isolator ispe study 2008 copy
TRANSCRIPT
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Lysfjord/PorterFinal Survey Results 2008
Barrier Isolation History and Trends2008 Final Data
Jack Lysfjord, Lysfjord Consulting LLC, Michael Porter, Merck
December, 2008
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Lysfjord/PorterFinal Survey Results 2008
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Filling Barrier IsolatorsWorld-Wide
1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______
84 172 199 256 304 391
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Filling Barrier IsolatorsAsia Only
1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______
11 19 30 42 50 59
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Filling Barrier IsolatorsEurope Only
1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______
57 85 97 116 146 196
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Filling Barrier Isolators North America Only
1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______
35 49 66 90 105 133
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Total
0
5
10
15
20
25
30
35
1985
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Barrier Isolator Filling Line –Deliveries by Year
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Barrier Isolator Filling Line –Deliveries by Year and Region
0
5
10
15
20
25
1985
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Africa Asia Europe Middle East North America
Total Responses: 387
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Asia Total Responses 59
0
1
2
3
4
5
6
7
8
1985
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Barrier Isolator Filling Lines –Deliveries by Year - Asia Only
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Europe Total Responses 193
0
5
10
15
20
25
1985
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Barrier Isolator Filling Lines –Deliveries by Year - Europe Only
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North America Total Responses 132
0
2
4
6
810
12
14
16
18
1985
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Barrier Isolator Filling Lines –Deliveries by Year - North America Only
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Barrier Isolator Filling Lines Companies with Highest Usage
Compaies with more than 5
0
5
10
15
20
25
30
Sanofi Baxter Pfizer J&J GSK Novartis Taiyo Eli Lilly Nipropharma Apotex Merck
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Barrier Isolator Filling Lines –Companies with Highest Usage - Asia Only
0
2
4
6
8
10
12
Taiyo Nipropharma Santen Astellas
Asia
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Barrier Isolator Filling Lines –Companies with Highest Usage - Europe Only
0
5
10
15
20
25
30
Sanofi J&J GSK Pfizer Novartis Pierre Fabre Baxter Crucell Eli Lilly
Europe
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Barrier Isolator Filling Lines –Companies with Highest Usage - North America Only
0
2
4
6
8
10
12
14
16
Baxter Pfizer Apotex Cardinal Health Eli Lilly Tyco Isogen
North America
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Number of Companies Using Barrier Isolation (confidential not included)
(Confidential Not Included)1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______
32 56 67 83 84 99
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Companies Using Barrier Isolation –By Region (confidential not included)
(Confidential Not Included)
Asia Europe NA ______ ______ ______
13 52 46
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Barrier Isolator Filling Lines –Number In Operation
1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______
34 70 90 116 230 283
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Barrier Isolator Filling Lines –Number In Operation - By Region
Asia Europe NA ______ ______ ______
45 123 115
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Barrier Isolator Filling Lines –with Reported FDA Approval
1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______
6 26 52 54 60 72
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Filling Line TypeGlobal
Total Reponses 297
0
50
100
150
200
250
300
Liquid Powder Both
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Filling Line Type Asia Only
Total Responses 50
05
101520253035404550
Liquid Powder Both
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Filling Line Type Europe Only
Total Responses 138
0
20
40
60
80
100
120
140
Liquid Powder Both
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Filling Line Type North America Only
Total Responses 108
0102030405060708090
100
Liquid Powder Both
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Container Type Total Responses 399
0
50
100
150
200
250
Vial / Bottle Syringe/Cart. Ampoule IV Bag Ophthalmic Other
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Container Type Asia Only
Total Responses 62
0
5
10
15
20
25
30
Vial / Bottle Ampoule IV Bag Syringe/Cart. Ophthalmic Other
Asia
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Container Type Europe Only
Total Responses 198
0102030405060708090
100
Vial / Bottle Syringe/Cart. Ampoule Other Ophthalmic IV Bag
Europe
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Container Type North America Only
Total Responses 136
0
10
20
30
40
50
60
70
80
90
Vial / Bottle Syringe/Cart. IV Bag Ophthalmic Ampoule Other
North America
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Maximum Speed
Total Responses 299
0
20
40
60
80
100
120
140
1-100 101-200 201-300 301-400 401-500 501-600 701-800
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Maximum Speed Asia Only
Total Responses 38
02468
1012141618
1-100 101-200 201-300 301-400 401-500 501-600 601-700 701-800
Asia
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Maximum Speed Europe Only
Total Responses 148
05
1015202530354045
1-100 101-200 201-300 301-400 401-500 501-600 601-700 701-800
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Maximum Speed North America Only
Total Responses 112
Europe
0
10
20
30
40
50
60
70
80
1-100 101-200 201-300 301-400 401-500 501-600 601-700 701-800
North America
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Barrier Isolator Construction1998 2000 2002 2004 2006 2008
Soft Wall 9 9 9 9 9 10
Hard Wall 73 134 166 206 244 295___ ___ ___ ___ ___ ___
Total 82 143 175 215 253 305
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Barrier Isolator Surrounding Room Classification
1998 2000 2002 2004 2006 2008
ISO 5 (100) 3 4 5 6 6 9
ISO 6 (1,000) 3 4 7 8 12 12
ISO 7 (10,000) 13 30 40 52 62 71
ISO 8 (100,000) 55 84 105 126 142 192
Unclassified 5 17 7 10 12 13___ ___ ___ ___ ___ ___
Total 79 139 164 202 234 297
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Barrier Isolator Sterilants
Alcohol Wipe 6CLO2 4Formalin 2H2O2 - Fog 11H2O2 - Spray 2H2O2 - Steam 1H2O2 - Vapor 284High Level Disinfectant 1Misc. Peracetic Acid 8Non-Aseptic 1Other 4TBD 1Grand Total 325
} H2O2 Sterilants Account for 92% of Total
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One or Two Piece Gloves Filling Lines
One Piece 111 46% of total Two Piece 130 54% of total Total 241
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Two Piece GloveIs Gauntlet Pleated?
No 103 86% of totalYes 17 14% of totalTotal 120
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Glove Replacement Period
Total Responses 158
0
10
20
30
40
50
60
70
80
EachCycle
3 cycles 6 cycles 2 weeks monthly 2 months 6 weeks 3 months 6 months asneeded
Each NewProduct
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Method for Integrity Testing of GlovesTotal Responses 218
0
20
40
60
80
100
120
140
PressureDecay
Visual Chemical Flow Bubble Test Proprietary Other Conductivity Manual
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Second Disposable Glove Used?
No 24 11% of total
Yes 202 89% of total
Total 226
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Open or Closed Isolator
Open Isolator 201 80% of total
Closed Isolator 49 20% of total
Total 250
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Pressure to Surrounding Rooms (12.5 Pascals = .05” Water)
Total Responses 391
0
10
20
30
40
50
60
70
-175
-125 -25
Neg
ativ
e
Pos
itive
1-10
11-2
0
21-3
0
31-4
0
41-5
0
51-6
0
61-7
0
71-1
00
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Pressure to Washer Rooms (12.5 Pascals = .05” Water)
Total Responses 83
0
5
10
15
20
25
30
35
40
-20 -10 -0.65 1-10 11-20 21-30 31-40 41-50 51-60 61-70 71-80 81-90 91-100
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Sterilizable Cool Zone with Depyrogenation Tunnel Used?
No 47 35% of totalYes 87 65% of totalTotal 134
* Was 49% in 2006
*
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Barrier Isolators Need for Containment?
Yes 90 42% of totalChemical 45Biological 24Antibiotic 7Chemical/Biological 9Chemical/Nuclear 2Radioactive 2Chemical/Radioactive 1
No 124 58% of total214
*
* But 100% of lines added between 2006 & 2008 data
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Do you Campaign Products (run for multiple days)?
No 50 41% of totalYes 71 59% of totalTotal 121
*
*51% in 2006 data
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Campaign Products (longest run)
0
5
10
15
20
25
2 3 4 5 6 7 8 10 14 28
# of Days
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0
50100
150200
250300
350400
450
1985
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Barrier Isolator Filling Line - Cumulative Deliveries
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Department | 1/31/2007 | © 2007 Robert Bosch LLC and affiliates. All rights reserved.
• World-wide increase in filling line isolators continue (391 + increased rate per year)
• Large increase in usage in Europe (50) from 2006• Asia (9) and North America (28) showed moderate growth in 2
years• Isolators are embraced by some companies and avoided by
others• Mergers impact the number of user companies• Data is getting harder to acquire• 92% of isolators are bio-decontaminated with H2O2
Trends and Conclusions
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Department | 1/31/2007 | © 2007 Robert Bosch LLC and affiliates. All rights reserved.
• Vials continue to be the predominant container overall• Syringes are rapidly growing in Europe approaching vials• Use of hard wall designed isolators continues to be predominant• Smooth sleeve gloves are even stronger than 2006 (86%)• Slight preference for 2-piece gloves (54%)• Second glove use increased to 89% (was 83% in 2006)• Containment need is increasing (42% of total) (100% in last two
years)• Campaigning is increasing (59%) (was 51% in 2006)• Sterilizable cool zone use increased to 65% (was 49% in 2006)
Trends and Conclusions
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Department | 1/31/2007 | © 2007 Robert Bosch LLC and affiliates. All rights reserved.
• Benchmarking Information:• Hard Wall Isolator• Vaporized H2O2 Sterilant• Class 100,000 Surrounding Room• Gloves Only - Minimize Half Suits• Two Piece Gloves with Smooth Sleeves or Gauntlets• Doing Glove Integrity Tests• Using Disposable Glove (2nd Glove)• Containment need is rapidly increasing – plan accordingly
Trends and Conclusions
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Thank YouThank You
For updates or comments contact Jack Lysfjord at +1-952-546-2082 or via e-mail at [email protected]
Jack LysfjordLysfjord Consulting, LLC
Michael PorterMerck