Design for CIP

By
Nicholas Jeffery and Elliott Sutton
Suncombe Ltd
 Topics to be Covered

1. What is CIP?
2. Why CIP?
3. Advantages of CIP
4. Cleaning in Place Detail
5. Types of CIP Systems
6. Sterilisation in Place
7. Monitoring
8. Design Consideration
9. Summary
 What is CIP (Clean in Place)?
CIP - Clean in Place
Equipment and techniques to allow cleaning of process
equipment without dismantling or manual cleaning

SIP - Sterilisation in Place

Heat or Chemical Sterilisation of Process Equipment

COP - Clean Out of Place

Move Parts and Equipment to a COP system for cleaning
Cleaning of Surfaces & Walls
 Why CIP?
Reproducible, Repeatable and Controllable Results
Reduction of Cleaning Time
Automatic cycles ensure every item is cleaned every
time
Increased productivity through reduction of down
time
Chemical Handling Reduction
Simple Operation
 Advantages of CIP
Cost and Utility Savings including chemicals, water and
effluent, labour time etc.
Health and Safety
Batch Traceability and Records
Stronger Chemicals and higher temperatures can be
used
More complex processing systems can be used
Environmental Issues and Legislation
 Why Use CIP
1) CIP is superior to any cleaning method
Automated, with parameter monitoring & control
Repeatability  reliability
Human errors eliminated
Eliminate contaminated products

2) Lower operating costs

Reduced labour costs
Cleaning turnaround time reduced
Water / solvents / detergents usage significantly reduced

3) Safety Improvement
Reduced exposure of product to personnel
No equipment dismantling / vessel entry
Eliminates hazardous activities, eg HP water blasting
 CIP Variables
Time Mechanical

Chemical

Temperature
 Temperature

Effect on cleaning operation:

Soil Effect
Proteins medium
Fats good
Sugars good
Salts good

Note : Generally a 10°C temperature increase will improve

cleaning efficiency by 50% (above 30°C)
 Mechanical
Effect on cleaning operation:
1) Turbulence in Piping
Laminar flow Re < 2,300
Transition flow 2,300 < Re < 3,000
LAMINAR FLOW
Turbulent flow Re > 3,000
Reynolds number, Re = D v r D is pipe internal diameter
µ v is fluid velocity
r is fluid density
µ is fluid viscosity

Note : Normally take velocity to be >2 m/s

TURBULENT FLOW  1½” tube at 2 m/s  Re = 78,000
 Mechanical (continued…)
Effect on cleaning operation :
2) Action in Equipment
a) Automatic Tank Wash devices
• Fixed Spray Devices
• Self-powered Rotating
• Self-powered Turbine
PROCESS
VESSEL
 Chemical (Detergent)
Effect on cleaning operation:

Soil Water Alkali Acid

Proteins poor good medium
Fats poor good medium
Sugars good -- --
Salts medium medium good

Note : required concentrations depend on soil level,

processes used, working time, temperture, ….
 Water Used for Cleaning Process
Quality of Water used for aqueous cleaning is
critical for performance:
• Chemical properties (pH, hardness, etc.)
• Biological properties (bioburden, endotoxins)

Pre-Rinsing. Solely for flushing out of residue prior to washing

step. Usually based on practicality of what water is available.
Washing. Most critical is water hardness – effects efficiency
of cleaning of aqueous surfactant solutions.

Rinsing. In general, the final rinse used for equipment should

use the same quality water as used in the final stage of
manufacture.
 Time (Duration)

The duration of each CIP cycle step is to be

optimised according to the main following
parameters :

Type of Process Equipment

Type of Process Carried Out
Duration of Process Run
Cleaning solution temperature
Chemical concentration
 Typical CIP Programme
Step Operation Cleaning Temp. Time Usage
Agent (ºC) (Min.)

1 Pre-Rinse Water 20 – 30 2–5 To drain

2 Alkali Clean 2% Caustic 70 – 90 5 – 30 Re-circulated

3 Inter-rinse Water 20 – 30 1–5 To drain

4 Acid clean 1% Phosphoric 50 – 70 3 – 15 Re-circulated

5 Inter-rinse Water 20 – 30 4 – 10 To drain

6 Sterilant Peracetic Acid 20 – 30 3 – 15 Re-circulated

7 Final Rinse Water 20 – 30 4 – 10 To drain

Types of CIP Systems

Boil Out (Fill / Flood) System

Total Loss
Single Use Recirculation
Re - Use (Recovery)
Multi Channel
Fixed & Mobile Systems
WIP and COP
 Boil Out System (Fill/Flood)
Detergent
Advantages
Water
(Solvent) No / Small Capital Investment
Very Small Vessels
Cleans Complicated Mixer Systems

PROCESS
No additional Equipment Need
VESSEL Solvent based
Heat
Disadvantages
High Detergent & Water Usage
Extended Cleaning Times
Health & Safety Considerations
Difficult to Monitor /Validate
Drain
 Total Loss System
Water

Spray ball
WATER
BREAK
TANK PROCESS
VESSEL
CIP
PUMP
ALTERNATIVE
DOSING POSITION

DRAIN

DETERGENT
DOSING PUMP
 Total Loss System
Water

Advantages
Improved Health & Safety
WATER Simple Installation
BREAK
TANK

CIP
PUMP To Disadvantages
Process High Detergent & Water Usage
Vessel
Extended Cleaning Time
Difficult to Monitor / Validate

DETERGENT
DOSING PUMP
 Single Use Recirculation System
DETERGENT
Water DOSING Advantages
PUMP Flexible System
WATER Lower Cost Installation (than Re-
BREAK Use)
TANK
Good Economy for Local
System
Small Floor Space
LOW CROSS CONTAMINATION
RISK
CIP PUMP

DRAIN
Disadvantages
Not Suitable for Large
Centralised Systems
CIP RETURN
PUMP
 Re-Use System
Advantages
Good Water / Detergent Usage
Detergent DETERGENT Centralised Systems & Controls
Dosing Pump TANK Drain

Disadvantages
Inflexibility
Fresh Higher Equipment & Installation
Water
Costs
CIP CROSS CONTAMINATION RISK FOR
PUMP
DIS-SIMILAR PRODUCTS OR
RAW/COOKED CONDITION

CIP RETURN
PUMP
 Re-Use System with Recovered Water Tank

Detergent DETERGENT RECOVERED

Dosing Pump TANK WATER TANK Spray ball
Drain
PROCESS
VESSEL

Fresh
Water

CIP PUMP

CIP
RETURN
PUMP
Multi-Channel Re-Use System
4
3
2
1

1 2 3 4 5

FRESH CAUSTIC ACID REUSED ASEPTIC

WATER SOLUTION SOLUTION WATER SOLUTION

1
2
3
4
Multi-Channel System

cross-contamination

SOLUTION
Vessel Vessel
A B
 System Comparisons
Re-Use Single Use
Solution Tanks 2 to 5 1 or none
Soln. Temperatures Fixed Adjustable
Soln. Concentrations Fixed Adjustable
Simultaneous 1 to 4 1 only
operations (Multi-channel)
Flexibility Poor High
Cross contamination High Risk Small Risk
Investment cost Higher Lower
Running Cost Lower Higher
MAIN CRITERIA CLEANING COST CLEANING QUALITY
 System Comparisons (continued…)
Example: 3000 L Storage Vessel, with 100 Lpm Sprayball
1.5% Detergent. 5 min Rinses. 20 min Detergent

SYSTEM WATER DETERGENT

Boil Out System 6500 L 45 L

Total Loss 3000 L 30 L

Single Use 1200 L 3L

Partial Re-Use 1100 L 2L

Full Re-Use 600 L 2L

Typical Pharmacuetical CIP Unit

Re-use System
 Mobile CIP Units

Reduces Pipework Installation

Limits to size of unit & Capacity

Service Requirements

Heating problems

Ideal for small cleaning duties

 WIP or CIP?
There is no legislative distinction
between Clean In Place (CIP) and
Wash In Place (WIP), however the
general industry view on the
terminology is that CIP means a
totally automatic cleaning
sequence with no manual
involvement, whereas as WIP
includes some manual intervention.
In practical terms CIP requires high
levels of validation, against WIP
which requires less stringent
validation.

Courtesy of Matcon
 ATEX CIP Considerations
The introduction of the ATEX
directive to include all components
that are ATEX certified, mechanical
as well as electrical
The problems with component
selection associated with systems
that reside continually in an ATEX
area
Can use aqueous or solvent cleaning
media
ATEX rated spraydevices
Inert atmospheres for spray cleaning
 When is a CIP Application not
a CIP Application?

Answer: When it is a COP

Application.

COP or Cleaning Out of Place

is when the equipment is
moved to the cleaning
equipment prior to a CIP
clean
SIP (Sterilisation in Place)
Sterilization is not to be considered as part of
the cleaning process.
Purpose of Sterilization is to destroy any form
of micro-organism.
Chemical Sterilization
- Chlorine, hypochlorite, hydrogen peroxide, ozone,
peracetic acid
Thermal Sterilization
- dry heat, steam, superheated water
 Monitoring Systems
Conductivity To Monitor Strength
To Separate Phases
Temperature In Feed Line to Control
In Return Line to Monitor
Flow In Feed & Return to Confirm Rate
Pressure In Feed Line for Spray Device
In Return for Integrity Testing
Time From the Control System
Turbidity In Return Line to Monitor
 CIP/Process Design
„Cleanability‟ of components & fittings
used for process installations
Safety breaks & circuit separation
Circuit balancing of CIP circuit
Prevention of „dead legs‟ in process circuits
Surface finish of tanks and piping
Welding techniques
Equipment/System to be cleaned…
Made of corrosion-resistant and cleanable materials
Must confine the cleaning solution
Must be drainable, with no pockets or ledges
Any corners should be rounded
Gaskets & seals – crevice-free, non-absorbent, non-
reactive, non-porous (FDA-approved elastomers)
Minimum interconnecting fittings in piping
All valves & instruments should be cleanable
Use of hoses should be minimised
C IP IN PU T

Circuit
Separation
C IP O U TPU T

Routing Plate

C IP IN PU T

C IP O U TPU T

C IP IN PU T

Routing Plate

C IP O U TPU T
C IP O U TPU T

C IP IN PU T
 Circuit Balance
CIP INPUT
15 m3/h
Always have a higher output
flow than input flow for CIP

CIP INPUT
10 m3/h 15 m3/h
CIP OUTPUT

20 m3/h
CIP OUTPUT
 Safety Break
C IP IN PU T

System
C IP IN PU T
Double block
and bleed
C IP IN PU T

Always have safe separation

between process and cleaning

Routing Plate

C IP IN PU T
C IP IN PU T

Preventation of
Deadlegs
Beware of Dead-legs
PR OC ESS
in the process and
cleaning circuits
C IP IN PU T

PR OC ESS
 L=5D Dead-legs
uncleanable

L=3D
limit of
cleanability
L=1D

OK

L=0D
OK

Best
Zero dead-leg
valve
 Pipework Velocity
- Mechanical Action

Ensure sufficient fluid

flow velocities in the
process and cleaning
Laminar Flow circuits
(Low Velocity)
Re 2300

Turbulent Flow
(High Velocity)
Re 3000
 Spray Devices – Fixed
Low Pressure – High Flow

Advantages
No maintenance
Special Spray Patterns
Easier to Monitor
Less Pump Power Disadvantages
Higher Water Usage
Less Mechanical Action
Less Bounce Back
Longer cleaning times
 Spray Device – Rotating
High Pressure – Low Flow
Advantages
Lower Water Usage
Greater Mechanical Action
Greater Bounce Back ‘Turbodisk’
Greater Throw Distances
Disadvantages
Higher Pump Power
More Difficult to Monitor
Generally Higher Cost
More Difficult to “Aim” Spray
Higher Maintenance

Jets Slotted
 Surface Finish
% minutes

100
30

roughness roughness
0 (µm) 0 (µm)
0 3 0 3

REDUCTION % OF MICRO-ORGANISMS TIME TO DESTROY 99,9%

AFTER A STANDARD CIP CYCLE OF MICRO-ORGANISMS
(relative values) (relative values)
 Welding Techniques

Poor Hand Weld Orbital Weld

• Difficult to clean
• Drainage problems
• Corrosion
 Summary of CIP/SIP
Evaluation of Cleaning Risk

CIP Unit Selection (Skid Packages)

Flexibility allowing Customisation

CIP / SIP / Process Interface from start

Incorporate Hygienic Design

Monitoring to Ensure Repeatability

 Thank You For
Your Attention
For More Information Contact Suncombe
Tel: +44 (0)20 8443 3454
www.suncombe.com