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`re . ··-···· . ---···-----·· .. -.. ·-·····-·-.---·----..
`,,.-- ~ . .
`.... _/
`• • •
`
`Date
`5-4-01
`CONFIDENTIAL – PROTECTIVE ORDER MATERIAL
`
`__ .... _ _..,..
`
`~------·-·-·-..,......·--
`
`Entered By:
`~~
`
`ALCON 2022
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`

`

`Book:
`
`\ ~03L\ Page: C>9,\ - ,?.,
`
`EQUIPMENT FOR PET TESTING:
`
`Asset#
`A1692
`10-1367
`
`N11ma:
`D Microscope# 13
`D Balance# 10
`
`D (3) A. niger. Weekly & Daily Preparations
`Name:
`Incubator I 16 (20-25"C)
`CentrifUge # 3
`Laminar Flow Hood #1
`Spectrophotometer# 12
`Refrigerator # 19
`Electronic Repeater P4'ettor Model Plus(# 41)
`Refrioerator # 22
`
`O (8) Sharon Fowler (Purple Tape)
`Name:
`Water Bath #25
`Incubator #19 (20-25°C)
`Incubator 120 (30-35°C)
`Electronic Repeater P~ttor Model Plus (#48)
`Thermometer#
`o Milliflex Unit #17 (check if necessary)
`Other:
`D (9) LaFonda Somerville (Rose Tape)
`Name:
`Water Bath #6
`Incubator# 16 (20-25"C)
`Incubator #20 (30-35°C)
`Electronic Repeater Pipettor Model Plus (#49)
`Thermometer #
`o M illiflex Unit #21 {check if necessary)
`Other:
`:::J (10) Cade Pippin (Orange Tape)
`Name:
`Water Bath #21
`Incubator# 16 (20-25°C)
`Incubator #20 (30-35°C)
`Electronic Repeater Pipettor Model Plus (#47)
`Thermometer #
`o Millinex Unit #2 (check if necessary)
`Other:
`O (11) Other:
`Name:
`
`Asset#
`10-11n
`102619
`10-1367
`A0762
`
`Asset#
`A0083
`102619
`10-1177
`A1594
`
`103169
`
`Asset#
`A0329
`102619
`10-1177
`A0975
`
`103168
`
`Asset#
`A2595
`102619
`10-1177
`A1443
`
`102970
`
`Asset#
`A2594
`10-1023
`102620
`A2591
`
`1) General Equipment
`ame:
`D 2Pectrophotometer #12
`e( Ref erator # 22
`
`0 (2) Stock Cultures, Culture Transfers
`Name:
`Incubator# 15 (30-35°C)
`Incubator# 19 (20-25"C)
`Refrigerator # 22
`Refrigerator # 19
`DOther:
`DOther:
`D Other:
`
`Individual Eau/1Jment:
`G--(4) Cristina Gutierrez (Aqua Tape)
`Name:
`Water Bath #22
`lnctJ>ator #19 (20-25"C)
`lnctJ>ator #15 (30-35"C)
`Electronic Repeatef Pipettor Model Plus (1'46)
`Thermometer# s.~ 51~~~ l 9 ~
`D Millinex Unit #20 (check if necessary)
`Olher:
`O (5) Elise Miller (Grey Tape)
`Name:
`Water Bath #26
`lncubator#19 (20-25"C)
`lncubator#15 (30·35°C)
`Electronic Repeater Pipettor Model Plus (#34)
`hermometer #
`Milliflex Unit #19 (check if necessary)
`Other:
`0 (6) Kathleen Afford (Red Tape)
`Name:
`Water Bath #30
`Incubator #19 (20-25"C)
`Incubator #15 (30-35°C)
`Electronic Repeater Pipettor Model Plus (#42)
`Thermometer #
`o Mllliflex Unit #16 (check if necessary)
`Other:
`O (7) Na'Kedra Higgins (Pink Tape)
`Name:
`Water Bath #29
`Incubator# 16 (20-25°C)
`Incubator #20 (30-35°C)
`Electronic Repeater Pipettor Model Plus (#74)
`Thermometer #
`Other:
`
`I Comments'
`
`Asset #
`A0885
`13900
`
`Asset#
`10-1023
`1-3832
`13606
`A-1692
`A0762
`A1442
`
`Asset#
`A0328
`102619
`102620
`A1596
`
`10-2969
`
`Asset#
`32523
`10-1023
`102620
`A1793
`
`1031 70
`
`Asset#
`A0038
`10-1023
`102620
`A1595
`
`1-7716
`
`Asset#
`
`ANALYST ~,~
`_Ii.vi
`
`•
`
`VERIFIED BYo _
`
`_
`
`_
`
`M11.12 Rev. 1
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`..... :t_._-_c "'\-"--(cid:173)
`DATE: __ '-\.....__-:J.
`
`DATE: ____._4......;:- d'--"1.......,--0;...../ _
`
`_
`
`

`

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`
`FB_BatchRop.04.LIMS039.2.052005.P0002254
`
`Batch#: 07-47278
`
`Database: LIMSAR
`
`y ! folcJT
`
`Date:
`
`Approved by: ~~
`
`'--1-fa....::;)
`
`Date: 10-APR-2007
`
`Record Created by: a~ MCMILLEN
`Compounded by: L/h 6;rJ Date:
`
`Tare Wt.:•t; C., 7'S';
`
`Osmolallty: ~
`
`Final pH= 7. S'-1
`
`Initial pH= 4. 7 ct
`
`Date
`
`Data
`
`Weighed By/ Witnessed by/
`
`Date
`
`Expiration
`
`Lot ID
`
`Actual Amt
`
`Cale Amt.
`
`Grade Concentration
`
`03g
`
`6259
`
`25g
`
`g
`
`I /V
`
`tJRIFIED WATER
`
`ODIUM HYDROXIDE
`
`.HYDROCHLORIC ACID
`
`INC CHLORIDE
`
`ROPYLENE GLYCOL
`
`Component
`
`FID Life Cycle: Exploratory
`
`Reference Number: LN 13292:45
`
`AL-37807 vehicle V'lith 0.012% Zinc Chloride at pH 7.5
`
`Formulation ID: 112294 V.
`Batch Number: 07-47278
`
`Page 1of1
`
`10-APR-2007 08:11am
`Batch Report
`
`e
`
`Report Date:
`
`e
`
`Alcari
`
`R&D LIMS
`
`e
`
`External: N
`Jurisdiction: US Only
`
`Location: R&D FORT WORTH
`
`zatus; SCHEDULED
`
`'Ii !o/tE!=
`
`Date
`
`Bate~ Pre Approved By _(li...:;;:i""~..;.....~t ... a.£:=::::..i......... _______ _
`
`Comments:
`
`Batch Density:
`Target pH: 7.5
`
`Target Batch Weight (g): 250
`
`Units: ml
`Project Num: 225692
`
`Batch Size: 250 ml
`Dosage Form: SOLUTION
`Primary Purpose: MICROBIOLOGY
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`~ -I
`
`0
`,C ..
`~
`µ
`
`,.I:.
`
`FB_BalchRep.04.LIMS039.2 .052005, P0002254
`
`Batch#: 07-47249
`
`Database: LIMSAR
`
`le ( r:::t--
`r ... WL' ~o7.:<'ly Final Wt., ~ '%: ')') ~ Batch Wt.' GI.~· OI ~
`
`<2[f {f?1?
`
`Approved by:
`
`Date: L{
`
`Date. 06-APR-2007
`
`'t -b -.o)
`
`Data:
`
`Osmolallty: :J'=:)
`
`J.b.-.....et)=! ~ J
`S. 5(:.
`
`7/
`
`I N
`
`s to 100%
`sto pH s.s
`s to pHS~)
`
`0&25g
`
`(625g
`
`sto100%
`s tO pH 5.5
`Stopl·:CS.S
`
`25°k WN t/O
`.25% WN 'lo
`
`.0
`
`.1%WN%
`
`Date
`
`Date
`
`Witnessed by/
`
`Weighed By/
`
`Lot ID
`
`Actual Amt
`
`Cale Amt.
`
`Grade Concentration
`
`Record Croated by.
`
`Compounded by:
`
`Initial pH = 1~ • 8' L/-
`
`rRIFIED WATER
`
`OIUM HYORO)<IOE
`
`ANNITOL
`
`-M
`
`PROPYLENE GLYCOL
`Component
`
`External: N
`
`Jurisdiction: US Only
`
`L(-~ -tJ/
`Status: SCHEDULED
`
`Batch Density:
`
`Date
`
`Target Batch Weight (g): 250
`
`Batch Pre Approved By ~h
`/
`
`d
`
`Comments:
`
`Batch Size: 250 ml
`
`Location: R&D FORT WORTH
`
`FID Life Cycle: Exploratory
`
`Target pH: 5.5
`Reference Number: LN 13292:38
`
`Units: ml
`Project Num: 225692
`
`Dosage Fonn: SOLUTION
`
`Primary Purpose: MICROBIOLOGY
`
`AL-37807 vehicle with Zinc Chloride and Prop. Gly. at pH 5.5
`
`Formulation ID: 112286 V.
`Batch Number: 07-47249
`
`Pago 1of1
`
`06·APR·2007 07:59am
`Batch Report
`
`e
`
`Report Date:
`
`e
`
`Alcari
`
`R&D LIMS
`
`e
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`
`-~
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`
`FB_BatehRep.04.LIMS039 2.052005.P0002254
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`Batch#: 07-47250
`
`Database: LIMSAR
`
`1.1/1; fO:.
`
`~so. oS.J
`
`•••• ,
`
`... .,...by' ~ u
`•>
`Tare Wl: 1<i7. 4~Flnalwt.A'?J/, ·c_, ~.
`
`Compounded by: ;)/ct <CH l'n ~ Date: '1-~ -OJ
`Osmolallty: "2-'-5
`lnltlal pH= ~ "· 5/
`
`Date: 06-APR-2007
`
`Record Created by:
`
`"I' I< IT
`
`I .. A .I 11
`
`• -r -
`
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`I.
`
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`j 31-Jul-2007
`
`z ·
`
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`
`I 07-46291:-1
`
`(1 f'J) I -
`
`• I 111 <: 07-46293-1
`00197505
`
`.::; . 0403
`'> . (. -:.7;_) 00202476
`00199672
`
`Date
`
`Date
`
`Weighed By/ Witnessed byl
`
`Expntlon
`
`pate
`
`00201560
`
`Lot ID
`
`Actual Amt
`
`as to DH 6.5
`0625g
`
`rs to pH 6.5
`
`625g
`59
`
`tF_r'~ pH 6.5
`
`QS to oH 6.5
`o.0250/o WN %
`
`025"A. WN %
`
`NF
`µsp
`
`"'F
`
`CalcAmt.
`
`Grad• Concentration
`
`'.PURIFIED WATER
`I OfU~ HYOROXl~E --~-~
`HYDROCHLORIC ACID
`
`~NC CHLORIDE
`
`BORIC ACID
`
`GLYCOL
`
`FID Life Cycle: Exploratory
`
`Ref'erence Number: LN 13292:39
`
`AL-37807 vetilcle with Zinc Chloride and Prop. Gly. at pH 6.5
`
`Formulation ID: 112287 V.
`Batch Number: 07 -47250
`
`Page 1 of1
`
`06-APR-2007 08:03am
`Batch Report
`
`Report Date:
`
`e
`
`e
`
`• Alcari
`
`R&DLIMS
`
`External: N
`
`Jurisdiction: US Only
`
`Location: R&D FORT WORTH
`
`'f. {p.-07
`Status: SCHEDULED
`
`Date
`
`Batch Pre Approved By __ .... /6'--"'----L~-----------
`Comments:
`
`~ /
`
`/ J
`
`Batch Density:
`Target pH: 6.5
`
`Target Batch Weight (g): 250
`
`Batch Size: 250 ml
`
`Units: ml
`Project Num: 225692
`
`Dosage Fonn: SOLUTION
`Primary Purpose: MICROBIOLOGY
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

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`LOQ10
`
`Date Assayed 4/1112007
`
`LIMS No 200250592
`
`•
`
`--
`
`----------
`
`Preservative NONE
`
`Proc No. PROC-0001139 V4.0
`
`---
`
`225692
`
`Date: t\-30-0]
`
`Analyst: ~ • .t\.w:h.u-ug,
`
`Rev.10
`M44.11
`
`I I PROJECTED TO:
`
`Peptone Rinse
`
`, \
`
`• ~ I 01-'{111ou.-1 lo-t -4<P~ct
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`Peptone
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`Dav 7
`Initial
`Dav7
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`Day 7
`24 hour
`6 hour
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`Date of
`
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`Initial
`References
`Media/Org.
`
`ATCC 16404
`A. niger
`ATCC 10231
`C. albicans
`
`ATCC 8739
`E.coli
`
`ATCC 9027
`P. aeruginosa
`
`ATCC 6538
`S. aureus
`Organism
`Test
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`
`Ori:ianism Counts at Dilutions
`
`Project
`
`Age initial
`
`Lot Number 07-47278, initial
`
`Formulation/Product 112294 AL-37807 VEHICLE WITH 0.012% ZINC
`
`PRESERVATIVE scl!N DATA AND S~MMARY
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`~
`~
`
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`Date: tJ-L{-0/
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`Verified by: i1Mz YJ!lllkJ.
`
`<Y'Fail PhEur B c;g E.!!..
`G-Fail PhEur A Sai,~,tj:_, e oL
`0 Fail JP --------
`0 Fail USP -------
`
`.)
`
`0 Pass PhEur B
`0 Pass PhEur A
`Gi>ass JP
`G1>ass USP
`PROJECTED TO:
`
`...... _. ~·· ~ .
`·:g_,,.
`
`-
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`. -
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`-
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`1 .o~q: c"t1-lo
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`Preo. Ref.
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`Temp C°C)
`Waterbath Transfer
`
`Asset No.
`Waterbath
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`MCTA
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`Ll!. 4.-~~·01
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`LIMS No 200250480
`
`Date Assayed 4/11/2007
`
`•
`
`Proc No. PROC-0001139 V4.0
`
`Preservative NONE
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`For Filtration Tests onlv:
`Day 7
`24 hours
`6 hours
`Initial
`References
`···--·-
`
`Le.,m~
`
`Analyst: ~·~ ~ Date: 4.-30-0\
`
`Re11.10
`M44.11
`
`Dav 7
`24 hours
`6 hours
`
`Peptone Rinse
`
`·~ MCTA Cassettes I Funnels
`
`PRESERVATIVE SC.N DATA AND SUMMARY
`
`Formulation/Product 112286 AL-37807 VEHICLE WITH ZINC CHLORI
`
`•
`
`l.D ~
`
`I I
`\ l\U,
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`. ·. . : ~.~.i: ··~·, .... 't. .~ •
`10·2
`
`Organism Counts at Dilutions
`225692
`
`Project
`
`Age initial
`
`\l\)'T' c.
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`Ll-11?>.-cri Dav 7
`11..l -l\ -01
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`Initial
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`24 hour
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`L\-l~-IY1 24 hour
`1..\-\\-04
`6 hour
`Initial
`1.\-\\-01
`Sample
`Date of
`
`-\\-01
`
`14
`
`14
`
`11
`
`ATCC 16404
`A. niger
`ATCC 10231
`C. albicans
`
`ATCC 8739
`E.coli
`
`ATCC 9027
`P.aeruginosa
`
`ATCC 6538
`S. aureus
`Organism
`Test
`
`Lot Number07-47249, initial
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`~
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`
`Date Assayed 4/11/2007
`
`LIMS No 200250481
`
`•
`
`-
`
`10·5
`
`Proc No. PROC--0001139 V4.0
`--------
`
`Preservative NONE
`
`lD.O 'JC \O~
`1.'4 'JC 11'\5
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`Verified by:~ ~ Date: 5-qff]
`
`Prep. Ref.
`A. niger
`
`Loa Ref.
`Temo C°Cl
`Waterbath Transfer
`
`~ --
`
`0 Fail PhEur B -------
`e-Fail Ph Eur A 'Sot..~ Ee.
`0 FailJP --------
`0 Fall USP --------
`
`.,----
`
`-
`
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`
`.
`
`G--Pass Ph Eur B
`0 Pass Ph Eur A
`0"Pass JP
`CYPass USP
`PROJECTED TO
`
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`0
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`
`10""
`
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`
`-
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`-
`
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`
`-
`
`-
`
`PRESERVATIVE scl:N DATA AND SUMMARY
`
`Formulation/Product 112287 AL-37807 VEHICLE WITH ZINC CHLORI
`
`24 hour
`6 hour
`Initial
`
`Time
`
`Sampling
`
`24 hour
`6 hour
`Initial
`4-IB-OI Day 7
`L\ -I 1 . .-C>1
`L\-l\-01
`4-\\-C..,
`Sample
`Date of
`
`ATCC6538
`S. aureus
`Organism
`Test
`
`4-t~-oi Dav 7
`Initial
`4•1\•0,
`'-1.-1~-01 Dav 7
`1..\-l\-01
`Initial
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`1..\.-1:2..-01
`24 hour
`Ll-l\-01
`6 hour
`i..\.-\\-01
`Initial
`[l.\.-\~-01 Day 7
`4.-\1-01
`ILl-\\-01
`ATCC 9027
`P.aeruginosa L\-l\-01
`
`ATCC 16404
`A. niger
`ATCC 10231
`C. albicans
`
`ATCC 8739
`E.coli
`
`Lot Number 07-47250, initial
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`\ °'
`
`. ..
`0
`. '61
`\NTC
`
`,.
`()
`~C\
`
`I
`
`'""t'N't"'r
`' --
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`
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`
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`
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`
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`
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`
`Organism Counts at Dilutions
`225692
`
`Project
`
`Age initial
`
`L\. ·20 -01
`
`Analyst: t Ht n~ ~ Date:
`
`Rev.10
`M44.11
`
`Dav 7
`24 hours
`6 hours
`
`Peptone Rinse
`
`I MCTA Cassettes I Funnels
`
`~
`
`( ~"
`
`. .
`
`-
`
`-
`
`MCTA
`
`Ctubes)
`Polysaline Polysaline
`
`(bulk)
`
`(bulk)
`Peptone
`
`ftubes)
`Peptone
`
`For Filtration Tests only:
`Day 7
`24 hours
`6 hours
`Initial
`References IJ!tneA~
`
`. ----.....
`
`. ·~ n
`
`..
`
`

`

`AIPetResults.05.UMS 126.0.072004
`
`Database: LIMSAR
`
`_;
`
`...D
`0
`~ . ,
`().>
`0
`
`
`-~
`
`Report Approved by: Elise Miller on 04-MAY-2007 03:45pm
`
`Projected to Pass USP, JP. EPB: Projected to Fail EPA (Sa,Pa,Ec,An)
`
`Comments:
`Result Summary:
`
`Limits of Detection: Not Established
`
`8.0E4
`9.3E2
`<10
`<10
`<10
`
`2.6E4
`3.9E2
`3.8E2
`
`1.9E5
`4.4E4
`6.7E4
`
`USP: PROJECTED PASS
`PH-EUR B: PROJECTED PASS
`PH-EUR A: PROJECTED FAIL
`JP: PROJECTED PASS
`
`1.7E6
`6.0E5
`1.1E6
`8.1E5
`1.1E6
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`TDAY
`
`24 HR
`
`6HR
`
`INIT
`
`301401682 , 301401684
`
`12034:091
`
`Ref#:
`Project No.: 225692
`Preservative: NONE
`Task IDs:
`
`Package: 150ml plastic Millipore
`Stability Data initial
`Product: AL-37807 VEHICLE WITH 0.012% ZINC
`Submission ID: 100096214
`
`container/150ml
`
`PET SCREEN INTERNATIONAL
`
`Method:
`Date Assayed: 11-APR-2007
`Series No.:
`User Sample ID: 07-47278, initial
`Sample ID:
`
`200250592
`
`Page 1 of 1
`
`Report Date: 15-MAY-2007 03:15 PM
`
`(MTP PROC-0001139 (V-4.0))
`SCREEN IN.NATIONAL Preservative Evaluation &mary
`
`• Alcari
`
`R&D LIMS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`AIPetResults.05. LIMS 12e.0.072004
`
`Database: LIMSAR
`
`0
`l ,,....
`' 51
`
`
`-~
`
`,I::.
`v>
`
`Report Approved by: Elise Miller on 04-MA Y-2007 03 :45pm
`
`(Sa, Ee)
`Projected to Pass USP, JP; Projected to Fa~ EPA (Sa,Pa,Ec,Ca) & EPB
`
`Comments:
`Result Summary:
`
`Limits of Detection: Not Established
`
`9.0E3
`6.2E4
`6.4E3
`<10
`7.0E1
`
`1.5E5
`5.9E3
`6.7E5
`
`4.5E5
`4.8E4
`9.6E5
`
`USP: PROJECTED PASS
`PH-EUR B: PROJECTED FAIL
`PH-EUR A: PROJECTED FAIL
`JP: PROJECTED PASS
`
`1.7E6
`6.0E5
`1.1E6
`8.1E5
`1.1E6
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`7DAY
`
`24 HR
`
`6HR
`
`INIT
`
`3014C0921 , 301400923
`
`12034:091
`
`Ref#:
`Project No.: 225692
`Preservative: NONE
`Task IDs:
`
`Package: 150mL Millipore filter uniV150mL
`Stablllty Data initial
`Product: AL-37807 VEHICLE WITH ZINC CHLORI
`Submission ID: 100096141
`
`PET SCREEN INTERNATIONAL
`
`Method:
`Date Assayed: 11-APR-2007
`Series No.:
`User Sample ID: 07-47249, initial
`Sample ID:
`
`200250480
`
`Page 1 of 1
`
`Report Date: 15-MAY-2007 03:16 PM
`
`(MTP PROC-0001139 (V-4.0))
`SCREEN IN.NATIONAL Preservative Evaluation &mary
`
`• Alcari
`
`R&DLIMS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`~
`-F;
` \.))
`
`-~
`
`,(cid:173)-
`
`AIPetResults.05 LIMS126.0.072004
`
`Database: LIMSAR
`
`Report Approved by: Elise Miller on 04-MAY-2007 03:45pm
`
`Projected to Pass USP,JP,EPB; Projected to Fail EP~ (Sa,Pa,Ec)
`
`Comments:
`Result Summary:
`
`Limits of Detection: Not Established
`
`1.9E4
`6.1E3
`<10
`<10
`<10
`
`5.1E4
`5.6E2
`6.0E3
`
`3.2E5
`2.9E4
`7.4E5
`
`USP: PROJECTED PASS
`PH-EUR B: PROJECTED PASS
`PH-EUR A: PROJECTED FAIL
`JP: PROJECTED PASS
`
`1.7E6
`6.0E5
`1.1E6
`8.1E5
`1.1E6
`
`ATCC16404
`ATCC10231
`ATCC8739
`ATCC9027
`ATCC6538
`
`Test Organism
`
`70AY
`
`24HR
`
`6HR
`
`INIT
`
`301400926 ,301400928
`
`12034:091
`
`Ref#:
`Project No.: 225692
`Preservative: NONE
`Task IDs:
`
`Package: 150mL Millipore filter uniU150mL
`Stability Data initial
`Product: AL-37807 VEHICLE WITH ZINC CHLORI
`Submission ID: 100096142
`
`PET SCREEN INTERNATIONAL
`
`Method:
`Date Assayed: 11-APR-2007
`Serles No.:
`User Sample ID: 07-47250, initial
`Sample 10:
`
`200250481
`
`Page 1 of 1
`
`Report Date: 15-MAY-2007 03:16 PM
`
`(MTP PROC-0001139 (V-4.0))
`SCREEN IN.NATIONAL Preservative Evaluation &mary
`
`• Alcari
`
`R&DL/MS
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Alcari
`R&DLIMS
`
`•
`
`\~o3 4_: oci l - \~
`Intermediate Sample Results Report
`Report Date: 15-MAY-2007 03:17 PM
`
`Page 1of 1
`
`LIMS Submission ID : 100096214
`Requester
`: Bhagwati Kabra
`: FORMULATION DEVELOPMEN
`Customer Datagroup
`Logged By
`: MCMILLEN
`
`Project Number
`Mail Code
`Telephone Extension :
`CC: Reports To
`
`225692
`R1-26
`8328
`KABRA
`
`Sample Information
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`=200250592
`: 07-47278, initial
`: 112294 AL-37807 VEHICLE WITH 0.012% ZINC
`:SOLUTION
`:A NEW MATERIAL TYPE
`: MICROBIOLOGY
`: PET LAB
`: 04/10/2007
`
`: initial
`AGE
`: 04-24-07
`DATE NEEDED
`: MICROBIOLOGY
`LABORATORY
`: 1
`NUMBER OF UNITS
`: 150ml plastic Mllllpore container/150ml
`PKG/FILL VOL
`: MICROBIOLOGY STUDY
`PURPOSE
`STORAGE CONDITION : RT.AMBIENT
`
`Result Information
`Task ID
`Component
`301401682 USP
`301401682 PH-EUR A
`301401682 PH-EUR B
`301401682 JP
`301401682 RESULT SUMMARY
`
`301401682 LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`301401682 PET SCREEN INTERNATIONAL
`
`REFERENCE NVMBE.R
`WORK DONE BY
`PROCEDURE NUMBER
`DATE RECEIVED
`DATE ON TEST
`
`PRESERVATIVE
`
`12034:091
`. GUTIERREZC
`PROC.0001139 (V-4.0)
`. 10-APR--07
`11-APR--07
`NONE
`
`Units
`
`Rep
`
`Result Value
`PROJECTED PASS
`PROJECTED FAIL
`PROJECTED PASS
`PROJECTED PASS
`Projected to Pass USP, JP, EPB;
`Projected to Fail EPA (Sa,Pa,Ec,An)
`Not Established
`
`Procedure
`
`PET SCREEN
`INTERNATIONAL
`
`Method
`Oatagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Elise Miller on 04-MAY-2007 03:45pm
`
`Database: LIMSAR
`
`AISampleResults.07.LIMS110.1.012004.P0002241
`
`•
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Alcari
`R&DLIMS
`
`•
`
`\~a3Ll~ o"t l -l )
`Intermediate Sample Results Report
`Report Date: 15-MAY-2007 03:18 PM
`
`Page 1 of 1
`
`LIMS Submission ID : 100096141
`Reauester
`: Bhagwati Kabra
`Customer Datagroup
`: FORMULATION DEVELOPMEN
`Logged By
`: MCMILLEN
`
`Project Number
`Mail Code
`Telephone Extension :
`CC: Reports To
`
`225692
`R1-26
`8328
`KA BRA
`
`Sample lnfonnation
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`=200250480
`: 07-47249, initial
`: 112286 AL-37807 VEHICLE WITH ZINC CHLORI
`:SOLUTION
`:A NEW MATERIAL TYPE
`: MICROBIOLOGY
`: PET LAB
`: 04/06/2007
`
`AGE
`DATE NEEDED
`LABORATORY
`NUMBER OF UNITS
`PKG/FILL VOL
`PURPOSE
`STORAGE CONDITION
`
`: initial
`:04-20-07
`: MICROBIOLOGY
`: 1
`: 150mL Millipore filter unit/150mL
`: MICROBIOLOGY STUDY
`: RT ,AMBIENT
`
`Result Information
`Task ID
`Component
`301400921 USP
`301400921 PH-EUR A
`301400921 PH-EUR B
`301400921
`JP
`301400921 RESULT SUMMARY
`
`301400921
`
`LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`301400921 PET SCREEN INTERNATIONAL
`
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DATE RECEIVED
`DATE ON TEST
`PRESERVATIVE
`
`. 12034:09 I
`GUTIERREZC
`PROC-0001139 {V-.f 0)
`09·APR.()7
`11-APR.()7
`. NONE
`
`Units
`
`Rep
`
`Result Value
`PROJECTED PASS
`PROJECTED FAIL
`PROJECTED FAIL
`PROJECTED PASS
`Projected to Pass USP, JP; Projected
`to Fail EPA (Sa.Pa.Ee.Ca) & EPB
`(Sa,Ec)
`Not Established
`
`Procedure
`
`PET SCREEN
`INTERNATIONAL
`
`Method
`Datagroup
`
`Condition
`
`MICRO-ALL
`
`APPROVED
`
`Report Approved by: Elise Miller on 04-MAY-2007 03:45pm
`
`Database: UMSAR
`
`AISampleResutts.07.LIMS110.1.012004.P0002241
`
`•
`
`•
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`

`

`Alcari
`R&DLIMS
`
`•
`
`\~0~4: o~ l-\<4
`Intermediate Sample Results Report
`Report Date: 15-MAY-2007 03:18 PM
`
`Page 1 of 1
`
`LIMS Submission ID: 100096142
`Requester
`: Bhagwati Kabra
`Customer Datagroup
`: FORMULATION DEVELOPMEN
`Logged By
`: MCMILLEN
`
`Project Number
`Mail Code
`Telephone Extension :
`CC: Reports To
`
`225692
`R1 -26
`8328
`KABRA
`
`Sample lnfonnation
`
`LIMS Sample ID
`Sample Description
`Sample Type
`Material Name
`Material Type
`Laboratory/Supv.
`Specific Location
`Date Logged
`
`=200250481
`: 07-47250, Initial
`: 112287 AL-37807 VEHICLE WITH ZINC CHLORI
`: SOLUTION
`:A NEW MATERIAL TYPE
`: MICROBIOLOGY
`:PET LAB
`: 04/0612007
`
`AGE
`DATE NEEDED
`LABORATORY
`NUMBER OF UNITS
`PKG/FILL VOL
`PURPOSE
`STORAGE CONDITION
`
`: initial
`: 04-20-07
`: MICROBIOLOGY
`: 1
`: 150ml Millipore filter uniU150ml
`: MICROBIOLOGY STUDY
`: RT.AMBIENT
`
`•
`
`•
`
`Result Information
`Component
`Taskm
`301400926 USP
`301400926 PH-EURA
`301400926 PH-EUR B
`301400926 JP
`301400926 RESULT SUMMARY
`
`301400926 LIMITS OF DETECTION
`
`Task Information
`
`Task ID
`
`Method
`
`301400926 PET SCREEN INTERNATIONAL
`
`REFERENCE NUMBER
`WORK DONE BY
`PROCEDURE NUMBER
`DATE RECEIVED
`DA TE ON Tr.ST
`PRESERVATIVE
`
`12034:091
`GUTIERREZC
`PROC-0001139 (V-4.0)
`. OQ-APR--07
`. t 1-APR-07
`NONE
`
`Units
`
`Rep
`
`Result Value
`PROJECTED PASS
`PROJECTED FAIL
`PROJECTED PASS
`PROJECTED PASS
`Projected to Pass USP,JP,EPB;
`Projected to Fail EPA (Sa.Pa.Ee)
`Not Established
`
`Procedure
`
`PET SCREEN
`INTERNATIONAL
`
`Method
`Data group
`
`Condition
`
`MICRO.ALL
`
`APPROVED
`
`Report Approved by: Elise Miller on 04-MAY-2007 03:45pm
`
`Database: LIMSAR
`
`AJSampleResults.07.LIMS 110.1.012004.P0002241
`
`CONFIDENTIAL – PROTECTIVE ORDER MATIERAL
`
`