Five terms of vessel manufacturing
1) Mechanical Characteristics
2) Automation
3) Operation Characteristics
4) Testing
5) Qualification.
1) Mechanical Characteristics:-
A) Volumes Ranging from 0.5 L to 80 KL working capacity.
Calculate volume (Litres)
Ex. Cylinder vessel:
B) Space Conserving design.
Before manufacturing vessel, we know the how much space availability for vessel assemble like height, diameter calculation.
C) Materials SS316L & SS304. (GMP2)
D) Surface Finished.
As per client requirement Matt finished (0.8 um) or Mirror finished (0.4 um).
E) Pressure Range
As per client requirement.Client give as working pressure of material or solvent, solution.
Ex:- if working pressure is 3 kg/cm2.
than Design pressure is 1.5 X working pressure = 1.5 X 3= 4.5 kg/cm2.
and hydrotest pressure is 1.3 X Design pressure = 1.3 X 4.5 = 5.85 kg/cm2.
F) Temperature
As per Client requirement. Client give as temperature of material or solvent, solution
G) Main shell, Jacket, Cladding
Main Shell :- It is requirement for manufacturing material. Main shell thickness is depend upon pressure and capacity.
As per client requirement.
Jacket :- It is requirement for cooling and heating purpose.
Cladding :- It is requirement for insulation.
H) Components
As per Client requirement. Which components to be requirement.
like piping, valve, temperature sensor, rupture disc, safety valve, gauge, pressure transmitter, spray ball, vent filter, filter cartridge, drive unit, load cell, steam trap etc.
I) Stationary OR mobility
As per client requirement. Wheels are require or not.
LDPU :- low duty polyurethane
MDPU :- Medium duty polyurethane
HDPU :- Heavy duty polyurethane
J) Nozzel Types
As per client requirement.
NA connects, In-gold fittings, BSP fittings (British standard pipe)
K) Zero Dead Leg (GMP5)
2) Automation
Manual, semi automatic and fully automatic as per requirement.
This system help to various devies like VFD (variable frequency drive), PLC (program logic control), HMI (Human Machine interface), analog card, pnumatic bank, logic etc.
process and recipe-relevant data can be recorded in a suitable data storage solution.
3) Operational Characteristics
A) Manual / Automated SIP (Steam in process).
B) Manual / Automated CIP (Clean in process).
C) Manual / Automated Process transfers.
D) Sterile sampling (Sampling Valve).
E) Automated pH adjustment. (Help to pH sensor)
F) Temperature control with various Heating and cooling utilities. (Chilled water, Hot water)
G) Sterile Powder Addition (Hopper, Charging Ball).
H) Sterile liquid Addition. (Injectable)
I) Manual / Automated pressurisation And Depressurisation of vessel through 0.2 micron filter (HEPA filter type)
J) Automated independent line sterilisations for outlet, sampling, vent filter etc.
K) Speed control of mechanically and magnetical coupled agitators / homogenisers. (Drive unit, Tank plate, Bearing pin, Mixer)
M) All safety for proper operation of the vessels including pressure gauges, rupture discs, light / sight glass, safety valve, pressure transmitter etc.
4) Testing
FAT content all type of operation, test, documentation and verification
A) P&ID (Pipe & Instrumentation Drawing) verification, As-built drawing
B) Dimensional Test (Measurement Height, Diameter, Leg PCD, Thickness, Bottom dish nozzle to ground distance)
C) Surface finish verification (RA machine)
D) Weld joint verification as per P&ID.
E) All components verification and functional testing as per functionally specifications.
F) Calibration Checks.
G) Hydrotest: vessel & Jacket
H) Spray ball coverage test with riboflavin, UV lamp.
I) Drain-ability - Complete, for vessel and product contact components, tubes
J) System operation, calibration & Programming, control loop I/Os, Electrical and hardware check
k) Volume verification
5) Qualification
A) Equipment Qualification Plan
B) Quality Assurance Plan (QAP)
C) Validation of the software.
D) Compliance with cGMP (current Good Manufacturing Practice), GAMP (Good automated manufacturing practice), CFR (Code of Federal Regulation) 21 Part 11
E) Full material trace-ability for vessels, piping and all components.
F) IQ /OQ Qualification documentation and validation support.
1) Mechanical Characteristics
2) Automation
3) Operation Characteristics
4) Testing
5) Qualification.
1) Mechanical Characteristics:-
A) Volumes Ranging from 0.5 L to 80 KL working capacity.
Calculate volume (Litres)
Ex. Cylinder vessel:
B) Space Conserving design.
Before manufacturing vessel, we know the how much space availability for vessel assemble like height, diameter calculation.
C) Materials SS316L & SS304. (GMP2)
D) Surface Finished.
As per client requirement Matt finished (0.8 um) or Mirror finished (0.4 um).
E) Pressure Range
As per client requirement.Client give as working pressure of material or solvent, solution.
Ex:- if working pressure is 3 kg/cm2.
than Design pressure is 1.5 X working pressure = 1.5 X 3= 4.5 kg/cm2.
and hydrotest pressure is 1.3 X Design pressure = 1.3 X 4.5 = 5.85 kg/cm2.
F) Temperature
As per Client requirement. Client give as temperature of material or solvent, solution
G) Main shell, Jacket, Cladding
Main Shell :- It is requirement for manufacturing material. Main shell thickness is depend upon pressure and capacity.
As per client requirement.
Jacket :- It is requirement for cooling and heating purpose.
Cladding :- It is requirement for insulation.
H) Components
As per Client requirement. Which components to be requirement.
like piping, valve, temperature sensor, rupture disc, safety valve, gauge, pressure transmitter, spray ball, vent filter, filter cartridge, drive unit, load cell, steam trap etc.
I) Stationary OR mobility
As per client requirement. Wheels are require or not.
LDPU :- low duty polyurethane
MDPU :- Medium duty polyurethane
HDPU :- Heavy duty polyurethane
J) Nozzel Types
As per client requirement.
NA connects, In-gold fittings, BSP fittings (British standard pipe)
K) Zero Dead Leg (GMP5)
2) Automation
Manual, semi automatic and fully automatic as per requirement.
This system help to various devies like VFD (variable frequency drive), PLC (program logic control), HMI (Human Machine interface), analog card, pnumatic bank, logic etc.
process and recipe-relevant data can be recorded in a suitable data storage solution.
3) Operational Characteristics
A) Manual / Automated SIP (Steam in process).
B) Manual / Automated CIP (Clean in process).
C) Manual / Automated Process transfers.
D) Sterile sampling (Sampling Valve).
E) Automated pH adjustment. (Help to pH sensor)
F) Temperature control with various Heating and cooling utilities. (Chilled water, Hot water)
G) Sterile Powder Addition (Hopper, Charging Ball).
H) Sterile liquid Addition. (Injectable)
I) Manual / Automated pressurisation And Depressurisation of vessel through 0.2 micron filter (HEPA filter type)
J) Automated independent line sterilisations for outlet, sampling, vent filter etc.
K) Speed control of mechanically and magnetical coupled agitators / homogenisers. (Drive unit, Tank plate, Bearing pin, Mixer)
M) All safety for proper operation of the vessels including pressure gauges, rupture discs, light / sight glass, safety valve, pressure transmitter etc.
4) Testing
FAT content all type of operation, test, documentation and verification
A) P&ID (Pipe & Instrumentation Drawing) verification, As-built drawing
B) Dimensional Test (Measurement Height, Diameter, Leg PCD, Thickness, Bottom dish nozzle to ground distance)
C) Surface finish verification (RA machine)
D) Weld joint verification as per P&ID.
E) All components verification and functional testing as per functionally specifications.
F) Calibration Checks.
G) Hydrotest: vessel & Jacket
H) Spray ball coverage test with riboflavin, UV lamp.
I) Drain-ability - Complete, for vessel and product contact components, tubes
J) System operation, calibration & Programming, control loop I/Os, Electrical and hardware check
k) Volume verification
5) Qualification
A) Equipment Qualification Plan
B) Quality Assurance Plan (QAP)
C) Validation of the software.
D) Compliance with cGMP (current Good Manufacturing Practice), GAMP (Good automated manufacturing practice), CFR (Code of Federal Regulation) 21 Part 11
E) Full material trace-ability for vessels, piping and all components.
F) IQ /OQ Qualification documentation and validation support.
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