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 Introduction
 Types of homogenizers
 Qualification protocol
 Installation Qualification
 Operational Qualification
 Conclusion
 References
2
INTRODUCTION
 A homogenizer is a piece of laboratory equipment used for
the homogenization of various types of materials such as
tissue, plant, food, soil etc.
 Homogenizers are mainly used in the pharmaceutical
industry in the manufacture of dispersion systems such as
emulsions and suspensions.
 In addition they are also used in the manufacture of
liposome's, nanosuspensions, solid–lipid nanoparticles,
micro-encapsulation etc.
3
 The main principle involved in the working of a
homogenizer is homogenization.
 Homogenization , process in which one component is
made uniform throughout the other. Generally this
procedure involves reducing the size of the particles
of one component of the mixture and dispersing them
evenly throughout the other component
 Homogenization encompasses techniques of
emulsification of one liquid into another, dispersing
solid particles uniformly in a product, and disrupting
cell membranes.
4
Homogenization is defined as an intensive mixing of
mutually insoluble phases to obtain a suspension or
emulsion.
 This particular machine is very much essential to
manufacture medicinal creams and lotions of required
texture.
 It also helps to create more stable products as
compared to other equipments like stirrers, agitators
or colloid mills.
 The uniformity in particle size is achieved by
applying pressure and stress.
 Homogenizers also ensure the product with higher
stability, a longer shelf life and clinically more
effective.
1. red stop
button
9PUMP BODY
2.GREEN START 10.OUTER CHECK
VALUE
3.PRESSURE
GUAGE
11.H. VALUE
4.P.REGULATOR 12.CONTROL
CYLINDER
5.CYLINDER CAP 13.H.P . GUAGE
6. SS CYLINDER 14. GAUGE
NIPPLE
7.STATIONARY
FITTING
15 .P.CONTROL
SUPPLYHOSE
8. INLET CHECK
VALUE
16.GLASS
SAMPLE
CYLINDER
8
High Pressure Homogenisation is a process of
increasing the consistency of a product by
means of dispersions. The product is displaced
under the generation of high pressure and is
forced through homogenising valve gap.
Cavitations turbulence and sheer force break
the product into particles of size less than 1
microns..
Effect of homogenization on fat and casein fractions in fluid milk
 The pump forces liquid into the valve area at a high pressure.
As the product is forced through the adjustable gap , its
velocity increases tremendously with a corresponding decrease
in pressure.
 The emerging product then impinges on the impact ring(2).
This sudden change in energy causes increased Turbulence,
shear, and cavitation, resulting in droplet size reduction and
uniform dispersion of particles.
 High pressure homogenizers are used in emulsification,
preparation of microparticles and nanodispersions, liposomes,
and in cell disruption.
12
 Single stage and two stage homogenization are
available
 High pressure homogenizer can smash bacterial cell,
fungal cell and other kinds of cells, with a reduction
rate of more than 90%.
 The core parts of our high pressure homogenizer are
made of high strength materials, and hence they have
a long service life.
 Special feeding device can avoid air plug
phenomenon.
Clean-in-place and sterilization-in-place are
available.
Circulation cooling system is optional, for the
cooling protection of multiple processes.
High pressure homogenizer is designed with a
compact structure. It is safe to use and is easy
to install, operate and maintain.
1. High-pressure homogenizer is widely used to process food,
beverage, pharmaceuticals, dairy, and chemicals, etc.
2. It can be used as milk homogenizer, beverage mixer and ice cream
mixer.
3. Our high pressure homogenizer can process feed liquid into fine
materials and mix them under the action of crushing, strong impact
and expansion caused by loss of pressure.
4. Applied in the production of emulsion, jelly, fruit juice and seriflux,
high pressure homogenizer can avoid or decrease the delamination
of liquid material.
5. Besides, high pressure homogenizer can also improve the
appearance of liquid materials, making it more colorful, fragrant
and delicious.
6. It can also be used as high pressure transmission pump. high
pressure homogenizer can be used in the production of powder.
TYPES OF HOMOGENIZERS
 Various types of homogenizers used in
pharmaceutical industries are
a) High pressure homogenizer
b) Micro fluidizer
c) Rotor-Stator homogenizer
d) Ultrasonic homogenizer
16
HIGH PRESSURE HOMOGENIZER
 Auguste Gaulin introduced the first high-pressure homogenizer in
1900 for homogenizing milk.
 The basic high-pressure homogenizer consists of a positive
displacement pump attached to a homogenizing valve assembly .
17
Laboratory scale model of a Gaulin type high pressure homogenizer.
18
• The microfluidizer is a high-pressure homogenizer works, on
a different principle.
• The pre-homogenized liquid is forced through an interaction
chamber using a high-pressure pump.
• The interaction chamber consists of ceramic microchannels,
which cause the liquid feed to split into two streams.
• These streams are then recombined at very high velocities
producing forces of shear, impact, and cavitation, which cause
droplet or particle-size reduction in emulsions and
suspensions
19
Microfluidizer used in laboratory scale
20
• Rotor-stator mixers are capable of handling liquids at
much higher viscosities, compared to high-pressure
homogenizer and the microfluidizer.
• A rotor-stator homogenizer consists of an impeller in
close tolerance to a stationary housing, which restricts the
flow of liquid caused by the impeller movement. Shear
and impact comminute particles and droplets caught
between the rotor and stator.
• Similar to colloidal mill the gap between the rotating
truncated cone (rotor) and its housing (stator) is
adjustable.
21
An in-line rotor/stator homogenizer
22
 An ultrasonic homogenizer consists of a generator,
converter, and horn tip.
 The converter consists of a piezoelectric quartz
crystal, which transforms electrical energy into high
intensity vibrations and transmits them to the horn tip
immersed in the liquid. Droplet size reduction occurs
mainly by intense shock waves generated in close
proximity to the tip.
 Droplet size reduction in ultrasonic homogenizers is
affected by sonication intensity, viscosity of the
mixture, emulsifier concentration, and time of
sonication.
23
Ultrasonic Homogenizer
24
validation is defined as documented evidence that
helps to prove that the systems, facilities and process
perform their job adequately and consistent by as
specified
Qualification protocol:
 Installation Qualification
 Operational Qualification
 Performance Qualification
25
Qualification protocol
Installation Operational Qualification Performance
Qualification Qualification
Equipment
description
Utility Calibration Equipment Equipment
requirements requirements functions operations
Materials
Safety
features
Aim: To assure that the equipment is properly installed
according to the specifications.
Information documented
 Introduction, objectives
 Purpose of facility equipment
 Design and construction details
 Details of services required
 Acceptance level
27
Before installation:
1.Obtain manufacturing recommendations for installation site
requirements.
2.Check the site for fulfillment of manufacturing
recommandations.
3.Allow sufficient shelf space for equipment SOPS.
During installation:
 Check the documentation for operating manuals, maintenance
and sops.
 Check equipment for any damage.
 Install accessories.
 Switch on the instrument and ensure that all the modules
power up and perform electronic, self test.
 Prepare an installation report.
28
Installation
1. Carefully unpack and examine shipment. Any damage
claims should be field with the carrier immediately.
2. Remove the nuts and bolts on the four inch clamp
assembly.
3. Assemble the bladder on to the adapter plate.
4. After installing the shock absorber valve o-ring, install
the shock absorber valve assembly snugly on to the
adapter plate.
5. Then, slide the bladder adapter plate assembly in to the
dampner screen.
6. Insert the dampner screen in to the dampner housing and
centre the supporting ring in the gasket.
7. Assemble the bolts and nuts and tighten.
29
 Verify approve
purchase order.
 Verify invoice
 Check manufacture and
supplier
 Verify model number
and serial number
 Check for any physical
damage
 User manual
 Maintenance manual
 List of change parts
 Electrical drawings
 Mechanical drawings
31
 The HPH consists of a high pressure pump driven by a
special excenter.
 For higher flow rates and a pulsation free volume up to
4 high pressure pumps are used.
 Due to the reduction of cross section in the
homogenizing valve a high pressure is built up in front
of the valve by the constant flow from the pump.
 The pressure is relieved.
 Highly turbulent streams.
 Size reduction and mixing.
32
33
34
It is a process of demonstrating that an instrument will
functions according to its operational specifications in
selected environment.
 Identification.
 Visual inspection.
 Functioning of switches and indicator lights.
 Check and calibration of sensors, probes, guages, air
flow rates.
 Equipment integrity and efficiency tests.
 Cleaning procedures.
 Acceptance criteria.
35
Operational Qualification of HPH
 Install an air line with a pressure reducing valve and a
tire inflating chuck in close proximity to the dampner
location.
 Change the bladder. Determination of the pre-charge
pressure.
 Install the steam pump.
 Check the bladder pressure once in a week and
recharge as needed.
36
 Verify alarm control
 Perform calibration requirements, identified in the manual or
established by the validation team.
 Operate the equipment at low, medium, and high speed per
operations manual to verify the operating control
 Verify that all switches and push buttons are functioning properly.
 Establish procedures for operation, maintenance, and calibration.
 Establish training program for relevant staff.
 First of all solution is introduced into the
homogenizing equipment, which is further
forced through a special valve, that too at
extremely high pressure. The large particles
then are reduced to a smaller size according to
the application.
FACTORS
High efficiency
Uniform size
Constant flow
 Validation is a requirement for good manufacturing practices and
other regulatory requirements.
 Qualification and validation only appear to be the beginning of a
continous development process in the quality assurance of the
pharmaceutical industry.
 The goal is to produce certain assurance of batch uniformity and
integrity of the product manufactured.
 Pharmaceutical validation and process control are necessary to
ensure that the drug product will meet/ set pharmaceutical standards
for identity, strength, quality, evaluation safety and efficacy.
 Continuous awareness of validation requirements and application of
validation principles will thus help to ensure that pharmaceutical
products will be able to be developed and produced with the quality
and reproducibility required from regulatory agencies across the
world.
 Validation of pharmaceutical equipment is necessary to know about
the equipment is properly working.
39
References
 Agallo,J, “Validation: an unconventional review and reinvention”,
PDA J Pharm science techno,49(4):175-179 (1995).
 Akers, J, “Simplifying and improving process validation”,
Journal of Parenteral Science and Technology,47(6):281-284
(1993).
 Chows, “Pharmaceutical Validation and Process Controls in drug
development”, Drug Inf journal,(31); 195-201(1997).
 Haider,s.J, “Validation Master Plan and guide lines for DQ,IQ,OQ
and PQ”, Validation standard operating procedures,vol2;14-
26(2006).
 Harder,S.W, “The validation of cleaning procedures”,
pharmaceutical technology,8(5):29-34(1984).
 Hoffmann ,a,simonium,k.j,plattener,m, “Computer system
validation:an overview of official requirements and standards”,
Pharmaceutical ACTA Helvetiae,72(6):317-325 (1998).
40
• Jatto ,E,okhamafe,A.O, “An over view of pharmaceutical
validation and process controls in drug development”, Tropical
Journal of Pharmaceutical research” ,1(2):115-122(2002).
• Lachman ,L,Lieberman,H.A,Kanig,J.L, “The Theory and Practise
of Industrial Pharmacy”,(3):832-833(1990). Peither,L.T,“Equipment
and facility Qualification”, pharmaceutical process validation, Nash,
r. a, watcher, a. h, (3): 443-462 (2003).
• Tracy,D.S,Nash,R.A, “A validation approach for laboratory
information management system", Journal of validation
Technology,9(1):6-14(2002).
• www.pdh center.com
• www.pdh online.org
41
THANK YOU
42

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Homogenizer Validation Guide

  • 1. 1
  • 2.  Introduction  Types of homogenizers  Qualification protocol  Installation Qualification  Operational Qualification  Conclusion  References 2
  • 3. INTRODUCTION  A homogenizer is a piece of laboratory equipment used for the homogenization of various types of materials such as tissue, plant, food, soil etc.  Homogenizers are mainly used in the pharmaceutical industry in the manufacture of dispersion systems such as emulsions and suspensions.  In addition they are also used in the manufacture of liposome's, nanosuspensions, solid–lipid nanoparticles, micro-encapsulation etc. 3
  • 4.  The main principle involved in the working of a homogenizer is homogenization.  Homogenization , process in which one component is made uniform throughout the other. Generally this procedure involves reducing the size of the particles of one component of the mixture and dispersing them evenly throughout the other component  Homogenization encompasses techniques of emulsification of one liquid into another, dispersing solid particles uniformly in a product, and disrupting cell membranes. 4
  • 5. Homogenization is defined as an intensive mixing of mutually insoluble phases to obtain a suspension or emulsion.
  • 6.  This particular machine is very much essential to manufacture medicinal creams and lotions of required texture.  It also helps to create more stable products as compared to other equipments like stirrers, agitators or colloid mills.  The uniformity in particle size is achieved by applying pressure and stress.  Homogenizers also ensure the product with higher stability, a longer shelf life and clinically more effective.
  • 7. 1. red stop button 9PUMP BODY 2.GREEN START 10.OUTER CHECK VALUE 3.PRESSURE GUAGE 11.H. VALUE 4.P.REGULATOR 12.CONTROL CYLINDER 5.CYLINDER CAP 13.H.P . GUAGE 6. SS CYLINDER 14. GAUGE NIPPLE 7.STATIONARY FITTING 15 .P.CONTROL SUPPLYHOSE 8. INLET CHECK VALUE 16.GLASS SAMPLE CYLINDER
  • 8. 8
  • 9. High Pressure Homogenisation is a process of increasing the consistency of a product by means of dispersions. The product is displaced under the generation of high pressure and is forced through homogenising valve gap. Cavitations turbulence and sheer force break the product into particles of size less than 1 microns..
  • 10.
  • 11. Effect of homogenization on fat and casein fractions in fluid milk
  • 12.  The pump forces liquid into the valve area at a high pressure. As the product is forced through the adjustable gap , its velocity increases tremendously with a corresponding decrease in pressure.  The emerging product then impinges on the impact ring(2). This sudden change in energy causes increased Turbulence, shear, and cavitation, resulting in droplet size reduction and uniform dispersion of particles.  High pressure homogenizers are used in emulsification, preparation of microparticles and nanodispersions, liposomes, and in cell disruption. 12
  • 13.  Single stage and two stage homogenization are available  High pressure homogenizer can smash bacterial cell, fungal cell and other kinds of cells, with a reduction rate of more than 90%.  The core parts of our high pressure homogenizer are made of high strength materials, and hence they have a long service life.  Special feeding device can avoid air plug phenomenon.
  • 14. Clean-in-place and sterilization-in-place are available. Circulation cooling system is optional, for the cooling protection of multiple processes. High pressure homogenizer is designed with a compact structure. It is safe to use and is easy to install, operate and maintain.
  • 15. 1. High-pressure homogenizer is widely used to process food, beverage, pharmaceuticals, dairy, and chemicals, etc. 2. It can be used as milk homogenizer, beverage mixer and ice cream mixer. 3. Our high pressure homogenizer can process feed liquid into fine materials and mix them under the action of crushing, strong impact and expansion caused by loss of pressure. 4. Applied in the production of emulsion, jelly, fruit juice and seriflux, high pressure homogenizer can avoid or decrease the delamination of liquid material. 5. Besides, high pressure homogenizer can also improve the appearance of liquid materials, making it more colorful, fragrant and delicious. 6. It can also be used as high pressure transmission pump. high pressure homogenizer can be used in the production of powder.
  • 16. TYPES OF HOMOGENIZERS  Various types of homogenizers used in pharmaceutical industries are a) High pressure homogenizer b) Micro fluidizer c) Rotor-Stator homogenizer d) Ultrasonic homogenizer 16
  • 17. HIGH PRESSURE HOMOGENIZER  Auguste Gaulin introduced the first high-pressure homogenizer in 1900 for homogenizing milk.  The basic high-pressure homogenizer consists of a positive displacement pump attached to a homogenizing valve assembly . 17 Laboratory scale model of a Gaulin type high pressure homogenizer.
  • 18. 18
  • 19. • The microfluidizer is a high-pressure homogenizer works, on a different principle. • The pre-homogenized liquid is forced through an interaction chamber using a high-pressure pump. • The interaction chamber consists of ceramic microchannels, which cause the liquid feed to split into two streams. • These streams are then recombined at very high velocities producing forces of shear, impact, and cavitation, which cause droplet or particle-size reduction in emulsions and suspensions 19
  • 20. Microfluidizer used in laboratory scale 20
  • 21. • Rotor-stator mixers are capable of handling liquids at much higher viscosities, compared to high-pressure homogenizer and the microfluidizer. • A rotor-stator homogenizer consists of an impeller in close tolerance to a stationary housing, which restricts the flow of liquid caused by the impeller movement. Shear and impact comminute particles and droplets caught between the rotor and stator. • Similar to colloidal mill the gap between the rotating truncated cone (rotor) and its housing (stator) is adjustable. 21
  • 22. An in-line rotor/stator homogenizer 22
  • 23.  An ultrasonic homogenizer consists of a generator, converter, and horn tip.  The converter consists of a piezoelectric quartz crystal, which transforms electrical energy into high intensity vibrations and transmits them to the horn tip immersed in the liquid. Droplet size reduction occurs mainly by intense shock waves generated in close proximity to the tip.  Droplet size reduction in ultrasonic homogenizers is affected by sonication intensity, viscosity of the mixture, emulsifier concentration, and time of sonication. 23
  • 25. validation is defined as documented evidence that helps to prove that the systems, facilities and process perform their job adequately and consistent by as specified Qualification protocol:  Installation Qualification  Operational Qualification  Performance Qualification 25
  • 26. Qualification protocol Installation Operational Qualification Performance Qualification Qualification Equipment description Utility Calibration Equipment Equipment requirements requirements functions operations Materials Safety features
  • 27. Aim: To assure that the equipment is properly installed according to the specifications. Information documented  Introduction, objectives  Purpose of facility equipment  Design and construction details  Details of services required  Acceptance level 27
  • 28. Before installation: 1.Obtain manufacturing recommendations for installation site requirements. 2.Check the site for fulfillment of manufacturing recommandations. 3.Allow sufficient shelf space for equipment SOPS. During installation:  Check the documentation for operating manuals, maintenance and sops.  Check equipment for any damage.  Install accessories.  Switch on the instrument and ensure that all the modules power up and perform electronic, self test.  Prepare an installation report. 28
  • 29. Installation 1. Carefully unpack and examine shipment. Any damage claims should be field with the carrier immediately. 2. Remove the nuts and bolts on the four inch clamp assembly. 3. Assemble the bladder on to the adapter plate. 4. After installing the shock absorber valve o-ring, install the shock absorber valve assembly snugly on to the adapter plate. 5. Then, slide the bladder adapter plate assembly in to the dampner screen. 6. Insert the dampner screen in to the dampner housing and centre the supporting ring in the gasket. 7. Assemble the bolts and nuts and tighten. 29
  • 30.  Verify approve purchase order.  Verify invoice  Check manufacture and supplier  Verify model number and serial number  Check for any physical damage  User manual  Maintenance manual  List of change parts  Electrical drawings  Mechanical drawings
  • 31. 31
  • 32.  The HPH consists of a high pressure pump driven by a special excenter.  For higher flow rates and a pulsation free volume up to 4 high pressure pumps are used.  Due to the reduction of cross section in the homogenizing valve a high pressure is built up in front of the valve by the constant flow from the pump.  The pressure is relieved.  Highly turbulent streams.  Size reduction and mixing. 32
  • 33. 33
  • 34. 34
  • 35. It is a process of demonstrating that an instrument will functions according to its operational specifications in selected environment.  Identification.  Visual inspection.  Functioning of switches and indicator lights.  Check and calibration of sensors, probes, guages, air flow rates.  Equipment integrity and efficiency tests.  Cleaning procedures.  Acceptance criteria. 35
  • 36. Operational Qualification of HPH  Install an air line with a pressure reducing valve and a tire inflating chuck in close proximity to the dampner location.  Change the bladder. Determination of the pre-charge pressure.  Install the steam pump.  Check the bladder pressure once in a week and recharge as needed. 36
  • 37.  Verify alarm control  Perform calibration requirements, identified in the manual or established by the validation team.  Operate the equipment at low, medium, and high speed per operations manual to verify the operating control  Verify that all switches and push buttons are functioning properly.  Establish procedures for operation, maintenance, and calibration.  Establish training program for relevant staff.
  • 38.  First of all solution is introduced into the homogenizing equipment, which is further forced through a special valve, that too at extremely high pressure. The large particles then are reduced to a smaller size according to the application. FACTORS High efficiency Uniform size Constant flow
  • 39.  Validation is a requirement for good manufacturing practices and other regulatory requirements.  Qualification and validation only appear to be the beginning of a continous development process in the quality assurance of the pharmaceutical industry.  The goal is to produce certain assurance of batch uniformity and integrity of the product manufactured.  Pharmaceutical validation and process control are necessary to ensure that the drug product will meet/ set pharmaceutical standards for identity, strength, quality, evaluation safety and efficacy.  Continuous awareness of validation requirements and application of validation principles will thus help to ensure that pharmaceutical products will be able to be developed and produced with the quality and reproducibility required from regulatory agencies across the world.  Validation of pharmaceutical equipment is necessary to know about the equipment is properly working. 39
  • 40. References  Agallo,J, “Validation: an unconventional review and reinvention”, PDA J Pharm science techno,49(4):175-179 (1995).  Akers, J, “Simplifying and improving process validation”, Journal of Parenteral Science and Technology,47(6):281-284 (1993).  Chows, “Pharmaceutical Validation and Process Controls in drug development”, Drug Inf journal,(31); 195-201(1997).  Haider,s.J, “Validation Master Plan and guide lines for DQ,IQ,OQ and PQ”, Validation standard operating procedures,vol2;14- 26(2006).  Harder,S.W, “The validation of cleaning procedures”, pharmaceutical technology,8(5):29-34(1984).  Hoffmann ,a,simonium,k.j,plattener,m, “Computer system validation:an overview of official requirements and standards”, Pharmaceutical ACTA Helvetiae,72(6):317-325 (1998). 40
  • 41. • Jatto ,E,okhamafe,A.O, “An over view of pharmaceutical validation and process controls in drug development”, Tropical Journal of Pharmaceutical research” ,1(2):115-122(2002). • Lachman ,L,Lieberman,H.A,Kanig,J.L, “The Theory and Practise of Industrial Pharmacy”,(3):832-833(1990). Peither,L.T,“Equipment and facility Qualification”, pharmaceutical process validation, Nash, r. a, watcher, a. h, (3): 443-462 (2003). • Tracy,D.S,Nash,R.A, “A validation approach for laboratory information management system", Journal of validation Technology,9(1):6-14(2002). • www.pdh center.com • www.pdh online.org 41