DEPYROGENATING TUNNELS
DEPYROGENATING TUNNELS
STERILINE ST series laminar flow depyrogenating tunnels have been designed to depyrogenize ampoules, vials and syringes
with a continuos process maintaining an ISO5 environment throughout the length of the tunnel.
The depyrogenating tunnels consist of three chambers:
the inlet chamber with its laminar flow unit keeps clean the transfer of glassware from the washing machine to the hot
chamber, dries and preheats glassware and protects from the hot air back flow coming from hot chamber;
the hot chamber subjects glassware to the thermal cycle for the depyrogenation (refer to below section);
the cooling chamber cools glassware to the suitable temperature to be discharged into the sterile room/isolator;
The improved design allows higher production speeds, more compact dimensions, energy saving and a better control of the
process parameters such as the air speed in the hot chamber and the pressure differential between the cooling chamber and the
inlet chamber.
More than 18 models and a wide range of options including automatic air balance, air speed monitoring and automatic adjustment,
conveyor belt cleaning system, doors position monitoring and automatic adjustment, pipes for D.E.H.S. test and particles control,
sterilizable cooling chamber, automatic discharge of final vials are available to meet specific customer requirements.
THERMAL CYCLE
The thermal cycle is designed to assure a
pyrogens reduction of 10 -3 (3 Log) or 10 -6
(6 Log) in accordance with the following
formula:
FT =
10
T-250
46,4
dt
and assuming a D value of 5 minutes
and a z value of 46,4C referred to E. Coli
endotoxins. D and z values are defined
respectively as the time required to reduce
pyrogens by one logarithm at 250C and
the temperature increment to change
the D value by a factor of 10. Thus the
glassware is submitted to a thermal cycle
equivalent to a 15 minutes (3 Log) or 30
minutes (6 Log) treatment at the constant
temperature of 250C. The microbial
lethality delivered by a cycle designed for
endotoxins inactivation provides a large
margin of safety with regard to sterility.
The perfect knowledge of heat exchange,
sterilization and depyrogenation rules
and the continuous parameters control
guarantee
the
reproducibility
and
reliability of cycle.
hEAT PENETRATION IN VIALS
AUTOMATION
PLC controlled Steriline depyrogenating tunnels are equipped with
touch screen PC for operator interface. The PC with color graphics
ensures easy access to statistics and control screens. 21CFR Part11
compliance is available. The data out screen features the set parameters
and the current process parameters enabling the operator to control the
operation of the tunnel. A diagnostic screen highlights alarm conditions
of the tunnel to enable operator to minimize production downtime. The
PC holds recipes for each type of glassware: once a format is selected
all the tunnel process parameters change automatically by means of PLC
without any other operation by the operator. The PC Hard Disk is capable
of storing many months of operational process information i.e. process
data trends, alarms history, batch reports, etc. Steriline provides
computer system validation documentation and testing in accordance
with GAMP guideline.
STC25 - ST0 - ST1 - ST2 - ST3
ST1 TUNNEL
STERILINE offers a wide range of
depyrogenating tunnels appropriate for any
production requirement.
The models STC25, ST0, ST1, ST2, and ST3
features a variety of production capabilities
for processing ampoules, small vials, and
syringes.
This series is compact in design to fit even
the tightest production spaces.
In addition to normal production facilities,
these models are suitable for use by research
and development laboratories.
ST SERIES
STC25
ST 0
ST 1
ST 2
ST 3
LENGTH mm
1382
1670
1980
2280
2280
WIDTH mm
1485
1260
1470
1470
1700
HEIGHT mm
2350
2400
2300
2300
2300
CONVEYOR BELTWIDTH mm
250
300
450
450
600
INLET AIR m /h
200
242
348
348
455
205
294
294
382
1400
850
1600
2200
2800
15
17
24
28
32
EXHAUST AIR m3/h
COOLINGWATER CONSUMPTION* lt/h
TOTAL POWER kW
*T cooling water 4 C
ST4 - ST5 - ST6 - ST7 - ST8 - ST9
ST6 TUNNEL
Steriline medium size depyrogenating tunnels, models ST4 through
ST9, were specifically developed as
a response to demand from
pharmaceutical manufacturers for
handling a wide range of container
types and sizes. These extremely
versatile, reliable, high performance
machines can handle from 1 to 1000ml
glassware in the same tunnel.
ST SERIES
ST 4
ST 5
ST 6
ST 7
ST 8
ST 9
LENGTH mm
2800
3075
2930
3260
3560
3870
WIDTH mm
1700
1700
1905
1905
1905
1905
HEIGHT mm
2300
2300
2350
2350
2350
2350
CONVEYOR BELTWIDTH mm
600
600
800
800
800
800
INLET AIR m /h
455
455
597
597
597
597
EXHAUST AIR m3/h
382
382
500
500
500
500
COOLINGWATER CONSUMPTION* lt/h
3250
4250
4250
4600
5000
5500
35
41
46
51
54
60
TOTAL POWER kW
*T cooling water 4 C
ST12 - ST14 - ST15 - ST18 - ST19 - ST20
ST14 TUNNEL
Steriline large size depyrogenating tunnels, models ST12, ST14, ST15 and ST18
through ST20, have been introduced to
accommodate the ever increasing speeds
demanded by todays modern production
lines. These models are suitable for higher
speed traditional glass processing. The
STERILINE feature that is unique to these
models is the utilization of two cooling chambers
instead of one. Two cooling chambers with
two different temperature set points reduces
thermal shock normally encountered when
cooling glassware too rapidly.
ST SERIES
ST 12 ST 12.1 ST 14 ST 15 ST 18 ST 19 ST 20
LENGTH mm
3160
3460
4220
4560
4680
6325
7720
WIDTH mm
2440
2440
2440
2440
2795
2795
2795
HEIGHT mm
2400
2400
2400
2400
2400
2400
2400
CONVEYOR BELTWIDTH mm
1250
1250
1250
1250
1600
1600
1600
INLET AIR m3/h
1270
1270
1270
1270
1615
2066
2066
EXHAUST AIR m3/h
1118
1118
1118
1118
1480
1871
1871
COOLINGWATER CONSUMPTION* lt/h
4820
5500
6910
6600
8510
10650
13950
63
71
83
83
94
124
156
TOTAL POWER kW
*T cooling water 4 C
STERILIZABLE COOLING CHAMBER
COOLING CHAMBER heating elements
The depyrogenating tunnels with sterilizable cooling
chamber have the following features:
Heating elements for sterilizing the cooling chamber
by means of dry heat;
Cooling chamber insulation to provide protection at
temperatures up to 230C;
Insulated airtight door at the tunnel exit, equipped
with high temperature resistant inflatable gaskets,
to protect the isolator during the cooling chamber
sterilization and to enable the isolator to be sterilized
without any leak of VHP into the tunnel.
The cooling chamber is sterilized by HEPA filtered hot
air at a temperature of approximately 200C.
The cycle time is defined during the pre-testing phase
at Steriline, calculated in order to ensure the coldest
point sterilization.
The minimum surface temperature anywhere in the
cooling chamber on any material should be above
170C.
The coldest point shall stay at a temperature of 170C
as long as necessary to achieve bacterial reduction of
6 log according to the following formula:
FH =
AUTOMATIC TIGHT DOOR
10
T-170
20
dt
Once the cooling chamber sterilization cycle has
been started:
The airtight door closes and the insulated gaskets
inflate;
The cooling water circuit drains;
All tunnel heaters start;
The cooling chamber temperature raises up to
the predefined set point, that is maintained for the
predefined sterilization time.
high temperature resistant inflatable gaskets
AUTOMATIC DISCHARGE
OF FINAL VIALS
In presence of isolator it is difficult for the operator
to manually remove the remaining vials at the end
of the batch.
Therefore the depyrogenating tunnels are equipped
with the automatic discharge bar to fully discharge
the glassware at the end of the process.
AUTOMATIC DISCHARGE BAR
TUNNELS OUTPUT
(for a Pyrogens reduction by 3 Log)
AMPOULES-DIN 58377
V
[ml]
[mm] [mm]
W
[g]
THOUSANDS / HOUR
STC25 ST0
ST1
ST2
ST3
ST4
ST5
ST6
ST7
ST8
ST9 ST12 ST12.1 ST12.2 ST14 ST15 ST18 ST19 ST20
10,75
67
16
23
30
45
10,75
79
16
23
30
45
12,75
82
12
17
25
34
14,75
90
4,5
12
18
24
36
10
17,75
109
12
16
24
32
20
22,50
120
3,5
7,5
10
15
20
25
22,55
135
3,5
7,5
10
15
20
30
22,55
160
3,5
7,5
10
15
20
TUBE VIALS-DIN/ISO 8362-1
Size
[mm] [mm]
W
[g]
STC25 ST0
THOUSANDS / HOUR
ST1
ST2
ST3
ST4
ST5
ST6
ST7
ST8
ST9 ST12 ST12.1 ST12.2 ST14 ST15 ST18 ST19 ST20
2R
16
35
7,78 14,76 17,8 23.74 28,93
33
38,54
44
4R
16
45
6,1
7,78 14,76 17,8 23,74 28,93
33
38,54
44
6R
22
40
8,3
2,2
4,07
7,71
9,3
12,41 15,12 17,25 20,15
23
25,85 28,7
31,5
35,9
40,3
44,8
8R
22
45
9,4
2,2
4,07
7,71
9,3
12,41 15,12 17,25 20,15
23
25,85 28,7
31,5
35,9
40,3
44,8
10R
24
45
10,2
1,8
3,36
6,37
7,68 10,25 12,49 14,25 16,64
19
21,36 23,71
26
29,6
33,3
37
40,7
15R
24
60
12,8
1,8
3,36
6,37
7,68 10,25 12,49 14,25 16,64
19
21,36 23,71
26
29,6
33,3
37
40,7
20R
30
55
17,4
1,1
2,12
4,02
4,85
6,48
7,89
10,51
12
13,49 14,98 16,4
18,7
21
23,4
25,7
32,9
25R
30
65
20,2
1,1
2,12
4,02
4,85
6,48
7,89
10,51
12
13,49 14,98 16,4
18,7
21
23,4
25,7
32,9
30R
30
75
22,7
1,1
2,12
4,02
4,85
6,48
7,89
10,51
12
13,49 14,98 16,4
18,7
21
23,4
25,7
32,9
MOLDED VIALS-DIN/ISO 8362-4
Size
STC25 ST0
THOUSANDS / HOUR
ST1
ST2
4,16
7,88
9,51 12,68 15,45 17,63 20,59 23,5 26,41 29,33 32,1
3,63
6,88
8,29 11,06 13,48 15,38 17,96 20,5 23,04 25,58
16
1,8
3,45
6,54
53,5
21
1,3
2,21
58,8
24
1,96
58
29
0,7
36
58
30
36
62,8
35
50H
42,5
73
50
100H
51,6
94,5
89
[mm] [mm]
[g]
5H
20,8
41,3
14
2,2
7H
22,1
40,8
13
8H
23
46,8
10H
25,4
15H
26,5
20H
32
25H
30H
ST3
ST4
[ml]
50
[mm] [mm]
46
68
W
[g]
55
ST6
ST7
ST8
ST9 ST12 ST12.1 ST12.2 ST14 ST15 ST18 ST19 ST20
36,7
41,2
32
36
40
43,9
7,89 10,52 12,82 14,63 17,08 19,5 21,92 24,34 26,7
30,4
34,2
38
41,8
4,19
5,06
6,75
8,22
9,38 10,95 12,5 14,05 15,6
17,1
19,5
21,9
24,3
26,8
34,3
3,72
4,49
5,99
7,3
8,33
9,72
11,1 12,48 13,85 15,2
17,3
19,4
21,6
23,8
30,4
42,5
1,29
2,45
2,95
3,94
4,8
5,48
6,39
7,3
8,21
9,11
10
11,4
12,8
14,2
15,6
20
27,9
35,2
0,5
1,03
1,95
2,35
3,13
3,81
4,35
5,08
5,8
6,52
7,24
7,9
10,1
11,3
12,4
15,9
22,2
27,9
0,45
0,97
1,84
2,22
2,97
3,62
4,13
4,82
5,5
6,18
6,86
7,5
8,5
9,6
10,7
11,7
15
21
26,5
0,35
0,67
1,27
1,54
2,05
2,5
2,85
3,33
3,8
4,27
4,74
5,2
5,9
6,6
7,4
8,1
10,4
14,5
18,3
0,17
0,37
0,7
0,85
1,13
1,38
1,58
1,84
2,1
2,36
2,62
2,8
3,2
3,6
4,1
4,5
5,7
10,1
LIGHT INFUSION BOTTLES-ISO 8536-1
V
ST5
STC25 ST0
0,3
0,48
28
THOUSANDS / HOUR
ST1
ST2
ST3
ST4
ST5
ST6
ST7
ST8
0,91
1,09
1,46
1,78
2,03
2,37
2,7
ST9 ST12 ST12.1 ST12.1 ST14 ST15 ST18 ST19 ST20
3,3
3,7
4,2
4,7
5,2
5,7
7,4
10,3
13
100
49
104
95
0,18
0,41
0,77
0,93
1,24
1,51
1,73
2,3
2,5
2,8
3,1
3,5
4,4
4,9
6,3
8,8
11,1
250
68
125
170
0,20
0,39
0,47
0,62
0,76
0,86
1,15
1,29
1,4
1,7
1,8
2,2
2,4
3,1
4,4
5,5
500
78
177
290
0,15
0,28
0,33
0,44
0,54
0,62
0,72
0,82
0,92
1,1
1,2
1,4
1,6
1,7
2,2
3,1
3,9
1000
95
230
510
0,08
0,15
0,18
0,24
0,3
0,34
0,4
0,46
0,5
0,56
0,62
0,7
0,8
0,88
0,98
1,2
1,7
2,2
INFUSION BOTTLES-DIN 58363-1
V
[ml]
[mm] [mm]
W
[g]
STC25 ST0
THOUSANDS / HOUR
ST1
ST2
ST3
ST4
ST5
ST6
ST7
ST8
ST9 ST12 ST12.1 ST12.1 ST14 ST15 ST18 ST19 ST20
100
49
108
120
1,1
1,28
1,45
1,6
1,8
2,2
2,4
2,8
3,3
3,6
4,4
4,8
6,2
8,4
250
66
140
230
0,56
0,65
0,75
0,85
0,95
1,1
1,2
1,4
1,6
1,8
2,1
2,4
10,2
5
500
78
188
375
0,4
0,46
0,52
0,6
0,66
0,8
0,85
1,2
1,4
1,6
1,75
2,2
3,8
1000
95
238
600
0,6
0,7
0,8
0,9
1,2
1,7
1,8
2,4
Issued Feb. 2011 by
Issued June 2010
STERILINE srl - Via Tentorio, 30 - 22100 Como - ITALY
Ph. +39 031 592 064 - Fax +39 031 591 976 - www.steriline.it
