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www.alfalaval.com
Clean-In-Place (CIP) Procedures
Remove in-process residues
Control bioburden
Reduce endotoxin levels
Achieve a clean baseline of
all wetted components
Prevent Cross
Contamination
www.alfalaval.com © Alfa Laval Slide 5
T - time
A - action
C - chemicals
T - temperature
TACT – Sinner’s circle
Principle of the cleaning process
Time
Chemical
Action
Temperature
www.alfalaval.com © Alfa Laval Slide 6
T - time
TACT – Sinner’s circle
Principle of the cleaning process
Time
Chemical
Action
Temperature
Time = ressources Water
Power supply
Down time
Time
Chemical
Action
Temperature
Time
Chemical Action
Temperature
www.alfalaval.com © Alfa Laval
Technologies that support the tank cleaning process
Technologies
• Static Spray Ball (SSB) Operating pressure: 2 - 3 bar
Flow rate: 33 – 281.8gpm
7.5 - 64 m3/h
• Rotary Spray Head (RSH) Operating pressure: 2 - 3 bar
Flow rate: 15.4 – 66gpm
3.5 - 15 m3/h
• Rotary Jet Head (RJH) Operating pressure: 5 - 7 bar
Flow rate: 7.5 –145.3gpm
1.7 - 33 m3/h
www.alfalaval.com
Static Spray Ball
Lo
w flo
w a
rea
Static Spray Ball TACT
2 bar
33 – 317gpm (7.5 - 72 m3/h)
Technologies
Time
Chemical Action
Temperature
www.alfalaval.com
Fully developed
falling film
Technologies
Rotary Spray Head
Rotary Spray Head (RSH) TACT
2 - 3 bar
15.4 – 66 GPM (3.5 - 15 m3/h)
Time
Chemical
Action
Temperature
www.alfalaval.com
Technologies
Rotary Spray Head
Single axis dynamic Rotary Spray Head (RSH)
TACT
2- 3 bar
15.4 – 66 GPM (3.5 - 15 m3/h)
www.alfalaval.com © Alfa Laval
Portfolio - Rotary Spray Head
SaniMicro
Double ball bearing -
sanitary design
Suitable for food, dairy,
beverage, personal care and
pharmaceutical/biotech
www.alfalaval.com © Alfa Laval
Portfolio - Rotary Spray Head
SaniMidget/Magnum and MultiMidget/Magnum
SaniMidget & SaniMagnum Single ball
bearing - sanitary design
MultiMidget & MultiMagnum Double
ball bearing - versatility in application
and mounting
Food, dairy, beverage, personal care
and pharmaceutical/biotech
www.alfalaval.com
Sani SB´s
• Easy to maintain
• Uses standard tube fittings
• Effective Impact Spray for difficult
applications: Yogurt, Fruit jellies, syrups,
flavorings, fiber thickeners for yogurt
• PEEK Rotary Spray Ball can be easily
replaced if damaged or worn.
• Compact design, very durable materials
www.alfalaval.com © Alfa Laval
SSB Retractor (Static Spray Ball)
Designed for food and
pharmaceutical applications
where chambers, ducts,
cyclones, fluid beds and reactors
require efficient cleaning
Air-Air
Air - spring
Liquid – spring (on request)
Stroke length : 60 or 120mm
Portfolio - Retractor
www.alfalaval.com © Alfa Laval
SaniMidget Retractor (Rotary Spray Head)
Portfolio - Retractor
• Spray Dryers
• Sanitary bag filters
• Powder handling chute/system
• Mixers
• Tanks and process equipment
where baffles, agitator etc.
prevent a permanent tank
cleaning installation
www.alfalaval.com
Rotary Jet Head
Technologies
• Rotary Jet Head (RJH) TACT
5 - 7 bar
7.5 - 145.3gpm1.7 – 33 m3/h
Time
Chemical
Action
Temperature
www.alfalaval.com
Rotary Jet Head
Technologies
• Start –> 1 rev. • 1 rev. –> 1 cycle • 1 cycle –> full pattern
www.alfalaval.com
Blue testing media was applied to the wall of the tank and
the product was dried in for 2 hours using a 2KW heater
www.alfalaval.com
TJ20G has now been performing the first cycle out of
eight cycle, which it takes to build a complete pattern.
Note the beging of next cycle, marked as A
A
A
www.alfalaval.com
TJ20G
Portfolio - Rotary Jet Head
• Mixing, processing and fermentation tanks
(15 -150 m3) (4000 - 40000 USG) ,
depending on internals and tank shape/size,
multiple machines may be required
• Cell Culture, Purification, Media, Buffer
Prep.
• Spray Dryers and cyclones
www.alfalaval.com
Rotary Jet Head
Portfolio - Rotary Jet Head
• Mixing, processing and
fermentation tanks
• Tank Size (1.5 -150 m3)
(400 - 40000 USG)
• Pharmaceutical
• Hygienic design
www.alfalaval.com
SaniJet 20
Portfolio - Rotary Jet Head
• Down pipe
350 - 1500 mm
• Installation:
3” or 4” flange
www.alfalaval.com
Steam in Place (SIP)
Machines are lubricated by the
media flowing through them
It is not recommended that you
steam through the device
Bypass the TCM and steam the
tank space prior.
Once steam temp. is reached,
you can divert steam through
the TCM.
Goal is to achieve less than a
0.3bar delta P.
www.alfalaval.com
Benefit of Gamajet -Retrofit
GamaJet is a perfect fit
when retrofitting
existing installations
using spray balls
Fits trough openings of
2”, 3” or 4”
Typical sprayball
connection is 3” or 4”
© Alfa Laval Slide 37
www.alfalaval.com © Alfa Laval
Standard Connections
Sanitary Tri-Clamp
Butt Weld
R-Clip
Custom Fabricated
Connections are also
available
Inlet Connections
www.alfalaval.com
Example illustrated by “Sinner’s Circle”.
Principles and technologies
Previously – Cleaning result NOT satisfactory
Two Static Spray balls per tank
Cleaning time was 45 minutes
Flow rate 88gpm or 20m3/h @ 2.5 bar
Consumption = waste water produced 3962.6 gallons or 15 m3
Now – Cleaning result satisfactory
Installed one SaniJet 20 per tank
The tank was cleaned in only 12 minutes
Flow rate reduced to only 26.4 gpm or 6 m3/h @ 5 bar
Consumption 317 gallons or 1.2 m3
Action
Temperature Chemical
Time
Chemical
Temperature
Action
Time
www.alfalaval.com © Alfa Laval Slide 41
Why was the BladeClean created?
Cleaning the underside of tank agitator blades is notoriously
challenging
There was no ideal solution for this problem (until now!)
Multiple global customers asked if we could design a
product to solve this problem
We responded to those requests with the new BladeClean
www.alfalaval.com © Alfa Laval Slide 42
Designed for permanent installation, the retractable Alfa
Laval BladeClean is installed into the bottom of the tank.
Activates at 2 bar (30 psi) or higher, causing a cone of water
jets up to 7.6 m (25’) to spray upward at the underside of the
tank agitator blades.
Reaching up to 4.5 kg (10 lbs.) of force, the water jets clean
the agitator blades of product residue.
A positive seal is built in to prevent product migration.
Pair this device with your favorite Alfa Laval Gamajet or
Toftejorg rotary impingement tank cleaning device for a fast
and effective clean-in-place process.
How does the BladeClean work?
www.alfalaval.com © Alfa Laval Slide 43
Boosts tank productivity by reducing tank downtime for cleaning
Thoroughly and effectively cleans the underside of tank agitator
blades
Sanitary design to avoid contamination potential
Safety! No man entry required.
What are the benefits of the BladeClean?
www.alfalaval.com
Cleaning validation
Validation – RotaCheck
• Mixing, processing and fermentation tanks
• Special in-tank mounted sensors to track the
Rotary Jet Head operation
• The Sanitary Rotacheck system -verifies the
coverage -provides monitoring feed back to
control system
• Read out
- max time between hits
- no. of hits per minute
www.alfalaval.com
Rotacheck
Flush Mount Sanitary Connection
3A and EHEDG approved
O-Ring seal to atmosphere
No areas for entrapment or microbial
growth
Alfa Laval Hygienic Tank
Connection
www.alfalaval.com
Selling Point of Alfa Laval Q-doc for
Dynamic Spray Devices
The intended use of the Q-doc is a product adder which is
designed to supports our BioPharm customers at any level (end-
user, tank builder, systems integrator or engineering firm) in their
qualification/validation work
The Q-doc complies with Good Manufacturing Practice, GMP,
as well as Good Documentation Practice, GDP, and
demonstrates:
Hygienic Design, drainability and self cleaning
Safe and Traceable Materials help to ensure product integrity
Reliable and Repeatable Cleaning Performance
Long Service Life
Pharma/Biotech/Personal care
www.alfalaval.com
Purpose of Alfa Laval Q-doc for
Dynamic Spray Devices
The Q-doc follows the ISPE V-Model for
qualification/validation work and works from the
Requirement Specification, RS, through
Design Specification with Traceability Matrix
FAT IQ/OQ Documentation incl. Materials of Construction &
Manuals
SAT IQ/OQ Protocols to Define the Functional Design Space
RS can be used for discussion in the sales process
and if signed by end-user it can become the (their)
User Requirement Specification, URS
Pharma/Biotech/Personal care
www.alfalaval.com
Design Specification
with Traceability Matrix
The Design Specification acknowledge the
requirements and specify how each individual
requirement is handled
All the requirements are listed in the Traceability
Matrix, and are traced from the Requirements
Specification through to the delivered documentation
Pharma/Biotech/Personal care
www.alfalaval.com
Factory Acceptance Test
A complete Factory Acceptance Test, FAT, has been
performed on the specific Dynamic Cleaning Device
prior to shipment
The FAT (IQ and OQ) includes
Materials of construction, 3.1 Certificates, including
welding documentation, surface finish, passivation,
FDA Conformity, USP Class IV, TSE etc.
Performance of Specific Cleaning Device
Test of Documentation
Pharma/Biotech/Personal care
www.alfalaval.com
Manuals
The manuals
describes the intended use of the Dynamic
Cleaning Devices and limitations
are often the basis for developing Standard
Operation Procedures, SOPs, for installation,
operation and maintenance of the Dynamic
Cleaning Device.
Pharma/Biotech/Personal care
www.alfalaval.com
Site Acceptance Test
Protocols
The Site Acceptance Test Protocols for the IQ and OQ are
prepared and included in the Q-doc to define the functional design
space of the Dynamic Cleaning Device TOGETHER with the CIP
System (not included)
The SAT IQ/OQ Protocols are prepared for the specific
Dynamic Cleaning Device and includes
Test of Materials of construction
Performance verification
Test of Documentation
For the process owner (or his representative) to perform
Pharma/Biotech/Personal care
www.alfalaval.com
Rotary Spray Heads with Q-doc S
an
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Sa
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idg
et
Sa
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et
SB
3A
Mu
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idg
et
Sa
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et
Retr
ac
tor
Sa
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ag
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Mu
ltiM
ag
nu
m
Sa
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eg
a
Pharma/Biotech/Personal care
www.alfalaval.com
Rotary Spray Heads and Rotary Jet Heads
Portfolio
• ATEX - zone 0
• 3A - approval
• EHEDG - approval
• Q-doc - with all required cetificates
www.alfalaval.com
Superior Customer Service
© Alfa Laval Slide 58
A tear down of the machine Ultrasonic cleaning Detailed inspection, quotation, and a phone
call with an explanation. Reassembly
24-48 hour turnaround on parts, repairs, new orders, quotations The Most Comprehensive Repair Program which includes:
Hydraulic testing at customers operating conditions
One year warranty with all repairs and new machines
www.alfalaval.com © Alfa Laval
The benefits of the technologies
Principles and technologies
• Static Spray Ball Cheap to install
Less important tank
Low cleaning frequency
• Rotary Spray Head Full weting
Hygenique use
• Rotary Jet Head High efficient cleaning
Cost efficient
Time
Chemical Action
Temperature
Time
Chemical
Action
Temperature
Time
Chemical
Action
Temperature