isolator ispe study 2008 copy

Lysfjord/PorterFinal Survey Results 2008

Barrier Isolation History and Trends2008 Final Data

Jack Lysfjord, Lysfjord Consulting LLC, Michael Porter, Merck

December, 2008


2

Filling Barrier IsolatorsWorld-Wide

1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______

84 172 199 256 304 391


3

Filling Barrier IsolatorsAsia Only

1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______

11 19 30 42 50 59


4

Filling Barrier IsolatorsEurope Only

1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______

57 85 97 116 146 196


5

Filling Barrier Isolators North America Only

1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______

35 49 66 90 105 133


6

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


7

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


8

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


9

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


10

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


11

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


12

Barrier Isolator Filling Lines –Companies with Highest Usage - Asia Only

0

2

4

6

8

10

12

Taiyo Nipropharma Santen Astellas

Asia


13

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


14

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


15

Number of Companies Using Barrier Isolation (confidential not included)

(Confidential Not Included)1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______

32 56 67 83 84 99


16

Companies Using Barrier Isolation –By Region (confidential not included)

(Confidential Not Included)

Asia Europe NA ______ ______ ______

13 52 46


17

Barrier Isolator Filling Lines –Number In Operation

1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______

34 70 90 116 230 283


18

Barrier Isolator Filling Lines –Number In Operation - By Region

Asia Europe NA ______ ______ ______

45 123 115


19

Barrier Isolator Filling Lines –with Reported FDA Approval

1998 2000 2002 2004 2006 2008______ ______ ______ ______ ______ ______

6 26 52 54 60 72


20

Filling Line TypeGlobal

Total Reponses 297

0

50

100

150

200

250

300

Liquid Powder Both


21

Filling Line Type Asia Only

Total Responses 50

05

101520253035404550

Liquid Powder Both


22

Filling Line Type Europe Only

Total Responses 138

0

20

40

60

80

100

120

140

Liquid Powder Both


23

Filling Line Type North America Only

Total Responses 108

0102030405060708090

100

Liquid Powder Both


24

Container Type Total Responses 399

0

50

100

150

200

250

Vial / Bottle Syringe/Cart. Ampoule IV Bag Ophthalmic Other


25

Container Type Asia Only

Total Responses 62

0

5

10

15

20

25

30

Vial / Bottle Ampoule IV Bag Syringe/Cart. Ophthalmic Other

Asia


26

Container Type Europe Only

Total Responses 198

0102030405060708090

100

Vial / Bottle Syringe/Cart. Ampoule Other Ophthalmic IV Bag

Europe


27

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


28

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


29

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


30

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


31

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


32

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


33

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


34

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


35

One or Two Piece Gloves Filling Lines

One Piece 111 46% of total Two Piece 130 54% of total Total 241


36

Two Piece GloveIs Gauntlet Pleated?

No 103 86% of totalYes 17 14% of totalTotal 120


37

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


38

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


39

Second Disposable Glove Used?

No 24 11% of total

Yes 202 89% of total

Total 226


40

Open or Closed Isolator

Open Isolator 201 80% of total

Closed Isolator 49 20% of total

Total 250


41

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


42

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


43

Sterilizable Cool Zone with Depyrogenation Tunnel Used?


* Was 49% in 2006

*


44

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


45

Do you Campaign Products (run for multiple days)?


*

*51% in 2006 data


46

Campaign Products (longest run)

0

5

10

15

20

25

2 3 4 5 6 7 8 10 14 28

# of Days


47

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


48

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


49


• 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)



50


• 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



51

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

isolator ispe study 2008 copy

Documents

barrier isolation history

barrier isolation confidential

north america total

europe total responses

asia total responses

number of companies

highest usagecompaies

lysfjord consulting