Isolator ISPE Study 2008

Lysfjord/Porter
Final Survey Results 2008

Barrier Isolation
History and Trends
2008 Final Data
Jack Lysfjord, Lysfjord Consulting LLC,
Michael Porter, Merck
December, 2008
Lysfjord/Porter
2
Filling Barrier Isolators
World-Wide
1998 2000 2002 2004 2006 2008
______ ______ ______ ______ ______ ______
84 172 199 256 304 391
Lysfjord/Porter
3
Asia Only
1998 2000 2002 2004 2006 2008
______ ______ ______ ______ ______ ______
11 19 30 42 50 59
Lysfjord/Porter
4
Europe Only
1998 2000 2002 2004 2006 2008
______ ______ ______ ______ ______ ______
57 85 97 116 146 196
Lysfjord/Porter
5
North America Only
1998 2000 2002 2004 2006 2008
______ ______ ______ ______ ______ ______
35 49 66 90 105 133
Lysfjord/Porter
6
Total
0
5
10
15
20
25
30
35
1
9
8
5
1
9
8
8
1
9
8
9
1
9
9
0
1
9
9
1
1
9
9
2
1
9
9
3
1
9
9
4
1
9
9
5
1
9
9
6
1
9
9
7
1
9
9
8
1
9
9
9
2
0
0
0
2
0
0
1
2
0
0
2
2
0
0
3
2
0
0
4
2
0
0
5
2
0
0
6
2
0
0
7
2
0
0
8
2
0
0
9
Barrier Isolator Filling Line
Deliveries by Year
Lysfjord/Porter
7
Barrier Isolator Filling Line
Deliveries by Year and Region
0
5
10
15
20
25
1
9
8
5
1
9
8
8
1
9
8
9
1
9
9
0
1
9
9
1
1
9
9
2
1
9
9
3
1
9
9
4
1
9
9
5
1
9
9
6
1
9
9
7
1
9
9
8
1
9
9
9
2
0
0
0
2
0
0
1
2
0
0
2
2
0
0
3
2
0
0
4
2
0
0
5
2
0
0
6
2
0
0
7
2
0
0
8
2
0
0
9
Africa Asia Europe Middle East North America
Total Responses: 387
Lysfjord/Porter
8
Asia Total Responses 59
0
1
2
3
4
5
6
7
8
1
9
8
5
1
9
8
8
1
9
8
9
1
9
9
0
1
9
9
1
1
9
9
2
1
9
9
3
1
9
9
4
1
9
9
5
1
9
9
6
1
9
9
7
1
9
9
8
1
9
9
9
2
0
0
0
2
0
0
1
2
0
0
2
2
0
0
3
2
0
0
4
2
0
0
5
2
0
0
6
2
0
0
7
2
0
0
8
2
0
0
9
Barrier Isolator Filling Lines
Deliveries by Year - Asia Only
Lysfjord/Porter
9
Europe Total Responses 193
0
5
10
15
20
25
1
9
8
5
1
9
8
8
1
9
8
9
1
9
9
0
1
9
9
1
1
9
9
2
1
9
9
3
1
9
9
4
1
9
9
5
1
9
9
6
1
9
9
7
1
9
9
8
1
9
9
9
2
0
0
0
2
0
0
1
2
0
0
2
2
0
0
3
2
0
0
4
2
0
0
5
2
0
0
6
2
0
0
7
2
0
0
8
2
0
0
9
Deliveries by Year - Europe Only
Lysfjord/Porter
10
North America Total Responses 132
0
2
4
6
8
10
12
14
16
18
1
9
8
5
1
9
8
8
1
9
8
9
1
9
9
0
1
9
9
1
1
9
9
2
1
9
9
3
1
9
9
4
1
9
9
5
1
9
9
6
1
9
9
7
1
9
9
8
1
9
9
9
2
0
0
0
2
0
0
1
2
0
0
2
2
0
0
3
2
0
0
4
2
0
0
5
2
0
0
6
2
0
0
7
2
0
0
8
2
0
0
9
Deliveries by Year - North America Only
Lysfjord/Porter
11
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
Lysfjord/Porter
12
Companies with Highest Usage - Asia Only
0
2
4
6
8
10
12
Taiyo Nipropharma Santen Astellas
Asia
Lysfjord/Porter
13
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
Lysfjord/Porter
14
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
Lysfjord/Porter
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
Lysfjord/Porter
16
Companies Using Barrier Isolation
By Region (confidential not included)
(Confidential Not Included)
Asia Europe NA
______ ______ ______
13 52 46
Lysfjord/Porter
17
Number In Operation
1998 2000 2002 2004 2006 2008
______ ______ ______ ______ ______ ______
34 70 90 116 230 283
Lysfjord/Porter
18
Number In Operation - By Region
Asia Europe NA
______ ______ ______
45 123 115
Lysfjord/Porter
19
with Reported FDA Approval
1998 2000 2002 2004 2006 2008
______ ______ ______ ______ ______ ______
6 26 52 54 60 72
Lysfjord/Porter
20
Filling Line Type
Global
Total Reponses 297
0
50
100
150
200
250
300
Liquid Powder Both
Lysfjord/Porter
21
Filling Line Type
Asia Only
Total Responses 50
0
5
10
15
20
25
30
35
40
45
50
Liquid Powder Both
Lysfjord/Porter
22
Filling Line Type
Europe Only
Total Responses 138
0
20
40
60
80
100
120
140
Liquid Powder Both
Lysfjord/Porter
23
Filling Line Type
North America Only
Total Responses 108
0
10
20
30
40
50
60
70
80
90
100
Liquid Powder Both
Lysfjord/Porter
24
Container Type
Total Responses 399
0
50
100
150
200
250
Vial / Bottle Syringe/Cart. Ampoule IV Bag Ophthalmic Other
Lysfjord/Porter
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
Lysfjord/Porter
26
Container Type
Europe Only
Total Responses 198
0
10
20
30
40
50
60
70
80
90
100
Vial / Bottle Syringe/Cart. Ampoule Other Ophthalmic IV Bag
Europe
Lysfjord/Porter
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
Lysfjord/Porter
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
Lysfjord/Porter
29
Maximum Speed
Asia Only
Total Responses 38
0
2
4
6
8
10
12
14
16
18
1-100 101-200 201-300 301-400 401-500 501-600 601-700 701-800
Asia
Lysfjord/Porter
30
Maximum Speed
Europe Only
Total Responses 148
0
5
10
15
20
25
30
35
40
45
1-100 101-200 201-300 301-400 401-500 501-600 601-700 701-800
Lysfjord/Porter
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
Lysfjord/Porter
32
Barrier Isolator Construction
1998 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
Lysfjord/Porter
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
Lysfjord/Porter
34
Barrier Isolator Sterilants
Alcohol Wipe 6
CLO
2
4
Formalin 2
H
2
O
2
- Fog 11
H
2
O
2
- Spray 2
H
2
O
2
- Steam 1
H
2
O
2
- Vapor 284
High Level Disinfectant 1
Misc. Peracetic Acid 8
Non-Aseptic 1
Other 4
TBD 1
Grand Total 325
}
H
2
O
2
Sterilants
Account for
92% of Total
Lysfjord/Porter
35
One or Two Piece Gloves Filling Lines
One Piece 111 46% of total
Two Piece 130 54% of total
Total 241
Lysfjord/Porter
36
Two Piece Glove
Is Gauntlet Pleated?
No 103 86% of total
Yes 17 14% of total
Total 120
Lysfjord/Porter
37
Glove Replacement Period
Total Responses 158
0
10
20
30
40
50
60
70
80
Each
Cycle
3 cycles 6 cycles 2 weeks monthly 2 months 6 weeks 3 months 6 months as
needed
Each New
Product
Lysfjord/Porter
38
Method for Integrity Testing of Gloves
Total Responses 218
0
20
40
60
80
100
120
140
Pressure
Decay
Visual Chemical Flow Bubble Test Proprietary Other Conductivity Manual
Lysfjord/Porter
39
Second Disposable Glove Used?
No 24 11% of total
Yes 202 89% of total
Total 226
Lysfjord/Porter
40
Open or Closed Isolator
Open Isolator 201 80% of total
Closed Isolator 49 20% of total
Total 250
Lysfjord/Porter
41
Pressure to Surrounding Rooms
(12.5 Pascals = .05 Water)
Total Responses 391
0
10
20
30
40
50
60
70
-
1
7
5
-
1
2
5
-
2
5
N
e
g
a
t
i
v
e
P
o
s
i
t
i
v
e
1
-
1
0
1
1
-
2
0
2
1
-
3
0
3
1
-
4
0
4
1
-
5
0
5
1
-
6
0
6
1
-
7
0
7
1
-
1
0
0
Lysfjord/Porter
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
Lysfjord/Porter
43
Sterilizable Cool Zone with Depyrogenation
Tunnel Used?
No 47 35% of total
Yes 87 65% of total
Total 134
* Was 49% in 2006
*
Lysfjord/Porter
44
Barrier Isolators Need for Containment?
Yes 90 42% of total
Chemical 45
Biological 24
Antibiotic 7
Chemical/Biological 9
Chemical/Nuclear 2
Radioactive 2
Chemical/Radioactive 1
No 124 58% of total
214
*
* But 100% of lines added between 2006 & 2008 data
Lysfjord/Porter
45
Do you Campaign Products
(run for multiple days)?
No 50 41% of total
Yes 71 59% of total
Total 121
*
*51% in 2006 data
Lysfjord/Porter
46
Campaign Products (longest run)
0
5
10
15
20
25
2 3 4 5 6 7 8 10 14 28
# of Days
Lysfjord/Porter
47
0
50
100
150
200
250
300
350
400
450
1
9
8
5
1
9
8
8
1
9
8
9
1
9
9
0
1
9
9
1
1
9
9
2
1
9
9
3
1
9
9
4
1
9
9
5
1
9
9
6
1
9
9
7
1
9
9
8
1
9
9
9
2
0
0
0
2
0
0
1
2
0
0
2
2
0
0
3
2
0
0
4
2
0
0
5
2
0
0
6
2
0
0
7
2
0
0
8
2
0
0
9
Barrier Isolator Filling Line - Cumulative
Deliveries
Lysfjord/Porter
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 H
2
O
2
Trends and Conclusions
Lysfjord/Porter
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)
Lysfjord/Porter
50
Benchmarking Information:
Hard Wall Isolator
Vaporized H
2
O
2
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
Lysfjord/Porter
51
Thank You
Thank You
For updates or comments contact Jack Lysfjord at +1-952-546-2082
or via e-mail at jlysfjord@q.com
Jack Lysfjord
Lysfjord Consulting, LLC
Michael Porter
Merck

Isolator ISPE Study 2008

Enviado por

Dados do documento

Título original

Direitos autorais

Formatos disponíveis

Compartilhar este documento

Compartilhar ou incorporar documento

Opções de compartilhamento

Você considera este documento útil?

Este conteúdo é inapropriado?

Direitos autorais:

Formatos disponíveis

Isolator ISPE Study 2008

Enviado por

Direitos autorais:

Formatos disponíveis

Lysfjord/Porter

Final Survey Results 2008

Você também pode gostar