Clean and Pure steam in the Biopharm industry

Kieran O’Keeffe

European Business Manager

High Purity Products

Spirax Sarco Ltd.

Slide 2

Typical Steam Circuit

Tank Tank

Boiler

Feed Pump

Feed Tank

Make-up Water

H/Exchanger

Condensate

Condensate

Steam

Steam

Steam Process Vessel

Space HeatingSystem

Slide 3

Driving standards

Filtered

- 3A’s

- UK Heat preserved foods guide

- FDA (Materials)

Clean

- EN285

- HTM2031 / 2010

- FDA (Material)

Pure

- EN285

- HTM2031 / 2010

- ASME BPE

- FDA (Material)

- FDA cGMP

- USP

- ISPE

Slide 4

Pure Steam Generation

Pure Steam Generator

• cGMP, ISPE, BPE designed

• 3 phase moisture separation

• External compact evaporator column

• Generation Capacity from 50 kg/6T/hrGeneration Capacity from 50 kg/6T/hr•Units can be Electric or Steam/Steam

Slide 6

Quality V’s PurityDryness

Dryness of >95% is essential

Excess moisture can cause;- Damp loads in porous materials- Uneven temperature distribution in non-

porous loads

- Uncontrolled chemical composition of steam

Will have the effect of not sterilising correctly

Quality and purity

Slide 7

Quality V’s PuritySteam Dryness Testing procedure

D= (T1-T0)(4.18Mw+0.24) _ 4.18(Ts-T1)LMc L

T0 = intial temp of water in flaskT1 = final temp of water in flaskTs = average temp of water and condensate in flaskMw = Initial mass of water in flaskMc = mass of condensate collected (kg)L = latent heat of dry sat steam at temp Ts (kJ kg-1)

Quality and purity

Slide 8

Quality V’s PuritySuperheat

Superheat should not exceed 25 deg C (77 deg F)

Problems incurred with Superheat include- Poor heat penetration resulting in Failure to

sterilise- Scorching of textiles and paper- rapid deterioration of rubber

Quality and purity

Slide 9

Quality V’s PuritySteam Superheat Testing procedure

Superheat content = temperature of steam in the expansion tube – temperature of boiling water at local atmospheric pressure

Quality and purity

Slide 10

Quality V’s PurityNon-condensable gases (NCG)

Gases which can not be liquefied by compression under the range of temperature / pressure experience in the sterilising process.

NCG’s should not exceed 3.5% by volume

High NCG content can cause Bowie and Dick test failure

Quality and purity

Slide 11

Quality V’s PurityNon-condensable Gas Testing procedure

Fraction of NCG = vol of gas collected in the burette / vol of water collected in the measuring cylinder.

Quality and purity

Slide 12

Specific Volume Vs Pressure Saturated Steam

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Pressure (bar g)

Spe

cific

Vol

ume

(m3/k

g)

Slide 13

Steam Tables

Steam Properties

Slide 14

• Smaller bore steam mains needed and therefore less heat (energy) loss due to the smaller surface area.

• Lower capital cost of steam mains, both materials such as pipes, support work and labour.

• Lower capital cost of insulation (lagging).

• Dryer steam at the point of usage because of the drying effect of pressure reduction taking place.

Distribute at High Pressure

Slide 15

• Greater Cost

• Greater Heat Loss

• Greater Volume of Condensate Formed

• Lower Pressure to Steam Users

• Not Enough Volume of Steam

• Water Hammer and Erosion

Pipe Distribution

Slide 16

• On the basis of:

•Steam Velocity

•Pressure Drop

How is pipe sized ?

Slide 17

Steam Pipe Sizing Chart (kg/h)Pressure Velocity Pipe Size Nominal / Actual Inside Diameterbar g m/s 15 20 25 32 40 50 65 80 100 125 150

15.8 20.93 26.64 35.04 40.9 52.5 62.7 77.92 102.26 128.2 154.0515 9 15 25 43 58 95 136 210 362 569 822

0.4 25 14 25 41 71 97 159 227 350 603 948 136940 23 40 66 113 154 254 363 561 965 1517 219115 10 18 29 51 69 114 163 251 433 681 983

0.7 25 17 30 49 85 115 190 271 419 722 1135 163840 28 48 78 136 185 304 434 671 1155 1815 262115 12 21 34 59 81 133 189 292 503 791 1142

1 25 20 35 57 99 134 221 315 487 839 1319 190440 32 56 91 158 215 354 505 779 1342 2110 304615 18 31 50 86 118 194 277 427 735 1156 1669

2 25 29 51 83 144 196 323 461 712 1226 1927 278240 47 82 133 230 314 517 737 1139 1961 3083 445115 23 40 65 113 154 254 362 559 962 1512 2183

3 25 38 67 109 188 256 423 603 931 1603 2520 363940 61 107 174 301 410 676 964 1490 2565 4032 582215 28 50 80 139 190 313 446 689 1186 1864 2691

4 25 47 83 134 232 316 521 743 1148 1976 3106 448540 75 132 215 371 506 833 1189 1836 3162 4970 717615 34 59 96 165 225 371 529 817 1408 2213 3195

5 25 56 98 159 276 375 619 882 1362 2347 3688 532540 90 157 255 441 601 990 1411 2180 3755 5901 852115 39 68 111 191 261 430 613 947 1631 2563 3700

6 25 65 114 184 319 435 716 1022 1578 2718 4271 616740 104 182 295 511 696 1146 1635 2525 4348 6834 986715 44 77 125 217 296 487 695 1073 1848 2904 4194

7 25 74 129 209 362 493 812 1158 1788 3080 4841 698940 118 206 334 579 788 1299 1853 2861 4928 7745 11183

Pipe Sizing Chart Velocity

Slide 18

Pipeline Capacity and Pressure Drop

L

Fluid FlowP1 P2

Factor) Drop (Pressure F L

P - P 21

Slide 19

Steam Line Drainage

Slide 20

Adequate Support

Clean and Pure Steam Distribution

Condensate removal

Slide 21

Clean and Pure Steam Distribution

Condensate removal

- Steam traps should drain vertically downwards to avoid condensate hold up

Slide 22

Ineffective, and Proper Drain Points

Condensate

PocketSteam Trap Set25/30m

Cross Section

Cross Section

Steam Trap Set

Steam Flow

Steam Flow

•Correct

• Incorrect

Slide 23

Clean and Pure Steam Distribution

Steam take-off

Slide 24

Steam Line Reducers

Condensate

Correct

Incorrect

Steam

Steam

Condensate

Slide 25

Drop Leg

Shut Off Valve

Trap Set

Main

Steam Take - off

Slide 26

Recommended Support Spacing

Nominal Pipe Size Steel/Copper

Interval of Horizontal Run (m)

Interval of Vertical Run (m)

Bore O/D Mild Steel Copper Mild Steel Copper

12 15 - 1 - 1.2

15 18 2 1.2 2.4 1.4

20 22 2.4 1.4 3 1.7

25 28 2.7 1.7 3 2

32 35 2.7 1.7 3 2

40 42 3 2 3.6 2.4

50 54 3.4 2 4.1 2.4

65 67 3.7 2 4.4 2.4

80 76 3.7 2.4 4.4 2.9

100 108 4.1 2.7 4.9 3.2

125 133 4.4 3 5.3 3.6

150 159 4.8 3.4 5.7 4.1

200 194 5.1 - 6 -

250 267 5.8 - 5.9 -

Slide 27

Expansion Chart for Mild Steel Pipe

Temperature of Saturated Steam

Expansion of pipe (mm)

Len

gth

of

pip

e (m

m)

Temperature difference oC/metre

bar g 1 2 3 4 5 7.5 10 15 20 25 30

oC 120 133 143 152 158 162 183 200 214 225 235

Slide 28

Steam Pressure

Steam Main Size (mm)

(bar g) 50 65 80 100 125 150 200 250 300 350 400 450 500 600

9 9.5 15.1 19.7 28.1 38.1 49.4 71 105 139 164 216 272 320 436

9.3 11.3 14.1 16.5 20.6 24.5 31.5 39 46.5 51.5 60 64 72 88

10 9.9 15.7 20.4 29.2 39.6 51.3 77 109 144 171 224 282 332 463

9.8 11.9 14.6 16.9 21.3 25 33 41 49 54 62 67 75 90

11 10.4 16.5 21.6 30.7 41.7 54.1 81.1 115 152 180 236 298 350 488

10.9 13 15.7 17.7 22.5 26 36 45 53 59 67 73 81 97

• Ambient temperature 20 C, insulation efficiency 80%

• Lower figures represent running loads

Warm up load/running load per 50m of pipe``

Questions