Design Process Documentation
Filtration System
2D Drafting Documentation
Filtration
Types of filtration system
1. Normal Flow Filtration (NFF) System
2. Tangential Flow Filtration (TFF) System
Major components of the System
1. Control Panel
2. Process Tank
3. Pump
4. Filter & Filter Holder
Various lines in the System.
1. Inlet lines (Feed Line)
2. Outlet lines
3. Permeate line
4. Retentate line
5. Product recovery line
6. Bypass line
7. Buffer feed line
8. Spray ball line
9. Housing vent line
10. Tank vent line
11. Sample cooler line
12. Rupture disc line
13. Drain lines
Process Flow
Overview of Assembly
1. Chassis Assembly
2. Piping Assembly
3. Cable Trough Assembly
2D Drafting Documentation
1. 2D Piping
2. 2D Chassis
Filtration System
1. Normal Flow Filtration (NFF) System
2. Tangential Flow Filtration (TFF) System
• Major Components of the system
• Various lines in the system
• Process Flow
3. Overview of Assembly
• Chassis Assembly
• Piping Assembly
• Cable Trough Assembly
2D Drafting Documentation
• 2D Piping
• 2D Chassis
After understanding all the pre-requisites which are documented in P&ID (Piping
and Instrumentation Diagram) , let us see what is filtration, types of filtration and the
actual working process.
Filtration
• Filtration is any one of various mechanical, physical or biological operations that
separate solids from fluids.
Types of filtration system
1. Normal Flow Filtration (NFF) System
Cartridge or dead-end filtration flow is perpendicular to the filter media all fluid
passes through the media particles are retained in/on the filter.
2. Tangential Flow Filtration (TFF) System
• Cross-flow filtration, Flow is tangential to the filter surface. A small percentage of
the fluid flows through the filter media, Retained particles are swept away from
the filter surface.
• Fluid flow takes place from Process Tank to filter membrane via pump & to
back process tank. The waste fluids are sent to Drain via permeate piping line
and required fluids(final product) are sent to tank via retentate piping line.
Retentate line and permeate line both have product with different fluid
properties. Usually, the retentate line fluid is the useful or final product. (in
Merck projects)
• Either the permeate line fluid or retentate line fluid will be the final product
depending on the output or customer requirement. Sometimes, fluid in the
permeate line is considered as an end product.
Major components of the System
While building the system these components are placed before the piping assembly.
1. Control Panel
It contains switches for all the equipments & controls all the inputs given by the
operator
2. Process Tank
It used for recirculation of the feed and in performing a buffer exchange operation
3. Pump
There are three types of pumps which are mostly used in Merck system:
• Peristaltic Pump: It is more simple than a diaphragm pump and can work in
difficult environment & easy to install. it contains a tube inside the chamber
and two rollers which constantly compresses the hose/tube which in turn
creates vacuum and helps in drawing fluid through the tube; here the fluid is
present inside the tube which eliminates the chance of infecting of fluid by
pump
• Diaphragm Pump: It uses a reciprocating movement of a flexible diaphragm
which helps in suction of water
• Rotary Lobe Pump: They are highly used in hygienic processing industries. It
contains two or more lobes rotating around parallel shaft in the pump body
to move the fluid (both the shafts rotates in opposite direction); we can also
control the speed of the outlet flow by adjusting the speed of the lobes; can
handle large sized particles; can be easily cleaned; for HORIZONTAL PUMP
we need pump drain and connect it to the drain pipe
4. Filter & Filter Holder
Various lines in the System.
1. Inlet lines (Feed Line)
It comprises of WFI (Water For Injection) /CIP (Clean In Place)(uses chemical
agents for clean) inlet lines, CIP/SIP (Steam In Place) lines, steam inlet, air inlet,
jacket inlet and product inlet (WFI, CIP & SIP are used at time of cleaning the
system)
2. Outlet lines
• Jacket outlet line
• Product outlet line
• Permeate outlet line
3. Permeate line
This line contains the filtered out fluid to the tank
4. Retentate line
This contains the particles which are coming out of the filter membrane which is
either a byproduct or a waste
5. Product recovery line
Through this, the filtered product is obtained
6. Bypass line
Permeate bypass line & Retentate bypass line: only comes into play when cleaning
process is occurring
• Permeate Bypass line
• Retentate Bypass line
7. Buffer feed line
Through this we can add any extra fluid in the system
8. Spray ball line
It is present inside the tank for cleaning the tank
9. Housing vent line
It is present to disinfect the air before it enters the tank and to maintain the pressure
balance outside and inside the housing
10. Tank vent line
It helps in providing pressure/vacuum relief and low pressure storage tank
11. Sample cooler line
It is used for taking sample in a quick and easy way while maintaining the sterile
testing environment; also used to cool the sample for an immediate analysis
12. Rupture disc line
It is an emergency relief device made of thin metal diaphragm designed to rupture
at a predetermined pressure. It is an one time use only, so if it breaks we need to
replace it with a new one
13. Drain lines
Used whenever we require the entire fluid in the system to drain it completely. Drain
lines present in the system are:
• Main drain line
• Permeate drain line
• Product recovery drain line
• Pump drain line
• Steam drain line
Process Flow
• Various inputs from various points are introduced to the system.
• The process tank has a jacket surrounding it. Fluid is passed to the jacket via
jacket inlet line to reduce/maintain the temperature and pressure of the product
in the process tank. The fluid carries heat from the system and comes out via
jacket outlet line and is passed on to the sample cooler to reduce the
temperature of the fluid. The fluid from the sample cooler outlet is again passed
to the jacket inlet and the cycle repeats.
• Buffer feed line - Additional working fluid will be passed to the system when
more amount of product/output is required or when there is a shortage of fluid
in the process tank.
• Once various inputs are introduced into the system, the fluid from the process
tank is pumped into the filter holder after measuring various parameters like
temperature, pressure, conductivity, etc. There will be a product recovery line to
test the fluid sample before entering the filter holder for further filtration.
• The filter holder has 3 inlet and 3 outlet ports:
◦ Inlet Ports
1. Input (Feed line)
2. Permeate return line
3. Dummy port
◦ Outlet Ports
1. Permeate line
2. Retentate line
3. Dummy port
• The port diagonally opposite to the feed line is the retentate line. Both permeate
and permeate return line ports will be in the same line.
• The retentate line is directed towards the process tank i.e., the fluid will flow
towards the tank. The outlet from the filter will go to a sampling valve (nova-
septic valve), where the fluid sample can be collected. Then it will flow through
various instruments like pressure sensor, conductivity sensor, magnetic flow
meter to measure and keep a check on parameters like flow rate, pressure and
conductivity of fluid, etc. Then there will be a junction (nova-septic valve) where
the fluid from permeate line (permeate return line) will mix (only if required) and
then the fluid flows towards the process tank.
• The permeate line is directed towards the retentate line and then flows towards
the drain line. The outlet from the filter will go to a sampling valve (nova-septic
valve), where the fluid sample can be collected. Then it will flow through various
instruments like pressure sensor, pH sensor, UV sensor, mass flow meter to
measure and keep a check on parameters like flow rate, pressure and
conductivity of fluid, etc. Then there will be a junction where the fluid is directed
in two ways, one towards retentate line (permeate return line) and other towards
drain line (permeate drain line). Before connecting to the drain line, there will be
a permeate outlet port.
• Housing is a component where two different fluids(products) are pre-mixed
before sending it to the process tank. The output of the housing is input to the
process tank.
• Bypass lines are used to bypass(divert) the fluid flow without flowing through
the filter holder when filtration is not required but other operations are
necessary. Both permeate and retentate bypass lines are provided in the system.
• Once all the fluids are inlet to the process tank, the product is obtained after
processing/mixing which is done by the magnetic mixer. The magnetic mixer
also prevents fluids from accumulating at the bottom of the tank by continuous
circulation of the fluid.
• The cycle is repeated until the desired product concentration or desired fluid
properties are achieved. The final end product will be collected in the product
outlet line.
• All unwanted fluids at each stages are sent to the drain line, which is safely
drained out. The main drain line usually ends at the backside of the system
• CIP/SIP lines and air inlet lines are used for cleaning the entire system or
maintenance purpose. The CIP/SIP lines are linked with all the lines of the system
so that all the lines are cleaned. SIP cycle will run for 30 minutes where steam at
121 degree Celsius and 1.2 bar pressure is passed into the system for cleaning
process.
• Steam trap are used in drain lines to condensate steam and drain the fluids.
Steam trap construction consists of a bellow inside which expands and contracts
with change in temperature. The bellow contracts at a temperature of 117
degree Celsius. In steam inlet line, steam is passed at a temperature of 121
degree Celsius and 1.2 Bar pressure for cleaning process. In steam drain lines,
temperature transmitter will be present for recording temperature during SIP
cycle. The temperature transmitter has a probe which will be in contact with the
fluid to measure temperature. If Steam trap is near to the temperature
transmitter, steam gets trapped quickly which leads to temperature drop in the
transmitter. The SIP cycle stops only when the set temperature is reached. This
leads to incomplete SIP cycle or SIP cycle running again.
• Process tank having jacket - fluid passed through jacket inlet to maintain
pressure and temperature - fluid carries heat out of the system to sample cooler
to reduce the temperature of the fluid - buffer feed line - from process tank
fluid passed to filter holder after measuring the required parameters - product
recovery line: to test the fluid before it enters the filter holder - feed line and
retentate are diagonally opposite - permeate & permeate return line are in
same line - retentate line directed to process tank & outlet of the filter have a
sampling valve - fluid goes through various instruments, for eg pressure, temp
sensor - a junction at which permeate line will mix (if required) & fluid flows
towards the process tank - permeate line directed towards retentate line & flows
to drain line - outlet fluid will go to sampling valve for sample collection - at
junction fluid is directed in two ways: one towards retentate line & other
towards permeate drain line - before drain line there is a permeate outlet port -
At, HOUSING two different fluids are pre-mixed before sending to process tank -
housing output is process tank input - bypass line used when fluid not allowed
to go for filtration but other operations are necessary - magnetic mixer used at
bottom of tank to avoid accumulation of any fluid particle - cycle repeated until
the desired fluid is obtained - final product at product outlet line - all unwanted
fluids are sent to drain line - main drain line ends at the backside of the system -
CIP/SIP lines linked with all the lines - used for cleaning purpose - SIP cycle runs
for 30 mins at 21deg and 1.2 bar - Steam Traps condensate steam and drain the
fluid - steam traps have bellow which contracts at temperature 117deg Celsius -
Steam passed at temp 121 degree Celsius & 1.2 bar - SIP cycle stops when set
temperature is reached
Overview of Assembly
• Now that we have understood the process, let us understand the different units
in the main assembly.
• The main assembly unit divided into 3 different sub assemblies based on their
functionalities and ease of assemblies:
◦ Chassis Assembly: It has all the chassis, support and covers present in the
system
◦ Piping Assembly: it has all the piping related components
◦ Cable trough Assembly: it has all the electrical wiring present in the system.
it also contains hose(flexible pipe)
1. Chassis Assembly
• In chassis assemblies, first we build the outer most frame as per the required
overall dimensions (length, width and height) of the system and chassis material
cross-section. All the components (such as pipes, valves, etc..,) must be
assembled within the chassis assembly dimension. Once we complete the entire
piping section, we proceed with the complete chassis in order to give supports
for all the components
2. Piping Assembly
• After building of the initial outer frame/chassis, we start with the piping
assembly.
• For building any Piping assemblies few essential point are listed below:
◦ Whenever you are creating a new part or assembly, In model property the
units should be in mm.
A.
B.
• Pre-requisites for assembly:
1. Overall system dimension (LxBxH): given by us during conceptual layout
2. P&ID: Piping and Instrumentation Diagram
3. BOM: Bill of Materials
4. Pump inlet position: height from ground
5. After assembly of all components and after building all lines, the overall
system dimensions should not be exceeded. For example, if system height is
2800mm. This height depends on system size requirement.
• Selection of pipe (Size) with respect to P&ID is must. Some of the commonly
used sizes are listed below with ease of part number.
1. C -----> 1/2" Pipe
2. D-----> 3/4" Pipe
3. E -----> 1" Pipe
4. F -----> 1 1/2" Pipe
5. G -----> 2" Pipe
6. H -----> 2 1/2" Pipe
7. I -----> 3" Pipe
8. J -----> 4" Pipe
9. K -----> 6" Pipe
• We use ferrules for joining of any two pipes/sub-assemblies. Commonly two
types of ferrules are used:
1. When joining the pipe with same size, we go with Common ferrule.
How to Select the Ferrule in an Assembly is shown below:
FERRULES : used to join pipes of different sizes
2. While joining pipes with different size, we use Special ferrule.
3. For making turns in a line (when length or height is a constraint), we use elbows.
Elbows used are mainly of 4 types- 45 deg, 88 deg, 90 deg and 92 deg. How to
select elbow for assembly:
4. Types of elbows:
5. We can reduce the length of elbow, if necessary by giving assembly cuts. The
maximum length that any elbow can be reduced /cut is 35 mm per side for 1/2”
and 32 mm for 3/4”.After giving cuts, ensure that there is min. 8 mm gap
between curve end and elbow end. So that orbital welding head can be placed
for welding. For confirmation, assemble TC clamps and check.
6. Where ever there is a Junction (meeting of two or more Pipes at a point) in
piping, we use tee branches (same size tee or reducing tee). If there are more
number of lines in a junction, try to use blocks instead of multiple tees to avoid
spacing issues.
7. Angle towards drain/slope towards fluid flow is a must to avoid accumulation of
fluids (biomass/dead-lag) and to avoid correction in pipes. We provide slope by
giving 2 degree cuts in elbows, tees, valves, etc. or by giving 2 degree angle
constraint while assembly of components. Angle cuts are to be given in sub-
assembly and not to standard parts. Retentate line slope should be downwards
towards tank. Permeate line slope should be upward till start of drain line.
8. We should select any part in such a way that the Part should be driven from
Family table.
9. How to select tee for assembly:
10. Types of Tees:
11. Where ever we make use of Tees, there will be creation of branch hence Pressure
loss takes place. So to avoid more pressure loss we have an equation L/D ratio.
In order to maintain L/D ratio, we give 30mm cut to the branch
a. Pressure loss equation : L/D = 2 or 3 (It is preferred to maintain 2 but isn't possible
in some cases)
1. where L------> Length of shorter Diameter.
2. D ------------> Internal Diameter.
12. Reducer is used where two pipes of different sizes are to be coupled and
selection of proper reducer is a must. Whenever there is change in diameter of
pipe which is connected horizontally, we use Eccentric reducer so that flow will
have minimum distortion or slow flow of fluid is achieved and, Whenever there is
change in diameter of pipe which is connected vertically, use Concentric reducer
so that flow will have minimum distortion or slow flow of fluid is achieved.
13. In any fitment process we use many parts such as Tee, Elbow, Cross so on. While
selecting this kind of components surface finish plays an important role. Here we
use 2 different surface finishes:
a. SF1 (Surface Finish) >0.5 Micron Fitting Clean-ability.
b. SF4 (Surface Finish) >0.3 Micron Fitting Clean-ability.
14. Start the assembly with the placement of major components like control panel,
motor, pump, pellicon holder, tank. Then start building from pump inlet line
(feed line) and then continue with the process lines one by one as per fluid flow.
15. Fix the position such that the components are easily accessible for maintenance.
For example, while fixing the pump/motor position, there should be sufficient
space all around for removing/ dis-mantling the parts. There should be place for
man movement at certain places.
16. While starting a new sub-assembly, placement of first component(usually
ferrule) should be in such a way that it should ease while assembling in the main
assembly. Components to be assembled as per P&ID order and constraints to be
given only to the previous part/component (helps while editing). While
assembling two sub assemblies(ferrule to ferrule), we give a certain
distance in-between depending on pipe size. File Name and Description should
be of the same order as shown:
17. Standard distance between ferrules of two different sub assemblies are listed
below:
a. Pipe size or ferrule size ranges from 1/2” - 3/4” ----> 0.5 m
b. Pipe size or ferrule size ranges from 1” - 3” ---------> 1.5 mm
c. Pipe size or ferrule size ranges from 3” - 4” ---------> 2.0 mm
18. Sub-assemblies should not be too large (manufacturing aspect to be kept in
mind). Each sub-assembly usually contains a maximum of two spools. Min.
length of each spool should be 30mm. The maximum number of components
(ferrules, elbows, tees, etc.) in a sub-assembly is limited to 14 components.
19. Types of Valves used:
• There are 2 types of Nova-Septic valves:
20. While assembling Valves horizontally, it should be in the positive side with
respect to horizontal. Always consider alpha angle with respect to vertical plane
while giving plane constraint. The position of the valve should be such that it
should be less 45 degree with respect to horizontal. We need not consider alpha
angle if valve is mounted vertically.
21. After building the feed line, construct the product recovery drain line so that the
main drain line position can be fixed and the bottom-most point of the system
can be known. This helps in building further sub-assemblies within the overall
system height.
22. Usually, Magnetic flow meter is mounted vertically. Horizontal mounting is done
only when there is space constraint, because cost of horizontally mounted
magnetic flow meter is more than that of vertically mounted magnetic flow
meter. Magnetic flow meter always should be at a distance of 500 mm while
assembling to other sub assemblies.
• Display should be clearly visible from operator position.
23. Piping lines around the pellicon holder should be built such that there is enough
space for cassette loading and unloading. Usually, the lines are built parallel to
the center of holder.
24. Start building drain lines after all process lines are completed. Lines should be
built in such a way that it gives an aesthetic look to the system.
25. After completion of all piping lines, we assemble all the instruments present in
the system according to P&ID. Position of instruments is usually 2 degree inward
cut or 45 degree angle if mounted on tee. Some of the instruments used are :
• Pre filter:
It reduces the overall cost of operation by extending the life of the main filter
• Housing:
It contains cartridges for filtration. It contains different no. of rounds: 3,5,7,12,19
1. Vent Liner: its a type of housing
2. T line: T type of the shape
• View Glass:
It is used to check the fluid present inside the system
• Pressure Transmitter:
A mechanical device which measures the expansive force of a fluid or gaseous
sample
• Pressure Transmitter:
A mechanical device which measures the expansive force of a fluid or gaseous
sample
• Temperature Transmitter:
A tool to measure and alert the temperature change
• Conductivity Sensor & Transmitter:
These are analytical transmitter designed for monitoring electrical conductivity levels
within the solution
• pH Sensor and Transmitter:
It uses electrodes to sense and depicts the pH of the fluid inside the system at
different stages into electrical signals
• Level Switch:
Electrical or mechanical method to measure the level of the fluid
• Sample Cooler:
It is used for taking sample in a quick and easy way while maintaining the sterile
testing environment; also used to cool the sample for an immediate analysis
• Clean steam pressure reducing valve:
It is an angle pattern self-draining, 316 type stainless steel, sanitary pressure
regulating valve for fluid pressure control
• Level Sensor:
Monitor, maintain and measure liquid level
• Rupture Disc:
It is an emergency relief device made of thin metal diaphragm designed to rupture
at a predetermined pressure
• Staubli Stem (integrity port):
acts like a pressure cooker whistle
• Illumination Lamp:
Light present to look into the vessels to check the level of fluid
• Pressure Relief Valve:
It is used to relief the excess pressure from the system
• Sampling Port:
It is used to take the sample from the system
• Magnetic Mixer:
It keeps the fluid in the tank continuously moving, to avoid any particle to settle
down in the tank
• Steam Trap:
It should always be at a minimum distance of 300 mm from temperature transmitter
and towards drain. This ensures that there is no temperature drop due to the
condensate formed by the steam trap in the pipes near the temperature transmitter.
3. Cable Trough Assembly
• Cable trough is nothing but a covered enclosure (of rectangular cross-section)
for all the electrical wires and pneumatic hoses. They are laid/fixed on the
chassis supports with the help of fasteners. Cable trough is used so that no wire
or pneumatic hose is left uncovered or exposed outside.
• There are various cross-section of troughs used:
◦ 100x50 mm
◦ 50x50 mm
◦ 30x50 mm
◦ 30x30 mm
• Usually the main trough from the control panel is of larger cross-section (usually
50x100 mm) since all the wires and pneumatic hoses start branching from the
control panel. The branched cable troughs are of 50x50, 30x50 or 30x30
depending on number of wires/hoses running inside. Wires from all the
instruments and pneumatic hoses to all the pneumatic valves are routed via the
cable troughs.
• Few points to be kept in mind while designing cable trough assembly:
◦ Assemble cable troughs such that it is near to each and every valve and
instruments.
◦ Wires/tubes that can be exposed outside is for a maximum of 300 mm
length.
◦ Provide sufficient space for fasteners of cable trough top cover.
◦ Avoid small s-bends/branches as each trough contains 15 pneumatic hoses
and 7-8 wires approx.
◦ Maximum length of each cable trough can be 1220 mm so that
transportation of troughs can be easier. Split the trough for longer lengths.
2D Drafting Documentation
Steps to create a 2D drawing:
• Before creating drawing, open the part/assembly to be drafted.
• Set isometric view: Place front view Re-orient Dynamic re-orient first set vertical
to 45 deg, then horizontal to 30 deg click save. and name it ISOMETRIC.
• Set back isometric view similarly by giving -45 deg to vertical and name it as
ISOMETRIC2.
• Now create drawing as follows:
• File New Drawing Type the name and common name (name should be same as
part/assembly).
• Then click Browse template location (.frm format) select the standard template
click OK Error message Remove all Yes.
• Edit name, date and other basic details.
• Place the BOM table. Font used should be Verdana. Table table from file (if
changes are necessary).
• Right click long press on table cells for resizing. To change text size, Go to
Properties Text style.
• Click on general view and place the required view (default - isometric view).
• Double click on the view View display Display style to be No hidden Tangent
edges display style to be given solid check hidden line removal for quilts as yes
check hidden line removal for xhatches as yes click Apply OK.
• Next place front view. Project to top view, right view or left view as required.
Change view display for all the views as above.
• If certain parts/components are not clearly visible in front, top and side views,
we place special views (VIEW A) as required. Open the part re-orient as required
save the view as VIEW A. Then in Drawing window, select VIEW A while placing
the part /component.
• In order to show any inner component, we use section views to show the inner
dimensions/details.
• Open the part create the section as required and name it A, B, C, etc. Then in
Drawing window, Double click on the view required to show section Sections 2D
cross-section click on add (+ symbol) select the section required Arrow display
click on the view where section is required.
• Change scaling if required. Double click on the view Scale Custom set a value.
• To show detailed view: Layout detailed view select one point on the view where
you want the detailed view sketch a line around the point click where you want
to place the view.
• Ballooning parts/sub-assemblies: Table Create Balloons Create balloons - by view
Click on BOM table click on the view.
• Ballooning individual part: Table Create Balloons Create balloons - by
component Click on BOM table right click on the part right click again to select
sub-assembly middle mouse button.
• Place the balloons such that they do not overlap with each other and do not
