Alfalaval Pharma-line S 1 User manual

5300-0001
ESE02599-EN3 2016-07
Original manual
Instruction Manual
Alfa Laval Pharma-line S
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Table of contents
The information herein is correct at the time of issue but may be subject to change without prior notice
1. Description ............................................................................................. 4
1.1. Safety precautions ................................................................................ 4
1.2. Recycling information ............................................................................. 4
1.3. Application ......................................................................................... 5
1.4. Design ............................................................................................. 6
2. Installation .............................................................................................. 8
2.1. Clearance for dismantling ........................................................................ 8
2.2. Foundations ....................................................................................... 8
2.3. Positioning and slope ............................................................................. 8
2.3.1 Horizontal positioning ............................................................................. 8
2.3.2 Vertical positioning ................................................................................ 8
2.4 Levelling .............................................................................................. 9
2.5 Cleanliness provisions .............................................................................. 9
2.6 Connecting the heat exchanger to the piping system ........................................... 9
2.7 Fitting and piping .................................................................................... 10
3. Operation ............................................................................................... 11
3.1. Design and operating conditions ................................................................ 11
3.2. Operating procedures ............................................................................ 11
3.2.1 Start-up operation ................................................................................ 11
3.2.2 Operation .......................................................................................... 11
3.2.3 Shut-down operation ............................................................................. 12
4. Maintenance ........................................................................................... 13
4.1. Inspection ......................................................................................... 13
4.2. Indication of fouling ............................................................................... 13
4.3. Disassembly for inspection or cleaning ......................................................... 13
4.4. Locating leaks ..................................................................................... 13
4.5. Cleaning the heat exchanger .................................................................... 13
4.6. Gasket replacement .............................................................................. 13
5. Technical data ......................................................................................... 14
5.1. Technical data ..................................................................................... 14
6. Spare Parts ............................................................................................. 16
6.1. Alfa Laval Pharma-line S ......................................................................... 16
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1 Description
1.1 Safety precautions
Installation:
Always read the installation thoroughly. (See chapter 2 Installation). !
Always use a lifting crane or device when handling the heat exchanger.
Operation:
Always read the operation section thoroughly. (See chapter 3 Operation). !
Never introduce hot fluid suddenly when heat exchanger is empty or cold.
Never shock the heat exchanger with cold fluid when hot.
Transportation:
Always transport the heat exchanger in a horizontal position.
Always ensure that the unit is securely fixed during transportation.
Never lift or elevate in any way other than as described in this manual.
1.2 Recycling information
Packing
- Packing materials consist of wood, plastics and metal.
- Wood can be reused, recycled or used for energy recovery.
- Plastics should be recycled or burnt at a licensed waste incineration plant.
- Metal should be sent for material recycling.
Maintenance
-Allmet
al parts should be sent for material recycling.
-Allnon
-metal parts must be disposed of in accordance with local regulations.
Scrapping
- At the end of use, the equipment should be recycled according to relevant, local regulations. Besides the equipment itself,
any hazardous residues from the process liquid must be considered and dealt with in a proper manner. When in doubt, or in
the absence of local regulations, please contact your local Alfa Laval sales company.
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1 Description
1.3 Application
The Alfa Laval Pharma-line S is a high quality, double tube sheet shell & tube heat exchanger designed for the pharmaceutical
and biotechnology industries. The Pharma-line S is used in pharmaceutical water systems: Water For Injection (WFI), Purified
Water (PW), and for heating or cooling of pharmaceutical products.
It is available in a number of standard sizes and meets the stringent hygiene standards imposed both by control authorities and
the industry.
5300-0004
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1 Description
1.4 Design
The Pharma-line S is in hygienic design in line with ASME BPE, USP and cGMP requirements.
The Pharma-line S has no dead-legs and is fully drainable on the product side. All product wetted parts in the Pharma-line S are
mechanically polished to Ra <0.5 µm or electropolished to Ra >0.4 µm.
The tubes are seamless and polished prior to bending. The Pharma-line S U-tubes are bent to a larger radius than required in
ASME BPE. The Pharma-line S is easy to clean and can be steam sterilised. The gaskets are FDA approved and USP class VI.
Main components
5300-0005
A
C
D
D
F
E
G
G
J
K
B
H
A
B
C
D
E
F
G
H
J
NAC plate connection
Fronthead
Tubesheet
Lifting lug
Vent
Flange connection
Leg
Shell
Flange connection
Tube sheet Tubes are expanded into first sheet, welded and expanded into second sheet. Double tube
sheet minimises the risk of contamination
Shell Utility media flow on the shell side
Tube bundle Product flows through a number of tubes which are bundled together
Vent Vent connection on shell side for venting of air
Drain Drain connection on shell side for draining
NAC plate connection on
product side
Tri-clamp ferrule to be connected to the heat exchanger by an NAC plate. Tri-clamp ferrules
and gaskets are not supplied
Flange connection on shell side Inlet flange is at the back of the heat exchanger. Outlet flange is placed at the side of the shell
Lifting lug
Legs To be used when lifting the unit, fixed with bolts and movable, allowing for flexible positioning.
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1 Description
Working principles
In the Pharma-line S, the risk of mixing between the product and the heating or cooling (service) medium is eliminated as a result
of the double tube sheet design. The product flows in the tubes while the service medium flows in a cross flow around the
tubes, inside the shell. The service medium is sealed in the shell by the first tube sheet and the second tube sheet seals in the
product. In the event of a leak, the leakage of either fluid is easily visually detected.
A
5300-0006
A=Tubesheets
Documentation
The Pharma-line S is delivered along with a complete documentation package, including:
- Approved drawings and pressure test certificate signed by the relevant body.
For Pharma-line S´s in category I and II EC type examination and product verification from Zetterströms Rostfria AB.
Zetterströms Rostfria AB is certified to issue EC type examination and product verificatoin under Lloyds register (NB No.0038)
- List of welders, welding procedures and welder’s qualifications
- 3.1 Material certificates for pressure and product wetted steel parts
- FDA and USP class VI certificates for gaskets
- Liquid penetrant test report and procedure
- Surface roughness certificate
- Dimension control report or similar for applicable pressure vessel code
- Pressure test certificate
- Identification (technical sign)
- Quality system certificate
- CE documents when applicable.
Applicable for pressure vessel code TSG (China)
- Certificate of Conformity
-Radiographicte
st report
- Design calculations
- TSG Classified vessels are certified and registrated at SELO
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2 Installation
The Alfa Laval Pharma-line S can be installed either horizontally or vertically, on the floor, on the wall or in the ceiling. The flexible
legs on Pharma-line S facilitate easy installation, either it is horizontally or vertically.
For easy installation, lifting lugs are fastened to the unit with screws. Before lifting, make sure the lifting lugs are properly
secured. We recommend that the bolts are tightened before lifting the unit. If the Pharma-line S surface temperature is expected
to be hot or cold, the heat exchanger should be insulated.
2.1 Clearance for dismantling
Provide sufficient clearance at the stationary head side to permit dismantling of the front head cover and possible future
inspection of the tubes.
2.2 Foundations
Foundations and/or supports must be adequate so that the exchanger will not settle and impose excessive strain on the
exchanger. Foundation bolts should be set to allow for setting inaccuracies.
2.3 Positioning and slope
The legs can be fixed in 4 different positions, 0°, 90°, 180° and 270° which allows for a flexible installation, depending on where
theunitistobeinstalled.
Once the positioning of the unit has been decided, move the legs the desired position, tightening the bolts carefully before
installation.
5300-0007
2.3.1 Horizontal positioning
This is a typical installation. At the time of delivery, the legs are positioned horizontally.
Note that the exchanger must have a minimum slope of 1% and a maximum of 5%. The slope is required to ensure that the
tube side is fully drainable. The unit is not designed with a slope. Consequently, we recommend that the unit is tilted using a
suitable bracket or spacer.
2.3.2 Vertical positioning
If vertical positioning and full drainability is required on the product side, the unit should be installed with the product connections
downwards.
If the fluid on the utility side is steam, the flow should always be downwards, meaning that the inlet is on the top of the unit and
the outlet at the bottom, in order to be able to drain any condensate.
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2 Installation
2.4 Levelling
The heat exchanger must be set so that pipe connections can be made without forcing them. However, small forces may be
unavoidable. Acceptable forces are as follows:
- acceptable forces in all directions on the tube side are max 50 N
- acceptable forces in all directions on the shell side are max 100 N
2.5 Cleanliness provisions
Connector protectors
All exchanger openings should be inspected for foreign material. Protective plugs should not be removed until just prior
to installation.
Dirt removal
The entire system should be clean before starting operation.
2.6 Connecting the heat exchanger to the piping system
Connection product side; the NAC plate must be disassembled from the heat exchanger.
Mount the NAC plate on the piping before welding the Tri-clamp (TC) ferrule.
5300-0008
A
C
C
C
B
A: Not supplied with the heat exchanger
B: Not supplied with the heat exchanger
C: NAC plate supplied with the heat exchanger
NOTE: It is important that the NAC plate is assembled on the pipe before the TC is welded to the pipe.
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2 Installation
2.7 Fitting and piping
Bypass valves
It may be desirable for the user to provide valves and bypasses in the piping system to enable inspection and repairs.
Test connections
It may be desirable for the user to install a thermometer well and pressure gauge connections close to the exchanger.
Vents and drains
It may be desirable for the user to install vent and/or drain valves close to the heat exchanger. The shell side is equipped
with the option to vent and drain.
Vent and drain valves should be provided so the unit can be purged to prevent air, vapour or gas binding.
Before use of the vent and/or drain connection, it is necessary to install/connect piping to threaded hole 1/8" BSP.
Drains may discharge into an open manifold.
Pulsation and vibration
Care should be taken to eliminate or minimise the transmission of fluid pulsations and mechanical vibrations into the heat
exchanger.
Safety relief devices
The user is responsible for installing the required safety devices.
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3Operation
3.1 Design and operating conditions
The heat exchanger must not be operated under conditions, which exceed those specified on the name plate.
Warning! Failure to operate the heat exchanger within the design pressure and temperature specified on the name plate may
result in damage to the heat exchanger and potential injury to adjacent personnel.
Fluid and/or steam velocities in excess of design operating conditions on either the shell or tube side of the heat exchanger can
cause damaging erosion and/or vibrations in the tubes and tube plates.
If the heat exchanger surface temperature is expected to be hot or there are local regulations related to surface temperature, it
is the user’s responsibility to either insulate the unit or take precautions by labelling the unit with a warning about the hot
surface temperature in order to avoid risk of injury to personnel.
3.2 Operating procedures
Before operating the heat exchanger, please refer to the name plate for any special instructions.
Local safety and health regulations must be observed.
Incorrect start-up or shut-down sequences may cause leaking of tube-to-tube sheet and/or bolted flanged joints.
It is the customer’s responsibility to ensure proper start-up and operation when running media with a higher risk of damage to
the heat exchanger. This applies especially when running media of temperatures below freezing-point (0°C).
3.2.1 Start-up operation
During start-up, all vent valves should be opened and left open until all passages have been purged of air and are completely
filled with fluid. At start-up or after the unit not been in operation for couple of days it is important that fluid is introduced stepwise
into the heat exchanger. Fluid must be introduced so as to minimise differential expansion between the shell and the tubes. We
recommend that the colder medium is established first, followed by the gradual introduction of the hotter medium.
Both product and utility media should be introduced slowly, starting with a low flow rate and then step by step continue to
increase the low until the flow rate the unit is designed for has been reached.
Important to make sure there are no air present in the system.
It is recommended to install vent valves in close connection to both the utility side and the product side to ensure easy removal of
possible air in the system.
Caution! Flow rate adjustment should be made slowly in order to avoid the risk of a pressure surge (water hammer). A water
hammer is a short-lasting pressure peak that can appear during start-up or shut-down of a system, causing liquids to travel
along a pipe as a wave at the speed of sound. This can cause considerable damage to the equipment.
Dual Application If the heat exchanger is intended for dual application duties, it should be allowed to come to ambient
temperature between heating and cooling cycles.
3.2.2 Operation
In all installations, there should be no pulsation of fluids since this causes vibration and strain.
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3Operation
3.2.3 Shut-down operation
The heat exchanger must be shut down in a manner that minimises different expansions between shell and tubes. If the
system will be shut down for a shorter period, make sure the unit is filled up with water completely and no air is available in
the system. If the system should be shut down for a longer period and/or the unit should be disconnected from the system, it
is recommended to completely drain the heat exchanger.
If emptying the heat exchanger it is important to dry it completely. Recommended to empty it and then dry it by blow air into it,
to make sure no product nor utility media is left in the unit.
If a small amount of moisture remains in the tubes or shell and when combined with air it might cause corrosion of the stainless
tubes and other parts, hence it is important to secure no moisture is present. To reduce water retention after drainage, the tube
side of the heat exchanger should be blown out with air.
Temperature shocks
The heat exchanger should not be subjected to sudden temperature fluctuations. Hot fluid must not be suddenly introduced
when the unit is cold, nor cold fluid suddenly introduced when the unit is hot.
Bolted joints
The heat exchanger is pressure tested before leaving the manufacturer in accordance with EN 13445 standard requirements for
PED, or in accordance with ASME VIII standard requirements for ASME. However, normal relaxing of the gasketed joints may
occur in the interval between testing at the manufacturer and installation on site. Therefore, all external bolted joints may require
retightening after installation and, if necessary, after the heat exchanger has reached operating temperature.
Recommended bolt tightening procedure
If the bolts are tightened, it is important that they are tightened uniformly and in a diametrically staggered pattern.
1=Start
1
7
6
5
4
3
2
12
11
10
9
8
5300-0009
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4 Maintenance
4.1 Inspection
At regular intervals and as frequently as experience indicates, an examination should be made of the interior and exterior
condition of the unit. Failure to keep all tubes clean may result in decreased performance of the heat exchanger.
4.2 Indication of fouling
Heat exchangers subject to fouling or scaling should be cleaned periodically. A lightsludgeorscalecoatingonthetubegreatly
reduces its thermal efficiency. An increase in pressure drop and/or reduction in performance usually indicates that cleaning is
necessary. The unit should first be checked for air or vapour binding to confirm that this is not the cause for the reduction in
performance. Since the difficulty of cleaning increases rapidly as the scale thickness or deposit increases, the intervals between
cleaning should not be excessive.
4.3 Disassembly for inspection or cleaning
Before disassembly, the user must ensure that the unit has been depressurised, vented and drained.
To inspect the inside of the tubes and also make them accessible for cleaning, remove the front head cover.
Always replace the gasket when the front cover is loosened to make sure that the gasket seals correctly.
4.4 Locating leaks
The heat exchanger has double tube sheets and a leakage in the joint in the inner tube sheet will show as a leakage between the
double tube sheets. A leakage in the joint in the outer tube plate will also show as a leakage betweenthedoubletubesheets.
The following procedure may be used to locate perforated or split tubes inside the shell.
- Remove the front head cover and apply pressure in the shell. Any leakage coming out of any tube shows a leakage in a
tube inside the shell.
4.5 Cleaning the heat exchanger
The heat transfer surfaces of the heat exchanger must be clean to ensure satisfactory performance.
The method selected is the choice of the operator and will depend on the type of deposit and the facilities available in the plant.
Cleaning compounds must be compatible with the metallurgy of the heat exchanger.
Caution! If necessary, use proper protective equipment, such as safety boots, safety gloves and eye protection, when using
the cleaning agents.
4.6 Gasket replacement
Remove the front head cover to replace the gasket.
Tighten the bolts after replacement of the gasket.
It is important that bolts are tightened uniformly and in a diametrically staggered pattern, see section 3 Operation.
The bolts should first be tightened to 15 Nm (for all bolts) then tightened to 30 Nm. Then tighten the bolts to 50 Nm and
finally torque the bolts with full torque (70 Nm).
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5 Technical data
5.1 Technical data
Technical data
Heat transfer area 0.1 - 4.0 m2
Design temperature -10oC - 150oC
Design pressure FV/10 barg
Product wetted steel parts 316 L stainless steel, seamless tubes
Gaskets PTFE (FDA compliance & USP class VI certified)
Connections Plate to connect to Tri-clamp on tube side and flanges on service side
Pressure vessel codes PED and TSG (China) when necessary
Welding according to SS-EN ISO 15614-1, SS-EN287-1, SS-EN 1418, ASME IX
Surface finish product wetted parts Ra < 0.5µm MP or Ra < 0.4µm EP
Options
- Insulation mineral wool (ASTM C795) with stainless steel 304 cladding
C
B
A
5300-0010
M1
M2
T2
T1
A: Total length of heat exchanger
B: Length from product inlet connection to utility flange
C: Largest diameter of the unit
Standard units, measurements (approximate) [mm]
Type Shell OD
(mm)
Nozzles size
Tube
Nozzle size
Flange ABC
Pharma-line S 1 [mm]
Pharma-line S 1 - 0.1 76 1” DN50 1150 225 195
Pharma-line S 1 - 0.3 89 1” DN50 1150 225 195
Pharma-line S 1 - 0.4 101 1” DN50 1150 225 195
Pharma-line S 1 - 0.6 104 11/2” DN50 1150 230 195
Pharma-line S 1 - 0.7 141 2” DN80 1150 260 245
Pharma-line S 1 - 1.1 141 2” DN80 1150 260 245
Pharma-line S 1 - 1.2 168 2” DN80 1150 260 245
Pharma-line S 2 [mm]
Pharma-line S 2 - 0.3 76 1” DN50 2150 225 195
Pharma-line S 2 - 0.6 89 1” DN50 2150 225 195
Pharma-line S 2 - 1.0 101 1” DN50 2150 225 195
Pharma-line S 2 - 1.3 114 11/2” DN50 2150 230 195
Pharma-line S 2 - 1.4 141 2” DN80 2150 260 245
Pharma-line S 2 - 2.4 141 2” DN80 2150 260 245
Pharma-line S 2 - 2.6 168 2” DN80 2150 260 245
Pharma-line S 3 [mm]
Pharma-line S 3 - 0.4 76 1” DN50 3150 225 195
Pharma-line S 3 - 1.0 89 1” DN50 3150 225 195
Pharma-line S 3 - 1.6 101 1” DN50 3150 225 195
Pharma-line S 3 - 2.0 114 11/2” DN50 3150 230 195
Pharma-line S 3 - 2.2 141 2” DN80 3150 260 245
Pharma-line S 3 - 3.7 141 2” DN80 3150 260 245
Pharma-line S 3 - 4.0 168 2” DN80 3150 260 245
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5 Technical data
Nozzle schedule
Item Service Facing Standard and dimension
T1 Tube inlet NAC plate for Tri-clamp Suitable for ASME BPE
T2 Tube outlet NAC plate for Tri-clamp Suitable for ASME BPE
M1 Shell inlet Weld neck flange DIN2635/EN1092-1
M2 Shell outlet Weld neck flange DIN2635/EN1092-1
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6 Spare Parts
Gaskets and plate flanges are available as a spare part for Pharma-line S. Replacement gaskets should be purchased in the
material originally provided with your heat exchanger. When ordering replacement gaskets or plate flange, please refer to the
item No. in the spare part list for Pharma-line S.
6.1 Alfa Laval Pharma-line S
5300-0012
1
1
2
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6SpareParts
Gaskets and plate flanges are available as a spare part for Pharma-line S. Replacement gaskets should be purchased in the
material originally provided with your heat exchanger. When ordering replacement gaskets or plate flange, please refer to the
item No. in the spare part list for Pharma-line S.
Parts list
Pos. Qty Denomination
11
Plate flange
21
Gasket PTFE
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How to contact Alfa Laval
Contact details for all countries are
continually updated on our website.
Please visit www.alfalaval.com to access the information directly.
© Alfa Laval Corporate AB
This document and its contents is owned by Alfa Laval Corporate AB and protected by laws governing intellectual property and thereto related rights. It is the responsibility of the user of this
document to comply with all applicable intellectual property laws. Without limiting any rights related to this document, no part of this document may be copied, reproduced or transmitted in any
form or by any means (electronic, mechanical, photocopying, recording, or otherwise), or for any purpose, without the expressed permission of Alfa Laval Corporate AB. Alfa Laval Corporate AB
will enforce its rights related to this document to the fullest extent of the law, including the seeking of criminal prosecution.
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