(
`
`Tf\/ 'lt:..
`
`iTVlC--·
`
`~
`I
`
`)
`I
`
`Test Organism
`
`10-l
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`!NTL.-
`(7\.JTU
`!TNTC-
`-rrJ\V
`r-rN1L-
`nVTU
`-rrl/TL
`7111 "t(.,..-
`1
`/Q
`
`•
`
`MEDIA:
`Peptone Lot (tubes): ---~!_~----·- Saline Lot (tubes):()__'l_2'1.~'1_?1_ Polysaline Lot (tubes): [J_f_J_zg§..Z-f
`----~!_~---------- Saline Lot (bulk): --~-0 ________ Polysaline Lot (bulk):
`Peptone Lot (bulk):
`MCTA Lot: .t//7,57J5q Waterbath Asset No.: _d_.;;<696_.
`Waterbath Temp(°C): -'--0--=-'S_._:_i __
`
`NIA
`
`Letheenlot:O<..f-d73?c/--'"/
`
`Other: ________________ _
`
`ORGANISMS:
`
`:~::::Prep:?;:;:::_~--~;- T::~~~r Lo~=-e--=:__,·y'._ce_: ___ N/-A=~--~-----
`
`Verified By: -7'5f.-Jl-~~~~f-""-""-=-"''-'--" _ -~------ Date:
`- 2- Jcf-Q--f
`_ -'-----=
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051-/4
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, NO BORIC ACID
`
`Lot number: 04-37152-1
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 14
`
`Date of Sample:
`07/27/2004
`- - - - - - - -
`
`Or anism Counts at Dilutions
`
`Test Or anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E. coli
`ATCC 8739
`
`0
`
`0
`0
`D
`0
`
`Plate Count
`Avera e
`
`Initials
`-Date
`
`<-10
`
`..a-ID
`
`-<-(0
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`Peptone Lot (bulk):
`
`N/A
`
`Saline Lot (bulk):
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.:
`
`Letheen Lot: ______ _ Other: _________________ _
`
`Transfer Log Reference: N/A
`
`Date:
`
`Date:
`
`ORGANISMS:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`, /
`Page 051-/ ~
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, 85% ZnCL&BA
`. ---·····-····--·-·--···-···········-···-···-·--·······-······· ················-·····••.................
`···-·-·-·-···· .. -·········--·-········ .. -··-·-··-····------········-···-·--·-·-
`Sam p I e Timepoint:
`Day 14
`On Test:
`7/13/2004
`
`Date of Sample: - - - - - - - -
`07/27/2004
`Ornanism Counts at Dilutions
`
`Lot number: 04-37156-1
`
`Test Orn:anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`10-2
`
`lff 1
`
`ro
`0
`([)
`0
`
`17t}-t(..,
`
`1
`~
`
`J
`(
`)
`)
`0
`0
`0
`f)
`·1l1! 1C mrr...
`'fl\/ L
`\
`0
`
`10-3
`
`\
`I
`(
`)
`(
`l
`j. { 0
`.;LO °I
`)
`)
`
`10-4
`
`\
`/
`(
`\
`
`17
`()3
`")
`~
`
`10-5
`
`Plate Count
`Avera!!e
`
`L-(0
`
`Initials
`-Date
`flt_
`7{3v(of
`~
`1( 3D /o'f
`
`~ L/0
`/
`(
`)
`(
`l
`')
`(
`·)
`I
`
`~
`Lf() 1(30/of
`IL
`s
`~1x10 <t/3/0</
`IA-
`ff 1"3/t#
`
`I
`-g.ox10
`
`Saline Lot (tubes):
`
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`MCTA Lot: ____ _
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`N/A
`
`Polysaline Lot (bulk):
`
`NIA
`
`··--- Waterbath Temp(°C): - · · - - - -
`
`:~::::: Prepara~
`Verified By: ;!fh~ ~~-
`
`Transfer Log Reference: N/A
`
`Date:
`
`Date:
`
`_ 'l/3/oy
`S=---;q 1)<-/
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051- /ft;
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, 0.004%
`
`Lot number: 04-37157-3
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 14
`
`Date of Sample: - - - - - - - -
`07/27/2004
`Orn:anism Counts at Dilutions
`
`Test Ornanism
`
`10-I
`
`10·3
`
`10·4
`
`10·5
`
`Plate Count
`Averag:e
`
`10-2
`)
`----i
`I
`I
`~ (
`"
`I
`0
`0
`TNTL
`-rN1L..-·
`
`l
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`f)
`-
`0
`()
`0
`()
`n
`11V 1(.,.
`'f'N-f(,,
`
`/A
`
`<......
`
`'--..
`)
`(
`~
`(
`l
`)
`(
`
`z {()
`
`Lf 0
`
`<-£0
`
`5
`J.I x10
`
`'\
`
`I
`
`'2.
`/.~y_tO
`
`Initials
`-Date
`~
`1f3ofof
`(a_
`1(3o(of
`to---
`1(3o(of
`~
`<t/3/{)cf
`(P.._
`3(3/acf
`
`)
`(
`\
`(
`I
`I
`j,38
`i3
`ltd-
`tCf
`l5 1
`/
`7
`\
`17
`~
`z__
`~ ro~<.ts-:os-1--13
`Saline Lot (tubes):
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`N/A
`
`Polysaline Lot (bulk):
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.:
`
`Letheen Lot: ______ _
`
`ORGANISMS:
`
`n Reference: N/A
`A. niger Prep~af
`
`Transfer Log Reference: N/A
`
`~ ~/3q/ ~ ~</'
`
`-v
`
`6
`
`Analyst:
`Verified By:
`
`.
`
`-
`
`DDaattee'..
`
`--c7--~~~--~~~~----~
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051- /1
`
`PRESERVATIVE RAW DATA
`Product: !_~~~! ~~-~~-~-~~~_i:i:_,_f.J_() __ ~-~~-~~!~~-~~~~~! Lot number: 04-37160-1
`
`•
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 14
`
`Date of Sample:
`07/27/2004
`- - - - - - - -
`
`Orn:anism Counts at Dilutions
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`10-2
`
`10-3
`
`10·4
`
`10-5
`
`/
`
`/
`
`/
`
`10-l
`
`f)
`
`{)
`
`n I"'
`~
`~ /
`> v
`"--
`
`/
`
`/
`
`~~
`~ 4-(Q
`(
`5
`/.3.,. ,o
`)
`\
`
`3
`5,(py /O
`
`(
`
`Plate Count
`Averaee
`
`Initials
`-Date
`
`<-/0
`
`L{O
`
`rA--
`/(Y>fo~
`tft-
`/(3o{oV'
`~
`1{30/of
`~
`<g /8/Dtf
`/fl_
`'6(3/fJl{
`
`0
`()
`/
`CJ
`I '61
`-r1J tz... TN1[,,
`~o
`-nvrr--
`f7{
`(~
`Tfl/T(,,.
`!?'-f 1
`)
`-11{TL
`\
`-1'N 1'(.., S1
`Lf
`{(() S-4 ~ : () 5 f - J!J
`~ () IJ
`S~t (tubes):
`
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`N/A
`
`Polysaline Lot (bulk):
`
`N/A
`
`MCTA Lot:
`
`Waterbath Asset No.:
`
`Letheen Lot: ______ _
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`- - - - - - -
`
`Notebook 10545 Page~
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, NO ZINC CHLORID Lot number: 04-37150-1
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 28
`
`Date of Sample: - - - - - - -
`08/10/2004
`Ornanism Counts at Dilutions
`
`Test Orn:anism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`10·2
`3
`I
`{
`
`10·1
`15
`11
`0
`l I
`\
`TJ{TV -rrff{,;
`-nv''TV
`Jl'{\U
`-nJ(, -rN~
`l(V-rl---
`,-,V1l/
`--3
`0
`
`L5
`Jj
`
`10·3
`0
`b
`0
`0
`1qo
`JIJ3
`t)()l
`1~6
`?
`)
`
`10-4
`
`J
`I
`{
`)
`(
`)
`
`;J(p
`~I
`)
`I.....
`
`10·5
`
`Plate Count
`Avera!!e
`
`Initials
`-Date
`
`\
`z.,. ~
`J /.5t tO
`<l/13/0~
`(
`I ~
`</6'J.. 10
`\
`<6 / ( 3/o<{
`I
`I
`"I
`
`5
`f.~lf-10
`
`5 ~
`t1..0 x (0
`t/1do~
`(Iv
`<t I 11 /of
`(A-
`'--
`(.c.{ 'f.-(0 «( t 7 /o tf,
`
`/
`\
`(
`
`MEDIA:
`Peptone Lot (tubes): ------~!~-------- Saline Lot (tubes): aJ.:3._1fifl:.~ Polysaline Lot (tubes): {}_¢-3 2.!f_.J_ 6 - /
`
`•
`
`Peptone Lot (bulk): -----~!~------- Saline Lot (bulk):
`__ _!}_'.~------- Polysaline Lot (bulk):
`MCTA Lot/Jj_ 7SfJ59 Waterbath Asset No.: !}__25tJS Waterbath Temp(°C):
`Letheenlot:![J./-37L/37-·}
`Other: ________________ _
`
`NIA
`
`ORGANISMS:
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051-/~
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, NO BORIC ACID
`
`Lot number: 04-37152-1
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 28
`
`Date of Sample: - - - - - - - -
`08/10/2004
`Ornanism Counts at Dilutions
`
`10·1
`
`10·2
`
`10·3
`
`10-4
`
`D ""
`
`10-5
`
`/
`
`v
`
`/
`
`Plate Count
`Averae:e
`
`...c_fD
`
`Initials
`-Date
`(,._
`'6{ t3lo <f
`0
`0
`-< f D ~
`<6lc3/otf
`0
`ru
`~
`~ ~10 if 13(0~
`0
`J1
`)
`2- ~
`~
`)
`3.1 i tO
`I
`1
`if
`\
`;1t)'
`'6( 11/o<f
`\
`20
`-nvrc..-
`5 ~
`'T7v' TC
`llN\Z..
`J.5 y.. tO
`l
`3o
`~£1 /av -
`lf'(fV 1?'{"\V T7Y'fl/
`MEDIA: ---~~ lOs-4-~-; DS I - I~
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`~
`~ /
`/
`'
`""
`/ v
`
`,
`
`)
`
`/
`
`Peptone Lot (tubes):
`
`N/A
`
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`NIA
`
`Saline Lot (bulk):
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.: ____ _
`
`Letheen Lot: ______ _ Other: _________________ _
`
`Transfer Log Reference: N/A
`
`- - - - Date:
`
`Date:
`
`8/n(o_f ___ -
`f?-1q--Oc.../
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Analyst: ~- m
`Verified By: _ -~- _ _____ _
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051-)b
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, 85% ZnCL&BA
`
`Lot number: 04-37156-1
`
`Sample Timepoint:
`On Test:
`7(13/2004
`
`Day 28
`
`Date of Sample: - - - - - - - -
`08/10/2004
`
`Ornanism Counts at Dilutions
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`MEDIA:
`
`10-I
`
`10-2
`
`10-3
`
`10-4
`
`0
`0
`0
`0
`D
`-rrv ll
`INiV
`l Lf
`J..O
`
`/
`
`I'...
`
`to
`(u
`)
`
`I ""
`""~
`"' /
`> v
`/ v ~
`"'-
`-
`q,
`"\
`--rN-fV
`/
`~~
`-m}1V
`"
`)
`)
`'
`\
`~
`~ I 0 .S--({-$' .. 05' ( - I~
`Polysaline Lot (tubes):
`
`10-5
`
`/
`~/
`
`Plate Count
`Average
`
`.c:.. I 0
`
`..c._ ID
`
`L/O
`
`3.9 !JOfj
`
`)
`
`1
`2-
`/.
`f 10
`
`Initials
`-Date
`
`&---
`i/r3/o'f
`(;.._
`i(t3f Oi
`&-
`il15/o'f
`µ._
`i It 7(df
`µ._
`rf/t7/ot/
`
`Peptone Lot (tubes):
`
`N/A
`
`Peptone Lot (bulk):
`
`N/A
`
`Saline Lot (bulk):
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.: ____ _
`
`Letheen Lot: ______ _ Other: _________________ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Transfer Log Reference: N/A
`
`~:::=By:~
`•
`
`M40.02
`Rev.10
`
`Date:
`
`Date:
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051- )-/
`
`PRESERVATIVE RAW DATA
`
`•
`
`Product: TRAVATAN BAC-FREE, 0.004%
`
`Lot number: 04-37157-3
`
`Sample Timepoint:
`On Test:
`7/13/2004
`
`Day 28
`
`Date of Sample:
`
`08/10/2004
`
`- - - - - ' ' - ' - - - - - - - - - -
`
`Orn:anism Counts at Dilutions
`
`10-l
`
`10-2
`
`10-3
`
`104
`
`0 "'
`
`~
`/
`~ I/
`/
`~
`v
`
`/
`
`Plate Count
`Average
`
`Initials
`-Date
`(a_
`AC. /0 <l(t3fof
`~
`~10 ~ li~>fo+
`
`10-5
`
`/
`
`/
`
`'-
`
`Test Ornanism
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E. coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`MEDIA:
`
`•
`
`0
`0
`0
`0
`0
`TN1L
`(j\J'fl,r
`3 L/-
`~L,
`
`""
`~
`A:. ( 0
`/
`~ <i: / 13(0~
`"\ ~
`li\ITC
`1&xrar ~
`.J (
`<t/11/otf
`-rnf IC-
`\
`(
`&.
`)
`)
`{
`\
`~/J7/D<f
`~ \osLt-s·. osl-1~
`Saline Lot (tubes):
`Polysaline Lot (tubes):
`
`7(
`gJ
`)
`(
`
`2-
`l3-3 )l /{)
`
`Peptone Lot (bulk):
`
`N/A
`
`MCTA Lot: _____ Waterbath Asset No.:
`
`N/A
`
`Letheen Lot: ______ _ Other: _________________ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`Transfer Log Reference: N/A
`
`
`
`::~:~=By: ~ HH - - ~:::: z;?;~~~------
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051-~"'J-'
`
`•
`
`PRESERVATIVE RAW DATA
`Product: T~~A ~~N-~~~_:-FR~E, -~~ _ _sorbito~-~~-Pr~! Lot number: 04-37160-1
`Sample Timepoint: ------~~X-~~ ____ _
`7/13/2004
`08/10/2004
`On Test:
`Date of Sample: - - - - - - - -
`Oruanism Counts at Dilutions
`
`0
`{)
`0
`........ ""
`0
`"" ~10 ~ /(3{o~
`()
`""
`")
`)
`")
`'?-.
`/
`/
`)
`(
`0
`\
`(
`1~
`TJJU-
`""
`lf, ;> y.df
`I
`)
`{7V re:-
`1~
`MEDIA: -;;~NiA"-sam~~~~1 to5'<f S': o s\- I~
`
`10-5
`
`/
`
`Plate Count
`Averal!e
`
`..c..fO
`
`..c:./O
`
`(
`
`/~o xro
`
`Initials
`-Date
`lffe_
`<6(1~/ov
`t>-
`g le>f of
`(o._
`
`/!A-
`rt ft7/or/
`(&__
`(/;7/orj
`
`I
`
`I
`
`~
`
`Test Ornanism
`
`10-'
`
`10-2
`
`10-3
`
`10-4
`
`0 ""'
`
`"-
`
`..........
`
`v
`
`/
`
`/
`
`v
`
`/
`
`~ v
`/ !~
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`•
`
`Peptone Lot (tubes):
`
`N/A
`
`Sa m
`
`Polysaline Lot (tubes):
`
`Peptone Lot (bulk):
`
`N/A
`
`Saline Lot (bulk):
`
`N/A
`
`MCTA Lot:
`
`________ Waterbath Asset No.: ____ _
`
`Letheen Lot: ______ _ Other: _________________ _
`
`ORGANISMS:
`
`A. niger Preparation Reference: N/A
`
`::~~:::By: ~- m
`
`Transfer Log Reference: N/A
`
`: : : : : ~~to~---
`
`- -
`
`- - -
`
`M40.02
`Rev.10
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`USP PRESERVATIVE EVALUATION SUMMARY
`Product: !~:"-~!~~--~~~=~-~~~~~!?-~l_f"J~-~-~~~-~-1-~-~-------------- ___ _ __
`
`•
`
`Notebook 10545
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`_}
`
`Package:
`
`Procedure No.:
`
`NONE
`
`04-37150-1
`
`INITIAL
`
`Date Assayed: -
`
`Batch No.:
`
`FID No.:
`
`Project No.:
`
`150 ml Bulk
`PROC-0001136, V-2.0
`LIMS No.:
`SUMMARY OF RESULTS
`Organism Counts (CFU/mL or CFU/g)
`
`_____ _ __
`_____ _
`711312004
`
`107337
`
`225719
`
`200198154
`
`Test Organisms
`
`Initial
`
`7 Day
`
`14 Day
`
`28Day
`
`•
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C. albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`5
`tj./ x llJ
`
`.5
`/./ x 10
`
`3
`9.tx 10
`
`'J'
`/.5 x.10
`
`s
`q.1 x /0
`w
`5
`5
`/.0 x /0 5tJ X!O 3,q XIO
`
`!5
`/.3X 10
`
`I
`I
`/. 1f.t0 </-5x!D
`5
`)..O XIO
`
`5
`1·5X!O
`
`/
`
`:;
`9·5x 10
`
`4'
`
`.!;
`
`5
`6
`(p · ;;., ¥. I 0 63y/0 1,q x 10
`s
`._3.0 x /0 g,5 J. J{}
`
`I
`
`~
`/.1J10
`
`Not Done (ND)
`Limits of Detection Established D ------------------------------------(cid:173)
`Limits of Detection Not Established ~
`
`D Pass USP Requirements Li?'Fail USP ~ /)a,, [e.
`D Pass JP Requirements GrFail JP
`s~t-l-'-11'o---~ .... -I-: e-""-~--=G'------
`
`Analyst: _ _,_~~--------"=----.H-----='----- Date: _g7,~j;_;~z~A~v_51 __
`Date: _rf?_,_f_:?.__,__y/t_11___,y~---
`
`.Verified By:
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`Notebook 10545
`
`Page 051- )..t{
`
`Product: TRAVATAN BAC-FREE, NO BORIC ACID
`
`•
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`Procedure No.:
`
`Date Assayed:
`
`7/13/2004
`
`NONE
`
`04-37152-1
`
`INITIAL
`
`150 ml Bulk
`
`Batch No.:
`
`FID No.:
`
`Project No.:
`
`LIMS No.:
`PROC-0001136, V-2.0
`SUMMARY OF RESULTS
`Organism Counts (CFU/mL or CFU/g)
`
`107339
`
`225719
`
`200198155
`
`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
`
`5
`
`tJ./ x11J
`
`.....
`!/
`
`CJ. t/ 110
`
`L.. 10
`
`L(Q
`
`L
`
`(0
`
`<.. 10
`
`.c:.. 10
`
`~10
`
`-<-fD
`
`~10
`
`t/
`
`?-
`J./. / x f 0 .3.IXIO
`
`';).-
`
`(,
`
`<-10
`
`/. fJ x 10
`!f . 1
`;?. x 1{)
`1.5 XIO
`5
`t/.sx1v
`
`5 ;< /
`5
`~
`/, 0x10 1.qx10
`.5J(10
`
`Not Done (ND)
`Limits of Detection Established D-~---------
`Limits of Detection Not Established ~-
`
`~ss USP Requirements D Fail USP _______ _
`0' Pass JP Requirements D Fail JP
`
`Analyst: --.A-~~~:=..::::::{;;i~~~~=-:---- Date: J/f.? fe</
`Date: _fJ!_:r_,_0_tt_f ___ _
`
`Verified By:
`
`•
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`•
`
`Product: TRAVATAN BAC-FREE, 85% ZnCL&BA
`
`Notebook 10545
`
`Page 051-Js"
`
`Date Assayed:
`
`7/13/2004
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`Procedure No.:
`
`NONE
`
`04-37156-1
`
`INITIAL
`
`150 ml Bulk
`
`Batch No.:
`
`FID No.:
`
`Project No.:
`
`107341
`
`225719
`
`200198156
`
`PROC-0001136, V-2.0
`LIMS No.:
`SUMMARY OF RESULTS
`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
`9./ K/0
`
`I
`4.0xtO
`
`5
`tJ.fj xi()
`
`2-
`/.!5x 10
`
`~tcJ
`
`Lf0
`
`ztO
`
`L- ({)
`
`.(,p
`/. {) XID
`
`5
`1.5x10
`
`:a
`ef ft,yrO
`5
`1-/3 x /{}
`
`3
`9.5x1cf
`31x1{)
`
`'-10
`
`.::.. 10
`
`5
`J.-/ XIO
`
`t/-
`f.f1x10
`,...
`I
`~· 0 K 10 1·1xtfJ
`
`Not Done (ND)
`Limits of Detection Established D-~-----------
`Limits of Detection Not Established B'"
`
`~~s USP Requirements D Fail USP _______ _
`~Pass JP Requirements D Fail JP
`
`Analyst: ~.l-LU· ~~~~~~--==~--- Date: ~gr;~"j.-~~/t_V-7'$1'_· __ _
`l/7/dJ__ __
`
`Date:
`
`.VerifiedBy: ___
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`Notebook 10545
`
`Page 051- ~
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`Product: !_~ V ~ T ~N ~~~--=~~-~!!. __ ~~~-~~~~~------------------------------------------------------
`
`•
`
`Preservative:
`
`NONE
`
`Date Assayed:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`04-37157-3
`- - - - - - - - - - - -
`INITIAL
`- - - - - - - - - - -
`150 ml Bulk
`- - - - - - - - - - - - -
`Procedure No.:
`PRO C -0001136, V-2.0
`LIMS No.:
`SUMMARY OF RESULTS
`
`Batch No.:
`
`FID No.:
`
`Project No.:
`
`7/13/2004
`· - - - - - - - - - -
`
`107047
`
`225719
`
`200197918
`- - -
`
`Organism Counts (CFU/mL or CFU/g)
`
`Test Organisms
`
`Initial
`
`7 Day
`
`14 Day
`
`28Day
`
`•
`
`S. aureus
`ATCC 6538
`
`P. aeruginosa
`ATCC 9027
`
`E.coli
`ATCC 8739
`
`C albicans
`ATCC 10231
`
`A. niger
`ATCC 16404
`
`5
`Cl/ x10
`
`I
`rt.5fr0
`
`LIO
`
`<!_ 10
`
`5
`q.9x1tJ
`
`I
`3.oxrO
`
`b
`/.0x10
`
`t/
`/.1x1tJ
`
`LIQ
`
`.,L.
`
`/c)
`
`~10
`
`.c_f0
`
`5
`5
`l/5x10 J./ XltJ
`
`'f
`
`'7& x ro
`
`J.5x1r!
`q -
`-3
`5'
`.!) )\ 10 50X!O
`
`~
`
`;. {p x 10 3-3Xf0
`
`'2..-
`
`Not Done (ND)
`Limits of Detection Established 0 _____________ _
`Limits of Detection Not Established ~
`
`~s USP Requirements D Fail USP _______ _
`IB"" Pass JP Requirements D Fail JP
`
`Analyst: ____,~~~~-~--/--.PL-----='-"---- Date: -~/i-~_'IJ'/_~_iJ.,_,'f_· __
`f>jy J/t::t,,_y __ _
`
`Date:
`
`.Verified By:
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`USP PRESERVATIVE EVALUATION SUMMARY
`
`•
`
`Product: TRAVATAN BAC-FREE, No Sorbitol or ProlGlycol
`
`Notebook 10545
`
`Page 051-~1
`
`Date Assayed:
`
`711312004
`
`Preservative:
`
`Lot Number:
`
`Stability Data:
`
`Package:
`
`Procedure No.:
`
`NONE
`
`04-37160-1
`
`INITIAL
`
`150 ml Bulk
`
`Batch No.:
`
`FID No.:
`
`Project No.:
`
`107340
`
`225719
`
`200198273
`
`PROC-0001136, V-2.0
`SUMMARY OF RESULTS
`Organism Counts (CFU/mL or CFU/g)
`
`LIMS No.:
`
`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
`t):1 x10
`
`5
`fJ.4~10
`
`(,
`/.0~1/J
`
`L/Q
`
`<fO
`
`.L 10
`
`~10
`
`<... (0
`
`~10
`
`..L 10
`
`-< I 0
`
`...::.. /D
`
`1.6x1o'
`
`5
`t/5/( 1()
`
`5
`5
`/.f XIO
`71-f '>< 10
`1 5.tt; '/-10
`.3-Lf '110
`
`3
`
`I
`/.Ox 10
`
`3
`. P..x 10
`
`Not Done (ND)
`Limits of Detection Established D ~
`Limits of Detection Not Established ~
`
`~yss USP Requirements D Fail USP _______ _
`GJ1>ass JP Requirements D Fail JP
`
`Analyst: _ _____!_~~~~~=t;::d~~~~~ Date: ~f't~*~~~~-C:'.'.1_,.y: __ _
`Date: _fj-+r-· _.?_,.{/._t?_,__]"' __ _
`
`··verified By:
`
`M40.03
`Rev.6
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`
`
`~
`
`I
`
`'--~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~_JV\
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